Expiration date: 04/2026

The composition and form of issue:

Solution for injection. 1 ml contains:

human insulin (HR 1799) (100% soluble human insulin) 1,429 mg (40 IU)

3,571 mg (100 IU)

excipients: metacresol sodium dihydrogen phosphate dihydrate glycerol (85%) sodium hydroxide (used for pH), concentrated hydrochloric acid (used for pH) water for injections 

to a solution of 40 IU/ml in vials of clear colourless glass 10 ml in a cardboard pack of 5 vials a solution of 100 IU/ml in vials of clear colourless glass 5 ml in a cardboard pack of 5 bottles or cartridges made of transparent colorless glass in a 3 ml in a cardboard pack of 5 cartridges.

Description pharmaceutical form:

Clear, colorless or almost colorless liquid.

Description pharmacological action:

Insuman rapid GT contains insulin that is identical in structure to human insulin and obtained by genetic engineering using a K12 strain of Escherichia coli.

Hypoglycemic effect occurs rapidly within 30 min and peaks within 1-4 h after s/to the introduction of the drug. The effect lasts for 7-9 hours

Indications:

Diabetes mellitus, requiring insulin treatment.

Insuman rapid GT is indicated for the treatment of diabetic coma and ketoacidosis, as well as to achieve metabolic compensation of diabetic patients in the pre-, intra - and postoperative period.

Contraindications:

• a hypersensitivity reaction to the insulin or any excipients of the drug, with the exception of cases where insulin therapy is vital
  
• hypoglycemia.
  

Application of pregnancy and breast-feeding:

Treatment Insuman rapid GT pregnancy should continue. Insulin does not cross the placental barrier.

During pregnancy, especially after the first trimester, one should expect an increase in insulin requirements. However, immediately after birth the need for insulin usually decreases, which entails a significant risk of hypoglycemia. If pregnancy or when planning a pregnancy, must inform the doctor.

In the period of breastfeeding no restrictions for insulin therapy not available. However, it may require adjustment of the dose and diet.

Side effects:

Hypoglycaemia, the most frequent side-effects may develop, if the dose of insulin exceeds the demand for it (see "Special instructions"). Recurrent episodes of hypoglycemia can lead to the development of neurological symptoms, including coma, convulsions. Such episodes in some cases can lead to death.

Significant fluctuations in the level of glucose in the blood can cause short-term violations from the side of organs of vision. Also, especially during intensive insulin therapy, may transient worsening of diabetic retinopathy. Patients with proliferative retinopathy, without the use of a course of laser therapy, severe hypoglycemic conditions can lead to transient blindness.

Sometimes at the site of injection may occur atrophy or hypertrophy of adipose tissue, which can avoid constantly changing the site of injection. In rare cases it may be slight redness at the injection site, which disappears with continued therapy. In the formation of significant erythema, accompanied by itching and swelling and its rapid spread beyond the borders of the injection site, and also at occurrence of other serious adverse reactions to the drug components (insulin, metacresol) should immediately inform the doctor, as in some cases, such reactions can endanger the patient's life. Severe hypersensitivity reactions are rare. They can also be accompanied by the development of angioedema, bronchospasm, drop in blood pressure and rarely, anaphylactic shock. Hypersensitivity reactions require immediate correction to the ongoing treatment with insulin and taking appropriate emergency measures of assistance.

Possible formation of antibodies to insulin, which may require dose adjustment of insulin. It is also possible to sodium retention with subsequent swelling of tissues, especially after intensive insulin treatment.

With a sharp decrease in blood glucose level may develop hypokalemia (complications from the CCC) or the development of brain edema.

Due to the fact that some side effects can be, under certain conditions, life-threatening, it is necessary when they occur be sure to inform the attending physician.

Drug interactions:

Simultaneous reception of some drugs can weaken or intensify the hypoglycemic action of the drug Insuman rapid GT. So when you use insulin you can't take any other drugs without special permission of a doctor.

Hypoglycemia can occur if patients simultaneously with insulin receive ACE inhibitors, acetylsalicylic acid or other salicylates, amphetamine, anabolic steroids and male sex hormones, cibenzoline, fibrates, disopyramide, cyclophosphamide, fenfluramine, fluoxetine, guanetidin, ifosfamide, MAO inhibitors, oral hypoglycemic drugs, pentoxifylline, phenoxybenzamine, phentolamine, propoksifen, somatostatin and its analogs, sulfonamides, tetracyclines, tritoqualine or trofosfamide.

The weakening of the action of insulin can be observed with concomitant administration of insulin and Corticotrophins, corticosteroids, diazoxide, heparin, isoniazid, barbiturates, nicotinic acid, phenolphthalein, phenothiazine derivatives, phenytoin, diuretics, danazol, doxazosin, glucagon, estrogen and progestogen, somatropin, sympathomimetic agents and thyroid hormones.

For patients receiving both insulin and clonidine, reserpine, or lithium salts, can be observed as the attenuation and potentiation of insulin action. Pentamidine may cause hypoglycemia followed by hyperglycemia.

Drinking alcohol can cause hypoglycemia, or to reduce the already low level of glucose in the blood to dangerous levels. Alcohol tolerance in patients receiving insulin, reduced. Acceptable amounts of alcohol consumed should be determined by your doctor. Chronic alcoholism, like excessive consumption of laxatives can have an impact on the level of glucose in the blood.

Beta-blockers increase the risk of hypoglycemia and simpatoliticescoe along with other drugs (clonidine, guanetidin reserpine) may weaken or even mask the manifestations of hypoglycemia.

Method of application and dose:

The selection of doses of insulin the patient is carried out by the doctor individually, depending on diet, level of physical activity and lifestyle. The insulin dose is determined based on the level of glucose in the blood, as well as on the basis of the level of physical activity and the status of carbohydrate metabolism. Insulin treatment requires appropriate self-preparation of the patient. The doctor must give the necessary instructions, how often to determine the level of glucose in the blood, and to give appropriate advice in the event of any changes in diet or insulin therapy.

The average daily insulin dose is 0.5 to 1.0 IU/kg, and 40-60% of the dose accounted for human insulin of prolonged action.

Insuman rapid GT, you normally enter n/a (deep), for 15-20 minutes before eating. Place of injection each time it is necessary to change. Allowed in the/m introduction. Change the injection site (e.g. abdomen to the thigh) should be made only after consultation with your doctor. Insuman rapid GT may be injected in/in in the treatment of hyperglycemic coma and ketoacidosis, as well as to achieve metabolic compensation in the pre-, intra - and postoperative period in patients with diabetes. In the treatment of diabetic coma and ketoacidosis is a large volume of therapeutic interventions aimed at maintaining acid-base balance, electrolyte balance, etc.

Insuman rapid GT is not used in different kinds of insulin pumps (including implants), which uses a silicone coating.

You can't mix Insuman rapid GT with different insulin concentrations (e.g. 40 and 100 IU/ml), insulins of animal origin or other drugs.

In the transition from animal origin insulin to human insulin may require lower doses of insulin. The transition from other types of insulin in the preparation can be carried out only under medical supervision. Especially frequent monitoring of the status of carbohydrate metabolism essential in the first weeks after such a transition.

Change the dose of insulin may also be required to change the body weight of the patient in lifestyle changes (including diet, physical activity level, etc.).

It must be remembered that the concentration of insulin can is 40 IU/ml (10 ml vials) or 100 IU/ml (for 5 ml vials or 3 ml cartridges), so you need to use only plastic syringes, designed for the concentration of insulin in the case of using the bottles or syringe pen optipen PRO1 in the case of using cartridges. Plastic syringe should not contain any other drug or its residues.

Before the first set of insulin from the vial you need to remove the plastic cap (a cap — evidence of an unopened bottle). The injection solution should be absolutely transparent and colorless, without visible foreign particles. Before you set insulin from the vial into the syringe suck the amount of air equal to the prescribed dose of insulin and inject it into the vial (not into liquid). Then the vial with the syringe turn the syringe downwards and collect the right amount of insulin. Before injection it is necessary to remove from the syringe air bubbles.

In the injection take the skin fold, insert the needle under the skin and slowly inject the insulin. After injection, remove the needle slowly and press the injection site with a cotton swab for a few seconds. The date of the first set of insulin from the vial should be written on the label of the bottle.

After opening the vials can be stored at a temperature not exceeding 25 °C for 4 weeks protected from light and heat.

Overdose:

Symptoms: severe and sometimes ginepraia hypoglycemia.

Treatment: if the patient is conscious, he should immediately take glucose followed by administration of the carbohydrate foods (see "Special instructions"). If the patient is unconscious, you must enter the glucagon/m or s/C or a concentrated solution of dextrose (glucose)/V. If necessary, the re-introduction of a concentrated dextrose solution. In children, the amount of dextrose is established in proportion to the body weight of the child.

In cases of severe or prolonged hypoglycemia after an injection of glucagon or administration of dextrose is recommended infusion of a less concentrated dextrose solution to prevent hypoglycemia. In young children it is necessary to carefully monitor the level of glucose in the blood, in connection with the possible development of severe hyperglycemia.

Under certain conditions, it is recommended hospitalization of patients in the intensive care unit for closer monitoring and control of the therapy.

Special instructions:

Possible immunological cross-reaction to human insulin with insulins of animal origin. In case of hypersensitivity of the patient to insulin of animal origin, as well as metacresol, tolerability Insuman the rapid GT should be evaluated in the clinic with the help of intradermal tests. If the intradermal test revealed hypersensitivity to human insulin (immediate reaction, Arthus phenomenon), further treatment should be under clinical control. Quite a large number of patients with hypersensitivity to insulin animal origin hampered the transition to human insulin with regard to cross-immunological reaction to human insulin and insulin of animal origin.

Hypoglycemia can develop if the amount of glucose exceeds the demand for it.

There are certain clinical symptoms and signs that should indicate to the patient or others about the sharp drop in the level of glucose in the blood. These include: sudden sweating, palpitation, tremor, hunger, drowsiness, sleep disturbance, anxiety, depression, irritability, unusual behavior, anxiety, paresthesia in the mouth and around the mouth, pallor, headache, coordinamenti movements, as well as transient neurological disorders (disturbance of speech and vision, paralytic) symptoms and unusual feelings. When the growing drop in blood glucose, the patient may lose self-control and even consciousness. In such cases, there may be the cold and moisture of the skin, and may have convulsions.

Many patients as a result of adrenergic feedback mechanism can develop the following symptoms, indicating the decrease in the level of blood glucose: sweating, humidity of the skin, anxiety, tachycardia (rapid heartbeat), high blood pressure, tremor, chest pain, heart rhythm disturbance.

Therefore, every patient with diabetes mellitus and receiving insulin, must learn to recognize unusual symptoms that are characteristic of developing hypoglycemia. Patients, regular monitoring of glucose levels in the blood, less risk of hypoglycemia. The propensity for severe hypoglycemia may impair the ability of the patient to driving and managing any equipment. The patient himself can adjust their noticed a decrease in the level of glucose by the intake of sugar or food with high carbohydrate content. With this purpose the patient should always be in possession of 20 grams of glucose. In the more severe state of hypoglycemia are shown s/C injection of glucagon (which can be done by a doctor or nursing staff). After sufficient improvement, the patient should eat. Immediately if hypoglycemia persists, you should call a physician immediately. You must immediately inform the doctor about the hypoglycemia, so that he made a decision about the need for correction insulin doses.

Under certain circumstances, the symptoms of hypoglycemia can be mild or absent. Such situations occur in elderly patients, the presence of lesions of the nervous system (neuropathy), mental concomitant diseases, concomitant medication other medicines (see "Interactions"), supporting the low blood sugar levels, changing insulin.

Possible reasons for the sharp decline in the level of glucose in the blood: insulin overdose, an incorrect injection of insulin (in elderly patients), the transition to another type of insulin, skipping meals, vomiting, diarrhoea, physical exercise, reducing stressful situations, alcohol consumption, diseases, lowering the need for insulin (severe liver disease or kidney disease, underactive adrenal, pituitary or thyroid glands), changing the injection site (e.g. skin of the abdomen, shoulder or hip), as well as interaction with other medicines (see "Interactions").

The risk of hypoglycemia is high at the beginning of treatment with insulin, when switching to another insulin product in patients with low supporting level of glucose in the blood.

A special risk group consists of patients with episodes of hypoglycemia and a significant narrowing of the coronary or cerebral vessels (violation of the coronary or cerebral circulation), as well as patients with proliferative retinopathy.

A poor diet, skipping insulin injections, increased need for insulin in the result of infectious or other diseases, decreased physical activity can lead to increased level of glucose in the blood (hyperglycemia) and a possible increase in the level of ketone bodies in the blood (ketoacidosis). Ketoacidosis can develop over several hours or days. When the first symptoms of metabolic acidosis (thirst, frequent urination, loss of appetite, fatigue, dry skin, deep and rapid breathing, high concentrations of acetone and glucose in urine) it is necessary urgent medical intervention.

With the change of doctor (such as during hospitalization by reason of accident, illness while on holiday), the patient should inform the doctor that he had diabetes.

In patients with renal insufficiency may be reduced insulin requirements by changing its metabolism.

Patients with severely impaired liver function also can be reduced the need for insulin by changing its metabolism and reduce gluconeogenesis.

Storage conditions:

To avoid contact with the walls of the refrigerator.