* Pharmacist CJSC *

Country of origin

Denmark / Russia

Group of goods

Medical.

Features of sale

R.

Analogue of human insulin short action

Forms of release

• 3 ml - Cartridges Glass (5) - blisters (1) - packs cardboard.

pharmachologic effect

Hypoglycemic drug, an analogue of a short-acting human insulin, produced by the biotechnology method of recombinant DNA using the Saccharomyces Cerevisiae strain, in which the amino acid proline in position B28 is substituted for aspartic acid. Co. interacts specific receptor The outer cytoplasmic membrane of cells and forms an insulin receptor complex that stimulates intracellular processes, incl. Synthesis of a number of key enzymes (hexokineas, piruvatakenase, glycogenxintytase). The decrease in the blood glucose content is due to the increase in its intracellular transport, enhanced with tissues, stimulation of lipogenesis, glycogenogenesis, reduced glycosis production of the liver. The substitution of the amino acid proline in position B28 on aspartic acid in the drug Novorad Penfil reduces the tendency of molecules to the formation of hexamers, which is observed in the human insulin solution. In this regard, Novorad Penfill is much faster from subcutaneous fatty fiber and begins to act much faster than soluble human insulin. Novorad Penfilla is stronger reduced blood glucose levels in the first 4 hours after meals, than soluble human insulin. The effect of the drug Novorad Penfill after p / to the introduction is shorter than soluble human insulin. After p / k administration, the effect of the drug begins for 10-20 minutes after administration. The maximum effect is observed after 1-3 hours after injection. The duration of the preparation is 3-5 hours. When applying Novorad Penfil in patients with diabetes Type i is noted to reduce the risk of night hypoglycemia compared to soluble human insulin. Significant increase in the risk of day hypoglycemia is not marked. Novorad Penfill is an equipotential soluble human insulin based on praying indicators

Structure

• insulin aspart100 unit * Auxiliary substances: glycerol, phenol, metactional, zinc chloride, sodium chloride, sodium hydrophosphate dihydrate, hydrochloric acid or sodium hydroxide, water d / and. * 1 unit corresponds to 35 μg of anhydrous insulin aspart.

Novorad Penfilla Indications for Application

• -cache diabetes type 1 (insulin-dependent); Type-type (insulin-independent) diabetes: stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (when conducting combination therapy), intercurrent diseases

Novorad Penfil Contraindications

• -Hyprcemia; -Furnish individual sensitivity to insulin aspart or any of the components of the drug. It is not recommended to use NEGPID Penfilla in children under 6 years old, because clinical researches This age group was not conducted

Novorad Penfill Dosage

• Novorad Penfill is designed for p / k and in / in administration. Novorad Penfill has a faster beginning and less duration of action than soluble human insulin. Thanks to the more rapid beginning of the action, Novorahid Penfil should be administered, as a rule, immediately before receiving food (if necessary, you can immediately be administered after meals). The dose of the drug is determined by the doctor individually in each particular case, based on the blood glucose level. Novorad Penfil is usually used in combination with medium duration insulin drugs or long actionwhich introduce at least 1 time / day. Usually the total daily need for insulin is from 0.5-1 units / kg body weight. With the introduction of the drug before eating, the need for insulin can be provided with the drug Novorad Penfil 50-70%, the remaining need for insulin is provided by insulin of extended action. The temperature of the inserted insulin must fit the room. Novorad Penfill is introduced into the area of \u200b\u200bthe front abdominal wall, hips, shoulder or buttocks. Injection places within the same body of the body must be changed regularly. As with the use of any other insulin drugs, the duration of the action of Novorahid Penphal depends on the dose, the place of administration, the intensity of blood flow, temperature and level of physical activity. P / k Introduction to the front abdominal wall provides faster suction compared with the introduction to other places. However, a faster start of action compared to soluble human insulin is maintained regardless of the localization of the injection site. If necessary, Novorad Penfill may be introduced into / in, but only by qualified medical personnel. For in / in administration, infusion systems with a preparation of new architects 100 U / ml are used with a concentration of 0.05 units / ml to 1 UR / ml ASPART insulin at a 0.9% solution of sodium chloride; 5% or 10% dextrose solution containing 40 mmol / l potassium chloride, using polypropylene bags for infusion. These solutions are stable when room temperature Within 24 hours. During insulin infusion, it is necessary to constantly monitor blood glucose levels. NEWORPHID can also be used for prolonged p / to insulin infusion (PPII) in insulin pumps developed for insulin infusion. PPIs should be produced into the front abdominal wall. Infusion sites should be changed periodically. When using an insulin pump for infusions, Novorahid Penfill should not be mixed with other types of insulins. Patients using PPPI should be fully trained by using the pump corresponding to the reservoir and the tube system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual attached to the infusion set. Patients receiving Novorah subfill with PPIs should have additional insulin in the event of a breakdown of an infusion system.

Novorad Penfil Side

• Side effects related to influence on carbohydrate exchange: hypoglycemia (reinforced sweating, pallor of skin, nervousness or tremor, feeling of anxiety, unusual fatigue, or weakness, violation of orientation, violation of the concentration of attention, dizziness, expressed feeling of hunger, temporary violation, headache, nausea, tachycardia). Pronounced hypoglycemia can lead to loss of consciousness and / or cramps, temporary or irreversible impaired brain work and to death. Frequency of occurrence side Effects Defined as: infrequent (\u003e 1/1000,<1/100), редкие (>1/10000, <1/1000); отдельные спонтанные случаи представлены как очень редкие и определены как <1/10000 – включая отдельные случаи. Аллергические реакции: нечасто – крапивница, кожная сыпь; очень редко – анафилактические реакции. Генерализованные аллергические реакции могут включать кожную сыпь, зуд кожи, повышение потоотделения, нарушения со стороны желудочно-кишечного тракта, ангионевротический отек, затруднение дыхания, тахикардию, снижение АД. Местные реакции: аллергические местные реакции (покраснение, отечность, зуд кожи в месте введения), обычно временные и проходящие по мере продолжения лечения; нечасто - липодистрофия. Прочие: в начале терапии редко - отеки, нечасто - нарушение рефракции. Эти побочные эффекты обычно носят временный характер

Storage conditions

• dry
• Store in the cold (T 2 - 5)
• bear from children
• storing

Synonyms

• 1 unit corresponds to 35 μg of anhydrous insulin aspart

Manufacturer: NOVO NORDISK A / S (Novo Nordisk A / C) Denmark

PBX code: A10AB05

Farm Group:

Release form: Liquid dosage forms. Solution for intravenous and subcutaneous administration.

Indications for use:

General characteristics. Structure:

The active ingredient: 100 units (3.5 mg) insulin asparta in 1 ml of solution. One cartridge contains 3 ml of a solution equivalent to 300 units.

Auxiliary substances: glycerol, phenol, metacrezol, zinc chloride, sodium chloride, sodium hydrophosphate dihydrate, sodium hydroxide 2 m, acid hydrochloric acid 2 m, water for injection.

Pharmacological properties:

Pharmacodynamics.Insulin ASPART is an analogue of the human insulin of a short action, produced by the methodology of recombinant DNA using the Saccharomyces Cerevisiae strain, in which the amino acid proline in position B28 is substituted with aspartic acid.

Interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinasis, pyruvatkinase, glycogenxintase, etc.). Reducing the blood glucose content is due to an increase in its intracellular transport, an increase in the absorption of tissues, stimulation of lipogenesis, glycogenesis, a decrease in the speed of glucose production by the liver, etc.

The substitution of the amino acid proline in position B28 on aspartic acid in insulin aspart reduces the tendency of molecules to the formation of hexamers, which is observed in the solution of ordinary insulin. In this regard, insulin asparta is much faster in the subcutaneous fatty fiber and begins to act faster than soluble human insulin. Insulin aspart is stronger reduced blood glucose content in the first 4 hours after meals, than soluble human insulin. The duration of the ASPART insulin after subcutaneous administration is shorter than soluble human insulin.

After subcutaneous administration, the effect of the drug begins for 10-20 minutes after administration. The maximum effect is observed 1-3 hours after injection. The duration of the preparation is 3-5 hours. Clinical studies involving patients with type 1 diabetes mellitus showed a decrease in the risk of night when using insulin aspart compared to soluble human insulin. The risk of daytime did not increase significantly.

Insulin aspart is an equipotential soluble human insulin based on praying indicators.

Adults. Clinical studies involving patients with type 1 diabetes mellitus demonstrate a lower postprandial blood glucose concentration when the aspart insulin is introduced compared with soluble human insulin.

Elderly. A randomized double-blind cross-study study of pharmacokinetics and pharmacodynamics (FC / PD) ASPART insulin and soluble human insulin in elderly patients with diabetes type 2 (19 patients aged 65-83 years, the average age of 70 years) was carried out. The relative differences between the pharmacodynamic properties between the insulin aspart and human insulin in the elderly patients were similar to those in healthy volunteers and in younger patients with diabetes.

Children and teenagers. The use of insulin aspart in children showed similar results of long-term glycemic control when compared with soluble human insulin.

Clinical study using soluble human insulin before intating food and insulin aspart after meals were carried out in small children (26 patients aged 2 to 6 years); As well as FC / PD, a study using a single dose was carried out in children (6-12 years) and adolescents (13-17 years old). The pharmacodynamic insulin profile Asparti in children was similar to those in adult patients.

Pregnancy. Clinical studies of comparative safety and insulin efficiency Aspart and human insulin in the treatment of pregnant women with type 1 diabetes (322 examined pregnant women, 157 were insulin asparti insulin, 165 - human insulin) did not reveal any negative impact of insulin aspart during pregnancy or the health of the fetus / Newborn.

Additional clinical studies in 27 women with gestational diabetes receiving insulin aspart and human insulin (insulin asparti received 14 women, human insulin - 13) indicate comparability of safety profiles along with a significant improvement in glucose control after meals in the treatment of aspart insulin.

Pharmacokinetics.After subcutaneous administration of insulin aspart, the time to achieve the maximum concentration (Tmax) in the blood plasma is average 2 times less than after the introduction of soluble human insulin. The maximum concentration in the plasma of blood (stacks) on average is 492 ± 256 pmol / l and is achieved 40 minutes after subcutaneous administration of a dose of 0.15 units / kg of body weight with patients with type 1 diabetes mellitus. The insulin concentration returns to the initial level 4-6 hours after the administration of the drug. The absorption speed is slightly lower in patients with type 2 diabetes, which leads to a lower maximum concentration (352 ± 240 pmol / l) and later Tmax (60 minutes). Intine-perceptual variability in Tmax is significantly lower when using insulin aspart compared with soluble human insulin, while specified variability in SMAs for insulin aspart more.

Pharmacokinetics in children (6-12 years old) and adolescents (13-17 years) with type 1 diabetes. Asparti insulin absorption occurs quickly in both age groups, with Tmax, similar to that in adults. However, there are differences in the two age groups, which emphasizes the importance of individual dosing of the drug.

Elderly. Relative differences in pharmacokinetics between aspart insulin and soluble human insulin in elderly patients (65-83 years old, the average age of 70 years) type 2 diabetes was similar to those in healthy volunteers and have more young patients with diabetes. The elderly patients had a decrease in the absorption rate, which led to a slowdown Tmax (82 (variability: 60-120) minutes), while the CMS was the same with such, observed in the younger patients with diabetes mellitus 2 and a little less than in patients with sugar type 1 diabetes.

Lack of liver function. A study of pharmacokinetics was conducted with the introduction of a single dose of insulin aspart 24 patients, the function of the liver of which is in the range from normal to a severe impairment. In persons with violation of the liver function, the absorption rate of insulin insulin was reduced and more inconstant, the result of which was a slowdown with about 50 minutes in persons with normal liver function to about 85 minutes in persons with impaired liver function of medium and severe severity. The area under the concentration-time curve, the maximum plasma concentration and the overall clearance of the drug (AUC, CL / F) were similar in persons with a reduced and normal liver function.

Lack of kidney function. A study was conducted by the pharmacokinetics of insulin aspart in 18 patients, the kidney function was fluid from normal to a severe impairment. There was no obvious effect of creatinine clearance on AUC, Cmax, Tmax insulin aspart. The data was limited to indicators for persons with impaired kidney function of medium and severe. Persons with renal failure, requiring dialysis, were not included in the study.

Preclinical safety data.During the preclinical tests, there was no danger for people on the basis of these generally accepted research of pharmacological safety, toxicity of reuse, genotoxicity and reproductive toxicity.

In in vitro tests, including binding to insulin receptors and insulin-like growth factor-1, as well as the effect on the growth of cells, the nature of insulin behavior aspart is very similar to those of human insulin. Research results also showed that insulin binding dissociation Aspart with insulin receptor is equivalent to such for human insulin.

Indications for use:

Sugar diabetes in adults, teenagers and children over 2 years old.

Method of use and dose:

NovoPid® Penfill® is a high-speed insulin analogue.

The dose of Novorad® Penfill® is determined by the doctor individually in accordance with the needs of the patient. Typically, the drug is used in combination with insulin drugs of medium duration or long-term action, which introduce at least 1 time per day. To achieve optimal control of glycemia, it is recommended to regularly measure the concentration of glucose in the blood and adjust the insulin dose. Usually, the individual daily need for insulin in adults and children ranges from 0.5 to 1 units / kg body weight. With the introduction of the drug in front of the meal, the need for insulin can be provided with the drug NovoPid® Penfill® by 50-70%, the remaining need for insulin is provided by insulin of extended action.

Increasing the physical activity of the patient, the change in the usual nutrition or related diseases can lead to the need for a dose correction. NovoPid® Penfill® has a faster beginning and less duration of action than soluble human insulin.

Thanks to the more rapid beginning of the action, Novorad® Penfill® should be entered, as a rule, immediately before taking food, if necessary, can be administered shortly after meals. Due to the smaller duration of action compared to human insulin, the risk of developing night hypoglycemia in patients receiving NovoPid® Penfill® is lower.

Special groups of patients.As with the use of other insulin preparations, in elderly patients and patients with renal or liver failure, the concentration of glucose in the blood should be more carefully monitored and adjust the aspart insulin dose.

Children and teenagers.Apply Novorahid® Penfill® Instead of soluble human insulin in children, children are preferable in the case when the rapid beginning of the drug is needed, for example, when a child is difficult to comply with the required time interval between injection and food intake.

Translation from other insulin preparations.When translating a patient with other insulin preparations to Novorahid® Penfill®, a dose correction may be required by Novorad® Penfill® and basal insulin.

Novorad® Penfill® is introduced subcutaneously to the front abdominal wall area, thigh, shoulder, deltid or buttock area. The injection places within the same area of \u200b\u200bthe body should be regularly changed to reduce the risk of developing lipodystrophy. As with all the use of insulin preparations, subcutaneous administration into the front abdominal wall provides faster suction compared to the introduction to other places. The duration of action depends on the dose, the place of administration, the intensity of blood flow, temperature and level of physical activity. However, a faster start of action compared to soluble human insulin is maintained regardless of the localization of the injection site.

Novorad® can be used for long-term subcutaneous insulin infusions (PPPI) in insulin pumps designed for insulin infusion. PPIs should be produced into the front abdominal wall. Infusion sites should be changed periodically.

When using an insulin pump for infusions, Novorad® should not be mixed with other types of insulins. Patients using PPIs should be fully trained using a pump corresponding to the reservoir and tubes system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual attached to the infusion set.

Patients receiving NovoPid® using PPIs should have additional insulin in the event of a breakdown of the infusion system.

Intravenous administration.If necessary, Novorad® can be administered intravenously, but only qualified medical personnel.

For intravenous administration, infusion systems are used with a New Arch / ml concentration with a concentration of 0.05 units / ml to 1 units / ml ASPART insulin in 0.9% sodium chloride solution; 5% dextrose solution or 10% dextrose solution containing 40 mmol / l potassium chloride using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours.

Despite stability for some time, a certain amount of insulin is initially absorbed by the infusion system material. During insulin infusion, it is necessary to constantly monitor the blood glucose concentration.

Features of application:

Pregnancy and lactation. Novorad® Penfill® can be prescribed during pregnancy.

The data of two randomized controlled clinical studies (157 + 14 examined pregnant women) did not reveal any adverse effects of insulin aspart on pregnancy or the health of the fruit / newborn compared to human insulin (see the section "Pharmacological properties"). It is recommended to careful control of blood glucose levels and monitoring pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes), throughout the pregnancy and during the possible occurrence of pregnancy. The need for insulin is usually reduced in the I trimester and gradually rises in the II and III trimesters of pregnancy. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy.

In the breastfeeding period, Novorad® Penfill® can be applied, because The introduction of insulin to a woman during breastfeeding period does not pose a threat to a child. However, the need for a dose correction may arise.

Before a long trip associated with changing time zones, the patient must consult with his doctor, as a time zone change means that the patient must take food and introduce insulin at another time.

Hyperglycemia. Insufficient dose of the drug or cessation of treatment, especially in type I diabetes mellitus, can lead to development and diabetic. As a rule, the symptoms appear gradually within a few hours or days. The symptoms are, drowsiness, redness and, dry mouth, increase the amount of urine allocated, thirst and loss of appetite, as well as the appearance of the smell of acetone in exhaled air. No appropriate treatment can lead to death.

Hypoglycemia. Passing of food intake, unplanned increased physical activity or too high with respect to the patient's need of an insulin dose can lead to.

After compensating for carbohydrate metabolism, for example, with intensified insulin therapy, patients may change typical symptoms-precursors, which patients should be informed.

Conventional precursor symptoms may disappear with a long flow.

The consequence of the pharmacodynamic features of an analogues of a short-acting insulin is that development when applying them can begin earlier than when using soluble human insulin.

Since Novorad® Penfill® should be applied in direct connection with food intake, it should take into account the high rate of the effect of the drug in the treatment of patients having concomitant diseases or taking drugs that slow down food suction. Related diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. The dose correction of the drug may also be required if there is a patient with concomitant, liver, impaired adrenal function, pituitary gland or thyroid gland.

When translating the patient to other types of insulin, early precursor symptoms can become less pronounced compared to those using the previous type of insulin.

Transfer of a patient with other insulin preparations.Patient translation to a new insulin type or an insulin preparation of another manufacturer must be carried out under strict medical monitoring. With a change in concentration, type, producer and type (human insulin, animal insulin, an analogue of human insulin), insulin and / or manufacturing methods may be required to change the dose or an increase in the frequency of injections compared to previously used insulin preparations. If you need a dose correction, it can already be produced at the first introduction of the drug or during the first weeks or months of treatment.

Reactions at the injection site.As in the treatment of other insulin preparations, reactions can develop at the place of administration, which is manifested by pain, redness, urticule, inflammation, hematoma, swelling and itching. The regular change of injection site in the same anatomical area can reduce symptoms or prevent the development of reactions. In very rare cases, it may be necessary to cancel NovoPid® Penfill®.

The simultaneous use of drugs of the thiazolidinedione group and insulin preparations.It has been reported on the cases of chronic in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if there are risk factors in such patients with chronic risk factors. This fact should be taken into account when prescribing patients with combination therapy with thiazolidinediones and insulin preparations. When appropriate such combined therapy, medical examinations of patients should be carried out to identify signs and symptoms of chronic, increasing body weight and availability. In case of deterioration in patients, symptomatics treatment with thiazolidinediones must be discontinued.

Precautions when used.NovoPid® Penfill® and needles are intended only for individual use. Repeated filling in the penfill® cartridge is not allowed. NovoPid® Penfill® cannot be used if it stopped being transparent and colorless, or if it was frozen. Inform the patient about the need to throw the needle after each injection.

NovoPid® can be used in insulin pumps (see "Method of Application and Dose"). The tubes, the inner surface of which is made of polyethylene or polyolefin, were monitored and recognized as suitable for use in the pumps.

In emergency cases (hospitalization, malfunction for insulin administration) NEPORPHID® for administration to the patient can be removed from the cartridge using an U100 insulin syringe.

Instructions for patients using Novorad® Penfill®.Do not use Novorad® Penfill®:
- In the case of allergies (hypersensitivity) to insulin aspart, or any other component of Novorad®.
- If you begin (low blood sugar).
- If the cartridge or system for introducing insulin with the installed cartridge dropped, or the cartridge is damaged or crushed.
- If the conditions for storing the drug or it was frozen.
- If insulin stopped being transparent and colorless.

Before using Novorad® Penfill®:
- Check the label to make sure that the correct type of insulin is selected.
- Always check the cartridge, including rubber piston. Do not use the cartridge if it has visible damage, or is visible between the piston and the white stripe on the cartridge. For further instructions, refer to the instructions for using the system to introduce insulin.
- Always use a new needle for each injection to prevent infection.
- Novorad® Penfill® and needles are intended only for individual use.

Mode of application.Novorad® is designed for subcutaneous injections or prolonged infusions in an insulin pumping system (PPPI). Novorad® can also be used intravenously under the strict control of the doctor. Never enter insulin intramuscularly.

Each time you change the place of injection within the anatomical area. This will help reduce the risk of formation of seals and ulcerations at the injection site. It is best to introduce a drug into the front abdominal wall, shoulder or the front surface of the hip. Insulin will act faster if it is introduced into the field of the front abdominal wall. Regularly measure the concentration of glucose in the blood.

How to make an injection:
- Insulin should be administered under the skin. Use the injection technique recommended by your doctor or medical sister, follow the instructions for the introduction of insulin, with the device being conducted in the manual for the introduction of insulin.
- Hold the needle under the skin at least 6 seconds. Keep the start button pressed until the needle is extracted from under the skin. This will ensure the introduction of a complete dose of the drug and will prevent blood from entering the needle or insulin cartridge.
- After each injection, be sure to remove and move the needle. Otherwise, fluid flow from the cartridge is possible, which can lead to an improper insulin dosage.

Do not fill in insulin cartridge reuse.

Novorad® Penfill® is designed for use with injection systems for introducing insulin company Novo Nordisk and N Novofine® needles or Novotivist®.

If simultaneously uses the drug Novorad® Penfill® and other insulin in the Penfill® cartridge, it is necessary to use two separate injection systems for the introduction of insulin, one for each type of insulin.

As a precautionary measure, you always carry a spare system to introduce insulin in case of loss or damage to your Novorad® Penfill®.

Impact on the ability to control the transc. cf. And fur. The ability of patients to the concentration of attention and the reaction rate may be violated during that it may be dangerous in those situations where these abilities are particularly necessary (for example, when managing a vehicle or working with machines and mechanisms). Patients need to be recommended to take measures to prevent development when managing transport and means and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms of precursors by developing or suffering from frequent episodes.

Side effects:

The adverse reactions observed in patients using Novorad® Penfill® preparation are mainly due to the pharmacological effect of insulin.

The most frequent side reaction is. The frequency of the occurrence of side effects varies depending on the patient's population, the dosing mode of the drug and the control of glycemia (see section below).

At the initial stage of insulin therapy, impairment of refraction may occur, and the reaction in the administration of the drug (pain, redness, inflammation, swelling and itching at the injection site). These symptoms are usually transient. A quick improvement in glycemic control can lead to a "acute pain" state, which is usually reversible. Intensification of insulin therapy with a sharp improvement in carbohydrate control can lead to a temporary deterioration in the state of diabetic, at the same time a long-term improvement in the control of glycemia reduces the risk of diabetic progression.

All the following adverse reactions based on the data obtained during clinical studies are distributed in groups according to the development frequency in accordance with MedDRA and organ systems. The frequency of the development of adverse reactions is defined as: very often (≥ 1/10); often (≥ 1/100 to<1/10); нечасто (≥1/1,000 до <1/100); редко (≥1/10,000 до <1/1,000), очень редко (<1/10,000) и неизвестно (невозможно оценить на основании имеющихся данных).

Violations by the immune system.Infrequently - lipodystrophy *

Common disorders and disorders at the injection site.Infrequent reactions in the locations of the introduction.Infrequently -

*Cm. "Description of individual adverse reactions"

Description of individual adverse reactions.Anaphylactic reactions.Very rare reactions of generalized hypersensitivity (including generalized, itching, increased sweating, gastrointestinal disorders, angioedema swelling, breathing difficulty, rapid heartbeat, decreased blood pressure), which are potentially life-threatening.

Hypoglycemia. Hypoglycemia is the most frequent side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Heavy can lead to loss of consciousness and / or cramps, temporary or irreversible impaired brain function up to death. Symptoms, as a rule, are developing suddenly. They may include "cold sweat", the pallor of the skin, increased fatigue, nervousness, or, feeling, unusual fatigue or weakness, violation of orientation, decrease in the concentration of attention, drowsiness, a pronounced feeling of hunger, violation, headache, nausea and rapid heartbeat.

Clinical studies have shown that the frequency of development varies depending on the population of patients, the dosing mode and control of glycemia. During clinical studies, the difference in the total frequency of episodes between patients receiving aspart insulin therapy, and patients using human insulin preparations are not revealed.

Lipodystrophy. Infrequent cases of the development of lipodystrophy have been reported. Lipodystrophia can develop at the injection site.

Interaction with other drugs:

There are a number of medicines that affect the need for insulin.

Hypoglycemic effect of insulin enhance oral hypoglycemic agents, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, drugs lithium salicylates .

The hypoglycemic effect of insulin weakens oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatopin, danazole, clonidine, blocks of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

Beta-adrenoblocators can mask the symptoms of hypoglycemia.

Otreotide / Lanreotide can both increase and reduce the need for insulin.

Alcohol can both rein and reduce the hypoglycemic effect of insulin.

Incompatibility.Some drugs, for example, containing a thiol or sulfite group, when added to the preparation of Novorahid® Penfill® can cause the destruction of insulin aspart. The drug NovoPid® Penfill® should not be mixed with other drugs. The exception is isophan insulin and solutions for infusion described in the section "Method of Application and Dose".

Contraindications:

Increased individual sensitivity to insulin AS part or any of the components of the drug.

Overdose:

A certain dose required to overdose insulin is not established, however, it may develop gradually if too high doses are introduced relative to the patient's need.

Light hypoglycemia The patient can eliminate himself, taking into the glucose or saham-containing food. Therefore, patients with diabetes are recommended to constantly carry sugar-containing products.

In the case of severe, when the patient is unconscious, it is necessary to introduce from 0.5 mg to 1 mg of glucagon intramuscularly or subcutaneously (a trained person may enter), or an intravenous solution of glucose (dextrose) (only a medical worker can enter). It is also necessary to intravenously enter dextrose in case 10-15 minutes after the administration of glucagon, the patient does not come into consciousness. After restoring consciousness, the patient is recommended to take food rich in carbohydrates for recurrence.

Storage conditions:

Store at temperatures from 2 to 8 ° C (in the refrigerator), but not next to the freezer. Do not freeze.Store cartridges in a cardboard pack for protection against light.Novorad® Penfill® should be protected from exposure to excess heat and light.For opened cartridges: Do not store in the refrigerator. Store at a temperature not higher than 30 ° C. Use for 4 weeks.Keep out of the reach of children. FROMrock fitness - 30 months. Do not use after the deadline specified on the cartridge and packaging label.

Leave terms:

On prescription

Packaging:

3 ml in cartridges made of hydrolytic grade glasses, which have bitten by discs from bromboutyl rubber / polyisoprene on one side and pistons from bromobutyl rubber on the other.

5 cartridges in a PVC blister / aluminum foil.

1 blister along with instructions for use in a cardboard pack.

Analogue of human insulin of average duration of action.
Preparation: Novomix® 30 Penfill®
The active substance of the drug: Insulin Aspart.
ATH encoding: A10AD05
KFG: an analogue of human insulin of an average duration of action with a rapid start of action
Registration number: P №015291 / 01
Registration date: 10/13/03
Owner reg. Undoj: Novo Nordisk A / S (Denmark)

Release form Novomix 30 Penfill, packaging of the drug and composition.

Suspension for p / to the introduction of white, when standing is stratified, forming a white precipitate and a colorless or almost colorless supernatant; With careful shaking, the precipitate is easily resuspended.

1 ml
Insulin aspart of two-phase
100 units *
Insulin aspart soluble
30%
Insulin Aspart Protamin Crystal
70%

Auxiliary substances: mannitol, phenol, metactional, zinc chloride, sodium chloride, phosphate dynatory dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid, water d / and.

* 1 unit corresponds to 35 μg of anhydrous insulin aspart.

3 ml - cartridges (5) for syringe knobs Novopen - Packaging Cell contour (1) - packs cardboard.

Description of the active substance.
All the information provided is presented only for familiarization with the drug, the possibility of application you need to consult with the doctor.

Pharmacological action Novomix 30 Penfill

Analogue of human insulin of average duration of action. In the molecular structure of this insulin of the amino acid, proline in position B28 is substituted with aspartic acid, which reduces the trend of molecules to the formation of hexamers, which is observed in the solution of ordinary insulin.

Interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex, stimulating intracellular processes, incl. Synthesis of a number of key enzymes (hexokineas, piruvatakenase, glycogenxintytase). The hypoglycemic effect is associated with an increase in intracellular vehicles and enhance the absorption of glucose tissues, stimulation of lipogenesis, glycogenogenesis, decrease in the speed of glucose products with liver.

Insulin aspart and human insulin have the same activity in the molar equivalent.

Insulin aspart is absorbed from subcutaneous fatty fiber faster and faster begins to act than soluble human insulin.

The duration of the insulin ASPART after p / k administration is less than soluble human insulin.

Pharmacokinetics of the drug.

Indications for use:

Type 1 diabetes (insulin-dependent); Type 2 diabetes (insulin-dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases.

Dosage and method of use of the drug.

The dose is installed individually, based on the level of glucose in the blood.

Side effect Novomix 30 Penfill:

Side effects related to the effect on carbohydrate exchange: hypoglycemia (reinforced sweating, pallor of skin, nervousness or tremor, feeling of anxiety, unusual fatigue, or weakness, violation of orientation, violation of the concentration of attention, dizziness, expressed feeling of hunger, temporary violation, headache , nausea, tachycardia). Pronounced hypoglycemia can lead to loss of consciousness and / or cramps, temporary or irreversible impaired brain work and to death.

Allergic reactions: Possible - urticaria, skin rash; Rarely anaphylactic reactions. Generalized allergic reactions may include skin rash, itching of the skin, increasing sweating, disorders from the gastrointestinal tract, angioedema edema, breathing difficulty, tachycardia, decreased blood pressure.

Local reactions: allergic reactions (redness, swelling, itching of the skin at the injection site), usually temporary and passing as treatment continues; Lipodystrophy is possible.

Others: At the beginning of therapy, rarely - swelling is possible a violation of refraction.

Contraindications for the drug:

Hypoglycemia, increased sensitivity to insulin aspartu.

Application during pregnancy and lactation.

Clinical experience in the use of insulin asprat during pregnancy is very limited.

In experimental studies on animals, there were no differences between the embryotoxicity and the teratogenicity of insulin aspart and human insulin. During the period of the possible occurrence of pregnancy and during the whole period, it is necessary to maintain a thorough monitoring of patients suffering from diabetes mellitus and control blood glucose levels. The need for insulin is usually reduced in the I trimester and gradually rises in the II and III trimesters of pregnancy. During childbirth and immediately after them, the need for insulin can dramatically decrease. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy.

Insulin asprat can be used during lactation (breastfeeding), this may require an insulin dose correction.

Special instructions for applying Novomix 30 Penfill.

Insufficient dose of insulin or cessation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, symptoms of hyperglycemia appear gradually, within a few hours or days. Symptoms of hyperglycemia are nausea, vomiting, drowsiness, redness and dry skin, dry mouth, increase the amount of urine, thirst and loss of appetite, as well as the appearance of the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia can lead to death. After compensating carbohydrate exchange, for example, with intensive insulin therapy, patients may change typical symptoms of hypoglycemia for them.

In patients with diabetes, with optimal metabolic control, the late complications of diabetes are developing later and progressing slower. In this regard, it is recommended to conduct activities aimed at optimizing metabolic control, including monitoring the level of glucose in the blood.

The consequence of the pharmacodynamic features of the analogues of the short action insulin is that the development of hypoglycemia when applying them begins earlier than when using soluble human insulin.

It should take into account the high rate of development of the hypoglycemic effect in the treatment of patients having concomitant diseases or making drugs that slow down the suction of food. In the presence of concomitant diseases, especially infectious genesis, the need for insulin, as a rule, increases. Violation of the kidney or liver function can lead to a decrease in insulin need.

When transferring the patient to other types of insulin, early symptoms of hypoglycemia may vary or becoming less pronounced compared to those using the previous type of insulin.

Patient translation to a new insulin type or an insulin preparation of another manufacturer must be carried out under strict medical monitoring. With a change in concentration, type, producer and type (human insulin, animal insulin, an analogue of human insulin) insulin and / or manufacturing methods may be required to change the dose.

Changing the insulin dose may be required when a dieting change and with increased physical exertion. Exercise performed immediately after meals can increase the risk of hypoglycemia. Pass of food intake or unplanned physical exertion can lead to the development of hypoglycemia.

A significant improvement in the state of carbohydrate compensation can lead to the state of acute pain neuropathy, which is usually reversible.

Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with a sharp improvement in glycemic control can be accompanied by a temporary deterioration of diabetic retinopathy.

Impact on the ability to driving vehicles and control mechanisms

The ability of patients to the concentration of attention and the reaction rate may violate during hypoglycemia and hyperglycemia, which may be dangerous in those situations where these abilities are particularly necessary (for example, when driven by car or working with machines and mechanisms). Patients need to be recommended to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms of harbingers of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, it should be considered the feasibility of performing such works.

Interaction Novomix 30 Penfill with other drugs.

Hypoglycemic effect of insulin enhance oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations Drugs containing ethanol.

The hypoglycemic effect of insulin weakens oral contraceptives, GKS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylate, it is possible both weakening and strengthening the effect of the drug.

Drugs containing thiol or sulphite, when adding to insulin, cause its destruction.

pharmachologic effect

Insulin ASPART is an analogue of the human insulin of a short action, produced by the methodology of recombinant DNA using the Saccharomyces Cerevisiae strain, in which the amino acid proline in position B28 is substituted with aspartic acid.

Interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex, stimulating intracellular processes, incl. Synthesis of a number of key enzymes (hexokineas, piruvatakenase, glycogenxintytase). The decrease in the blood glucose content is due to the increase in its intracellular transport, enhanced with tissues, stimulation of lipogenesis, glycogenogenesis, reduced glycosis production of the liver.

The replacement of the amino acid proline in position B28 on aspartic acid in the New Archprid ® Penfill ® reduces the tendency of molecules to the formation of hexamers, which is observed in the human insulin solution. In this regard, Novoorpid ® Penfill ® is much faster in the subcutaneous fatty fiber and begins to act much faster than soluble human insulin. Novorad ® Penfill ® is stronger reduced blood glucose levels in the first 4 hours after meals than soluble human insulin.

The effect of the drug Novorad ® Penfill ® after n / k administration is shorter than soluble human insulin.

After p / k administration, the effect of the drug begins for 10-20 minutes after administration. The maximum effect is observed after 1-3 hours after injection. The duration of the preparation is 3-5 hours.

Clinical studies involving patients with type 1 diabetes mellitus demonstrated a decrease in the risk of night hypoglycemia when using inspart insulin compared to soluble human insulin. The risk of day hypoglycemia was reliably increased.

Insulin aspart is an equipotential soluble human insulin based on praying indicators.

Adults. Clinical studies involving patients with type 1 diabetes mellitus demonstrate a lower postprandial blood glucose concentration when the aspart insulin is introduced compared to soluble human insulin.

Elderly. A randomized double-blind cross-study study of pharmacokinetics and pharmacodynamics (FC / PD) ASPART insulin and soluble human insulin in elderly patients with diabetes type 2 (19 patients aged 65-83 years, the average age of 70 years) was carried out. The relative differences between the pharmacodynamic properties between insulin aspart and soluble human insulin in the elderly patients were similar to those in healthy volunteers and in younger patients with diabetes.

Children and teenagers. The use of insulin aspart in children showed similar results of long-term glycemic control when compared with soluble human insulin.

Clinical study using soluble human insulin before meals and insulin aspart after meals were carried out in young children (26 patients aged 2 to 6 years); As well as pharmacokinetic / pharmacodynamic (FC / PD) study using a single dose was carried out in children (6-12 years) and adolescents (13-17 years). The pharmacodynamic insulin profile Asparti in children was similar to those in adult patients.

Pregnancy. Clinical studies of comparative safety and insulin efficiency Aspart and human insulin in the treatment of pregnant women with type 1 diabetes (322 examined pregnant women, 157 were insulin asparti insulin, 165 - human insulin) did not reveal any negative impact of insulin aspart during pregnancy or the health of the fetus / Newborn.

Additional clinical studies of 27 women with gestational diabetes receiving insulin aspart and human insulin (insulin Asparti received 14 women, human insulin - 13) indicate comparability of safety profiles along with a significant improvement in glucose control after meals in the treatment of aspart insulin.

Preclinical Safety Data

During the preclinical studies, there was no danger for people on the basis of these generally accepted research of pharmacological safety, toxicity of reuse, genotoxicity and reproductive toxicity.

In in vitro tests, including binding to insulin receptors and insulin-like growth factor-1, as well as the effect on the growth of cells, the nature of insulin behavior aspart is very similar to those of human insulin. Research results also showed that insulin binding dissociation Aspart with insulin receptor is equivalent to such for human insulin.

Pharmacokinetics

Suction

After p / k insertion of insulin aspart, the time of reaching C Max in the blood plasma is 2 times less than after the introduction of soluble human insulin. C Max in the blood plasma average is 492 ± 256 pmol / l and is achieved 40 minutes after p / k administration at a dose of 0.15 units / kg body weight to patients with type 1 diabetes mellitus. The insulin concentration returns to the initial level after 4-6 hours after the administration of the drug. The absorption rate is slightly lower in patients with type 2 diabetes mellitus, which leads to a lower C max (352 ± 240 pmol / l) and later the achievement of it (60 min). Intine perceptual variability in the time of reaching C max is significantly lower when using insulin aspart, compared with soluble human insulin, while specified variability in the value of C Max for insulin aspart more.

Pharmacokinetics in special clinical cases

Pharmacokinetics in children (6-12 years old) and adolescents (13-17 years) with type 1 diabetes. Aspart insulin absorption occurs quickly in both age groups with T MAX, similar to that in adults. However, there are differences with MAX in two age groups, which emphasizes the importance of the individual dosage of the drug.

Elderly patients: The relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years old, the average age of 70 years old) type 2 diabetes was similar to those in healthy volunteers and have more young patients with diabetes. The elderly patients had a decrease in the absorption rate, which led to a slowdown T Max - 82 (variability 60-120) min, while C max was the same with such, observed in younger patients with type 2 diabetes and slightly less than in patients with sugar type 1 diabetes.

Lack of liver function.Pharmacokinetics was conducted with the introduction of a single dose of insulin aspart 24 patients whose liver function is in the range from normal to a severe impairment. In persons with impaired liver function, the absorption rate of insulin aspart was a reduced and more non-permanent, the result of which was slowing T Max about 50 minutes in persons with normal liver function to about 85 minutes in persons with impaired liver function of medium and severe severity. AUC, C MAX plasma and general clearance (CL / F) were similar in persons with a reduced and normal liver function.

Lack of kidney function.A study was conducted by the pharmacokinetics of insulin aspart in 18 patients, the kidney function was fluid from normal to a severe impairment. The clear effect of creatinine clearance on AUC, C MAX, T MAX insulin aspart was not detected. The data was limited to indicators for persons with impaired kidney function of medium and severe. Persons with renal failure, requiring dialysis, were not included in the study.

Indications

- Sugar diabetes in adults, teenagers and children over 2 years old.

Dosing mode

Novorad ® Penfill ® is a high-speed analogue of insulin. The dose of Novorahid ® Penfill ® is determined by the doctor individually in accordance with the needs of the patient.

Typically, the drug is used in combination with insulin preparations of medium duration or long-term action, which are introduced at least 1 time / day. To achieve optimal control of glycemia, it is recommended to regularly measure the concentration of glucose in the blood and adjust the insulin dose. Typically, the individual daily need for insulin in adults and children ranges from 0.5 to 1 units / kg body weight. With the introduction of the drug in front of the meal, the need for insulin can be provided by the drug NEPPID ® Penfill ® by 50-70%, the remaining insulin need is provided by insulin of extended action.

Increasing the physical activity of the patient, the change in the usual nutrition or related diseases can lead to the need for a dose correction.

Novorad ® Penfill ® has a faster beginning and less duration of action than soluble human insulin. Thanks to the more rapid beginning of the action, NovoPid ® Penfill ® should be entered, as a rule, immediately before receiving food, if necessary, can be administered shortly after meals. Due to the lower duration of action compared to human insulin, the risk of developing night hypoglycemia in patients receiving NovoPid ® Penfill ® is lower.

elderly patients and patients with renal or hepatic insufficiency

Children and teenagers.

Translation from other insulin preparations

When translating a patient with other insulin drugs to Novorahid ® Penfill ®, a dose correction of Novorad ® Penfill ® and basal insulin may be required.

Novorad ® Penfill ® is introduced into the front abdominal wall area, thigh, shoulder, deltoid or buttock area. The injection places within the same area of \u200b\u200bthe body should be regularly changed to reduce the risk of developing lipodystrophy. As with the use of all drugs, insulin, the introduction into the front abdominal wall provides faster suction compared to the introduction to other places. The duration of action depends on the dose, the place of administration, the intensity of blood flow, temperature and level of physical activity. However, a faster start of action compared to soluble human insulin is maintained regardless of the localization of the injection site.

Novorad ® can be used for prolonged p / to insulin infusion (PPII) in insulin pumps developed for insulin infusion. PPIs should be performed in the front of the abdominal wall. Infusion sites should be changed periodically.

When using an insulin pump for infusions, NovoPid ® should not be mixed with other types of insulins.

Patients using PPIs should be fully trained using a pump corresponding to the reservoir and tubes system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual attached to the infusion set. Patients receiving NovoPid® using PPIs should have additional insulin in the event of a breakdown of the infusion system.

In / in introduction

If necessary, Novorad ® can be introduced into / in, but only by qualified medical personnel.

For in / in administration, infusion systems with a new architect δ / ml preparation with a concentration of 0.05 units / ml to 1 UR / ml of insulin aspart at a 0.9% sodium chloride solution, 5% dextrose solution or 10% dextrose solution containing 40 mmol / L potassium chloride, using polypropylene containers for infusion. These solutions are stable at room temperature for 24 hours. Despite stability for some time, a certain amount of insulin is initially absorbed by the material of the infusion system. During insulin infusion, it is necessary to constantly monitor the blood glucose concentration.

Precautions

Novorad ® Penfill ® and needles are intended only for individual use. Repeated filling of the Penfill ® cartridge is not allowed.

NovoPid ® Penfill ® cannot be used if it stopped being transparent and colorless, or if it was frozen. Inform the patient about the need to throw the needle after each injection.

Novorad ® can be used in insulin pumps. The tubes, the inner surface of which is made of polyethylene or polyolefin, were monitored and recognized as suitable for use in the pumps.

In emergency cases (hospitalization, malfunction of an insulin device) NEPORPID ® for administration to the patient can be removed from the cartridge using an insulin syringe U100.

Instructions for patients using NovoPid ® Penfill ®

Do not use Novorad ® Penfill ®

- in the case of allergies (hypersensitivity) to insulin aspart, or any other component of NovoPid ®;

- if you begin hypoglycemia (low blood glucose);

- if the cartridge or the system for introducing insulin with the installed cartridge dropped, or the cartridge is damaged or crushed;

- If the storage conditions of the drug or it was frozen.;

- If insulin stopped being transparent and colorless.

Before using Novorad ® Penfill ®

- Check the label to make sure that the correct type of insulin is selected;

- Always check the cartridge, including rubber piston. Do not use the cartridge if it has visible damage, or is visible between the piston and the white stripe on the cartridge.

For further instructions, refer to the instructions for using the system to introduce insulin.

- Always use a new needle for each injection to prevent infection;

- Novorad ® Penfill ® and needles are intended only for individual use.

Mode of application

Novorad ® is designed for subcutaneous injections or prolonged infusions in an insulin pumping system (PPPI). Novorad ® can also be used intravenously under the strict control of the doctor. Never enter insulin intramuscularly.

Each time you change the place of injection within the anatomical area. This will help reduce the risk of formation of seals and ulcerations at the injection site. It is best to introduce a drug into the front abdominal wall, shoulder or the front surface of the hip. Insulin will act faster if it is introduced into the field of the front abdominal wall. Regularly measure the concentration of glucose in the blood.

How to make an injection

Insulin should be administered under the skin. Use the injection technique recommended by your doctor or medical sister, follow the instructions for the introduction of insulin, provided in the instrument manual for insulin.

Hold the needle under the skin at least 6 seconds. Keep the start button pressed until the needle is extracted from under the skin. This will ensure the introduction of a complete dose of the drug and will prevent blood from entering the needle or insulin cartridge.

After each injection, be sure to remove and discard the needle. Otherwise, fluid flow from the cartridge is possible, which can lead to an improper insulin dosage.

Do not fill in insulin cartridge reuse. Novorad ® Penfill ® is designed for use with injection systems for introducing insulin company Novo Nordisk and New Fine ® I needles or Novotivist ®.

If the NEGPID ® Penfill® and other insulin in the Penfill ® cartridge ® are simultaneously used, it is necessary to use two separate injection systems to introduce insulin, one for each insulin type. As a precautionary measure, you always carry a spare system to introduce insulin to the case of loss or damage your New Archd ® Penfill ®.

Side effect

The adverse reactions observed in patients using the drug Novorad ® Penfill ® are mainly due to the pharmacological effect of insulin.

The frequency of the occurrence of side effects varies depending on the patient's population, the dosing mode of the drug and the control of glycemia (see section below). At the initial stage of insulin therapy, disorders of refraction, swelling and reactions in the field of administration of the drug (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur. These symptoms are usually transient. The rapid improvement in the control of glycemia can lead to the state of acute pain neuropathy, which is usually reversible.

Intensification of insulin therapy with a sharp improvement in carbohydrate control can lead to a temporary deterioration of the state of diabetic retinopathy, while at the same time a long-term improvement in the control of glycemia reduces the risk of insulin therapy progression with a sharp improvement in carbohydrate control can lead to a temporary deterioration in the state of diabetic retinopathy, at the same time long-term improvement The control of glycemia reduces the risk of progression of diabetic retinopathy.

The list of adverse reactions is presented in the table.

All the following adverse reactions based on the data obtained during clinical studies are distributed in groups according to the development frequency in accordance with MedDRA and organ systems. The frequency of the development of adverse reactions is defined as follows: Very often (≥1 / 10); Often (≥1 / 100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10 000, <1/1000); очень редко (<1/10 000) и неизвестно (невозможно оценить на основании имеющихся данных).

Impaired immune system	Infrequently - urticaria, skin rash, rashes on the skin
	Very rarely - anaphylactic reactions *
Violations from metabolism and nutrition	Very often - hypoglycemia *
Nervous System Violations	Rarely - peripheral neuropathy (acute pain neuropathy)
Violations	Infrequently - disorders of refraction
	Infrequently - diabetic retinopathy
Disturbing from the skin and subcutaneous fabrics	Infrequently - lipidodystrophy *
General disorders and disorders at the injection site	Infrequently - reactions in the places of administration, swelling

*Cm. Descriptions of individual adverse reactions

Descriptions of individual adverse reactions

Anaphylactic reactions. Very rare reactions of generalized hypersensitivity are noted (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema swelling, breathing difficulties, rapid heartbeat, decreased blood pressure), which are potentially life-threatening.

Hypoglycemia. Hypoglycemia is the most frequent side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Heavy hypoglycemia can lead to loss of consciousness and / or cramps, temporary or irreversible impaired brain function up to death. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include cold sweat, pallor of skin, increased fatigue, nervousness or tremor, feeling of anxiety, unusual fatigue, or weakness, violation of orientation, decrease in the concentration of attention, drowsiness, expressed feeling of hunger, impairment, headache, nausea and rapid heartbeat. Clinical studies have shown that the frequency of the hypoglycemia varies depending on the population of patients, the dosing mode and control of glycemia. During clinical studies, the difference in the total frequency of the occurrence of hypoglycemia episodes between patients receiving aspart insulin therapy, and patients using human insulin preparations.

Lipodystrophy. Infrequent cases of the development of lipodystrophy have been reported. Lipodystrophia can develop at the injection site.

Contraindications for use

- Increased individual sensitivity to insulin aspart or any of the components of the drug.

Application in pregnancy and breastfeeding

Novorad ® Penfill ® can be prescribed during pregnancy. The data of two randomized controlled clinical studies (157 + 14 of the examined pregnant women) did not reveal any adverse effects of insulin aspart on the course of pregnancy or the health of the fruit / newborn compared to human insulin.

It is recommended to careful control of blood glucose levels and monitoring pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes), throughout the pregnancy and during the possible occurrence of pregnancy. The need for insulin is usually reduced in the I trimester and gradually rises in the II and III trimesters of pregnancy. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy.

During the breastfeeding period, Novorad ® Penfill ® can be applied, because The introduction of a nursing mother insulin does not pose a threat to a child. However, the need for a dose correction may arise.

Using Novorad ® Penfill ® Instead of soluble human insulin in children, preferably in the case when the rapid beginning of the drug is needed, for example, when a child is difficult to comply with the required time interval between injection and food intake.

Overdose

Symptoms:a certain dose required to overdose insulin is not established, however hypoglycemia It may develop gradually if too high doses are introduced relative to the patient's need.

Treatment: light hypoglycemiathe patient can eliminate himself, taking into the glucose or saham-containing food. Therefore, patients with diabetes are recommended to constantly carry sugar-containing products.

When severe hypoglycemia When the patient is unconscious, it should be administered from 0.5 mg to 1 mg of glucagon in / m or P / K (a trained person can enter), or in / into glucose solution (dextrose) (only a medical worker can enter). It is also necessary to enter dextrose in the case, if 10-15 minutes after the glucagon administration, the patient does not come into consciousness. After the recovery of consciousness, the patient is recommended to take food rich in carbohydrates for the prevention of hypoglycemia recurrence.

Medicinal interaction

There are a number of medicines that affect the need for insulin.

The hypoglycemic effect of insulin is reinforced by oral hypoglycemic drugs, Mao inhibitors, ACE inhibitors, carboanhydrase inhibitors, non-selective beta-adrenoblays, bromocriptine, sulfonamide, anabolic steroids, tetracycles, clofibrate, ketoconazole, furnacesol, pyridoxine, teophylline, cyclophosphamide, phenfluramine, lithium, salicylamina.

The hypoglycemic effect of insulin weakens oral contraceptives, GKS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatopin, danazole, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Beta-adrenoblocators can mask the symptoms of hypoglycemia.

Otreotide / Lanreotide can both increase and reduce the need for insulin.

Alcohol can both rein and reduce the hypoglycemic effect of insulin.

Incompatibility. Some drugs, for example, containing a thiol or sulphite group, when added to the preparation of Novorahid ® Penfill ® can cause the destruction of insulin aspart. The drug Novorad ® Penfill ® should not be mixed with other drugs. The exception is Isophan insulin and solutions for infusion.

Conditions of vacation from pharmacies

The drug is released by the prescription.

Terms and Storage Terms

Store at temperatures from 2 ° to 8 ° C (in the refrigerator), but not next to the freezer. Do not freeze. Store cartridges in a cardboard pack for protection against light. It should be protected from exposure to excess heat and light. Opened cartridges do not store in the refrigerator. Store at a temperature not higher than 30 ° C. Use for 4 weeks. Keep out of the reach of children.

Shelf life - 30 months.

Application with violations of liver function

As with the use of other insulin preparations, patients with hepatic insufficiency It should be more carefully monitored by the concentration of glucose in the blood and adjust the aspart insulin dose individually.

Application with violations of the kidney function

As with the use of other insulin preparations, Patients with renal failure It should be more carefully monitored by the concentration of glucose in the blood and adjust the aspart insulin dose individually.

Application in elderly patients

As with the use of other insulin preparations, elderly patientsit should be more carefully monitored by the concentration of glucose in the blood and adjust the aspart insulin dose individually.

special instructions

Before a long trip associated with changing time zones, the patient must consult with his doctor, as a time zone change means that the patient must take food and introduce insulin at another time.

Hyperglycemia

Insufficient dose of the drug or cessation of treatment, especially with type 1 diabetes mellitus, can lead to the development of hyperglycemia and diabetic ketoacidosis. As a rule, symptoms of hyperglycemia appear gradually, within a few hours or days. Symptoms of hyperglycemia are nausea, vomiting, drowsiness, redness and dry skin, dry mouth, increase the amount of urine, thirst and loss of appetite, as well as the appearance of the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia can lead to death.

Hypoglycemia

Passing of food intake, unplanned increased physical activity or too high in relation to the patient's need for insulin dose can lead to hypoglycemia. After compensating carbohydrate metabolism, for example, with intensified insulin therapy, patients may change typical symptoms of hypoglycemia for them, which patients should be informed. Ordinary precursor symptoms can disappear with long-term flow of diabetes.

The consequence of the pharmacodynamic features of an analogues of insulin of a short action is that the development of hypoglycemia when applying them can begin earlier than when using soluble human insulin.

Since Novorad ® Penfill ® should be applied in direct connection with food intake, it is necessary to take into account the high rate of the effect of the drug in the treatment of patients having concomitant diseases or receiving drugs that slow down food suction. Related diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. The dose correction of the drug may also be required if a patient has concomitant kidney diseases, liver, impaired adrenal function, pituitary gland or thyroid gland.

When translating the patient to other types of insulin, early symptoms of hypoglycemia harbingers may become less pronounced compared to those using the previous type of insulin.

Transfer of a patient with other insulin preparations

Patient translation to a new insulin type or an insulin preparation of another manufacturer must be carried out under strict medical monitoring. With a change in concentration, type, producer and type (human insulin, animal insulin, an analogue of human insulin), insulin and / or manufacturing methods may be required to change the dose or an increase in the frequency of injections compared to previously used insulin preparations. If you need a dose correction, it can already be produced at the first introduction of the drug or during the first weeks or months of treatment.

Reactions at the place of administration

As in the treatment of other insulin preparations, reactions can develop at the place of administration, which is manifested by pain, redness, urticule, inflammation, hematoma, swelling and itching. The regular change of injection site in the same anatomical area can reduce symptoms or prevent the development of reactions. In very rare cases, it may be necessary to cancel Novorad ® Penfill ®.

The simultaneous use of drugs of the thiazolidinedione group and insulin preparations

It has been reported on the development of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if there are risk factors in such patients with chronic heart failure. This fact should be taken into account when prescribing patients with combination therapy with thiazolidinediones and insulin preparations. When appropriate such combined therapy, it is necessary to conduct medical examinations of patients for the identification of signs and symptoms of chronic heart failure, increasing body weight and edema. In case of deterioration in patients, symptoms of heart failure treatment with thiazolidinediones must be discontinued.

Impact on the ability to driving vehicles and control mechanisms

The ability of patients to the concentration of attention and the reaction rate may violate during hypoglycemia, which may be dangerous in those situations where these abilities are particularly necessary (for example, when managing a vehicle or working with machines and mechanisms). Patients need to be recommended to take measures to prevent the development of hypoglycemia when managing vehicles and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms of harbingers of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.

Catad_pgroup insulins

Novorad Penfill - Official Instructions for Application

Instruction
medical use of the drug

Registration number:

N012703 / 01

Tradename: Novorad® Penfill®

MNN: Insulin Aspart.

Dosage form:

Solution for subcutaneous and intravenous administration

Structure:

1 ml of the drug contains:
active substance: Insulin aspart 100 units (3.5 mg);
excipients: Glycerol 16 mg, phenol 1.5 mg, metacrezol 1.72 mg, zinc chloride 19.6 μg, sodium chloride 0.58 mg, sodium hydrophosphate dihydrate 1.25 mg, sodium hydroxide 2m about 2.2 mg, hydrochloride acid 2m About 1.7 mg, water for injection up to 1 ml.
One cartridge contains 3 ml of a solution equivalent to 300 units.

Description
Transparent, colorless solution.

Pharmacotherapeutic Group:

Hypoglycemic agent, analogue of a short-acting human insulin.

ATX code-A10Av05.

Pharmacological properties:

Pharmacodynamics
Insulin ASPART is an analogue of the human insulin of a short action, produced by the methodology of recombinant DNA using the Saccharomyces Cerevisiae strain, in which the amino acid proline in position B28 is substituted with aspartic acid. Interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinasis, pyruvatkinase, glycogenxintase, etc.). Reducing the blood glucose content is due to an increase in its intracellular transport, an increase in the absorption of tissues, stimulation of lipogenesis, glycogenesis, a decrease in the speed of glucose production by the liver, etc.

The substitution of the amino acid proline in position B28 on aspartic acid in insulin aspart reduces the tendency of molecules to the formation of hexamers, which is observed in the solution of ordinary insulin. In this regard, insulin asparta is much faster in the subcutaneous fatty fiber and begins to act faster than soluble human insulin. Insulin aspart is stronger reduced blood glucose content in the first 4 hours after meals, than soluble human insulin. The duration of the ASPART insulin after subcutaneous administration is shorter than soluble human insulin.

After subcutaneous administration, the effect of the drug begins for 10-20 minutes after administration. The maximum effect is observed 1-3 hours after injection. The duration of the preparation is 3-5 hours.

Clinical studies involving patients with type 1 diabetes mellitus demonstrated a decrease in the risk of night hypoglycemia when using insulin aspart compared to soluble human insulin. The risk of day hypoglycemia was reliably increased.

Insulin aspart is an equipotential soluble human insulin based on praying indicators.

Adults. Clinical studies involving patients with type 1 diabetes mellitus demonstrate a lower postprandial blood glucose concentration when the aspart insulin is introduced compared with soluble human insulin.

Older: A randomized double-blind cross-study study of pharmacokinetics and pharmacodynamics (FC / PD) ASPART insulin and soluble human insulin in elderly patients with diabetes type 2 (19 patients aged 65-83 years, the average age of 70 years) was carried out. The relative differences between the pharmacodynamic properties between the insulin aspart and human insulin in the elderly patients were similar to those in healthy volunteers and in younger patients with diabetes.

Children and teenagers. The use of insulin aspart in children showed similar results of long-term glycemic control when compared with soluble human insulin.
Clinical study using soluble human insulin before meals and insulin aspart after meals were carried out in young children (26 patients aged 2 to b years); As well as FC / PD, a study using a single dose was carried out in children (6-12 years) and adolescents (13-17 years old). Pharmacodynamic insulin profile Aspartum of children was similar to those in adult patients.

Pregnancy: Clinical studies of comparative safety and insulin efficiency Aspart and human insulin in the treatment of pregnant women with type 1 diabetes (322 examined pregnant women, 157 were insulin asparti insulin, 165 - human insulin) did not reveal any negative impact of insulin aspart during pregnancy or the health of the fetus / Newborn.
Additional clinical studies in 27 women with gestational diabetes receiving insulin aspart and human insulin (insulin asparti received 14 women, human insulin - 13) indicate comparability of safety profiles along with a significant improvement in glucose control after meals in the treatment of aspart insulin.

Pharmacokinetics.
After subcutaneous administration of insulin aspart, the time to achieve the maximum concentration (T MAX) in the blood plasma is 2 times less than after the introduction of soluble human insulin. The maximum concentration in the blood plasma (CMA) is 492 ± 25b PMOL / L and is achieved 40 minutes after subcutaneous administration of the dose of 0.15 units / kg of body weight with patients with type 1 diabetes mellitus. The insulin concentration returns to the initial level 4-6 hours after the administration of the drug. The absorption speed is slightly lower in patients with type 2 diabetes, which leads to a lower maximum concentration (352 ± 240 pmol / l) and later T Max (60 minutes). Intine-perceptual variability on T Max is significantly lower when using insulin aspart, compared with soluble human insulin, while specified variability in with GPH for insulin aspart.

Pharmacokinetics in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes. Aspart insulin absorption occurs quickly in both age groups, with T MAX, similar to that in adults. However, there are differences with MAs in two age groups, which emphasizes the importance of individual dosing of the drug. Elderly: the relative differences in pharmacokinetics between insulin aspart and soluble human insulin in the elderly patients (65-83 years old, the average age of 70 years) type 2 diabetes was similar to those in healthy volunteers and in younger patients with diabetes. The elderly patients had a decrease in the absorption rate, which led to a slowdown T Max (82 (variability: 60-120) minutes), whereas with Mach was the same with such, observed in the younger patients with diabetes mellitus 2 and a little less than that patients with diabetes type 1 type.

Lack of liver function: A study of pharmacokinetics was conducted with the introduction of a single dose of insulin aspart 24 patients, the function of the liver of which is in the range from normal to a severe impairment. In persons with impaired liver function, the absorption rate of insulin ASPART was reduced and more non-permanent, the result of which was slowing T MAX from about 50 minutes in persons with a normal liver function to about 85 minutes in persons with impaired liver function of medium and severe severity. The area under the concentration-time curve, the maximum plasma concentration and general clearance of the drug (AUC, with MAs and CL / F) were similar in persons with a reduced and normal liver function.

Lack of kidney function. A study was conducted by the pharmacokinetics of insulin aspart in 18 patients, the kidney function was fluid from normal to a severe impairment. The clear effect of creatinine clearance on AUC, C MAX, T MAX insulin aspart was not detected. The data was limited to indicators for persons with impaired kidney function of medium and severe. Persons with renal failure, requiring dialysis, were not included in the study.

Preclinical safety data: During the preclinical tests, there was no danger for people on the basis of these generally accepted research of pharmacological safety, toxicity of reuse, genotoxicity and reproductive toxicity.

In in vitro tests, including binding to insulin receptors and insulin-like growth factor-1, as well as the effect on the growth of cells, the nature of insulin behavior aspart is very similar to those of human insulin. Research results also showed that insulin binding dissociation Aspart with insulin receptor is equivalent to such for human insulin.

Indications for use:

Sugar diabetes in adults, teenagers and children over 2 years old.

Contraindications:

Increased individual sensitivity to insulin aspart or any of the components of the drug.

Application during pregnancy and in breastfeeding period
Novorad® Penfill® can be prescribed during pregnancy. The data of two randomized controlled clinical studies (157 + 14 surveyed pregnant women) did not reveal any adverse effects of insulin aspart on pregnancy or the health of the fruit / newborn compared to human insulin (see section "

Pharmacological properties:

"). It is recommended to careful control of blood glucose levels and monitoring pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes), throughout the pregnancy and during the possible occurrence of pregnancy. The need for insulin is usually reduced in the I trimester and gradually rises in the II and III trimesters of pregnancy. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy.

In the breastfeeding period, Novorad® Penfill® can be applied, because The introduction of insulin to a woman during breastfeeding period does not pose a threat to a child. However, the need for a dose correction may arise.

Method of use and dose:

NovoPid® Penfill® is a high-speed insulin analogue. The dose of Novorad® Penfill® is determined by the doctor individually in accordance with the needs of the patient. Typically, the drug is used in combination with insulin drugs of medium duration or long-term action, which introduce at least 1 time per day. To achieve optimal control of glycemia, it is recommended to regularly measure the concentration of glucose in the blood and adjust the insulin dose.

Usually, the individual daily need for insulin in adults and children ranges from 0.5 to 1 units / kg body weight. With the introduction of the drug in front of the meal, the need for insulin can be provided with the drug NovoPid® Penfill® by 50-70%, the remaining need for insulin is provided by insulin of extended action. Increasing the physical activity of the patient, the change in the usual nutrition or related diseases can lead to the need for a dose correction.

Novorad® Penfill® has a faster beginning and less duration of action than soluble human insulin, thanks to a more rapid start of action, NEPORPID® Penfill® should be administered immediately before taking food, if necessary, can be administered shortly after meals. Due to the smaller duration of action compared to human insulin, the risk of developing night hypoglycemia in patients receiving NovoPid® Penfill® is lower.

Special groups of patients
As with the use of other insulin preparations, in elderly patients and patients with renal or liver failure, the concentration of glucose in the blood should be more carefully monitored and adjust the aspart insulin dose.

Children and teenagers
Apply Novorahid® Penfill® Instead of soluble human insulin in children, children are preferable in the case when the rapid beginning of the drug is needed, for example, when a child is difficult to comply with the required time interval between injection and food intake.

Translation from other insulin preparations
When translating a patient with other insulin preparations to Novorahid® Penfill®, a dose correction may be required by Novorad® Penfill® and basal insulin.

Novorad® Penfill® is introduced subcutaneously to the front abdominal wall area, thigh, shoulder, deltid or buttock area. The injection places within the same area of \u200b\u200bthe body should be regularly changed to reduce the risk of developing lipodystrophy. As with all the use of insulin preparations, subcutaneous administration into the front abdominal wall provides faster suction compared to the introduction to other places. The duration of action depends on the dose, the place of administration, the intensity of blood flow, temperature and level of physical activity. However, a faster start of action compared to soluble human insulin is maintained regardless of the localization of the injection site. Novorad® can be used for long-term subcutaneous insulin infusions (PPPI) in insulin pumps designed for insulin infusion. PPIs should be produced into the front abdominal wall. Infusion sites should be changed periodically. When using an insulin pump for infusions, Novorad® should not be mixed with other types of insulins.

Patients using PPIs should be fully trained using a pump corresponding to the reservoir and tubes system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual attached to the infusion set.

Patients receiving NovoPid® using PPIs should have additional insulin in the event of a breakdown of the infusion system.

Intravenous administration
If necessary, Novorad® can be administered intravenously, but only qualified medical personnel. For intravenous administration, infusion systems are used with a New Arch / ml concentration with a concentration of 0.05 units / ml to 1 units / ml ASPART insulin in 0.9% sodium chloride solution; 5% dextrose solution or 10% dextrose solution containing 40 mmol / l potassium chloride using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours. Despite stability for some time, a certain amount of insulin is initially absorbed by the infusion system material. During insulin infusion, it is necessary to constantly monitor the blood glucose concentration.

Side effect:

The adverse reactions observed in patients using Novorad® Penfill® preparation are mainly due to the pharmacological effect of insulin.

The most frequent side reaction is hypoglycemia. The frequency of the occurrence of side effects varies depending on the patient's population, the dosing mode of the drug and the control of glycemia (see section below).

At the initial stage of insulin therapy, disorders of refraction, swelling and reactions in the field of administration of the drug (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur. These symptoms are usually transient. A quick improvement in glycemic control can lead to the state of "acute pain neuropathy", which is usually reversible. Intensification of insulin therapy with a sharp improvement in carbohydrate control can lead to a temporary deterioration of diabetic retinopathy, at the same time, long-term improvement in glycemia control reduces the risk of progression of diabetic retinopathy.

The list of adverse reactions is presented in the table.

Impaired immune system	Infrequently - urticaria, skin rash, rashes on the skin
	Very rarely - anaphylactic reactions *
Violations from metabolism and nutrition	Very often - hypoglycemia *
Nervous System Violations	Rarely - peripheral neuropathy ("Acute pain neuropathy")
Violations	Infrequently - violation of refraction
	Infrequently - diabetic retinopathy
Disturbing from the skin and subcutaneous fabrics	Infrequently - lipodystrophy *
General disorders and disorders at the injection site	Infrequently - reactions in the introduction places
	Nearby - Otka

*Cm. "Description of individual adverse reactions"

All the following adverse reactions based on the data obtained during clinical studies are distributed in groups according to the development frequency in accordance with MedDRA and organ systems. The frequency of the development of adverse reactions is defined as: very often (≥ 1/10); often (≥ 1/100 to<1/10); нечасто (≥1/1,000 до <1/100); редко (≥1/10,000 до <1/1,000), очень редко (<1/10,000) и неизвестно (невозможно оценить на основании имеющихся данных).

Description of individual adverse reactions:
Anaphylactic reactions
Very rare reactions of generalized hypersensitivity (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema swelling, breathing difficulties, rapid heartbeat, decreased blood pressure), which are potentially life-threatening.

Hypoglycemia
Hypoglycemia is the most frequent side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Heavy hypoglycemia can lead to loss of consciousness and / or cramps, temporary or irreversible impaired brain function up to death. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include "cold sweat", pallor of skin, increased fatigue, nervousness or tremor, feeling of anxiety, unusual fatigue or weakness, violation of orientation, decrease in the concentration of attention, drowsiness, expressed feeling of hunger, violation, headache, nausea and rapid heartbeat . Clinical studies have shown that the frequency of the hypoglycemia varies depending on the population of patients, the dosing mode and control of glycemia. During clinical studies, the difference in the total frequency of the occurrence of hypoglycemia episodes between patients receiving aspart insulin therapy, and patients using human insulin preparations.

Lipodystrophy
Infrequent cases of the development of lipodystrophy have been reported. Lipodystrophia can develop at the injection site.

Overdose:

A certain dose required to overdose insulin is not established, however, hypoglycemia can develop gradually if too high doses are introduced relative to the patient's need.

Light hypoglycemia The patient can eliminate himself, taking into the glucose or saham-containing food. Therefore, patients with diabetes are recommended to constantly carry sugar-containing products.
- In the case of severe hypoglycemia, when the patient is unconscious, it should be administered from 0.5 mg to 1 mg of glucagon intramuscularly or subcutaneously (a trained person may introduce), or an intravenous solution of glucose (dextrose) (only a medical worker can enter). It is also necessary to intravenously enter dextrose in case 10-15 minutes after the administration of glucagon, the patient does not come into consciousness. After the recovery of consciousness, the patient is recommended to take food rich in carbohydrates for the prevention of hypoglycemia recurrence.

Interaction with other medicines

There are a number of medicines that affect the need for insulin.

Hypoglycemic effect of insulin enhance oral hypoglycemic agents, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, drugs lithium salicylates .

The hypoglycemic effect of insulin weakens oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatopin, danazole, clonidine, "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

Beta-adrenoblockers can mask the symptoms of hypoglycemia, octreotide / lounterotide can both increase and reduce the need for insulin.

Alcohol can both rein and reduce the hypoglycemic effect of insulin.

Incompatibility
Some drugs, for example, containing a thiol or sulfite group, when added to the preparation of Novorahid® Penfill® can cause the destruction of insulin aspart.

The drug NovoPid® Penfill® should not be mixed with other drugs. The exceptions are Isophane-insulin and solutions for infusion described in the section "

Method of use and dose:

».

special instructions

Before a long trip associated with changing time zones, the patient must consult with his doctor, as a time zone change means that the patient must take food and introduce insulin at another time.

Hyperglycemia
Insufficient dose of the drug or cessation of treatment, especially with type 1 diabetes mellitus, can lead to the development of hyperglycemia and diabetic ketoacidosis. As a rule, symptoms of hyperglycemia appear gradually, within a few hours or days. Symptoms of hyperglycemia are nausea, vomiting, drowsiness, redness and dry skin, dry mouth, increase the amount of urine, thirst and loss of appetite, as well as the appearance of the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia can lead to death.

Hypoglycemia
Passing of food intake, unplanned increased physical activity or too high in relation to the patient's need for insulin dose can lead to hypoglycemia.

After compensating carbohydrate exchange, for example, with intensified insulin therapy, patients may change typical symptoms of hypoglycemia for them, which patients should be informed.

Ordinary precursor symptoms can disappear with long-term flow of diabetes.

The consequence of the pharmacodynamic features of an analogues of insulin of a short action is that the development of hypoglycemia when applying them can begin earlier than when using soluble human insulin.

Since Novorad® Penfill® should be applied in direct connection with food intake, it should take into account the high rate of the effect of the drug in the treatment of patients having concomitant diseases or taking drugs that slow down food suction.

Related diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. The dose correction of the drug may also be required if a patient has concomitant kidney diseases, liver, impaired adrenal function, pituitary gland or thyroid gland.

When translating the patient to other types of insulin, early symptoms of hypoglycemia harbingers may become less pronounced compared to those using the previous type of insulin.

Transfer of a patient with other insulin preparations
Patient translation to a new insulin type or an insulin preparation of another manufacturer must be carried out under strict medical monitoring. With a change in concentration, type, producer and type (human insulin, animal insulin, an analogue of human insulin), insulin and / or manufacturing methods may be required to change the dose or an increase in the frequency of injections compared to previously used insulin preparations. If you need a dose correction, it can already be produced at the first introduction of the drug or during the first weeks or months of treatment.

Reactions at the place of administration
As in the treatment of other insulin preparations, reactions can develop at the place of administration, which is manifested by pain, redness, urticule, inflammation, hematoma, swelling and itching. The regular change of injection site in the same anatomical area can reduce symptoms or prevent the development of reactions. In very rare cases, it may be necessary to cancel NovoPid® Penfill®.

The simultaneous use of drugs of the thiazolidinedione group and insulin preparations
It has been reported on the development of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if there are risk factors in such patients with chronic heart failure. This fact should be taken into account when prescribing patients with combination therapy with thiazolidinediones and insulin preparations. When appropriate such combined therapy, it is necessary to conduct medical examinations of patients for the identification of signs and symptoms of chronic heart failure, increasing body weight and edema. In case of deterioration in patients, symptoms of heart failure treatment with thiazolidinediones must be discontinued.

Impact on the ability to manage vehicles and working with mechanisms
The ability of patients to the concentration of attention and the reaction rate may violate during hypoglycemia, which may be dangerous in those situations where these abilities are particularly necessary (for example, when managing a vehicle or working with machines and mechanisms). Patients need to be recommended to take measures to prevent the development of hypoglycemia when managing vehicles and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms of harbingers of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.

Release form:

Solution for subcutaneous and intravenous administration 100 U / ml.
3 ml in cartridges made of hydrolytic grade glasses, which have bitten by discs from bromboutyl rubber / polyisoprene on one side and pistons from bromobutyl rubber on the other.
5 cartridges in a PVC blister / aluminum foil.
1 blister along with instructions for use in a cardboard pack.

Storage conditions:

Store at temperatures from 2 ° C to 8 ° C (in the refrigerator), but not next to the freezer. Do not freeze.
Store cartridges in a cardboard pack for protection against light.
Novorad® Penfill® should be protected from exposure to excess heat and light.
For opened cartridges: Do not store in the refrigerator. Store at a temperature not higher than 30 ° C. Use for 4 weeks.
Keep out of the reach of children.

Shelf life:

30 months. Do not use after the deadline specified on the cartridge and packaging label.

Conditions of vacation from pharmacies:

On prescription.

Manufacturer:

Novo Nordisk A / s
Novo Alle
DK-2880 Bagswerd, Denmark

Representation
Novo Nordisk A / s
119330, Moscow, Lomonosovsky Prospekt, 38, Office 11

Precautions when using
NovoPid® Penfill® and needles are intended only for individual use. Repeated filling in the penfill® cartridge is not allowed.

NovoPid® Penfill® cannot be used if it stopped being transparent and colorless, or if it was frozen. Inform the patient about the need to throw the needle after each injection. Novorad® can be used in insulin pumps (see "

Method of use and dose:

"). The tubes, the inner surface of which is made of polyethylene or polyolefin, were monitored and recognized as suitable for use in the pumps.

In emergency cases (hospitalization, malfunction for insulin administration) NEPORPHID® for administration to the patient can be removed from the cartridge using an U100 insulin syringe.

Instructions for patients using NovoPid® Penfill®

Do not use Novorad® Penfill®

In the case of allergies (hypersensitivity) to insulin aspart or any other component of NovoPid®.

If you begin hypoglycemia (low blood sugar).

If the cartridge or the system for introducing insulin with the installed cartridge dropped, or the cartridge is damaged or crushed.

If the conditions for storing the drug or it was frozen.

If insulin stopped being transparent and colorless.

Before use of Novorad® Penfill®

Check the label to make sure that the correct type of insulin is selected.

Always check the cartridge, including rubber piston. Do not use the cartridge if it has visible damage, or is visible between the piston and the white stripe on the cartridge. For further instructions, refer to the instructions for using the system to introduce insulin.

Always use a new needle for each injection to prevent infection.

NovoPid® Penfill® and needles are intended only for individual use.

Mode of application
Novorad® is designed for subcutaneous injections or prolonged infusions in an insulin pumping system (PPI). Novorad® can also be used intravenously under the strict control of the doctor. Never enter insulin intramuscularly.
Each time you change the place of injection within the anatomical area.This will help reduce the risk of formation of seals and ulcerations at the injection site. It is best to introduce a drug into the front abdominal wall, shoulder or the front surface of the hip. Insulin will act faster if it is introduced into the field of the front abdominal wall. Regularly measure the concentration of glucose in the blood.

How to make an injection

Insulin should be administered under the skin. Use the injection technique recommended by your doctor or medical sister, follow the instructions for the introduction of insulin, provided in the instrument manual for insulin.

Hold the needle under the skin at least B seconds. Keep the start button pressed until the needle is extracted from under the skin. This will ensure the introduction of a complete dose of the drug and will prevent blood from entering the needle or insulin cartridge.

After each injection, be sure to remove and discard the needle. Otherwise, fluid flow from the cartridge is possible, which can lead to an improper insulin dosage.

Do not fill in insulin cartridge reuse.
Novorad® Penfill® is designed for use with injection systems for introducing insulin company Novo Nordisk and N Novofine® needles or Novotivist®.
If simultaneously uses the drug Novorad® Penfill® and other insulin in the Penfill® cartridge, it is necessary to use two separate injection systems for the introduction of insulin, one for each type of insulin.
As a precautionary measure, you always carry a spare system to introduce insulin in case of loss or damage to your Novorad® Penfill®.