Home Prevention Basal gt. Rules for using Insuman Basal GT to lower glucose levels

Basal gt. Rules for using Insuman Basal GT to lower glucose levels

  • 3 ml - colorless glass cartridges, mounted in SoloStar® syringe pens (5) - cardboard packs. 5 ml - colorless glass bottles (5) - cardboard packs.

Description of the dosage form

  • Suspension for subcutaneous administration, white or almost white, easily dispersible.

pharmachologic effect

Hypoglycemic drug, insulin average duration actions. Insuman® Basal GT contains insulin, identical in structure to human insulin, obtained by genetic engineering using E. coli K12 135 pINT90d. Mechanism of action: - reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects; - increases the transport of glucose into cells and the synthesis of glycogen in muscles and liver, improves the utilization of pyruvate, inhibits glycogenolysis and gluconeogenesis; - increases lipogenesis in the liver and adipose tissue and suppresses lipolysis; - promotes the entry of amino acids into cells and protein synthesis; - increases the flow of potassium into cells. The effect of Insuman® Basal GT begins gradually and continues long time. After subcutaneous administration, the hypoglycemic effect occurs within 1 hour and reaches a maximum after 3-4 hours. The effect lasts for 11-20 hours.

Pharmacokinetics

In healthy patients, T1/2 of plasma insulin is approximately 4-6 minutes and lengthens with renal failure. However, it should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Special conditions

If glycemic control is insufficient or a tendency toward episodes of hyper- or hypoglycemia appears, before deciding to adjust the insulin dose, be sure to check compliance with the prescribed insulin regimen, ensure that insulin is injected into the recommended area, check the correct injection technique and all other factors which may affect the effect of insulin. Since the simultaneous use of a number of drugs can weaken or enhance the hypoglycemic effect of the drug Insuman Basal GT, when using it, you should not take any other drugs without the special permission of a doctor. Hypoglycemia Hypoglycemia occurs when the dose of insulin exceeds the need. The risk of developing hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin drug, in patients with low maintenance blood glucose concentrations. As with all insulins, extreme caution is warranted and intensive monitoring of blood glucose concentrations is recommended in patients for whom hypoglycemic episodes may be particularly problematic. clinical significance such as patients with severe stenosis of the coronary or cerebral arteries (risk of cardiac or cerebral complications hypoglycemia), as well as in patients with proliferative retinopathy, especially if they have not undergone photocoagulation ( laser therapy), since they have a risk of transient amaurosis (total blindness) with the development of hypoglycemia. There are certain clinical symptoms and signs that should indicate to the patient or others about developing hypoglycemia. These include: increased sweating, humidity skin, tachycardia, disorders heart rate, increased blood pressure, chest pain, tremor, anxiety, hunger, drowsiness, sleep disturbances, fear, depression, irritability, unusual behavior, anxiety, paresthesia in and around the mouth, pale skin, headache, impaired coordination of movements, as well as transient neurological disorders(impaired speech and vision, paralytic symptoms) and unusual sensations. With an increasing decrease in glucose concentration, the patient may lose self-control and even consciousness. In such cases, the skin may become cold and damp, and cramps may occur. Therefore, every patient, with diabetes mellitus People receiving insulin must learn to recognize unusual symptoms that indicate developing hypoglycemia. Patients who regularly monitor blood glucose levels are less likely to develop hypoglycemia. The patient himself can correct the decrease in blood glucose concentration he notices by taking sugar or foods high in carbohydrates. For this purpose, the patient should always have 20 g of glucose with him. In more severe conditions of hypoglycemia, a subcutaneous injection of glucagon is indicated (which can be done by a doctor or nursing staff). After sufficient improvement

Compound

  • insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml. insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml.

Insuman Basal GT indications for use

  • - diabetes mellitus requiring treatment with insulin.

Insuman Basal GT contraindications

  • - hypoglycemia; - increased sensitivity to insulin or to any of the auxiliary components of the drug, except in cases where insulin therapy is vital. With caution - in case of renal failure (a decrease in the need for insulin is possible due to a decrease in insulin metabolism); - in elderly patients (a gradual decrease in renal function can lead to an ever-increasing decrease in the need for insulin); - in patients with liver failure (the need for insulin may be reduced due to a decrease in the ability to gluconeogenesis and a decrease in insulin metabolism); - in patients with severe stenosis of the coronary and cerebral arteries (in these patients, hypoglycemic episodes may be of particular clinical significance, since there is increased risk cardiac or cerebral complications of hypoglycemia); - in patients with proliferative retinopathy, especially those who have not received treatment with photocoagulation (laser therapy)

Insuman Basal GT dosage

  • 100 IU/ml

Insuman Basal GT side effects

  • Hypoglycemia Hypoglycemia, most common by-effect insulin therapy, can develop if the dose of administered insulin exceeds the need for it. Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma and seizures. Prolonged or severe episodes of hypoglycemia can be life-threatening for patients. In many patients, symptoms and manifestations of neuroglycopenia may be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Typically, with a more pronounced or faster decrease in blood glucose concentration, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are more pronounced. At sharp decline concentration of glucose in the blood, hypokalemia may develop (complications from of cardio-vascular system) or the development of cerebral edema. Listed below are the adverse events observed in clinical studies, which are classified by system-organ classes and in order of decreasing frequency of occurrence. Violations by immune system Allergic reactions immediate type to insulin or to excipients of the drug (frequency unknown), may manifest as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (frequency unknown), decreased blood pressure (frequency unknown) and anaphylactic shock(infrequent reactions) and may be life threatening

Drug interactions

Concomitant use with oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cybenzoline, cyclophosphamide, fenfluramine, guanethidine, ifosfamide, phenoxybenzamine, fen tolamine, somatostatin and its analogues, sulfonamides, tetracyclines, tritoqualine or trofosfamide can enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. Combined use with corticotropin, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, those present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthaleino

Storage conditions

  • store in a dry place
  • Store refrigerated (t 2 - 5)
  • keep away from children
  • store in a place protected from light

Synonyms

  • Biogulin Lente U40, Isofan Insulin ChM, Levulin L, Levulin N, Monotard, Humulin L, Humulin N
  • 3 ml - colorless glass cartridges, mounted in SoloStar® syringe pens (5) - cardboard packs. 5 ml - colorless glass bottles (5) - cardboard packs.

Description of the dosage form

  • Suspension for subcutaneous administration, white or almost white, easily dispersible.

pharmachologic effect

Hypoglycemic drug, intermediate-acting insulin. Insuman® Basal GT contains insulin, identical in structure to human insulin, obtained by genetic engineering using E. coli K12 135 pINT90d. Mechanism of action: - reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects; - increases the transport of glucose into cells and the synthesis of glycogen in muscles and liver, improves the utilization of pyruvate, inhibits glycogenolysis and gluconeogenesis; - increases lipogenesis in the liver and adipose tissue and suppresses lipolysis; - promotes the entry of amino acids into cells and protein synthesis; - increases the flow of potassium into cells. The effect of Insuman® Basal GT begins gradually and lasts for a long time. After subcutaneous administration, the hypoglycemic effect occurs within 1 hour and reaches a maximum after 3-4 hours. The effect lasts for 11-20 hours.

Pharmacokinetics

In healthy patients, T1/2 of plasma insulin is approximately 4-6 minutes and is prolonged in renal failure. However, it should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Special conditions

If glycemic control is insufficient or a tendency toward episodes of hyper- or hypoglycemia appears, before deciding to adjust the insulin dose, be sure to check compliance with the prescribed insulin regimen, ensure that insulin is injected into the recommended area, check the correct injection technique and all other factors which may affect the effect of insulin. Since the simultaneous use of a number of drugs can weaken or enhance the hypoglycemic effect of the drug Insuman Basal GT, when using it, you should not take any other drugs without the special permission of a doctor. Hypoglycemia Hypoglycemia occurs when the dose of insulin exceeds the need. The risk of developing hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin drug, in patients with low maintenance blood glucose concentrations. As with all insulins, extreme caution and intensive monitoring of blood glucose concentrations is recommended in patients for whom hypoglycemic episodes may be of particular clinical significance, such as patients with severe coronary or cerebral artery stenosis (risk of cardiac or cerebral complications of hypoglycemia) , as well as in patients with proliferative retinopathy, especially if they have not undergone photocoagulation (laser therapy), since they have a risk of transient amaurosis (complete blindness) with the development of hypoglycemia. There are certain clinical symptoms and signs that should indicate to the patient or others that hypoglycemia is developing. These include: increased sweating, skin moisture, tachycardia, heart rhythm disturbances, increased blood pressure, chest pain, tremor, anxiety, hunger, drowsiness, sleep disturbances, feelings of fear, depression, irritability, unusual behavior, feelings of anxiety, paresthesia in mouth and around the mouth, pallor of the skin, headache, impaired coordination of movements, as well as transient neurological disorders (speech and vision disturbances, paralytic symptoms) and unusual sensations. With an increasing decrease in glucose concentration, the patient may lose self-control and even consciousness. In such cases, the skin may become cold and damp, and cramps may occur. Therefore, every patient with diabetes who receives insulin must learn to recognize unusual symptoms that are a sign of developing hypoglycemia. Patients who regularly monitor blood glucose levels are less likely to develop hypoglycemia. The patient himself can correct the decrease in blood glucose concentration he notices by taking sugar or foods high in carbohydrates. For this purpose, the patient should always have 20 g of glucose with him. In more severe conditions of hypoglycemia, a subcutaneous injection of glucagon is indicated (which can be done by a doctor or nursing staff). After sufficient improvement

Compound

  • insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml. insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml.

Insuman basal indications for use

  • - diabetes mellitus requiring treatment with insulin.

Insuman basal contraindications

  • - hypoglycemia; - hypersensitivity to insulin or to any of the auxiliary components of the drug, except in cases where insulin therapy is vital. With caution - in case of renal failure (a decrease in the need for insulin is possible due to a decrease in insulin metabolism); - in elderly patients (a gradual decrease in renal function can lead to an ever-increasing decrease in the need for insulin); - in patients with liver failure (the need for insulin may be reduced due to a decrease in the ability to gluconeogenesis and a decrease in insulin metabolism); - in patients with severe stenosis of the coronary and cerebral arteries (in these patients, hypoglycemic episodes may be of particular clinical significance, since there is an increased risk of cardiac or cerebral complications of hypoglycemia); - in patients with proliferative retinopathy, especially those who have not received treatment with photocoagulation (laser therapy)

Insuman basal dosage

  • 100 IU/ml

Insuman basal side effects

  • Hypoglycemia Hypoglycemia, the most common side effect of insulin therapy, can occur if the dose of insulin administered exceeds the need. Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma and seizures. Prolonged or severe episodes of hypoglycemia can be life-threatening for patients. In many patients, symptoms and manifestations of neuroglycopenia may be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Typically, with a more pronounced or faster decrease in blood glucose concentration, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are more pronounced. With a sharp decrease in the concentration of glucose in the blood, hypokalemia (complications from the cardiovascular system) or the development of cerebral edema may develop. Listed below are adverse events observed in clinical studies, classified by organ system class and in decreasing order of frequency. Immune system disorders Immediate allergic reactions to insulin or to excipients of the drug (frequency unknown), may manifest as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (frequency unknown), decreased blood pressure (frequency unknown) and anaphylactic shock (uncommon reactions) and may be life-threatening

Drug interactions

Concomitant use with oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cybenzoline, cyclophosphamide, fenfluramine, guanethidine, ifosfamide, phenoxybenzas nom, phentolamine, somatostatin and its analogues, sulfonamides, tetracyclines, tritoqualine or trophosfamide may enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. Combined use with corticotropin, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, those present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthaleino

Storage conditions

  • store in a dry place
  • Store refrigerated (t 2 - 5)
  • keep away from children
  • store in a place protected from light

Synonyms

  • Biogulin Lente U40, Isofan Insulin ChM, Levulin L, Levulin N, Monotard, Humulin L, Humulin N

Suspension for subcutaneous administration- 1 ml:

  • active ingredients: human insulin (100% crystalline protamine insulin) - 3.571 mg (100 IU);
  • excipients: protamine sulfate - 0.318; metacresol (m-cresol) - 1.5 mg; phenol - 0.6 mg; zinc chloride - 0.047 mg; sodium dihydrogen phosphate dihydrate - 2.1 mg; glycerol (85%) - 18.824 mg; sodium hydroxide (used to adjust pH) - 0.576 mg; concentrated hydrochloric acid (used to adjust pH) - 0.246 mg; water for injection - up to 1 ml.

Suspension for subcutaneous administration, 100 IU/ml. 5 ml of the drug in a bottle of transparent and colorless glass (type I). The bottle is sealed with a stopper, crimped with an aluminum cap and covered with a protective plastic cap. 5 bottles are placed in a cardboard box.

3 ml of the drug in a cartridge made of transparent and colorless glass (type I). The cartridge is sealed on one side with a stopper and crimped with an aluminum cap, on the other side with a plunger. Additionally, 3 metal balls are placed in the cartridge. 5 cartridges each in a blister pack made of PVC film and aluminum foil. 1 blister pack is placed in a cardboard box.

3 ml of the drug in a cartridge made of transparent and colorless glass (type I). The cartridge is sealed on one side with a stopper and crimped with an aluminum cap, on the other side with a plunger. Additionally, 3 metal balls are placed in the cartridge. The cartridge is built into the SoloStar® disposable syringe pen. 5 SoloStar® syringe pens are placed in a cardboard box.

Description of the dosage form

White or almost white suspension, easily dispersible.

pharmachologic effect

Hypoglycemic.

Pharmacokinetics

In healthy individuals, T1/2 of plasma insulin is approximately 4–6 minutes. In patients with severe renal failure it is longer. However, it should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Pharmacodynamics

Insuman® Basal GT contains insulin, which is identical in structure to human insulin and obtained by genetic engineering using the Escherichia coli strain K12 135 pINT90d.

Mechanism of action of insulin:

  • reduces blood glucose concentrations, promotes anabolic effects and reduces catabolic effects;
  • increases the transfer of glucose into cells and the formation of glycogen in muscles and liver and improves the utilization of pyruvate, inhibits glycogenolysis and glyconeogenesis;
  • increases lipogenesis in the liver and adipose tissue and inhibits lipolysis;
  • promotes the entry of amino acids into cells and protein synthesis;
  • increases the flow of potassium into cells.

Insuman® Basal GT is insulin long acting with a gradual onset of action. After subcutaneous administration, the hypoglycemic effect occurs within 1 hour and reaches a maximum within 3–4 hours. The effect persists for 11–20 hours.

Indications for use Insuman basal gt

Diabetes mellitus requiring treatment with insulin.

Contraindications to the use of Insuman basal gt

  • hypersensitivity reaction to insulin or to any of the auxiliary components of the drug, except in cases where insulin therapy is vital;
  • hypoglycemia.

With caution: renal failure (possibly reduced insulin requirements due to decreased insulin metabolism); elderly patients (a gradual decline in kidney function can lead to an ever-increasing decrease in insulin requirements); liver failure (the need for insulin may be reduced due to a decrease in the ability to gluconeogenesis and a decrease in insulin metabolism); severe stenosis of the coronary and cerebral arteries (in these patients, hypoglycemic episodes may be of particular clinical significance, since there is an increased risk of cardiac or cerebral complications of hypoglycemia); patients with proliferative retinopathy, especially those not treated with photocoagulation (laser therapy), because With hypoglycemia, they have a risk of transient amaurosis - complete blindness; patients with intercurrent diseases (since intercurrent diseases often increase the need for insulin).

If the patient has one of these diseases or conditions, be sure to consult a doctor before using the drug.

Insuman basal gt Use during pregnancy and children

Treatment with Insuman® Basal GT during pregnancy should be continued. Insulin does not cross the placental barrier. Effective maintenance of metabolic control throughout pregnancy is imperative for women who had diabetes mellitus before pregnancy or for women who develop gestational diabetes mellitus.

Insulin requirements during pregnancy may decrease during the first trimester of pregnancy and usually increase during the second and third trimesters of pregnancy. Immediately after birth, insulin requirements decrease rapidly (increased risk of hypoglycemia). During pregnancy and especially after childbirth, careful monitoring of blood glucose concentrations is mandatory.

If you become pregnant or plan to become pregnant, you must inform your doctor.

During breastfeeding There are no restrictions on insulin therapy, but adjustments to the insulin dose and diet may be required.

Insuman basal gt Side effects

Hypoglycemia. The most common side effect of insulin therapy can develop if the dose of insulin administered exceeds the need for it. Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma and seizures. Prolonged or severe episodes of hypoglycemia can be life-threatening for patients.

In many patients, symptoms and manifestations of neuroglycopenia may be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Typically, with a more pronounced or faster decrease in blood glucose concentration, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are more pronounced.

With a sharp decrease in the concentration of glucose in the blood, hypokalemia (complications from the cardiovascular system) or the development of cerebral edema may develop.

The following are the adverse events observed in clinical studies, which are classified by system-organ class and in order of decreasing frequency of occurrence: very common (≥1/10); frequent (≥1/100 and

From the immune system: immediate allergic reactions to insulin or excipients of the drug (frequency unknown), may manifest as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (frequency unknown), decreased blood pressure (frequency unknown ) and anaphylactic shock (infrequent reactions) and can be life-threatening. Allergic reactions require immediate appropriate urgent measures help. The use of insulin may cause the formation of antibodies to insulin (frequency unknown). In rare cases, the presence of such insulin antibodies may require changes in the insulin dose to correct the tendency toward hyper- or hypoglycemia.

Metabolism and Nutrition: Insulin can cause sodium retention (frequency unknown) and edema (common), especially when previously poor metabolic control is improved by more intensive insulin therapy.

From the side of the organ of vision: significant changes glycemic control may cause transient visual disturbances (frequency unknown) due to a temporary change in the turgor of the lenses of the eyes and their refractive index.

Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, more intensive insulin therapy with dramatic improvements in glycemic control may be associated with a transient worsening of diabetic retinopathy (frequency unknown). In patients with proliferative retinopathy, especially if they are not treated with photocoagulation (laser therapy), severe hypoglycemic episodes may cause transient amaurosis (complete loss of vision) (frequency unknown).

From the skin and subcutaneous tissues: as with any insulin therapy, lipodystrophy may develop at the injection site (frequency unknown) and local absorption of insulin may slow down.

Constantly changing injection sites within the recommended injection area may help reduce or stop these reactions.

General and administration site disorders: Mild injection site reactions are common. These include redness at the injection site (frequency unknown), pain at the injection site (frequency unknown), itching at the injection site (frequency unknown), hives at the injection site (frequency unknown), swelling at the injection site (frequency unknown), or inflammatory reaction at the injection site (frequency unknown).

Most severe reactions to insulin at the injection site usually disappear after a few days or weeks.

Drug interactions

Concomitant use with oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cybenzoline, cyclophosphamide, fenfluramine, guanethidine, ifosfamide, phenoxybenzas nom, phentolamine, somatostatin and its analogues, sulfonamides, tetracyclines, tritoqualine or trophosfamide may enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia.

Combined use with corticotropin, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, those present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic drugs (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthalein, phenytoin derivatives, doxazosin can weaken the hypoglycemic effect of insulin.

Beta-blockers, clonidine, and lithium salts can either potentiate or weaken the effect of the hypoglycemic action of insulin.

With ethanol. Ethanol can either potentiate or weaken the hypoglycemic effect of insulin. Drinking ethanol can cause hypoglycemia or reduce already low blood glucose levels to dangerous levels. Ethanol tolerance is reduced in patients receiving insulin. Acceptable quantities alcohol consumption should be determined by a doctor.

With pentamidine. With simultaneous use, hypoglycemia may develop, which can sometimes develop into hyperglycemia. When used together with sympatholytic agents such as beta-blockers, clonidine, guanethidine and reserpine, weakening or complete absence symptoms of reflex (in response to hypoglycemia) activation of the sympathetic nervous system.

Dosage Insuman basal gt

Target blood glucose concentrations, insulin preparations to be used, and insulin dosing regimen (doses and times of administration) must be determined and adjusted individually to suit diet, insulin levels, and physical activity and the patient's lifestyle.

There are no precisely regulated rules for insulin dosing. However, the average daily dose of insulin is 0.5–1 IU/kg/day, with long-acting human insulin accounting for 40–60% of the required daily dose insulin.

The doctor should give the necessary instructions on how often to determine the concentration of glucose in the blood, and also give appropriate recommendations in case of any changes in diet or insulin regimen.

Switching from another type of insulin to Insuman® Basal GT

When switching patients from one type of insulin to another, adjustments to the insulin dosage regimen may be necessary: ​​for example, when switching from animal insulin to human insulin, or when switching from one human insulin preparation to another, or when switching from a treatment regimen with soluble human insulin to a regimen including longer-acting insulin.

After switching from animal-derived insulin to human insulin, a reduction in the insulin dose may be necessary, especially in patients who were previously managed on sufficiently low blood glucose concentrations; in patients prone to developing hypoglycemia; in patients who previously required high doses of insulin due to the presence of antibodies to insulin. The need for dose adjustment (reduction) may arise immediately after switching to a new type of insulin or develop gradually over several weeks.

When switching from one type of insulin to another and then in the subsequent first weeks, careful monitoring of blood glucose concentrations is recommended. In patients who required high doses of insulin due to the presence of antibodies, it is recommended to switch to another type of insulin under medical supervision in a hospital.

Additional insulin dose changes

Improved metabolic control may lead to increased insulin sensitivity, which may reduce the body's need for insulin.

A dose change may also be necessary if:

  • changes in the patient's body weight;
  • lifestyle changes (including diet, level of physical activity, etc.);
  • other circumstances that may increase susceptibility to hypo- or hyperglycemia.

Dosage regimen for special groups of patients

Elderly persons. In older people, the need for insulin may be reduced. It is recommended that initiation of treatment, increasing doses and titration of maintenance doses in elderly patients with diabetes mellitus should be carried out with caution to avoid hypoglycemic reactions.

Patients with liver or kidney failure. In patients with liver or kidney failure, the need for insulin may be reduced.

Administration of the drug Insuman® Basal GT

Insuman® Basal GT is usually administered deeply subcutaneously 45–60 minutes before meals. The injection site within the same injection area must be changed each time. Changing the area of ​​insulin administration (for example, from the abdominal area to the thigh area) should only be done after consultation with a doctor, because Insulin absorption and, accordingly, the effect of lowering blood glucose concentrations may vary depending on the area of ​​administration (for example, the abdominal area or the thigh area).

Insuman® Basal GT is not used in various kinds insulin pumps (including implanted ones).

IV administration of the drug is absolutely excluded!

Do not mix Insuman® Basal GT with insulins of other concentrations, with insulins of animal origin, insulin analogues or other drugs.

Insuman® Basal GT can be mixed with all human insulin products from the Sanofi-aventis group. Insuman® Basal GT must not be mixed with insulin intended specifically for use in insulin pumps.

It must be remembered that the insulin concentration is 100 IU/ml (for 5 ml bottles or 3 ml cartridges), so you must use only plastic syringes designed for this insulin concentration when using bottles, or OptiPen Pro1 or ClickSTAR syringe pens in when using cartridges. The plastic syringe must not contain any other drug or its residues.

Before the first set of insulin from the bottle, you must remove the plastic cap (the presence of a cap is evidence of an unopened bottle). Immediately before collection, the suspension should be well mixed, and no foam should form. This is best done by turning the bottle, holding it at an acute angle between your palms. After mixing, the suspension should have a uniform consistency and milky white color. The suspension cannot be used if it is of any other type, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the bottle. In such cases, you should use another bottle that meets the above conditions, and you should also inform your doctor.

Before drawing insulin from the vial, a volume of air equal to the prescribed dose of insulin is sucked into the syringe and injected into the vial (not into the liquid). Then the bottle along with the syringe is turned over with the syringe downwards and the required amount of insulin is drawn out. Before injection, it is necessary to remove air bubbles from the syringe. A fold of skin is taken at the injection site, a needle is inserted under the skin and insulin is slowly injected. After the injection, the needle is slowly removed and the injection site is pressed with a cotton swab for several seconds. The date of the first draw of insulin from the vial should be written on the bottle label.

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

Before installing the cartridge (100 IU/ml) into the OptiPen Pro1 and ClickSTAR syringe pen, it is necessary to keep it for 1–2 hours at room temperature (injections of cooled insulin are more painful). After this, gently turn the cartridge over (up to 10 times) to obtain a homogeneous suspension. Each cartridge additionally has 3 metal balls for faster mixing of its contents. After installing the cartridge in the syringe pen, before each insulin injection, the syringe pen should be turned over several times to obtain a homogeneous suspension. After mixing, the suspension should have a uniform consistency and milky white color. The suspension cannot be used if it is of any other type, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the cartridge. In such cases, you should use another cartridge that meets the above conditions, and you should also inform your doctor. Remove any air bubbles from the cartridge before injection.

The cartridge is not designed for mixing Insuman® Basal GT with other insulins. Empty cartridges cannot be refilled. If the syringe pen breaks down, you can administer the required dose from the cartridge using a regular syringe. It must be remembered that the insulin concentration in the cartridge is 100 IU/ml, so you must use only plastic syringes designed for this insulin concentration. The syringe must not contain any other drug or its residues.

After installing the cartridge, it can be used for 4 weeks. It is recommended to store at a temperature not exceeding 25 °C in a place protected from light and heat. While using the cartridge, the pen syringe should not be stored in the refrigerator (as injections with chilled insulin are more painful). After installing a new cartridge, you must check the correct operation of the syringe pen before injecting the first dose.

Patient instructions

Instructions for use and handling of the SoloStar® pre-filled syringe pen

Before first use, the syringe pen must be kept at room temperature for 1–2 hours.

Before use, you should inspect the cartridge inside the syringe pen after thoroughly mixing the suspension in it by rotating the syringe pen around its axis, holding it at an acute angle between the palms. It should only be used if, after mixing, the suspension has a uniform consistency and a milky white color. The syringe pen cannot be used if the suspension in it after mixing has any other form, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the cartridge. In such cases, you should use a different syringe pen and also inform your doctor.

Empty SoloStar® syringe pens should not be reused and must be destroyed.

To prevent infection, the prefilled pen should only be used by one patient and not shared with another person.

Handling the SoloStar® syringe pen

Before using the SoloStar® syringe pen, you should carefully read the information on use.

Important information on using the SoloStar® syringe pen

Before each use, carefully attach a new needle to the pen and perform a safety test. Only needles compatible with SoloStar® should be used.

Special precautions must be taken to avoid needle-related accidents and the possibility of transmitting infection.

Under no circumstances should the SoloStar® syringe pen be used if it is damaged or if the patient is not sure that it will work properly.

It is always necessary to have a spare SoloStar® syringe pen available in case of loss or damage to a working copy of the SoloStar® syringe pen.

Storage instructions

It is necessary to study the section “Storage Conditions” regarding the rules for storing the SoloStar® syringe pen.

If the SoloStar® syringe pen is stored in the refrigerator, it should be removed from there 1–2 hours before the intended injection so that the suspension reaches room temperature. Injecting chilled insulin is more painful.

The used SoloStar® syringe pen must be destroyed.

Exploitation

The SoloStar® syringe pen must be protected from dust and dirt.

The outside of the SoloStar® syringe pen can be cleaned by wiping it with a damp cloth.

Do not immerse, rinse or lubricate the SoloStar® syringe pen in liquid, as this can damage it.

The SoloStar® syringe pen accurately doses insulin and is safe to use. It also requires careful handling. Situations in which damage to the SoloStar® syringe pen may occur should be avoided. If the patient suspects that a working copy of the SoloStar® syringe pen may have been damaged, a new syringe pen should be used.

Stage 1: Insulin control

It is necessary to check the label on the SoloStar® pen to ensure that it contains the appropriate insulin. For Insuman® Basal GT, the SoloStar® syringe pen is white with a green button for administering the injection. After removing the cap of the syringe pen, control appearance insulin contained in it: the insulin suspension after mixing should have a uniform consistency and milky white color.

Stage 2. Connecting the needle

It is necessary to use only needles that are compatible with the SoloStar® syringe pen.

For each subsequent injection, always use a new sterile needle. After removing the cap, the needle must be carefully installed on the syringe pen.

Stage 3. Carry out the safety test (always carried out after mixing the suspension, see above).

Before each injection, a safety test must be performed to ensure that the pen and needle are working properly and that air bubbles have been removed.

Measure out a dose equal to 2 units.

The outer and inner needle caps must be removed.

With the syringe pen facing upward, gently tap the insulin cartridge with your finger so that all air bubbles are directed towards the needle.

Fully press the injection button.

If insulin appears at the tip of the needle, the pen and needle are working correctly.

If no insulin appears at the needle tip, then step 3 can be repeated until insulin appears at the needle tip.

Stage 4. Dose selection (always carried out after mixing the suspension, see above)

The dose can be set with an accuracy of 1 unit: from the minimum dose - 1 unit to the maximum dose - 80 units. If it is necessary to administer a dose exceeding 80 units, 2 or more injections should be given.

The dosage window should show "0" after completion of the safety test. After this, the required dose can be set.

Stage 5. Dose administration

The patient should be informed about the injection technique by a healthcare professional.

The needle must be inserted under the skin. The injection button must be pressed fully. It is held in this position for another 10 s until the needle is removed. This ensures that the selected dose of insulin is administered completely.

Stage 6: Removing and discarding the needle

In all cases, the needle should be removed and discarded after each injection. This prevents contamination and/or infection, air from entering the insulin container, and insulin leakage.

Special precautions must be taken when removing and discarding the needle. Recommended safety precautions for removing and disposing of needles (such as one-handed capping techniques) should be followed to reduce the risk of needle-related accidents and prevent infection.

After removing the needle, you should close the SoloStar® syringe pen with the cap.

Overdose

Symptoms: Insulin overdose, such as administering too much insulin relative to food intake or energy expenditure, can lead to severe and sometimes prolonged life threatening hypoglycemia.

Treatment: mild episodes of hypoglycemia (the patient is conscious) can be stopped by taking carbohydrates orally. Adjustments to your insulin dose, food intake, and physical activity may be necessary.

More severe episodes of hypoglycemia with coma, convulsions or neurological disorders can be treated with intramuscular or subcutaneous administration of glucagon or intravenous administration of a concentrated dextrose solution.

In children, the amount of dextrose administered is set in proportion to the child's body weight. After an increase in blood glucose concentrations, maintenance carbohydrate intake and observation may be required. After the apparent clinical elimination of the symptoms of hypoglycemia, its re-development is possible.

In cases of severe or prolonged hypoglycemia, following a glucagon injection or dextrose injection, it is recommended to infuse with a less concentrated dextrose solution in order to prevent the recurrence of hypoglycemia.

In young children, it is necessary to carefully monitor the concentration of glucose in the blood, due to possible development severe hyperglycemia.

Precautionary measures

If glycemic control is insufficient or a tendency toward episodes of hyper- or hypoglycemia appears, before deciding to adjust the insulin dose, be sure to check compliance with the prescribed insulin regimen, ensure that insulin is injected into the recommended area, check the correct injection technique and all other factors which may affect the effect of insulin. Because simultaneous use of a number of drugs can weaken or enhance the hypoglycemic effect of the drug Insuman® Basal GT; when using it, you should not take any other drugs without the special permission of a doctor.

Hypoglycemia. Occurs when the dose of insulin exceeds the need for it. The risk of developing hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin drug, in patients with low maintenance blood glucose concentrations.

As with all insulins, extreme caution and intensive monitoring of blood glucose concentrations is recommended in patients for whom hypoglycemic episodes may be of particular clinical significance, such as patients with severe coronary or cerebral artery stenosis (risk of cardiac or cerebral complications of hypoglycemia) , as well as in patients with proliferative retinopathy, especially if they have not undergone photocoagulation (laser therapy), because they have a risk of transient amaurosis (total blindness) if hypoglycemia develops.

There are certain clinical symptoms and signs that should indicate to the patient or others that hypoglycemia is developing. These include: increased sweating, skin moisture, tachycardia, heart rhythm disturbances, increased blood pressure, chest pain, tremor, anxiety, hunger, drowsiness, sleep disturbances, feelings of fear, depression, irritability, unusual behavior, feelings of anxiety, paresthesia in mouth and around the mouth, pallor of the skin, headache, impaired coordination of movements, as well as transient neurological disorders (speech and vision disturbances, paralytic symptoms) and unusual sensations. With an increasing decrease in glucose concentration, the patient may lose self-control and even consciousness. In such cases, the skin may become cold and damp, and cramps may occur. Therefore, every patient with diabetes who receives insulin must learn to recognize unusual symptoms that are a sign of developing hypoglycemia. Patients who regularly monitor blood glucose levels are less likely to develop hypoglycemia. The patient himself can correct the decrease in blood glucose concentration he notices by taking sugar or foods high in carbohydrates. For this purpose, the patient should always have 20 g of glucose with him.

In more severe conditions of hypoglycemia, a subcutaneous injection of glucagon is indicated (which can be done by a doctor or nursing staff). After sufficient improvement in the condition, the patient should eat. If hypoglycemia cannot be eliminated immediately, you should urgently call a doctor. It is necessary to immediately inform the doctor about the development of hypoglycemia so that he can decide on the need to adjust the insulin dose. Failure to follow a diet, skipping insulin injections, increased need for insulin as a result of infectious or other diseases, and decreased physical activity can lead to an increase in the concentration of glucose in the blood (hyperglycemia), possibly with an increase in the concentration of ketone bodies in the blood (ketoacidosis). Ketoacidosis may develop over several hours or days. At 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 the urine) urgent medical intervention is necessary.

When changing doctors (for example, when hospitalized due to an accident, illness during vacation), the patient must inform the doctor that he has diabetes.

Patients should be warned about conditions where symptoms warning of hypoglycemia may vary, be less severe, or be completely absent, such as:

  • with a significant improvement in glycemic control;
  • gradual development of hypoglycemia;
  • in elderly patients;
  • in patients with autonomic neuropathy;
  • in patients with a long history of diabetes mellitus;
  • in patients simultaneously receiving treatment with certain medicines. Such situations can lead to the development of severe hypoglycemia (and possibly loss of consciousness) before the patient realizes that he is developing hypoglycemia.

If normal or reduced values ​​of glycosylated hemoglobin are detected, the possibility of developing repeated, unrecognized (especially nocturnal) episodes of hypoglycemia should be considered.

Reducing the risk of hypoglycemia requires that the patient strictly follow the prescribed dosage and diet regimen, administer insulin injections correctly, and be alerted to the symptoms of developing hypoglycemia.

Factors that increase susceptibility to the development of hypoglycemia require careful monitoring and may require dose adjustment. These factors include:

  • changing the area of ​​insulin administration;
  • increasing insulin sensitivity (for example, eliminating stress factors);
  • unusual (increased or prolonged) physical activity;
  • intercurrent pathology (vomiting, diarrhea);
  • insufficient food intake;
  • skipping meals;
  • alcohol consumption;
  • some uncompensated endocrine diseases(such as hypothyroidism and anterior pituitary insufficiency or adrenal insufficiency);
  • simultaneous use of certain drugs.

Intercurrent diseases. Intercurrent illnesses require intensive metabolic control. In many cases, urine tests for the presence of ketone bodies are indicated, and insulin dosage adjustments are often necessary. Insulin requirements often increase. Patients with type 1 diabetes should continue to regularly consume at least small amounts of carbohydrates, e.g.

Bibliography:

  1. Anatomical Therapeutic Chemical Classification (ATX);
  2. Nosological classification (ICD-10);
  3. Official instructions from the manufacturer.
**** HOECHST MARION ROUSSEL Aventis Pharma Deutschland GmbH Sanofi-Aventis Deutschland GmbH/Sanofi-Aventis Vosto Hoechst Marion Roussel GmbH

Country of origin

Germany Germany/Russia

Product group

Digestive tract and metabolism

Intermediate-acting human insulin

Release forms

  • 3 ml - colorless glass cartridges, mounted in SoloStar® syringe pens (5) - cardboard packs. 5 ml - colorless glass bottles (5) - cardboard packs.

Description of the dosage form

  • Suspension for subcutaneous administration, white or almost white, easily dispersible.

pharmachologic effect

Hypoglycemic drug, intermediate-acting insulin. Insuman® Basal GT contains insulin, identical in structure to human insulin, obtained by genetic engineering using E. coli K12 135 pINT90d. Mechanism of action: - reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects; - increases the transport of glucose into cells and the synthesis of glycogen in muscles and liver, improves the utilization of pyruvate, inhibits glycogenolysis and gluconeogenesis; - increases lipogenesis in the liver and adipose tissue and suppresses lipolysis; - promotes the entry of amino acids into cells and protein synthesis; - increases the flow of potassium into cells. The effect of Insuman® Basal GT begins gradually and lasts for a long time. After subcutaneous administration, the hypoglycemic effect occurs within 1 hour and reaches a maximum after 3-4 hours. The effect lasts for 11-20 hours.

Pharmacokinetics

In healthy patients, T1/2 of plasma insulin is approximately 4-6 minutes and is prolonged in renal failure. However, it should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Special conditions

If glycemic control is insufficient or a tendency toward episodes of hyper- or hypoglycemia appears, before deciding to adjust the insulin dose, be sure to check compliance with the prescribed insulin regimen, ensure that insulin is injected into the recommended area, check the correct injection technique and all other factors which may affect the effect of insulin. Since the simultaneous use of a number of drugs can weaken or enhance the hypoglycemic effect of the drug Insuman Basal GT, when using it, you should not take any other drugs without the special permission of a doctor. Hypoglycemia Hypoglycemia occurs when the dose of insulin exceeds the need. The risk of developing hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin drug, in patients with low maintenance blood glucose concentrations. As with all insulins, extreme caution and intensive monitoring of blood glucose concentrations is recommended in patients for whom hypoglycemic episodes may be of particular clinical significance, such as patients with severe coronary or cerebral artery stenosis (risk of cardiac or cerebral complications of hypoglycemia) , as well as in patients with proliferative retinopathy, especially if they have not undergone photocoagulation (laser therapy), since they have a risk of transient amaurosis (complete blindness) with the development of hypoglycemia. There are certain clinical symptoms and signs that should indicate to the patient or others that hypoglycemia is developing. These include: increased sweating, skin moisture, tachycardia, heart rhythm disturbances, increased blood pressure, chest pain, tremor, anxiety, hunger, drowsiness, sleep disturbances, feelings of fear, depression, irritability, unusual behavior, feelings of anxiety, paresthesia in mouth and around the mouth, pallor of the skin, headache, impaired coordination of movements, as well as transient neurological disorders (speech and vision disturbances, paralytic symptoms) and unusual sensations. With an increasing decrease in glucose concentration, the patient may lose self-control and even consciousness. In such cases, the skin may become cold and damp, and cramps may occur. Therefore, every patient with diabetes who receives insulin must learn to recognize unusual symptoms that are a sign of developing hypoglycemia. Patients who regularly monitor blood glucose levels are less likely to develop hypoglycemia. The patient himself can correct the decrease in blood glucose concentration he notices by taking sugar or foods high in carbohydrates. For this purpose, the patient should always have 20 g of glucose with him. In more severe conditions of hypoglycemia, a subcutaneous injection of glucagon is indicated (which can be done by a doctor or nursing staff). After sufficient improvement

Compound

  • insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml. insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml.

Insuman Basal GT indications for use

  • - diabetes mellitus requiring treatment with insulin.

Insuman Basal GT contraindications

  • - hypoglycemia; - hypersensitivity to insulin or to any of the auxiliary components of the drug, except in cases where insulin therapy is vital. With caution - in case of renal failure (a decrease in the need for insulin is possible due to a decrease in insulin metabolism); - in elderly patients (a gradual decrease in renal function can lead to an ever-increasing decrease in the need for insulin); - in patients with liver failure (the need for insulin may be reduced due to a decrease in the ability to gluconeogenesis and a decrease in insulin metabolism); - in patients with severe stenosis of the coronary and cerebral arteries (in these patients, hypoglycemic episodes may be of particular clinical significance, since there is an increased risk of cardiac or cerebral complications of hypoglycemia); - in patients with proliferative retinopathy, especially those who have not received treatment with photocoagulation (laser therapy)

Insuman Basal GT dosage

  • 100 IU/ml

Insuman Basal GT side effects

  • Hypoglycemia Hypoglycemia, the most common side effect of insulin therapy, can occur if the dose of insulin administered exceeds the need. Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma and seizures. Prolonged or severe episodes of hypoglycemia can be life-threatening for patients. In many patients, symptoms and manifestations of neuroglycopenia may be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Typically, with a more pronounced or faster decrease in blood glucose concentration, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are more pronounced. With a sharp decrease in the concentration of glucose in the blood, hypokalemia (complications from the cardiovascular system) or the development of cerebral edema may develop. Listed below are adverse events observed in clinical studies, classified by organ system class and in decreasing order of frequency. Immune system disorders Immediate allergic reactions to insulin or to excipients of the drug (frequency unknown), may manifest as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (frequency unknown), decreased blood pressure (frequency unknown) and anaphylactic shock (uncommon reactions) and may be life-threatening

Drug interactions

Concomitant use with oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cybenzoline, cyclophosphamide, fenfluramine, guanethidine, ifosfamide, phenoxybenzas nom, phentolamine, somatostatin and its analogues, sulfonamides, tetracyclines, tritoqualine or trophosfamide may enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. Combined use with corticotropin, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, those present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthaleino

Storage conditions

  • store in a dry place
  • keep away from children
  • store in a place protected from light
Information provided by the State Register of Medicines.

Synonyms

  • Biogulin Lente U40, Isofan Insulin ChM, Levulin L, Levulin N, Monotard, Humulin L, Humulin N

Insuman Bazal GT
Buy Insuman Basal GT in pharmacies
Insuman Basal GT in the drug directory

DOSAGE FORMS
suspension for subcutaneous injection 100IU/ml

MANUFACTURERS
Aventis Pharma Deutschland GmbH (Germany)
Aventis Pharma Deutschland GmbH

Sanofi-Aventis Deutschland GmbH
packed by Sanofi-Aventis Vostok (Germany)

GROUP
Intermediate-acting insulins

COMPOUND
Insulin isophane (human genetically engineered).

INTERNATIONAL NON-PROPENTED NAME
Insulin isophane (human genetically engineered)

SYNONYMS
Biosulin N, Gansulin N, Gensulin N, Insuran NPH, Protafan HM, Protafan HM penfill, Rinsulin NPH, Rosinsulin S, Humodar B 100 Rek, Humulin NPH

PHARMACHOLOGIC EFFECT
Medium-acting insulin preparation. Reduces the concentration of glucose in the blood, increases its uptake by tissues, enhances lipogenesis and glycogenogenesis, protein synthesis, and reduces the rate of glucose production by the liver. Interacts with a specific receptor on the outer cell membrane and forms an insulin receptor complex. The decrease in glucose content in the blood is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, protein synthesis, a decrease in the rate of glucose production by the liver (decreased glycogen breakdown), etc. After subcutaneous injection, the effect occurs within 1-2 hours. Maximum effect - in the interval between 2-12 hours, duration of action -18-24 hours depending on the composition of insulin and dose, reflects significant inter- and intrapersonal variations. Absorption and onset of action depend on the route of administration (s.c. or i.m.), location (abdomen, thigh, buttocks) and volume of injection, insulin concentration in the drug, etc. Distributed unevenly in tissues; does not penetrate the placental barrier and into breast milk. Destroyed by insulinase, mainly in the liver and kidneys. Excreted by the kidneys.

INDICATIONS FOR USE
Diabetes mellitus type 1. Diabetes mellitus type 2; stage of resistance to oral hypoglycemic drugs, partial resistance to oral hypoglycemic drugs ( combination therapy); intercurrent diseases, surgical interventions(mono- or combination therapy), diabetes mellitus during pregnancy (if diet therapy is ineffective).

CONTRAINDICATIONS
Hypersensitivity, hypoglycemia.

SIDE EFFECT
Allergic reactions (urticaria, angioedema- fever, shortness of breath, decreased blood pressure); hypoglycemia (pallor of the skin, increased sweating, perspiration, palpitations, tremor, hunger, agitation, anxiety, paresthesia in the mouth, headache, drowsiness, insomnia, fear, depressed mood, irritability, unusual behavior, uncertainty of movements, speech disorders and vision), hypoglycemic coma; hyperglycemia and diabetic acidosis (at low doses, skipping an injection, non-compliance with the diet, against the background of fever and infections): drowsiness, thirst, loss of appetite, facial flushing); impairment of consciousness (up to the development of precomatose and comatose state); transient visual disturbances (usually at the beginning of therapy); immunological cross reactions with human insulin; an increase in the titer of anti-insulin antibodies with a subsequent increase in glycemia; hyperemia, itching and lipodystrophy (atrophy or hypertrophy of subcutaneous fat) at the injection site. At the beginning of treatment, swelling and refractive error occur (they are temporary and disappear with continued treatment).

INTERACTION
Pharmaceutically incompatible with solutions of other drugs. The hypoglycemic effect is enhanced by sulfonamides (including oral hypoglycemic drugs, sulfonamides), MAO inhibitors (including furazolidone, procarbazine, selegiline), carbonic anhydrase inhibitors, ACE inhibitors, non-steroidal anti-inflammatory drugs (including salicylates), anabolic steroid(including stanozolol, oxandrolone, methandrostenolone), androgens, bromocriptine, tetracyclines, clofibrate, ketoconazole, mebendazole, theophylline, cyclophosphamide, fenfluramine, Li+ preparations, pyridoxine, quinidine, quinine, chloroquinine, ethanol. The hypoglycemic effect is weakened by glucagon, somatropin, glucocorticosteroids, oral contraceptives, estrogens, thiazide and loop diuretics, BMCC, thyroid hormones, heparin, sulfinpyrazone, sympathomimetics, danazol, tricyclic antidepressants, clonidine, calcium antagonists, diazoxide, morphine, marijuana, nicotine , phenytoin, epinephrine, H1-histamine receptor blockers. Beta-blockers, reserpine, octreotide, pentamidine can both enhance and weaken the hypoglycemic effect of insulin.

METHOD OF APPLICATION AND DOSAGE
Subcutaneously, 1-2 times a day, 30-45 minutes before breakfast (change the injection site each time). IN special cases the doctor can prescribe intramuscular injections drug. Intravenous administration of intermediate-acting insulin is prohibited! Doses are selected individually and depend on the glucose content in the blood and urine, and the characteristics of the course of the disease. Typically doses are 8-24 IU once a day. In adults and children with high sensitivity for insulin, a dose of less than 8 IU/day may be sufficient; in patients with reduced sensitivity, a dose exceeding 24 IU/day. At a daily dose exceeding 0.6 IU/kg - in the form of 2 injections in different places. Patients receiving 100 IU or more per day should be hospitalized when replacing insulin. Transfer from one drug to another should be carried out under the control of blood glucose levels.

OVERDOSE
Symptoms: perspiration, palpitations, tremor, hunger, anxiety, paresthesia in the mouth, pallor, headache, drowsiness, insomnia, fear, depressed mood, irritability, unusual behavior, uncertainty of movements, speech and vision disturbances, hypoglycemic coma, convulsions. Treatment: if the patient is conscious, dextrose is prescribed orally; glucagon is administered subcutaneously, intramuscularly or intravenously or intravenously hypertonic solution dextrose. When a hypoglycemic coma develops, 20-40 ml (up to 100 ml) of a 40% dextrose solution is injected intravenously until the patient emerges from the comatose state.

SPECIAL INSTRUCTIONS
When foreign bodies If the substance becomes cloudy or precipitates on the glass of the bottle, the drug solution cannot be used. The temperature of the administered insulin should be at room temperature. The insulin dose must be adjusted in cases infectious diseases, in case of dysfunction thyroid gland, Addison's disease, hypopituitarism, chronic renal failure and diabetes mellitus in people over 65 years of age. The causes of hypoglycemia can be: insulin overdose, drug replacement, skipping meals, vomiting, diarrhea, physical stress; diseases that reduce the need for insulin, changing the injection site, as well as interaction with other drugs. It is possible to reduce the concentration of glucose in the blood when transferring a patient from animal insulin to human insulin. Transferring a patient to human insulin should always be medically justified and carried out only under the supervision of a physician. The tendency to develop hypoglycemia may impair the ability of patients to actively participate in traffic, as well as maintenance of machines and mechanisms. Patients with diabetes can relieve self-perceived mild hypoglycemia by eating sugar or eating foods high in carbohydrates (it is recommended to always have at least 20 g of sugar with you). It is necessary to inform the attending physician about hypoglycemia in order to decide whether treatment adjustments are necessary. During pregnancy, it is necessary to take into account a decrease (I trimester) or increase (II-III trimesters) in the need for insulin. During and immediately after childbirth, the need for insulin may decrease dramatically. During lactation, daily monitoring is necessary for several months (until insulin needs stabilize).

STORAGE CONDITIONS
List B. Store in a cool, dry place at a temperature of 2-8 degrees. WITH.



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