Instructions for use, description of the drug, abstract. Insulin Apidra Solostar: Instructions for use.
About insulin "Apidra"
Methods of treating diabetes differ high degree efficiency and, at the same time, not all of them are easy enough human organism. The most promising and optimal in this regard are insulins of a short type of impact. It is they who help many of the diabetics and make it possible to restore the body as quickly as possible, as well as the gastrointestinal tract. What is it possible to say about insulin "Apidra"?
Store at least one handle or syringes and insulin vials if you break the handle. Below is given helpful information For those who are treated with insulin. Insulin can not be stored in the refrigerator, but when room temperatureAnd it can be safely used for about 1 month after the first use. It should also be protected from extreme temperatures, excessive fluctuations in temperature and sunlight.
Insulin is not used: It should be stored in the refrigerator, never in the freezer, and it should be removed by at least 30 minutes before the injection and bring to room temperature while holding it on the palm within a few minutes. It is important to hold at least one feather if you break the handle.
About the composition and form of release
So, "Apidra" is a short action insulin. From the point of view of an aggregate state is a solution. It is intended exclusively for subcutaneous implementation and is completely transparent, as well as colorless (in some cases a certain weak shade is still present).
Insulin injection should be subcutaneous. To ensure proper absorption insulin injections should be carried out in subcutaneous tissue, and not in muscles or dermis. The most appropriate sites for the correct injection of insulin are 4. Implementation of multiple injections on the same site inside the site can cause problems such as swelling, depression or redness of the skin, hematoma and severe lipodystrophy. Therefore, it is important to always check the injection places before the introduction of insulin.
Rotate sites. Turn the parties. Rotate within sites. An efficient demonstration scheme includes dividing injection sites to quadrants by introducing into a quadrant per week, and then move clockwise. Injection methods vary depending on the needle length.
Its main component, which in the minimum relationship is available in, insulin under the name of glyzulin, which is characterized by a rapid effect and continuous effect. The auxiliary substances are:
- cresol;
- drometamol;
- sodium chloride;
- polysorbat and many others, which are also available.
All of them, together, form without a doubt a unique drug, which is capable of obtaining with any type of diabetes mellitus: both the first and second. Insulin "Apidra" is produced in the form of special cartridges from colorless glass.
Up to 5 mm needle is located at an angle of 90 degrees relative to the injection site. Inject Insulin Feather. Below are instructions common to all insulin handles. Attach the needle to the handle and screw it into the cartridge. Keep the pen with the needle up and fully press the button until the insulin drop appears. If it is not displayed, select another 2 units. Only after checking that the needle is filled, select the dose administered.
Select the dose administered. Insert the needle into the skin, following the recommended injection technique. When the needle is inserted, press the button completely. Important: Wait 10 seconds before pulling the needle. Do not forget to recycle the material. This is a method that regulates the ready-to-eat insulin dose to give food a carbohydrate content of this particular meal.
On pharmacological effects
How does "apida" affect glucose?
Insulin Depliance is an equivalent of a human hormone capable of recombination. As is known, on the strength of exposure, it can be comparable to soluble human insulinBut it is characterized by the fact that it begins to "work" much more quickly and has a less significant duration of impact. At the same time most useful.
It is a planning system that requires commitment, but ensures flexibility and freedom of choice in FIDE. To find out the amount of carbohydrates, you need to learn to recognize which products they contain, and especially be able to calculate their content in grams.
Below are groups of products containing carbohydrates. Cereals and derivatives: flour, pasta, rice, polenta, bread, crackers, and the like. Sweets: Pies, Pies, Snacks, Chocolate, Ice Cream, etc. Water and not sweet drinks. Carbohydrates are essentially consisting of 2 groups.
The most important and fundamental effect is not only from insulin, but also on its analogues, constant regulation should be considered in terms of glucose transfer. The presented hormone reduces blood sugar concentration, which stimulates the use of glucose using peripheral tissues, as with. In particular, it concerns skeletal muscles and adipose tissue. Also insulin "Apidra" inhibits the formation of glucose in the liver. In addition, it suppresses all the processes associated with lipolysis in adipocytes, proteolysis and accelerates the interaction of the protein.
Simple carbohydrates that quickly absorb: sugar, juice, sweet drinks, candy, honey. Complex carbohydrates whose absorption is slower: grain and derivatives, legumes and potatoes. This difference is very important, especially when carbohydrates are taken for hypoglycemia treatment.
If part of the food consumed does not correspond to 100 g, it will be necessary to apply the proportion. For example, if the total bread contains 65 g of carbohydrates in 100 g and takes up to 50 g, the share of content in grams of carbohydrates in portions is obtained. The same applies to other products, but for pasta and cereals, such as rice and are written, it is important to note that the carbohydrate content specified in the table relates to crude mass; Therefore, if they are weighed after cooking, the value is adjusted.
According to the results of numerous studies, it was proved that blades, being the main component and being implemented two minutes before the use of food, could provide the same controlling the Glucose ratio after eating, which is suitable for dissolving the human type insulin. At the same time, it should be administered in 30 minutes before meals.
First, we need to weigh all carbohydrate products, but over time and practice, we usually learn from evaluating the weight of the products. The table of carbohydrates, which we speak is mainly correct, but this is a simplification. Commercially available products have variable carbohydrate content depending on the quality of manufacture and brand, therefore, when it is possible, it is always better to consult with a product of the product consumed.
This allows you to adjust the insulin dose before receiving glucose in each meal. To make a decision on the dose of insulin before meals, you need to consider four elements. Dinner 20 hours with: steak, bread, salad, banana, ice cream. Physical activity: this is the most difficult factor for calculation, because it is not easy to quantify exercise, especially if it is a playful and unplanned.
About dosage
Most. an important point In the process of using any drug, including insulin solutions, the dosage refinement should be considered. "Apidenta" is recommended to introduce shortly (minimum zero and a maximum of 15 minutes) before or immediately after eating food.
The drug is permissible to use in combination with the specific means of hypoglycemic type.
At first it may seem complex method, but it's just a matter of practice, and then it becomes an automatic process! In everyday practice, it can be useful to use conventional kitchen utensils for feeding products without having to use balance. An example of the table is below.
Insulin is a hormone that plays a key role in regulating the level of glucose in the bloodstream. Insulin deficiency or inability to adequately react to insulin can lead to diabetes symptoms. In addition to its role in blood sugar level control, insulin also participates in fat storage.
How to choose a dose of "Apidra"?
Algorithm for dosing insulin "Apidra" every time should be selected solely individually. In the event that renal failure is diagnosed, it is possible to reduce the need for this hormone.
Thus, the hormone insulin plays an important role in the organism metabolism, adjusting the method of using the body and storage of glucose and fat. A large number of body cells depends on insulin to obtain glucose from the blood, which will be used as an energy.
Various types of insulin: rapid action, intermediate or long term
The chemical structure of high-speed insulin was modified in such a way that it was quickly absorbed into the bloodstream. This change in the chemical structure of insulin is not able to reduce blood sugar levels, but affects the insulin absorption rate. The high-speed insulin is thus absorbed into the bloodstream within a few minutes and has many potential advantages for people with diabetes.
Diabetics with violation of such an organ, as the liver more than likely to reduce the need for insulin production. This occurs due to the reduced ability to the glucine neogenesis and the slowdown of metabolism in the insulin plan. All this makes a clear definition and, not less important, the observance of the designated dosage is extremely important in the process of treating diabetes.
Currently, there are three high-speed insulin. The last addition to high-speed insulin is called glulian-insulin. High-speed insulins are used in insulin pumps to ensure low, but continuous insulin levels. This continuous stream is often called basal insulin and is necessary for normal change Sugar levels in blood between meals and during sleep. Other high-speed insulin units are injected during meals to compensate for the increase in glucose from food you eat.
About injections
Drug needs to be implemented with subcutaneous injections, as well as by constant infusion. It is recommended to do this exclusively in subcutaneous and fatty cells using a special pump system.
Subcutaneous injections must be carried out in:
- abdominal region;
- shoulders;
- hips.
The introduction of insulin "Apidra" using continuous infusion into the subcutaneous or fat tissue should be carried out in the abdomen. Areas are not only injections, but also infusions in the previously represented areas, specialists are recommended to alternate with each other with any new component implementation. The degree of absorption forcing and, as a result, such factors such as the area of \u200b\u200bimplementation, physical exertion and other "floating" conditions can have on the launch and length of exposure.
Intermediate insulin begins to work in 2-4 hours, with a peak of about 6-7 hours after reception and lasts about 20 hours. Intermediate insulin is an isophane insulin, also known as neutral Protamin Hagedorn. Intermediate insulin is often used to treat twice a day. It can be mixed with insulin soluble, but ready-to-use options are also available.
There are two insulin drugs long action. Insulin of long-term action is introduced once a day to maintain a stable blood sugar level. This long insulin should be administered at the same time every day to avoid any space in the insulin coating or the "accumulation" doses of insulin. Sometimes it is recommended to receive insulin of a long-term action adjuvant before eating to avoid a blood sugar burst after eating.
How to carry out injections?
The subcutaneous introduction into the wall of the abdominal region becomes a guarantee of much more accelerated absorption than the introduction into the rest of the human body. Be sure to comply with the precautions to eliminate the drug entering the blood vessels.
Like all medicines, insulin injections can cause side effects. For example, hypoglycemia may occur, which is an abnormally low blood sugar concentration. Hypoglycemia symptoms include dizziness, chills, blurred vision, weakness, headaches and fainting. Other possible side effects are obtained from the injection itself. For example, when injections may occur pain, redness or skin swelling.
Insulin in bodybuilding and weight lifting
Insulin is one of the anabolic body hormones to strengthen the muscles. In particular, it is a hormone highlighted by the pancreas in response to the available nutrients. Food rich in carbohydrates, proteins or both, causes an increase in circulating insulin.
After the introduction of insulin "Apidra" is forbidden to massage the place of administration. Diabetics should also be instructed by the correct technique of injection. That is what will be a key to 100% effective treatment.
About conditions and storage time
For maximum effect in the process of using any medicinal component, you should remember the conditions and storage times. So, the cartridges and systems of this type must be maintained in a little accessible place for children, which should also be characterized by a significant protection against light.
Insulin acts on target cells to increase the absorption and storage of the main nutrients for muscle buildings. Insulin increases nutritioners that transfer glucose and amino acids into muscle cells, avoiding catabolism of these nutrients stored in the form of carbohydrates, proteins or fats.
Thus, an increase in insulin level creates an anabolic environment that promotes muscle growth. Consumption of protein and carbohydrates immediately before training prevents the use of muscle proteins for use in energy. But the period after training is even more important when it comes to maximizing muscle growth.
At the same time, the temperature regime should also be observed, which should be from two to eight degrees.
The component should not be frozen.
After the use of cartridges and cartridge systems has begun, they should also be reduced to a little accessible place for children, which have reliable protection not only from the penetration of light, but also sunlight. At the same time, the temperature indicators should be no more than 25 degrees of heat, otherwise it can say on the quality of insulin "apida".
In the world of bodybuilding insulin is easily accessible if you are looking for it. It takes once a day and is often used before racing. Insulin "feeds" muscles with sugar. Increase sugar will give you more time to work until your exhaustion. However, it can harm your natural ability to produce insulin, because the pancreas will stop production if your body will report that it is enough.
Like any anabolic or steroid, the use of insulin for bodybuilding can lead to health problems. There may be high blood pressure, heavy breathing and even diabetes, especially if you do not handle injection doses.
For more reliable protection from the effect of light, it is necessary to maintain not only cartridges, but also such systems specialists are recommended in their own packages that are made from special cardboard. The shelf life of the described component is two years.
How to use insulin with growth hormone
Insulin is essentially a hormone produced by the pancreas, and regulates the level of glucose in the body. It carries glycogen and other nutrients into the muscles. It binds to another protein outside insulin receptor cells, which modifies cellular metabolism. Insulin increases protein synthesis and causes cells to delay blood amino acids to turn them into proteins.
Growth hormone is produced by a pituitary. It stimulates the growth of tissues, protein sediments and the distribution of subcutaneous fat deposits. Growth hormone also stimulates growth in most organism tissues due to an increase in the number of cells. Also increases the transfer of amino acids and protein synthesis. This, of course, why the bodybuilders use it.
All about shelf life
The shelf life of the drug, which is in the cartridge or this system after primary use is four weeks. It is advisable to remember to mark the number on the packaging in which the primary insulin fence was carried out. It will be an additional guarantee successful treatment Dragic diabetes of any type.
On side effects
Side effects that are characterized by insulin "Apidra" should be noted separately. First of all, we are talking about such a phenomenon as hypoglycemia. It is formed due to the use of unnecessarily significant insulin dosages, that is, such that turn out to be much larger than the real need for it.
From such a function of the body, as the exchange of substances, hypoglycemia is also very formed. All signs of its formation are characterized by suddenness: a pronounced cold sweat appears, tremor and much more. The danger in this particular case is that hypoglycemia will increase, and this can lead to human death.
Local reactions are also possible, which are subject to:
- hyperemia;
- swelling;
- significant toide (in place of injection).
Probably besides this, the development of spontaneous allergic reactionsIn some cases, we are talking about a gloomy or allergic dermatitis. However, sometimes it reminds not skin problems, but just suffocations or other physical symptoms. In any case, all represented side EffectsNo doubt can be avoided if you comply with recommendations and remember the correct and competent use of such insulin as "Apidra."
About contraindications
On contraindications that exist to any medicinal medium should be paid special attention. This is what will be the key to the fact that insulin will work out 100%, being truly effective tool Restoration and protection of the body. Thus, to contraindications prohibiting the use of "Apidra", a steady hypoglycemia should include and an increased degree of sensitivity to insulin with a gluability, as well as any other of the drug components.
Is it possible to use "apidra" pregnant?
With particular care to use this tool, it is necessary for those women who are at any stage of pregnancy or breastfeeding. Since the presented type of insulin is a fairly strong drug, it can cause a certain harm not only to a woman, but also the fruit. However, this is probably not in all cases associated with diabetes. In this connection, it is recommended to pre-take advice from a specialist who denote the admissibility of the application of insulin "Apidra", as well as prescribed the desired dosage.
About special testimony
In the process of using any drug, it is necessary to take into account the significant number of the most different nuances. For example, the fact that the transition of diabetics on a fundamentally new kind of insulin or substance from another concern should be carried out under the strictest specialized observation. This is carried out due to the fact that an acute need may arise in adjusting the therapy in general.
The use of inadequate dosages of a component or a stop of treatment, especially people with diabetes The first type can lead to the formation of not only hyperglycemia, but also specific ketoacidosis. These are the states under which there is quite a real danger to human life.
Insulin human short action.Adjusting the doses of insulin may be necessary in case of a change in the algorithm of activity in the engine or when eating.
Irina Fattahova
The article is very useful. I think many people who suffer from this disease will help. Thank you for painted in detail how to store this drug. The doctor herself also prescribed him. The article is written a lot of good, I hope it will help me!
Preparation: Apidra ®
Active substance: Insulin Glulisine
ATH code: A10AB06
CFG: Insulin Human Short Action
Reg. Number: LS-002064
Registration date: 06.10.06
Owner reg. Undoj: Aventis Pharma Deutschland GmbH (Germany)
Dosage form, composition and packaging
Solution for p / k administration Transparent, colorless or almost colorless.
Excipients:m-cresol, thrometamol, sodium chloride, polysorbate 20, sodium hydroxide, hydrochloric acid concentrated, water d / and.
3 ml - colorless glass cartridges (1) - opticick cartridge system (5) - cardboard packs.
3 ml - colorless glass cartridges (5) - packing cell contour (1) - packs cardboard.
Description of the drug is based on officially approved instructions for use.
PHARMACHOLOGIC EFFECT
Insulin Depliance is a recombinant analogue of human insulin, which is equal to soluble human insulin, but begins to act faster and has a smaller duration of action.
Most important action Insulin and analogs of insulin, including insulin of glucine, is the regulation of glucose exchange. Insulin reduces glucose concentration in the blood, stimulating glucose absorption by peripheral tissues, especially skeletal muscles and adipose tissue, as well as inhibiting glucose formation in the liver. Insulin suppresses lipolysis in adipocytes, proteolysis and increases protein synthesis. Studies conducted in healthy volunteers and patients with diabetes mellitus showed that with p / to the introduction of insulin, glucaine begins to act faster and has a smaller duration of action than soluble human insulin. When p / to the introduction, the hypoglycemic effect develops after 10-20 minutes. When in / in the introduction, the hypoglycemic effects of insulin of depliance and soluble human insulin are equal in force. One unit of insulin of depliaisin has the same hypoglycemic activity, as was one unit of soluble human insulin.
In the study of phase I in patients with type 1 diabetes mellitus, hypoglycemic insulin insulin and soluble human insulin injected in a dose of 0.15 me / kg at different times in relation to the standard 15-minute reception of food.
The results of the study showed that insulin of gluelizin introduced 2 minutes before eating, ensured the same control of the glucose level after eating, as the soluble human insulin introduced 30 minutes before eating. With the introduction of 2 minutes before meals, insulin, glucine was provided by the best control of glucose levels after eating than soluble human insulin introduced 2 minutes before meals. Insulin Depliance introduced 15 minutes after the start of food intake, gave the same control of the glucose level after eating, as the soluble human insulin introduced 2 minutes before eating.
Obesity
The phase I study was carried out with insulin of gluelizin, insulin Lispro and soluble human insulin in a group of patients with obesity, demonstrated that in these patients insulin blasting preserves the development time of the effect. In this study, the achievement time of 20% of the total AUC was 114 min for insulin of depliance, 121 min for insulin Lispro and 150 min for soluble human insulin, and AUC 0-2 hours, reflecting also early hypoglycemic activity, was 427 MGHKG -1 for insulin Depliance, 354 MGHKG -1 for insulin Lispro, and 197 MGHKG -1 for soluble human insulin.
Clinical researches
Sugar diabetes type 1
In a 26-week clinical study of Phase III, in which there was a comparison of gluelizin insulin with insulin, administered by P / k shortly before the meal (in 0-15 minutes), patients with type 1 diabetes mellitus, using Glargy, insulin gluelizin as basal insulin It was comparable to insulin Lispro in terms of glucose control, which was assessed by concentration change glicated hemoglobin (HBA 1C) at the time of the end point of the study in comparison with the outcome. Comparison values \u200b\u200bof blood glucose concentration were observed, determined by self-control. With the introduction of insulin of depliance, in contrast to the treatment of insulin, Lispro did not need to increase the dose of basal insulin.
A 12-week clinical study of the phase III, conducted in patients with type 1 diabetes, which obtained as basal therapy of Glargine as basal therapy showed that the effect of insulin insulin imaging immediately after a meal was comparable with such when the insulin of depliance is directly before taking food (for 0 -15 min) or soluble human insulin (30-45 minutes before meals).
Among the patients who fulfilled the study protocol, in the group of patients who received insulin Xlucein, was observed a reliably greater decrease in HBA 1C compared with a group of patients receiving soluble human insulin.
Sugar diabetes type 2
A 26-week clinical study of Phase III with a 26-week continuation continued in the form of a safety study was made comparison of insulin of depliances (0-15 minutes before meals) with soluble human insulin (for 30-45 minutes of food), which were introduced P / to patients with type 2 diabetes mellitus, apart from this using as basal isofan insulin. The average body mass index of patients was 34.55 kg / m 2. Insulin Depliance showed itself comparable with soluble human insulin in terms of changes in the concentrations of HBA 1C after 6 months of treatment compared to the outcome (-0.46% for insulin of depliance and -0.30% for soluble human insulin, p \u003d 0.0029) and after 12 months of treatment compared Outcome (-0.23% for insulin of depliance and -0.13% for soluble human insulin, the difference is not reliably). In this study, most patients (79%) mixed their short-acting insulin with isofan insulin immediately before injection. 58 patients at the time of randomization used oral hypoglycemic drugs and received instructions to continue their use in the same dose.
Racial origin and floor
In controlled clinical studies In adults, there was no differences in the safety and effectiveness of insulin of blasting in the analysis of subgroups allocated on racial origin and the floor.
Pharmacokinetics
In insulin of depliance, the replacement of amino acids of the asparagin of human insulin in position B3 on lysine and lysine in position B29 on glutamic acid contributes to more rapid absorption from the injection site.
Absorption and bioavailability
Pharmacokinetic concentration curves-time in healthy volunteers and patients with type 1 and 2 diabetes mellitus demonstrated that glulicin insulin absorption compared to soluble human insulin was approximately 2 times faster with a achievement of approximately 2 times greater than the maximum concentration.
In a study conducted in patients with type 1 diabetes mellitus, after p / k insertion of insulin of depth, in a dose of 0.15 IU / kg with Max, it was achieved after 55 minutes and was 82 ± 1.3 microme / ml compared to C Max soluble human insulin, which was achieved After 82 minutes and was 46 ± 1.3 microme / ml. The average time of stay in the systemic blood flow at insulin of the DepliaCin was shorter (98 min) than that of soluble human insulin (161 min). In the study in patients with type 2 diabetes mellitus after p / k, the introduction of insulin of aluminum in a dose of 0.2 IU / kg with Max was 91 microme / ml (from 78 to 104 microme / ml).
With p / to the introduction of insulin of depliance into the front abdominal wall, the thigh or shoulder (area of \u200b\u200bthe deltoid muscle) absorption was faster when introduced into the front abdominal wall compared with the introduction of the drug in the thigh. The speed of absorption from the area of \u200b\u200bthe deltoid muscle was intermediate. The absolute bioavailability of insulin of depliance (70%) in different places of administration was similar and had low variability between different patients (the coefficient of variation is 11%).
Distribution and elimination
The distribution and removal of insulin of depliance and soluble human insulin after a / in administration are similar; V D is 13 liters and 22 l, t 1/2 - 13 and 18 minutes, respectively.
After p / k administration of insulin, the aluminum is excreted faster than soluble human insulin: at the same time t 1/2 is 42 minutes compared with T 1/2 of soluble human insulin 86 min. With cross-analysis analysis of insulin insulin, both in healthy individuals and people with diabetes type 1 and 2, T 1/2 was in the range from 37 to 75 minutes.
Pharmacokinetics in special clinical cases
In a clinical study conducted in individuals without diabetes mellitus with a wide range functional state Kidney (QC more than 80 ml / min, 30-50 ml / min, less than 30 ml / min), the speed of the effect of the insulin effect of the depthizin as a whole was preserved. However, insulin need renal failure can be reduced.
In patients with impaired liver function, pharmacokinetic indicators were not studied.
There are very limited data on the pharmacokinetics of insulin of blade in elderly patients with diabetes mellitus.
Pharmacokinetic and pharmacodynamic properties of insulin of blades were investigated in children (7-11 years old) and adolescents (12-16 years old) with type 1. In both age groups, insulin, the gluelizin is quickly absorbed, and the achievement time and value with MAX are similar to that Adults. As in adults, when administered immediately in front of the test with meals, insulin, glucine provides the best control of blood glucose after eating than soluble human insulin. Increased blood glucose concentrations after meals (AUC 0-6 h) amounted to 641 mg? Hour? DL -1 for insulin of depthiasis and 801 mg? Hour? For -1 for soluble human insulin.
Indications
Sugar diabetes, requiring insulin treatment (in adults).
Dosing mode
The preparation of apida should be administered shortly (in 0-15 minutes) before or shortly after meals.
The drug preparation should be applied in therapy schemes that include or insulin the average duration of action or insulin or an analog of prolonged insulin. The drug can be used in combination with oral hypoglycemic agents.
The dosing mode of the drug of the Apida is selected individually.
Introduction of the drug
The preparation of the apida is administered or by p / to injection or by continuous infusion into subcutaneous fat tissue using the pump system.
P / k injections should be produced into the area of \u200b\u200bthe abdomen, shoulder or hips, and the administration of the drug by continuous infusion into subcutaneous fat tissue is made in the abdomen area. Injection and infusion places in the above areas (belly, thigh or shoulder) should be alternate with each new introduction of the drug. On the speed of absorption and, accordingly, at the beginning and duration of action may affect the place of administration, physical exertion and other changing conditions. The introduction into the abdominal wall provides a somewhat faster absorption than the introduction to other of the above parts of the body.
Precautions should be followed to exclude the drug directly in blood vessels. After the administration of the drug, it is impossible to massage the field of administration. Patients must be trained in the correct technique of injection.
Mixing with insulin
The drug Apida cannot be mixed with any other drugs, except human isofan insulin.
Pumping device for continuous p / k infusion
When using the preparation of the Apidra with a pump system for insulin infusion it cannot be mixed with other drugs.
Terms of use of the drug
Because Picture preparation is a solution, no resuspension before its use is required.
Mixing with insulin
When mixing S. human Isofan Insulin The preparation of the apida is gaining first in the syringe. Injection should be carried out immediately after mixing, because There are no data on the use of mixtures cooked long before injection.
Cartridges
Cartridges should be used together with an insulin syringe knob, such as optipin pro1, and in accordance with the recommendations in the instructions provided by the device manufacturer.
Managers' instructions for using a syringe knob Optiz Pro1 relative to the boot of the cartridge, the needle attachment and insulin injection should be accurately performed. Before use, the cartridge should be inspecting and used only if the solution is transparent, colorless, not containing visible solid particles. Before installing the cartridge in the reusable syringe knob, the cartridge must be 1-2 hours at room temperature. Before carrying out an injection from the cartridge, remove air bubbles (see the instruction on using a syringe knob). Empty cartridges are not filled again. If the syringe knob opens is damaged, it cannot be used.
If the syringe knob is faulty, the solution can be dialed out of the cartridge into a plastic syringe, suitable for insulin at a concentration of 100 me / ml, and is introduced to the patient.
Opticlik cartridge system
The optical illuminated cartridge system is a glass cartridge containing 3 ml of aluminum insulin solution, which is fixed into a transparent plastic container with an attached piston mechanism.
The opticick cartridge system should be used together with the syringe knob of the opticalik in accordance with the recommendations of the instruction provided by the device manufacturer.
The manufacturer's instructions for using a syringe-handle opticick (relative to the load of the cartridge system, connection of the needle and conducting insulin injection) should be accurately performed.
If the syringe knob opticick is damaged or works incorrectly (as a result of a mechanical defect), it should be replaced with a good one.
Before installing the cartridge system, the syringe knob opticalik must be 1-2 hours at room temperature. Inspect the cartridge system before installing. It should be used only if the solution is transparent, colorless, not containing visible solid particles. Before carrying out an injection from the cartridge system, remove air bubbles (see instructions for using a syringe knob). Empty cartridges are not filled again.
If the syringe knob is not proper, the solution can be dialed out of the cartridge system into a plastic syringe, suitable for insulin at a concentration of 100 me / ml, and is introduced to the patient.
To prevent infection, the reusable syringe knob should be used only for one patient.
SIDE EFFECT
Hypoglycemia - The most frequent undesirable effect of insulin therapy, which may occur in the case of use of too high doses of insulin, exceeding the need for it.
Adverse reactions related to the introduction of the drug are observed in clinical studies are listed below on organ systems and in order to reduce the frequency of occurrence. When describing the frequency of occurrence, the following criteria are used: very often -\u003e 10%; often -\u003e 1% and< 10%; иногда - > 0.1% I.< 1%; редко - > 0.01% I.< 0.1%; очень редко - < 0.01%.
From the metabolism:very often - hypoglycemia. Symptoms of the development of hypoglycemia usually arise suddenly. These include the appearance of cold sweat, the pallor of the skin, the feeling of fatigue, nervous arousal or tremor, anxiety, weakness, confusion of consciousness, difficulty concentration of attention, drowsiness, excessive feeling of hunger, visual disorders, headache, nausea and severe heartbeat. Hypoglycemia can increase, which can lead to loss of consciousness and / or to the emergence of convulsions, as well as to a temporary or constant deterioration of the function of the brain or even a fatal outcome.
Local reactions:often - local sensitivity reactions (hyperemia, swelling and itching at the injection site). These reactions are usually transient and disappeared when the treatment is continued. Rarely - lipodystrophy (as a result of a violation of alternation of insulin injection places in any of the regions / administration of the drug in the same place /).
Allergic reactions: Sometimes - urticaria, a feeling of shy in the chest, bronchospasm, allergic dermatitis, itching. Heavy cases of generalized allergic reactions (including anaphylactic) can be life-threatening.
Contraindications
Hypoglycemia;
Increased sensitivity to insulin blasting or some of the components of the drug.
FROM cautionit should be applied during pregnancy.
Pregnancy and lactation
When prescribing the drug during pregnancy, caution should be taken. Mandatory thorough monitoring of blood glucose levels. Clinical data on the use of insulin of depliance during pregnancy is absent.
Patients with diabetes mellitus (including gestational) is necessary throughout the pregnancy to maintain optimal metabolic control. In the first trimester of pregnancy, the need for insulin can decrease, and in the II and III trimesters, it, as a rule, can increase. Immediately after childbirth, the need for insulin is quickly reduced.
IN experimental studies Reproductiveness was not identified any differences between the influence of the use of insulin of depliance and human insulin on the course of pregnancy, the development of embryo and fetus, childbirth and postnatal development.
It is not known whether insulin is distinguished in globein with breast milk, but human insulin does not stand out with breast milk and is not absorbed when taking inside.
During lactation ( breastfeeding) Correction of insulin doses and diet may be required.
SPECIAL INSTRUCTIONS
Translation of the patient to a new type of insulin or insulin of another manufacturer should be carried out under strict medical supervision, because It may be necessary to the correction of all therapy. The use of inadequate doses of insulin or cessation of treatment, especially in patients with type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis - states that are potentially life-threatening.
The time of possible development of hypoglycemia depends on the rate of occurrence of the effect of insulins used and, in connection with this, it may vary when changing the treatment regimen. To the conditions that can change or make less pronounced harbingers of the development of hypoglycemia include the long existence of diabetes, intensification of insulin therapy, the presence of diabetic neuropathy, the reception of some medicinal preparations (such as beta-adrenoblockers), or translation of the patient with an insulin of animal origin on human insulin.
Correction of insulin doses may also be required when changing the mode of motor activity or meals. Exercise stressPerformed immediately after eating may increase the risk of hypoglycemia. Compared to soluble human insulin after injection of high-speed analogs, hypoglycemia insulin may develop earlier.
Uncompensated hypoglycemic or hyperglycemic reactions can lead to loss of consciousness, coma development or death.
The need for insulin may vary in concomitant diseases or emotional overloads.
OVERDOSE
Symptoms: There are no special data on insulin insulin; The development of hypoglycemia is possible various degrees severity.
Treatment: Episodes of light hypoglycemia can be stopped by taking glucose or products containing sugar. Therefore, it is recommended that patients with diabetes constantly have a piece of sugar, candy, cookies or sweet fruit juice with them. The episodes of severe hypoglycemia, during which the patient loses consciousness, can be stopped by a / m or p / to the introduction of 0.5-1 mg of glucagon or in / in the administration of dextrose (glucose) if the patient does not respond to the introduction of glucagon for 10-15 minutes, It is also necessary to introduce dextrose in / c. After restoring consciousness, it is recommended to give a patient carbohydrates inside to prevent the repetition of hypoglycemia. After the introduction of glucagon to establish the cause of this severe hypoglycemia and prevent the development of other similar episodes, the patient should be observed in the hospital.
Medicinal interaction
Research by pharmacokinetic medicinal interaction The drug was not conducted. Based on the existing empirical knowledge for other similar drugs, the emergence of clinically significant pharmacokinetic interaction is unlikely. Some substances can affect the metabolism of glucose, which may require the correction of the doses of insulin of depliance and especially careful control of the treatment and condition of the patient.
For sharing oral hypoglycemic aPF inhibitors, Dizeciramide, fibrates, fluoxetine, Mao, Pentoxifyllin inhibitors, propoxyphen, salicylates and sulfonamide antimicrobial means can enhance the hypoglycemic effect of insulin and increase the predisposition to hypoglycemia.
With the joint use of GKS, Danazole, diazoxide, diuretics, isoniazide, derivatives of phenothiazine, somatopin, sympathomimetics (for example, epinephrine / adrenaline /, salbutamol, terbutal), hormones thyroid gland, estrogens, progestins (for example, oral contraceptives), protease inhibitors and antipsychotic medicinal products (for example, Olanzapine and Clozapine) can reduce the hypoglycemic effect of insulin.
Beta-adrenoblays, clonidine, lithium or ethanol salts can or potentiate or weaken the hypoglycemic effect of insulin. Pentamidine can cause hypoglycemia with subsequent hyperglycemia.
With the use of drugs with sympatholic activity (beta-adrenoblastors, clonidine, guanethidine and reserpine) symptoms of reflex adrenergic activation in hypoglycemia may be less pronounced or absent.
Pharmaceutical interaction
Due to the lack of studies of compatibility, insulin, blasting should not be mixed with any other drugs with the exception of human isofan insulin.
When administered using an infusion pump, the drug preparation should not be mixed with other drugs.
Conditions of vacation from pharmacies
The drug is released by the prescription.
Terms and Storage Terms
Cartridges and cartridge systems Optical should be stored in an inaccessible for children protected from light at temperatures from 2 ° to 8 ° C, do not freeze.
After starting the use of cartridges and cartridge systems, opticalik should be stored in an inaccessible for children protected from light at a temperature not higher than 25 ° C.
To protect against light impact, stored cartridges and cartridge systems opticalik in your own cardboard packaging.
Shelf life - 2 years. The shelf life of the drug in the cartridge, the parameter system of opticalik after the first use - 4 weeks. It is recommended to mark on the label the date of the first fence of the drug.
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