Апидра®

General characteristics. Structure:

Active agent: insulin глулизин - 100 PIECES (3,49 mg);
excipients: metacresol (m cresol) of 3,15 mg, трометамол (трометамин) 6,0 mg, sodium chloride of 5,0 mg, polysorbate 20 0,01 of mg, sodium hydroxide to рН 7,3, Acidum hydrochloricum to рН 7,3, water for injections to 1,0 ml.

Description. Transparent colourless liquid.

Pharmacological properties:

Pharmacodynamics. Insulin глулизин is a recombinant analog of human insulin which on force of action is equal to usual human insulin.
The most important effect of insulin and analogs of insulin, including insulin глулизин, glucose exchange regulation is. Insulin reduces concentration of glucose in blood, stimulating  glucose absorption with peripheral fabrics,   especially skeletal muscles and fatty tissue, and also inhibiting formation of glucose in a liver. Insulin suppresses a lipolysis in adipocytes, suppresses proteolysis and increases protein synthesis. The researches conducted at healthy volunteers and patients with a diabetes mellitus showed that at hypodermic introduction insulin глулизин begins to work quicker and has the smaller duration of action, than soluble human insulin. At hypodermic introduction the effect of insulin of a glulizin reducing concentration of glucose in blood begins in 10-20 minutes. At intravenous administration effects of decrease in concentration of glucose in blood of insulin of a glulizin and soluble human insulin are equal on force. One unit of insulin of a glulizin has the same hypoglycemic activity, as one unit of soluble human insulin.
In clinical trial of a phase I at patients with a diabetes mellitus of 1 type hypoglycemic profiles of insulin of a glulizin and the soluble human insulin entered subcutaneously in a dose of 0,15 PIECES/kg at different times in relation to standard 15 to minute meal were estimated. Results of a research showed that insulin глулизин, entered in 2 minutes prior to meal, provided the same glycemic control after food, as the soluble human insulin entered in 30 minutes prior to meal. At introduction in 2 minutes prior to meal insulin глулизин provided the best glycemic control after food, than the soluble human insulin entered in 2 minutes prior to meal. Insulin глулизин, entered in 15 minutes after the beginning of meal provided the same glycemic control after food, as the soluble human insulin entered in 2 minutes prior to meal.
The phase I research conducted with insulin gluliziny, insulin лизпро and soluble human insulin at group of patients with a diabetes mellitus and obesity showed that at these patients insulin глулизин keeps the characteristics of bystry action. In this research time of achievement of 20% of full AUC (the area under a curve "concentration time") made 114 minutes for insulin of a glulizin, 121 minutes for insulin лизпро and 150 minutes for soluble human insulin, and AUC(0-2 of hour) reflecting also early hypoglycemic activity, respectively made 427 mg/kg for insulin of a glulizin, 354 mg/kg for insulin лизпро, and 197 mg/kg for soluble human insulin.
Clinical trials Diabetes mellitus of 1 type.
In 26 week clinical trial of a phase III in which comparison of insulin of a glulizin with insulin лизпро was carried out entered subcutaneously shortly before food (for 0k15 minutes) to patients with the diabetes mellitus of 1 type using as basal insulin insulin гларгин insulin глулизин was comparable to insulin лизпро concerning glycemic control which was estimated on change of concentration of glikozilirovanny hemoglobin (YL1S) at the time of a final point of a research in comparison with initial. The comparable values of glucose of blood defined by self-checking were observed. At administration of insulin of a glulizin unlike treatment by insulin лизпро increase in a dose of basal insulin was not required.
12 week clinical trial of the III phase conducted at patients with a diabetes mellitus of 1 type receiving as basal therapy insulin гларгин showed that efficiency of administration of insulin of a glulizin directly after food was comparable to that at administration of insulin of a glulizin just before meal (in 0-15 minutes) or soluble human insulin (in 30-45 minutes prior to food).
In population of the patients who fulfilled the protocol of a research in group of the patients receiving before food insulin глулизин authentically bigger decrease in NL1S in comparison with group of the patients receiving soluble human insulin was observed.

Diabetes mellitus 2 types
26 week clinical trial of a phase III with the week continuation of a research of safety which followed it 26 were conducted for comparison of insulin of a glulizin (in 0-15 minutes prior to meal) with soluble human insulin (in 30-45 minutes of meal) which were entered subcutaneously at patients with a diabetes mellitus 2 types besides using insulin isophanes as basal insulin. The average index of body weight of patients made 34,55 kg/sq.m. Insulin глулизин proved to be comparable to soluble human insulin concerning changes of concentration of NL1S in 6 months of treatment in comparison with a reference value (-0,46% for insulin of a glulizin and-0,30% for soluble human insulin, p=0,0029) and in 12 months of treatment in comparison with a reference value (-0,23% for insulin of a glulizin and-0,13% for soluble human insulin, distinction is not reliable). In this research most of patients (79%) mixed insulin of short action with insulin isofan just before an injection. 58 patients at the time of randomization used peroral hypoglycemic means and received instructions for continuation of their reception in the same (not changed) dose.

Racial origin and floor
In controlled clinical trials at adults distinctions in safety and efficiency of insulin of a glulizin in the analysis of the subgroups allocated on race and a floor were not shown.

Pharmacokinetics. In insulin the glulizena amino acid substitution asparagine of human insulin in a B3 position on a lysine and a lysine in a B29 position on glutaminic acid promotes more bystry absorption.

Absorption and bioavailability
Pharmacokinetic curves "concentration time" at healthy volunteers and patients with a diabetes mellitus 1 and 2 types showed that absorption of insulin of a glulizin in comparison with soluble human insulin was approximately twice quicker, and the reached maximum plasma concentration (Stakh) was approximately twice more.
In the research conducted at patients with a diabetes mellitus of 1 type after hypodermic administration of insulin of a glulizin in a dose of 0,15 PIECES/kg, Ttakh (time of approach of the maximum plasma concentration) made 55 minutes, and Stakh made 82 ± 1,3 ¼¬àä/ml in comparison with Tmax, components are 82 minutes old, and Cmax, a component 46 ± 1,3 ¼¬àä/ml, for soluble human insulin. The average time of stay in a system blood-groove at insulin of a glulizin was shorter (98 minutes), than at soluble human insulin (161 minutes).
In a research at patients with a diabetes mellitus Stakh made 2 types after hypodermic administration of insulin of a glulizin in a dose of 0,2 PIECES/kg 91 ¼¬àä/ml with mezhkvartilny width from 78 to 104 ¼¬àä/ml.
At hypodermic administration of insulin of a glulizin to the area of a front abdominal wall, a hip or shoulder (to the area of a deltoid muscle) absorption was more bystry at introduction to area of a front abdominal wall in comparison with administration of drug to the area of a hip. Absorption speed from area of a deltoid muscle was intermediate.
Absolute bioavailability of insulin of a glulizin after hypodermic introduction made about 70% (73% of area of a front abdominal wall, 71 of area of a deltoid muscle and 68% from area of a hip) and had low variability at different patients.

Distribution
Distribution and removal of insulin of a glulizin and soluble human insulin after intravenous administration are similar, with distribution volumes, components of 13 liters both 21 liters, and elimination half-lives, components of 13 and 17 minutes, respectively.

Removal
After hypodermic introduction insulin глулизин is removed quicker, than soluble human insulin, having the seeming elimination half-life making 42 minutes in comparison with the seeming elimination half-life of soluble human insulin, components are 86 minutes old. In the cross analysis of researches of insulin of a glulizin, both at healthy faces, and at persons with a diabetes mellitus 1 and 2 types, the seeming elimination half-life was in range from 37 to 75 minutes.

Special groups of patients

- Patients with a renal failure
In the clinical trial conducted at persons without diabetes mellitus with a broad range of a functional condition of kidneys (the clearance of creatinine (CC)> of 80 ml/min., 30k50 in ml/min. <30 ml/min.), in general speed of approach of effect of insulin of a glulizin remained. However the need for insulin in the presence of a renal failure can be reduced.

- Patients with a liver failure
At patients with abnormal liver functions pharmacokinetic indicators were not studied.

- Elderly people
Patients have very limited data on pharmacokinetics of insulin of a glulizin with a diabetes mellitus of advanced age.
- Children and teenagers
Pharmacokinetic and pharmakodinamichesky properties of insulin of a glulizin were investigated at children (7-11 years) and teenagers (12-16 years) with a diabetes mellitus of 1 type. In both age groups insulin глулизин is quickly absorbed with Ttakh and Stakh similar that at adults (healthy volunteers and patients with a diabetes mellitus of 1 type). As well as at adults at introduction just before the test with meal insulin глулизин provides the best control of glucose of blood after food, than soluble human insulin. Increase in concentration of glucose in blood after food (AUC is 0-6 hours old - the area under a curve "concentration of glucose in blood - time" from 0 to 6 hours) made 641 mg / (ч*дл) for insulin of a glulizin and 801 mg / (ч*дл) for soluble human insulin.

Indications to use:

The diabetes mellitus demanding treatment by insulin at adults, teenagers and children is more senior than 6 years.

Route of administration and doses:

Apidr's drug should be administered shortly (in 0-15 minutes) to or soon after meal.
Apidr's drug has to be used in the schemes of treatment including or insulin of average duration of action or is long the operating insulin or an analog of insulin of long action, and also Apidr's drug can be used in combination with peroral hypoglycemic means.
The mode of a drug dosing of Apidr is selected individually.
Administration of drug
Apidr's drug is administered either by a subcutaneous injection or by continuous infusion in a hypodermic fatty tissue by means of pompovy system.
Subcutaneous injections of drug of Apidr should be made to the area of a stomach, shoulder or hip, and administration of drug by continuous infusion in a hypodermic fatty tissue is made to the area of a stomach. Places of injections and the place of infusions in above-mentioned areas (a stomach, a hip or a shoulder) have to alternate at  each new administration of drug. And, respectively, for the beginning and duration of action can influence the speed of absorption: an injection site, an exercise stress and other changing conditions. Hypodermic introduction to an abdominal wall provides a little more bystry absorption, than introduction to other above-stated body parts.
It is necessary to observe precautionary measures for a drug hit exception directly in blood vessels. After administration of drug it is impossible to make massage of area of introduction. Patients have to be taught the correct technique of carrying out injections.
Mixing with insulin
Apidr's drug should not mix up with any other drug, except human insulin isophanes.
The Pompovy device for performing continuous hypodermic infusion
When using drug of Apidr with pompovy system for infusion of insulin it cannot be mixed with other medicines.
For more information according to the treatment of drug (watch the section "Instructions for Use and Address").
It is necessary to carry out precisely instructions on the proper handling with previously filled syringes (watch the section "Instructions for Use and Address").
Special groups of patients
Renal failure
The need for insulin at a renal failure can decrease. Abnormal liver function
At patients with an abnormal liver function the need for insulin can decrease because of reduced ability to a gluconeogenesis and delay of metabolism of insulin.
Patients of advanced age
The available data on pharmacokinetics at the patients of advanced age suffering from a diabetes mellitus are insufficient.
The renal failure at advanced age can lead to decrease in need for insulin.
Children and teenagers
Apidr's drug can be used at children 6 years and teenagers are more senior.
Clinical information on use of drug for children is younger than 6 years is limited.

Features of use:

Instructions for use and address
As the drug Apidra® is solution, carrying out resuspending before its use is not required.

Bottles
Bottles of the drug Apidra® are intended for use with insulin syringes with the corresponding scale of units and for use with pompovy insulin system.
Before use examine a bottle. It has to be used only if solution is transparent, colourless and does not contain visible solid particles.

Continuous hypodermic infusional introduction by means of pompovy system
The drug Apidra® can be used for performing the continuous hypodermic infusion of insulin (CHII) by means of the pompovy system suitable for performing infusion of insulin with the corresponding catheters and tanks.
Infusional set and tank have to be replaced each 48 hours with observance of rules of an asepsis.
The patients receiving the drug Apidra® by NPII have to have in a stock alternative insulin on a case of refusal of pompovy system.

Previously filled the syringe handle Optiset®
Before use it is necessary to examine a cartridge the syringe handle inside. It should be used only if solution is transparent, colourless, does not contain visible solid particles and on a consistence reminds water.
Empty the syringe handle Optiset® should not be reused and are liable to destruction.
For prevention of infection previously filled the syringe handle it has to be used only by one patient and not be transferred to other person.

The address about the syringe handle Optiset®
Before use the syringe handle Optiset® attentively read information on use.

Important information on use syringe handle Optiset®
• At each next use always use a new needle. Use only the needles suitable for the syringe handle Optiset®.
• Before each injection always you carry out test on readiness the syringe handle to use (see below).
• If the syringe handle Optiset® is used new, an inspection of readiness for use has to be carried out with use of 8 units which are in advance gathered by the producer.
• The dose selector can be turned only in one direction.
• Never turn the dose selector (change of a dose) after pressing a start button of an injection.
• This insulin the syringe handle is intended only for use of the patient. Other person cannot betray it.
• If the injection to the patient is done by other person, he needs to show extra care in order to avoid accidental wound a needle and infections with an infectious disease.
• Never use damaged the syringe handle Optiset®, and also if you are not sure of its operability.
• Always have reserve the syringe handle Optiset® in case yours the syringe handle Optiset® will be damaged or will be lost.

Insulin check
After removal of a cap about the syringe handle marking on an insulin tank has to be checked to make sure that it contains appropriate insulin. It is necessary to check outward of insulin also: solution of insulin has to be transparent, colourless, not contain visible solid particles and have a consistence, similar to water. It is impossible to use the syringe handle Optiset® if insulin solution muddy, has chromaticity or foreign particles.
Accession of a needle
After removal of a cap it is necessary to connect accurately and densely a needle to the syringe handle. Readiness check the syringe handle to use.
Before carrying out each injection it is necessary to carry out a readiness inspection the syringe handle to use.
For new and unused the syringe handle the dose finger has to stand on figure 8 as it was in advance exposed by the producer.
If the syringe handle is used, the doser should be turned until the dose finger does not stop on figure 2. The doser will rotate only in one direction.
Pull out completely start button to gather a dose. Never rotate the dose selector after the start button is pulled out.
Outside and internal caps of a needle have to be removed. Keep an external cap to remove the used needle.
Holding the syringe handle with the needle directed up it is necessary to tap carefully with a finger on an insulin tank in order that vials of air rose up the direction to a needle.

After that against the stop press a start button.
If the drop of insulin is allocated from a needle tip, the syringe handle and a needle function correctly.
If the drop of insulin is not shown on a needle tip, it is necessary to repeat readiness check the syringe handle to use until insulin does not seem on a needle tip.

Choice of a dose of insulin
The dose from 2 units to 40 units with a step to 2 units can be established. If the dose exceeding 40 units it is required it is necessary to enter in two or more injections. Make sure that you have enough insulin for the necessary dose.
The scale of residual insulin on transparent capacity for insulin shows how many, approximately, insulin remained in the syringe handle Optiset®. This scale cannot be used for an insulin dose fence.
If the black piston is in the beginning of a color strip, so there are, about, 40 units of insulin.
If the black piston is in the end of a color strip, so there are, about, 20 units of insulin.
The dose selector should be turned until the arrow - a dose finger indicates the necessary dose.
Insulin dose fence
The start button of an injection needs to be pulled out to a limit to fill the insulin handle.
Check whether the necessary dose is completely gathered. Notice that the start button is displaced according to the amount of insulin which remained in capacity for insulin.
The start button allows to check what dose is gathered. During check the start button has to be withheld energized. The last visible wide line on a start button shows amount of the taken-away insulin. When the start button is withheld, visible only an upper part of this wide line.
Administration of insulin
Specially trained personnel have to explain to the sick technician of introduction of an injection.
The needle needs to be entered subcutaneously.
The start button of an injection needs to be pressed to a limit. The sounding click will stop when the start button of an injection is pressed to the full. Then the start button of an injection should be held in the pressed state within 10 seconds before to extend a needle from skin. It will provide introduction of all dose of insulin.

Removal of a needle
After each injection the needle should be removed about the syringe handle and to throw out in waste. It will prevent infection, and also insulin leak, intake of air and possible obstruction of a needle. Needles should not be reused.

After that it is necessary to put on back a cap for the syringe handle.

Cartridges
Cartridges have to be used together with insulin the syringe handle, such as Optipen® Pro1 or KLIKSTAR®, and according to recommendations in information provided by the producer of the device. They should not be used with others the syringe handles of reusable use as the accuracy of dosing was established only about the syringe handles Optipen® Pro1 and КликСТАР®.
Instructions of the producer for use the syringe handle Optipen® Pro1 or КликСТАР® concerning loading of a cartridge, accession of a needle and carrying out an injection  of insulin  have to    be carried out precisely.   Examine  a cartridge  before use. It should be used only if solution is transparent, colourless, not containing visible solid particles. Before insertion of a cartridge in the syringe handle of reusable use the cartridge has to be 1-2 hours at the room temperature. Before carrying out an injection follows from a cartridge were successful air bubbles (watch the instruction for use the syringe handle). The application instruction the syringe handle has to be carried out strictly. Empty cartridges cannot be filled repeatedly. If the syringe handle Optipen® Pro1 or КликСТАР® it is damaged, it cannot be used.
If the syringe handle works incorrectly, solution can be gathered from a cartridge in the plastic syringe suitable for insulin in concentration of 100 PIECES/ml, and is entered to the patient.
For the prevention of infection the syringe handle of reusable use it has to be used only at the same patient.

Cartridge Optiklik® system
The cartridge Optiklik® system represents the glass cartridge containing 3 ml of solution of insulin of a glulizin which is fixed in a transparent plastic container with the attached piston mechanism.
The Kartrizhdny Optiklik® system has to be used together with the syringe handle Optiklik® according to recommendations in information provided by the producer of the device.
Instructions of the producer for use the syringe handle Optiklik® concerning loading of cartridge system, accession of a needle and carrying out an injection of insulin have to be carried out precisely.
If the syringe handle Optiklik® it is damaged or works incorrectly, as a result of mechanical defect, it has to be replaced with new.
Before installation of cartridge system in the syringe handle Optiklik® it has to be 1-2 hours at the room temperature. Examine cartridge system before installation. It should be used only if solution is transparent, colourless, not containing visible solid particles. Before carrying out an injection it is necessary to remove air bubbles from cartridge system (watch the instruction for use the syringe handle). Empty cartridges cannot be filled repeatedly.
 
If the syringe handle works incorrectly, solution can be gathered from cartridge system in the plastic syringe suitable for insulin in concentration of 100 PIECES/ml, and is entered to the patient.
For the prevention of infection the syringe handle of reusable use it has to be used only for one patient.

Side effects:

The hypoglycemia, the most frequent undesirable effect of an insulin therapy, can arise in case of use of too high doses of insulin exceeding the need for it.
The following adverse reactions observed in clinical trials connected with administration of drug are listed below on systems of bodies and as reduction of frequency of emergence (very often meeting> 1/10; often meeting:> 1/100, <1/10; infrequently meeting:> 1/1000, <1/100; rare:> 1/10000, <1/1000; very rare:
<1/10000).
Metabolic disturbances
Very often: hypoglycemia
Symptoms of development of a hypoglycemia usually arise suddenly. However usually psychoneurological disturbances against the background of a neuroglycopenia (feeling of fatigue, unusual fatigue or weakness, decline in the ability to concentration of attention, drowsiness, visual frustration, a headache, nausea, confusion of consciousness or its loss, a convulsive syndrome) are preceded by symptoms of adrenergic counterregulation (activation of sympathoadrenal system in response to a hypoglycemia): feeling of hunger, irritability, nervous excitement or a tremor, concern, pallor of integuments, "cold" sweat, tachycardia, the expressed heartbeat (the quicker the hypoglycemia develops and than it is heavier, symptoms of adrenergic counterregulation are stronger expressed to those).
The attacks of a heavy hypoglycemia which are especially repeating can lead to defeat of a nervous system. Episodes of the long and expressed hypoglycemia can threaten life of patients as at increase of a hypoglycemia even death is possible.
Disturbances from skin and hypodermic fabrics
Often meeting: reactions in the place of injections and local reactions of hypersensitivity. During treatment local reactions of hypersensitivity (a hyperemia, puffiness and an itch in the place of an injection) can arise insulin. These reactions usually are passing, and normal at treatment continuation they disappear.
Rare: lipodystrophy.
As a result of disturbance of alternation of injection sites of insulin in any of areas (administration of drug in one and too the place) in an injection site development of a lipodystrophy is possible.
General disturbances
Not often meeting: system reactions of hypersensitivity.
System reactions of hypersensitivity can be shown in the form of a small tortoiseshell, feeling of constraint in breasts, suffocation, allergic dermatitis and an itch. Hard cases of a generalized allergy, including anaphylactic reactions, can be life-threatening.

Interaction with other medicines:

Researches on pharmacokinetic interactions were not conducted. On the basis of the available empirical knowledge concerning other similar medicines emergence of clinically significant pharmacokinetic interactions is improbable.
Some medicines can influence glucose metabolism that can demand correction of doses of insulin of a glulizin and especially careful control of treatment.
To the medicines capable to increase hypoglycemic effect of insulin and to increase predisposition to a hypoglycemia, belong: peroral hypoglycemic means, inhibitors of an angiotensin-converting enzyme, Disopyramidum, fibrata, fluoxetine, monoaminooxidase inhibitors, пентоксифиллин, propoxyhair dryer, salicylates and sulfanamide antimicrobic means.
To the substances capable to reduce hypoglycemic effect of insulin, belong: glucocorticosteroids, даназол, diazoxide, diuretics, an isoniazid, estrogen, gestagena (for example, in hormonal contraceptives), derivatives of a fenotiazin, соматропин, sympathomimetics (for example, Epinephrinum [adrenaline], salbutamol, тербуталин), hormones of a thyroid gland, inhibitors of HIV protease and atypical neuroleptics (for example, olanzapine and clozapine).
Beta adrenoblockers, clonidine, salts of lithium or alcohol can or potentiate or weaken hypoglycemic effect of insulin.

Pentamidine can cause a hypoglycemia with the subsequent hyperglycemia.
Besides, under the influence of drugs with sympatholytic activity, such as beta adrenoblockers, a clonidine, гуанетидин and Reserpinum, symptoms of reflex activation of sympathoadrenal system in response to a hypoglycemia can be less expressed or be absent.
Opportunity and features of a medical use of medicine pregnant women, women during breastfeeding, the children, adults having chronic diseases

Pregnancy
There is no enough information on use of insulin of a glulizin at pregnant women.
Reproductive researches on animals did not reveal any distinctions between insulin gluliziny and human insulin concerning the course of pregnancy, embryonic/fetalis development, childbirth and post-natal development.
Purpose of the drug Apidra® at pregnant women has to be carried out with care. Careful monitoring of concentration of glucose in blood is obligatory.
Patients with the being available before pregnancy or gestational diabetes mellitus need to support glycemic control during all pregnancy. During the first trimester of pregnancy the need for insulin can decrease, and during the second and third trimesters it, as a rule, can increase. At once after the delivery the need for insulin quickly decreases.
 
Patients with a diabetes mellitus should inform the doctor on approach or planning of pregnancy.

Women during breastfeeding
It is unknown whether insulin глулизин in women's milk is excreted. At women during feeding by a breast correction of the mode of dosing of insulin and a diet can be required.

Children and teenagers
The drug Apidra® can be used at children 6 years and teenagers are more senior. Clinical information on use of drug for children is younger than 6 years is limited.
Pharmacokinetic and pharmakodinamichesky properties of insulin of a glulizin were investigated at children (7-11 years) and teenagers (12-16 years) with a diabetes mellitus of 1 type. In both age groups insulin глулизин was quickly absorbed, and the speed of its absorption did not differ from that at adults (healthy volunteers and patients with a diabetes mellitus of 1 type). As well as at adults, in both age groups of children and teenagers at introduction just before the test with meal insulin глулизин provides the best control of glucose of blood after food, than soluble human insulin.
Patients with a renal failure
The need for insulin in the presence of a renal failure can be reduced.
Patients with an abnormal liver function
At patients with an abnormal liver function the need for insulin can decrease because of reduced ability to a gluconeogenesis and delay of metabolism of insulin.
Possible influence on ability of control of vehicles or occupations other potentially dangerous types of activity
Ability of the patient to concentration of attention and speed of psychomotor reactions can be broken as a result of a hypoglycemia or a hyperglycemia, and also as a result of visual frustration. It can represent a certain risk in situations when these abilities are important, for example, at control of vehicles or other mechanisms.
Patients should recommend    to be careful and avoid development
hypoglycemia during driving. It is especially important at patients, at
which it is reduced or there is no ability to realize the symptoms indicating development of a hypoglycemia or there are frequent episodes of a hypoglycemia. At such patients it is necessary to resolve individually an issue of a possibility of management by them of vehicles or other mechanisms.

Contraindications:

Hypersensitivity to insulin to a glulizin or to any of drug components.
Hypoglycemia.

With care
At pregnancy.
Pregnancy and feeding by a breast
There is no enough information on use of insulin of a glulizin at pregnant women.
Reproductive researches on animals did not reveal any distinctions between insulin gluliziny and human insulin concerning the course of pregnancy, embryonic/fetalis development, childbirth and post-natal development.
Purpose of the drug Apidra® Solostar® at pregnant women has to be carried out with care. Careful monitoring of level of glucose in blood is obligatory.
Patients with the being available before pregnancy or gestational diabetes mellitus need to support glycemic control during all pregnancy. During the first trimester of pregnancy the need for insulin can decrease, and during the second and third trimesters it, as a rule, can increase. At once after the delivery the need for insulin quickly decreases.
At women during feeding by a breast correction of the mode of dosing of insulin and a diet can be required.

Overdose:

At surplus of a dose of insulin in relation to the need for it which is defined by consumption of food and/or energy expenditure the hypoglycemia can develop.
There are no special data on overdose of insulin of a glulizin. However, at its overdose development of a hypoglycemia is possible.

Measures for assistance at overdose
Episodes of an easy hypoglycemia can be stopped by means of the reception of glucose or products containing quickly acquired carbohydrates. Therefore it is recommended that patients with a diabetes mellitus constantly had at themselves pieces of sugar, candy, cookies or sweet fruit juice.
Episodes  of a heavy  hypoglycemia  with  a coma,  spasms  or  neurologic frustration can be stopped by intramuscular or hypodermic introduction of 0,5-1 mg of the glucagon or intravenous administration concentrated (20%-40%) of solution of a dextrose (glucose). The supporting administration of carbohydrates intravenously or their intake and observation as resuming of a hypoglycemia after the showing clinical improvement of a condition of the patient is possible can be required by the patient.
After development of a heavy hypoglycemia for establishment of its reason and development of measures for prevention of its repetitions the patient needs hospitalization

Storage conditions:

Period of validity 2 years. Not to use after a period of validity. At a temperature from 2 °C to 8 °C in the place protected from light. Not to freeze! To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Solution for hypodermic introduction of 100 PIECES/ml.
1) On 10 ml of drug in a bottle from transparent, colourless glass (type I). The bottle is corked by a stopper, pressed out by an aluminum cap and covered with a protective lid. On 1 bottle together with the application instruction in a cardboard pack.
2) On 3 ml of drug in a cartridge from transparent, colourless glass (type I). The cartridge is corked on the one hand by a stopper and pressed out by an aluminum cap, on the other hand - a plunger.
a) on 5 cartridges in a blister strip packaging from PVC of a film and a foil
aluminum. On 1 blister strip packaging together with the application instruction
in a cardboard pack.
b) The cartridge is built in in one-time the syringe handle Optiset®. On the 5th syringe handles
ОптиСет® together with the application instruction in the cardboard pack supplied
cardboard fixer.
c) The cartridge is inserted into the cartridge Optiklik® system. On 5 cartridge systems
ОптиКлик® together with the application instruction in the cardboard pack supplied
cardboard fixer.