Insuman Rapid GT

General characteristics. Structure:

Active agent: insulin human (100% soluble human insulin) - 3,571 mg (100 ME);
 excipients: metacresol (m cresol),  dihydrophosphate sodium a dihydrate, глицерол (85%), sodium hydroxide (it is used for finishing pH), Acidum hydrochloricum (it is used for finishing pH), water for injections.
Description: transparent colourless liquid.

Pharmacological properties:

Pharmacodynamics. Инсуман® Slow motion of GT contains the insulin identical on the structure to human   insulin and    K12 of a strain of E. Coli received by method of genetic engineering with use. 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® Slow motion of GT is insulin with quick start of action and short duration of action. After hypodermic introduction the hypoglycemic effect occurs within 30 minutes and reaches a maximum within 1-4 hours. The effect remains within 7-9 hours.

Indications to use:

- The diabetes mellitus demanding treatment by insulin.
- Treatment of a diabetic coma and ketoacidosis.
- Achievement of metabolic compensation at patients with a diabetes mellitus at surgical interventions (before operation, during operation and in the postoperative period).

Route of administration and doses:

Selection of a dose of insulin at the patient is carried out by the doctor individually depending on a diet, the level of physical activity and lifestyle. The dose of insulin is defined on the basis of sugar level in blood, and also on the basis of the planned level of physical activity and a condition of carbohydrate metabolism. In more detail about calculation of dosages at diabetes read 1 and 2 types here. Treatment by insulin demands the corresponding self-training of the patient. The doctor has to give necessary instructions how often to determine sugar level in blood and, perhaps, in urine, and also to make the corresponding recommendations in case of any changes in a diet or in the insulin therapy mode.
The average daily dose of insulin makes from 0,5 to 1,0 ME on kg of body weight of the patient, and 40-60% of a dose are the share of insulin of the person of the prolonged action.
Upon transition from insulin of animal origin to insulin of the person the insulin dose decline can be required. Transition from other types of insulin to this drug can be carried out only under medical observation. Especially frequent control of a condition of carbohydrate metabolism is necessary in the first weeks after such transition.
Insuman Rapid is deeply usually entered by GT subcutaneously in 15-20 minutes prior to meal. Intramuscular administration of drug is allowed. The place of an injection every time should be changed. Change of area of an injection (for example from a stomach on a hip) has to is made only after consultation with the doctor.
Insuman Rapid can intravenously be entered by GT at treatment of a hyper glycemic coma and ketoacidosis, and also for achievement of metabolic compensation in before - intra-and the postoperative periods at patients with a diabetes mellitus.
Insuman Rapid is not used by GT in different insulin pompa (including implanted) where the silicone covering is used.
It is impossible to mix Insuman Rapid GT with insulin of other concentration (for example, 40ME/ml and 100ME/ml), with insulin of animal origin or other medicines. It is necessary to use only transparent, colourless solutions Insuman Rapid of GT without visible mechanical inclusions.
It is necessary to remember that concentration of insulin in a bottle 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.
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). Injection solution has to be absolutely transparent and colourless.
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.

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® GT Slow Motion, 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 indicate to the patient or people around 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 receiving insulin has to learn to distinguish the 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 level 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  it develops a hypoglycemia.
In case of detection of normal or reduced values of glikozilirovanny hemoglobin it is necessary to think of a 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® GT Slow Motion 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 clinical 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:

The hypoglycemia, the most frequent side effect, can develop if the dose of the entered insulin exceeds the need for it (see. "Precautionary measures and special instructions").
Significantly significant fluctuations of level of sugar in blood can cause short-term disturbances from organs of sight. Also, especially at an intensive insulin therapy, perhaps short-term deterioration in a course of a diabetic retinopathy. At patients with a proliferative retinopathy, without use of a course of laser therapy, serious hypoglycemic conditions can lead to a blindness.
In the place of injections there can sometimes be an atrophy or a hypertrophy of fatty tissue which it is possible to avoid constantly changing the place of injections. In rare instances there can be an insignificant reddening in the place of an injection disappearing at therapy continuation. At formation of the considerable erythema accompanied with an itch and hypostasis and its bystry distribution for borders of the place of an injection, and also at emergence of other heavy side reactions on drug components (insulin, m cresol) it is necessary to report at once about it to the doctor as in certain cases similar reactions can pose a threat of life of the patient. Heavy reactions of hypersensitivity quite rare. They can be also followed by development of a Quincke's disease, a bronchospasm, falling of arterial pressure and extremely seldom acute anaphylaxis. Reactions of hypersensitivity demand immediate correction in the carried-out therapy by insulin and acceptances of the appropriate urgent measures of the help.
Antibody formation to insulin is possible that can demand dose adjustment of the entered insulin. The sodium delay with the subsequent puffiness of fabrics, especially after an intensive course of treatment insulin is also possible.
At sharp decrease in level of sugar of blood development of a hypopotassemia (a complication is possible from cardiovascular system) or brain edematization.
As some side effects can be, under certain conditions, zhizne-menacing, it is necessary to inform surely at their emergence the attending physician.
If you noticed any side effects, please, see a doctor!

Interaction with other medicines:

Combined use with hypoglycemic means for oral administration, inhibitors of an angiotensin-converting enzyme, Disopyramidum, fibrata, fluoxetine, monoaminooxidase inhibitors,
pentoksifilliny, 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 increase 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 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.
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
to 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 (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® GT Slow motion at approach of pregnancy has to be 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 increases during the second and third trimester of pregnancy. 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 of any restrictions to an insulin therapy not
is available, however dose adjustment of insulin and a diet can be required.

Overdose:

Symptoms
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:

Solution for injections 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. 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. 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.