Insuman Bazal GT

General characteristics. Structure:

Active agent: insulin human (100% crystal insulin of protamin) - 3,571 mg (100 ME);
excipients: protamin sulfate - 0,318 mg, metacresol (m cresol) - 1,500 mg, phenol - 0,600 mg, zinc chloride - 0,047 mg, dihydrophosphate sodium a dihydrate - 2,100 mg, глицерол (85%) - 18,824 mg, sodium hydroxide (it is used for finishing рН) - 0,576 mg, Acidum hydrochloricum (it is used for finishing рН) - 0,246 mg, water for injections - to 1,0 ml.
Description: the suspension of white or almost white color which is easily dispersed.

Pharmacological properties:

Pharmacodynamics. Инсуман® Bazal of GT contains the insulin identical on the structure to human  insulin and     E. Coli of K12 135 pINT90d received by method of genetic engineering with use of a strain. Mechanism of effect of insulin:
- reduces concentration of glucose in blood, promotes anabolic effects and reduces catabolic effects;
- increases transfer of glucose in cells and formation of a glycogen in muscles and a liver and improves pyruvate utilization, inhibits a glycogenolysis and glyconeogenesis;
- increases a lipogenesis in a liver and fatty tissue and inhibits a lipolysis;
- promotes intake of amino acids in cells and to protein synthesis;
- increases intake of potassium in cells.
Инсуман® Bazal of GT is insulin of long action with the gradual beginning of action. After  hypodermic introduction the hypoglycemic effect occurs within 1 hour, and reaches a maximum within 3-4 hours. The effect remains within 11-20 hours.

Pharmacokinetics. At healthy faces   the insulin elimination half-life   makes about 4-6 minutes of plasma. At patients with a heavy renal failure it is more long. However it should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Indications to use:

The diabetes mellitus demanding treatment by insulin.

Route of administration and doses:

Target concentration of glucose in blood, insulin drugs which it is necessary to use, the insulin dosing mode (doses and time of introduction) have to be defined and adjusted individually to correspond to a diet, the level of physical activity and a way of life of the patient.
There are no precisely regulated rules of dosing of insulin. However the average daily dose of insulin makes 0,5-1,0 ME on body weight kg a day, and 40-60% of a necessary daily dose of insulin fall to the share of human insulin of the prolonged action.
The doctor has to give necessary instructions how often to define concentration of glucose in blood, and also to make the corresponding recommendations in case of any changes in a diet or in the insulin therapy mode. Transition from other type of insulin to Insuman® Bazal
At transfer of patients from one type of insulin on another correction of the mode of dosing of insulin can be required: for example, upon transition from insulin of animal origin to human insulin, or upon transition from one drug of human insulin to another, or upon transition from the treatment mode soluble human insulin on the mode including insulin of more long action.
After transition from insulin of animal origin to human insulin the insulin dose decline, especially at patients who were conducted on rather low concentration of glucose in blood earlier can be required; at the patients having tendency to development of gipoglikemiya; at patients for whom high doses of insulin in connection with existence of antibodies to insulin were required earlier. The need for correction (decrease) of a dose can arise at once after transition to a new type of insulin or gradually develop within several weeks.
Upon transition from one type of insulin to another and then in the next first weeks careful control of concentration of glucose in blood is recommended. At patients for whom high doses of insulin because of existence of antibodies were required it is recommended to pass to other type of insulin under medical observation in a hospital.
Additional change of a dose of insulin
Improvement of metabolic control can lead to increase in sensitivity to insulin therefore the need of an organism for insulin can decrease.
Change of a dose can be also required at:
- change of body weight of the patient;
- change of a way of life (including a diet, level of physical activity, etc.);
- other circumstances which can promote increase in predisposition to hypo - or a hyperglycemia (see the section "Special Instructions").
The dosing mode at special groups of patients
Elderly people
At elderly people the need for insulin can decrease (see sections "With care, "Special Instructions"). It is recommended that an initiation of treatment, increase in doses and selection of maintenance doses at patients of advanced age with a diabetes mellitus, were carried out with care to avoid hypoglycemic reactions.
Patients with a liver or renal failure
At patients with a liver or renal failure the need for insulin can decrease.
Administration of the drug Insuman® Bazal GT
Инсуман® Bazal GT is usually entered deeply subcutaneously in 45-60 minutes prior to meal. The place of an injection within one area of introduction every time should be changed. Change of area of administration of insulin (for example, from area of a stomach on area of a hip) has to is made only after consultation with the doctor as absorption of insulin and respectively effect of decrease in concentration of glucose in blood can vary depending on area of introduction (for example, area of a stomach or area of a hip).
Инсуман® Bazal GT is not used in different insulin pompa (including implanted).
Intravenous administration of drug is absolutely excluded!
It is impossible to mix Insuman® Bazal of GT with insulin of other concentration, with insulin of animal origin, analogs of insulin or other medicines.
Инсуман® Bazal of GT can mix up with all drugs of human insulin of the Sanofi-aventis group company. Инсуман® Bazal GT cannot be mixed with the insulin intended especially for use in insulin pompa.
It is necessary to remember that concentration of insulin makes 100 ME/ml (for bottles of 5 ml or cartridges of 3 ml) therefore it is necessary to use only plastic syringes expected this concentration of insulin in case of use of bottles or the syringe handles Optipen Pro1 or KLIKSTAR in case of use of cartridges. The plastic syringe should not contain any other drug or its residual quantities. Before the first set of insulin of a bottle it is necessary to remove a plastic cap (existence of a cap - the certificate of not opened bottle). Just before set suspension has to be well mixed, at the same time foam should not be formed. It is the best of all to do it, turning a bottle, holding it at an acute angle between palms. After hashing suspension has to have a homogeneous consistence and milky-white color. Suspension cannot be used if it has any other appearance i.e. if it остаетс transparent or formed flakes or lumps in the liquid, at a bottom or walls of a focon. In such cases it is necessary to use other bottle meeting above-mentioned conditions and also it is necessary to inform the doctor.
Before a set of insulin of a bottle in the syringe suck in the air volume equal to the appointed dose of insulin and enter it into a bottle (not in liquid). Then the bottle together with the syringe is overturned the syringe from top to bottom and gain the necessary amount of insulin. Before an injection it is necessary to remove vials of air from the syringe. In the place of an injection take a skin fold, enter a needle under skin and slowly enter insulin. After an injection the needle is slowly taken and press the place of a prick a cotton plug within several seconds. Date of the first set of insulin of a bottle should be written down on the label of a bottle.
After opening bottles can be stored at a temperature not above +25 °C within 4 weeks in the place protected from light and heat.
Before installation of a cartridge (100 ME/ml) in the syringe handle Optipen of Pro1 and KLIKSTAR stand him 1-2 hours at the room temperature (injections of the cooled insulin are more painful). After that, softly overturning a cartridge (to 10 times) achieve receiving homogeneous suspension. Each cartridge in addition has three metal balls for more bystry hashing of its contents. After establishment of a cartridge in the syringe handle, before each injection of insulin several times turn the syringe handle for receiving homogeneous suspension. After hashing suspension has to have a homogeneous consistence and milky-white color. Suspension cannot be used if it has any other appearance i.e. if it remains transparent or flakes or lumps in the liquid, at a bottom or walls of a cartridge were formed. In such cases it is necessary to use other cartridge meeting above-mentioned conditions and also it is necessary to inform the doctor. Remove any vials of air from a cartridge before an injection (see the Instruction for use the syringe handles Optipen Pro1 or KLIKSTAR).
The cartridge is not counted on drug Insuman® mixing Bazal by GT with other insulin. Empty cartridges are not subject to a refill. If there was a breakdown the syringe handle, it is possible to enter a required dose from a cartridge by means of the ordinary syringe. It is necessary to remember that concentration of insulin in a cartridge makes 100 ME/ml therefore it is necessary to use only plastic syringes expected this concentration of insulin. The syringe should not contain any other drug or its residual quantities.
After installation of a cartridge it can be used within 4 weeks. It is recommended to store at a temperature not above +25 °C in the place protected from light and heat. In the course of use of a cartridge the syringe handle should not be stored in the refrigerator (as injections the cooled insulin are more painful). After installation of a new cartridge check correctness of work the syringe handle to an injection of the first dose (see the Instruction for use the syringe handles Optipen
Pro1 or KLIKSTAR).

Features of use:

In case of insufficient glycemic control or emergence of a tendency to episodes hyper - or a hypoglycemia before making decision on dose adjustment of insulin it is necessary to check surely performance of the ordered mode of administration of insulin, to make sure that insulin is entered into the recommended area, to check correctness of carrying out the equipment of an injection and all other factors which can affect effect of insulin. As the concomitant use of a number of drugs (see the section "Interaction with Other Medicines") can weaken or strengthen hypoglycemic effect of the drug Insuman® Bazal of GT, at its use it is impossible to accept any other drugs without special permission of the doctor. Hypoglycemia
The hypoglycemia arises if the dose of insulin exceeds the need for it. The risk of development of a hypoglycemia is high in an initiation of treatment insulin, upon transition to other drug of insulin, patients with the low supporting concentration have glucose in blood.
As well as for all insulin, it is necessary to observe extra care and it is recommended to carry out intensive control of concentration of glucose to blood at patients for whom hypoglycemic episodes can have special clinical value, such as patients with the expressed stenosis of coronary or brain arteries (risk of cardial or cerebral complications of a hypoglycemia), and also at patients with a proliferative retinopathy, especially, if he did not carry out photocoagulation (laser therapy) as they have a risk of a passing amaurosis (total blindness) at development of a hypoglycemia. There are certain clinical symptoms and signs which have to specify to the patient or people around about the developing hypoglycemia. Treat them: the increased perspiration, humidity of integuments, tachycardia, disturbances of a cordial rhythm, increase in arterial pressure, retrosternal pains, a tremor, concern, feeling of hunger, drowsiness, sleep disorders, sensation of fear, a depression, irritability, unusual behavior, feeling of concern, paresthesia in a mouth and around a mouth, pallor of integuments, a headache, lacks of coordination of movements, and also passing neurologic disturbances (disturbances of the speech and sight, paralytic symptoms) and unusual feelings. At the accruing decrease in concentration of glucose of the patient can lose self-checking and even consciousness. In such cases the cold snap and humidity of skin can be observed, and also spasms can develop. Therefore each patient, with a diabetes mellitus, the receiving insulin, has to learn to distinguish the unusual symptoms which are a sign of the developing hypoglycemia. The patients who are regularly controlling concentration of glucose in blood are exposed to risk of development of a hypoglycemia less often. The patient can correct the decrease in concentration of glucose noticed by him in blood by reception of sugar or food with the high content of carbohydrates. For this purpose the patient always has to have at himself 20 g of glucose. At more serious conditions of a hypoglycemia it is shown п / to a glucagon injection (which the doctor or average medical personnel can make). After sufficient improvement of a state, the patient has to eat. If the hypoglycemia does not manage to be eliminated at once, then it is necessary to call the doctor urgently. It is necessary to inform the doctor on development of a hypoglycemia in order that he made the decision on need of dose adjustment of insulin at once. Non-compliance with a diet, the admission of injections of insulin, the increased need for insulin as a result of infectious or other diseases, decrease in physical activity can lead to increase in concentration of glucose in blood (hyperglycemia), it is possible with increase in concentration of ketonic bodies in blood (ketoacidosis). Ketoacidosis can develop within several hours or days. At the first symptoms of a metabolic acidosis (thirst, a frequent urination, appetite loss, fatigue, dry skin, deep and hurried breathing, high concentration of acetone and glucose in urine) urgent medical intervention is necessary.
When changing the doctor (for example, at hospitalization concerning accident, a disease during issue) the patient has to tell the doctor that he has a diabetes mellitus.
Patients should be warned about conditions when can change, be less expressed or be absent completely the symptoms warning about development of a hypoglycemia, for example:
- at significant improvement of glycemic control;
- at gradual development of a hypoglycemia;
- at patients of advanced age;
- at patients with vegetative neuropathy;
- at patients with the long anamnesis of a diabetes mellitus;
- at the patients who are at the same time receiving treatment by some medicines (see the section "Interaction with other medicines). Such situations can lead to development of a heavy hypoglycemia (and it is possible with a loss of consciousness) earlier, than the patient realizes that he at it develops
hypoglycemia.
In case of detection of normal or reduced values of glikozilirovanny hemoglobin it is necessary to consider the possibility of development of the repeating, not distinguished (especially night) episodes of a hypoglycemia.
For reduction of risk of emergence of a hypoglycemia it is required that the patient precisely followed the ordered mode of dosing and a diet, correctly carried out injections of insulin and it was warned about symptoms of the developing hypoglycemia.
The factors increasing predisposition to development of a hypoglycemia demand careful control and can demand dose adjustment. Treat these factors:
- change of area of administration of insulin;
- increase in sensitivity to insulin (for example, elimination of stressful factors);
- unusual (the increased or long physical activity);
- intercurrent pathology (vomiting, diarrhea);
- insufficient meal;
- admission of meal;
- alcohol intake;
- some noncompensated endocrine diseases (such as hypothyroidism and insufficiency of a front share of a hypophysis or insufficiency of bark of adrenal glands);
- a concomitant use of some medicines (see the section "Interaction with Other Medicines"). Intercurrent diseases
At intercurrent diseases intensive metabolic control is required. In many cases analyses of urine on presence of ketonic bodies are shown, and insulin dose adjustment is often necessary. The need for insulin often increases. Patients with a diabetes mellitus of 1 type have to continue to consume regularly at least a small amount of carbohydrates even if they can accept only a small amount of food or if they have a vomiting and they never have to stop administration of insulin completely. Cross immunological reactions
At quite large number of patients with hypersensitivity to insulin of animal origin transition to human insulin in connection with cross immunological reaction of human insulin and insulin of animal origin is complicated. At hypersensitivity of the patient to insulin of animal origin, and also to m cresol, portability of the drug Insuman® of Bazal of GT has to be estimated in clinic by intradermal tests. If at the intradermal test hypersensitivity to human insulin comes to light (immediate reaction, like Artyus), then further treatment should be carried out under medical control.
Influence on ability of control of vehicles or other mechanisms
Ability of the patient to concentration 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 (control of vehicles or other mechanisms) are important.
Patients should recommend to be careful and avoid a hypoglycemia during driving. It is especially important at patients at whom it is reduced or there is no understanding of 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.

Side effects:

Hypoglycemia
The hypoglycemia, the most frequent side effect of an insulin therapy, can develop if the dose of the entered insulin exceeds the need for it (see. "Special instructions"). Heavy repeated episodes of a hypoglycemia can lead to development of neurologic symptomatology, including a coma, spasms (see also section "Overdose"). Long or heavy episodes of a hypoglycemia can threaten life of patients.
At many patients to symptoms and manifestations of a neuroglycopenia symptoms reflex (in response to the developing hypoglycemia) can precede activation of a sympathetic nervous system. Usually at more expressed or more bystry decrease in concentration of glucose in blood the phenomenon of reflex activation of a sympathetic nervous system and its symptoms are more expressed.
At sharp decrease in concentration of glucose in blood development of a hypopotassemia (a complication is possible from cardiovascular system) or brain edematization.
The undesirable phenomena observed in clinical trials which are classified by system and organ classes and as reduction of frequency of occurrence are listed below: very frequent (> 1/10); frequent (> 1/100 and <1/10); infrequent (> 1/1000 and <1/100); rare (> 1/10000 and <1/1000); very rare (<1/10000); frequency is unknown (it is not possible to determine the frequency of occurrence of side effect by the available data). Disturbances from immune system
Allergic reactions of immediate type to insulin or to drug excipients (frequency is unknown), can be shown in the form of generalized skin reactions (frequency is unknown), a Quincke's disease (frequency is unknown), a bronchospasm (frequency is unknown), a lowering of arterial pressure (frequency is unknown) and an acute anaphylaxis (infrequent reactions) and can threaten the patient's life. Allergic reactions demand immediate acceptance of the appropriate urgent measures of the help. Use of insulin can cause antibody formation to insulin (frequency is unknown). In rare instances existence of such antibodies to insulin can demand change of a dose of insulin for correction of a tendency to hyper - or a hypoglycemia.
Disturbances from metabolism and food
Insulin can cause a sodium delay (frequency is unknown) and hypostases (often), especially at improvement of earlier insufficient metabolic control due to use of more intensive insulin therapy.
Disturbances from an organ of sight
Significant changes of glycemic control can cause passing visual frustration (frequency is unknown) owing to temporary change of turgor of crystalline lenses of eyes and their index of a refraction.
Long improvement of glycemic control reduces risk of progressing of a diabetic retinopathy. However more intensive insulin therapy with sharp improvement of glycemic control can be associated with temporary deterioration in a course of a diabetic retinopathy (frequency is unknown). At patients with a proliferative retinopathy, especially, if they do not receive treatment by means of photocoagulation (laser therapy), heavy hypoglycemic episodes can cause a passing amaurosis (total loss of sight) (frequency is unknown).
Disturbances from skin and hypodermic fabrics
As well as at any insulin therapy development of a lipodystrophy in the place of injections (frequency is unknown) and delay of local absorption of insulin is possible. Constant change of places of injections within the recommended area of introduction can promote reduction or the termination of these reactions. The general frustration and disturbances in an injection site
Often there are moderate reactions in an injection site. Pains in the place of an injection (frequency is unknown), an itch in the field of an injection (frequency is unknown), a small tortoiseshell in the place of an injection (frequency is unknown), puffiness in the field of an injection (frequency is unknown), or inflammatory reaction in the place of an injection concern to them reddening in the place of an injection (frequency is unknown) (frequency is unknown). The most expressed reactions to insulin in the place of an injection usually disappear in several days or several weeks.

Interaction with other medicines:

Combined use with hypoglycemic means for peroral
reception, inhibitors of an angiotensin-converting enzyme, Disopyramidum,
фибратами,флуоксетином,ингибиторамимоноаминооксидазы,пентоксифиллином, the propoxyhair dryer, salicylates, amphetamine, anabolic steroids and male sex hormones, tsibenzoliny, cyclophosphamide, fenfluraminy, guanetidiny, ifosfamidy, phenoxybenzamine, phentolamine, somatostatin and its analogs, streptocides, tetracyclines, tritokvaliny or trofosfamidy can strengthen hypoglycemic effect of insulin and increases predisposition to development of a hypoglycemia.
Combined use with corticotropin, glucocorticosteroids, danazoly, diazoxide, diuretics, a glucagon, an isoniazid, estrogen and progestogens (for example, present at the combined contraceptive means), derivatives of a fenotiazin, Somatotropinum, sympathomimetic means (for example, Epinephrinum, salbutamol, terbutaliny), thyroid hormones, barbiturates, niacin, phenolphthalein, Phenytoinum derivatives, doksazoziny can weaken hypoglycemic effect of insulin.
Beta adrenoblockers, clonidine, salts of lithium can or potentiate or weaken effect hypoglycemic effect of insulin.
With ethanol
Ethanol can or potentiate or weaken hypoglycemic effect of insulin. The use of ethanol can cause a hypoglycemia or reduce already low content of glucose in blood to dangerous level. Portability of ethanol at the patients receiving insulin is reduced. Admissible amounts of the consumed alcohol have to be defined by the doctor. With pentamidine
At a concomitant use development of a hypoglycemia which can sometimes pass into a hyperglycemia is possible.
At combined use with sympatholytics, such as beta adrenoblockers, a clonidine, гуанетидин and Reserpinum easing or total absence of symptoms reflex (in response to a hypoglycemia) activation of a sympathetic nervous system is possible.

Contraindications:

- Hypoglycemia.
- Reaction of hypersensitivity to insulin or to any of auxiliary components of drug, except for cases when an insulin therapy is vital.
If at you one of these diseases or states, before drug use surely consult with the doctor.
With care
- At a renal failure (decrease in need for insulin owing to insulin metabolism reduction is possible).
- At patients of advanced age (gradual depression of function of kidneys can lead to constantly increasing decrease in need for insulin).
- At patients with a liver failure (the need for insulin can decrease because of decline in the ability to a gluconeogenesis and insulin metabolism reduction).
- At patients with the expressed stenosis of coronary and brain arteries (at these patients hypoglycemic episodes can have special clinical value as there is an increased risk of cardial or cerebral complications of a hypoglycemia).
- At the patients with a proliferative retinopathy who were especially not receiving treatments by photocoagulation (laser therapy) as they at a hypoglycemia have a risk of a passing amaurosis - a total blindness.
- At patients with intercurrent diseases (as at intercurrent diseases the need for insulin often increases).
If at you one of these diseases or states, before drug use surely consult with the doctor. Pregnancy and period of a lactation
Treatment of Insuman® Bazal of GT at approach of pregnancy has to be
it is continued. Insulin does not get through a placental barrier.
Effective maintenance of metabolic control during all pregnancy
is obligatory for the women who had a diabetes mellitus before pregnancy
or at women at whom the gestational diabetes mellitus developed.
The need for insulin during pregnancy can decrease during the first
trimester of pregnancy and usually raises during the second and third
pregnancy trimester. Right after childbirth the need for insulin quickly
decreases (the increased risk of development of a hypoglycemia). At pregnancy careful monitoring of concentration of glucose in blood is also especially after the delivery obligatory.
At approach of pregnancy or when planning pregnancy it is necessary to inform the doctor surely.
During breastfeeding no restrictions to an insulin therapy are available, however dose adjustment of insulin and a diet can be required.

Overdose:

The insulin overdose, for example, introduction of excess amount of insulin in comparison with the consumed food or power expenditure, can give to heavy and sometimes a long and life-threatening hypoglycemia Treatment
Easy episodes of a hypoglycemia (the patient is in consciousness) can be stopped by reception of carbohydrates inside. Dose adjustment of insulin, the mode of meal and physical activity can be required.
Heavier episodes of a hypoglycemia with a coma, spasms or neurologic disturbances can be stopped by intramuscular or hypodermic introduction of a glucagon or intravenous administration of strong solution of a dextrose.
At children the quantity of the entered dextrose is established in proportion to the body weight of the child. After increase in concentration of glucose in blood the supporting reception of carbohydrates and observation as after the seeming clinical elimination of symptoms of a hypoglycemia its repeated development is possible can be required.
In cases of a heavy or long hypoglycemia after an injection of a glucagon or introduction of a dextrose it is recommended to make infusion by less strong solution of a dextrose to prevent repeated development of a hypoglycemia. At small children it is necessary to watch carefully concentration of glucose in blood, in connection with possible development of a heavy hyperglycemia.
Hospitalization of patients in intensive care units for more careful observation of their state and control of the carried-out therapy is under certain conditions recommended.

Storage conditions:

To store In the place protected from light at a temperature from 2 °C to 8 °C. Not to freeze!
To store in the places unavailable to children! Period of validity 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Suspension for hypodermic introduction of 100 ME/ml.
On 5 ml of drug in a bottle from transparent and colourless glass (type I). The bottle is corked by a stopper, pressed out by an aluminum cap and covered with a protective plastic lid. On 5 bottles together with the application instruction in a cardboard pack.
On 3 ml of drug in a cartridge from transparent and 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. In addition 3 metal balls are placed in a cartridge. On 5 cartridges in a blister strip packaging from PVC of a film and aluminum foil. On 1 blister strip packaging together with the application instruction in a cardboard pack.
On 3 ml of drug in a cartridge from transparent and 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. In addition 3 metal balls are placed in a cartridge. The cartridge is built in in one-time the syringe handle Solostar®. On the 5th syringe handles Solostar® together with the application instruction in a cardboard pack.