Characteristics, properties and use of insulin insulin rapid gt. Characteristics, properties and use of insulin insulin rapid gt How to use a disposable syringe pen rapid km

INN: Short-acting human insulin

Manufacturer: Sanofi-Aventis Deutschland GmbH

Anatomical-therapeutic-chemical classification: Insulin (human)

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 018747

Registration period: 29.02.2012 - 28.02.2017

Instructions

Tradename

Insuman® Rapid GT

International nonproprietary name

Human insulin

Dosage form

Solution for injection 100 IU/ml

Compound

1 ml of solution contains

active substance: human insulin 100 IU (3.571 mg),

Excipients: glycerin 85%, metacresol, sodium dihydrogen phosphate dihydrate, sodium hydroxide, concentrated hydrochloric acid, water for injection.

Description

Transparent colorless or almost colorless liquid.

Pharmacotherapeutic group

Medicines for the treatment of diabetes mellitus. Insulins and fast-acting analogues.

ATS code A10AV01

Pharmacological properties

Pharmacokinetics

Insuman ® Rapid GT is characterized by a rapid onset and a short period of action. The hypoglycemic effect appears within 30 minutes after subcutaneous administration, and reaches a maximum within 1-4 hours. The effect lasts for 7-9 hours.

The half-life of insulin from serum is approximately 4-6 minutes. It lengthens in severe renal failure. It should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Pharmacodynamics

Insuman ® Rapid is a neutral insulin solution (regular insulin).

Insuman ® Rapid GT contains insulin, identical in structure to human insulin, obtained using recombinant DNA technology using Escherichia coli.

Like human insulin, Insuman ® Rapid GT

Lowers blood glucose levels and enhances anabolic effects, in

while at the same time reducing catabolic effects

Increases glucose transport into cells and glycogen formation in muscles and liver, improves pyruvate utilization, suppresses glycogenolysis and glyconeogenesis

Increases lipogenesis in the liver and adipose tissue and suppresses lipolysis

Promotes the consumption of amino acids by cells and activates protein synthesis

Increases the flow of potassium into cells

Indications for use

Diabetes mellitus, when treatment with insulin is necessary.

Insuman® Rapid GT is also suitable for the treatment of hyperglycemic coma and ketoacidosis, as well as for achieving stabilization of patients with diabetes mellitus before, during and after surgery

Directions for use and doses

Desired blood glucose levels, insulin preparations to be used and dosage regimen (doses, time distribution) are selected individually in accordance with the patient's diet, level of physical activity and lifestyle.

Daily doses and administration time

There are no fixed rules for insulin dosing. The average daily need for insulin is 0.5-1.0 IU per 1 kg of patient body weight. The basic metabolic requirement is 40-60% of the daily insulin dose. Insuman ® Rapid GT is administered subcutaneously 15-20 minutes before meals.

In the treatment of severe hyperglycemia or ketoacidosis, insulin administration is part of a comprehensive therapeutic regimen that includes measures to protect the patient from possible serious complications by rapidly reducing blood glucose levels. Such treatment requires careful monitoring of the patient (assessment of metabolic status, acid-base and electrolyte balance, functional indicators of vital organs, etc.) in the intensive care unit or in similar conditions.

Secondary dose adjustment

Improving metabolic control may lead to increased

insulin sensitivity, leading to decreased insulin requirements. Dose adjustment may be required if the patient’s weight, lifestyle changes, or under other circumstances that may contribute to an increased tendency to hypoglycemia or hyperglycemia (see “Special Instructions”).

Special patient groups

The need for insulin may be reduced in cases of impaired liver or kidney function and in old age (see "Special Instructions").

Introduction

Insuman® Rapid GT is administered subcutaneously. Intravenous administration of the drug is allowed.

Insulin absorption, and therefore the hypoglycemic effect, may vary depending on the site of administration (eg, abdominal wall versus femoral area). The injection site must be changed within the same area each time.

Intravenous insulin therapy should be administered in an intensive care unit setting or with appropriate monitoring and equipment.

Side effects

The following side effects associated with the use of the drug and observed in clinical studies are listed in order of decreasing frequency: very common (≥ 1/10), common (≥ 1/100,< 1/10), нечастые (≥ 1/1.000, < 1/100), редкие (≥ 1/10.000, < 1/1.000), очень редкие (< 1/10.000) и частота неизвестна (на основании имеющихся данных не определяется).

Often

Hypoglycemia

Often

Edema (result of metabolic disorders)

Injection site reactions

Infrequently

Shock (immune origin)

Urticaria at the injection site

Rarely

The presence of antibodies to insulin, which may necessitate insulin dosage adjustments to correct the tendency toward hyperglycemia or hypoglycemia

Frequency unknown

Immediate allergic reactions (hypotension, angioedema, bronchospasm, generalized skin reactions) to insulin or excipients may be life-threatening

Formation of antibodies to insulin

Sodium retention in the body

Proliferative retinopathy, diabetic retinopathy, visual impairment - lipodystrophy, at the injection site, leading to slow absorption of insulin. Constantly changing injection sites within a given injection area may help reduce or prevent such reactions.

Inflammation, swelling, pain, itching, hyperemia at the injection site, which goes away after a few days or weeks

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Use in external or implanted insulin pumps, peristaltic pumps with silicone tubing

Drug interactions

A number of drugs affect glucose metabolism, which may require adjustment of the dose of human insulin.

To drugs that can enhance the hypoglycemic effect of insulin and increase susceptibility to hypoglycemia include oral antidiabetic agents, angiotensin-converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfonamides.

To drugs that can weaken the hypoglycemic effect of insulin, include glucocorticosteroid hormones, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetics [for example, epinephrine (adrenaline), salbutamol, terbutaline], thyroid hormones , protease inhibitors and atypical antipsychotic drugs (eg, olanzapine and clozapine).

Beta blockers, clonidine, lithium salts, and alcohol may both strengthen and weakenhypoglycemic effect of insulin.

Pentamidine can cause hypoglycemia, which sometimes gives way to hyperglycemia.

In addition, under the influence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, signs

adrenergic counterregulation may be weak or absent.

special instructions

Patients with hypersensitivity to Insuman ® Rapid GT, for the treatment of which there are currently no other insulin preparations available that would be better tolerated, its administration should be continued under conditions of strict medical supervision and, if necessary, in combination with antiallergic measures.

In case of allergy to animal insulin, before transferring the patient to Insuman ® Rapid GT is recommended to carry out an intradermal test, since cross-immune reactions are possible.

Insulin can cause sodium retention and edema, especially if previously poor metabolic control improves with increased insulin therapy.

If renal function is impaired, insulin requirements may be reduced due to decreased insulin metabolism. The progressive decline in kidney function in old age can lead to a steadily decreasing need for insulin.

In patients with severe hepatic impairment, insulin requirements may be reduced due to a reduction in gluconeogenesis and insulin metabolism.

If, as a result of treatment, it is not possible to achieve the desired level of glucose, and there is a tendency to episodes of hypo- or hyperglycemia, then before changing the dosage of the drug, it is necessary to check how clearly the patient follows the instructions for the administration regimen and dosage of the drug, injection technique -tions, changing injection sites and the presence of other factors affecting the effectiveness of treatment.

Transition to Insuman® Rapid GT

Switching a patient to another type or brand of insulin should be done under the strict supervision of a physician. Due to changes in concentration, grade (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of production, it may be necessary to change the dosage.

The need for dose adjustment (for example, reduction) may become obvious immediately after changing the drug and, conversely, may develop gradually over several weeks.

After switching from animal insulin to human insulin, a dosage reduction may be necessary in the following groups of patients:

Those who previously achieved lower blood glucose levels with treatment

Which have a tendency to develop hypoglycemia

Who previously required high doses of insulin due to the presence of insulin antibodies.

Close metabolic monitoring is recommended during transfer and in the first weeks after transfer. Patients who require higher doses of insulin due to the presence of antibodies may require medical supervision in an inpatient or similar setting when switching from one insulin product to another.

Hypoglycemia

Hypoglycemia, the most common adverse effect of insulin therapy, can occur if the insulin dose is too high compared to insulin requirements. Frequency varies with population and dose regimen, so it is not possible to indicate a specific frequency.

Severe and especially repeated attacks of hypoglycemia can cause neurological disorders. Prolonged and severe attacks of hypoglycemia can pose a threat to the patient's life.

In many patients, signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counterregulation. The more and faster the blood glucose level decreases, the more pronounced the phenomenon of counterregulation and its symptoms are.

Particular caution should be exercised and enhanced control of blood glucose levels is recommended in patients whose episodes of hypoglycemia may be of particular clinical significance, for example, in patients with severe stenosis of the coronary arteries or cerebral arteries (risk of developing cardiac or cerebral complications of hypoglycemia), as well as in patients with proliferative retinopathy, especially if they have not undergone photocoagulation treatment (risk of developing transient amaurosis after hypoglycemia). A marked change in glycemic control may cause temporary visual impairment due to a temporary change in the swelling of the eye's lens and its refractive index). The long-term existence of improved glycemic control reduces the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with a dramatic improvement in glycemic control may be associated with a temporary worsening of diabetic retinopathy.

Patients should be familiar with the conditions under which the warning signs of hypoglycemia are mild. In certain risk groups, symptoms that are precursors of hypoglycemia may change, be less pronounced, or be absent. Such patients include:

Patients whose glycemic control has improved markedly

Patients in whom hypoglycemia develops gradually

Elderly patients

After switching from animal to human insulin

In the presence of autonomic neuropathy

With long-term diabetes mellitus

If you have a psychiatric illness

When simultaneously treated with certain other drugs (see “Drug Interactions”)

In such cases, hypoglycemia can become severe (with possible loss of consciousness) even before the patient realizes that he has hypoglycemia.

In the presence of normal or reduced levels of glycosylated hemoglobin, the likelihood of repeated, unrecognized (especially nocturnal) episodes of hypoglycemia should be assumed.

Strict patient adherence to dosage and diet regimen, correct insulin administration, and awareness of the signs of hypoglycemia are necessary to reduce the risk of hypoglycemia. Factors that increase susceptibility to hypoglycemia require particularly careful monitoring and may necessitate dose adjustment. These include:

Changing the injection site

Increased insulin sensitivity (eg, as a result of removal of stressors)

Unusual, increased or longer physical activity

Intercurrent illness (eg, vomiting, diarrhea)

Inadequate food intake

Skipping meals

Alcohol consumption

Some uncompensated endocrine disorders (for example, with hypothyroidism and insufficiency of the anterior pituitary gland or adrenal cortex)

Concomitant treatment with certain other drugs

Intercurrent diseases

Intercurrent diseases require intensive metabolic control. In many cases, a urine test for ketones is indicated, and insulin dosage adjustment is also often required. The need for insulin often increases. Patients with type 1 diabetes should regularly take at least a small amount of carbohydrates, even if they are able to consume food only in small amounts or may not eat at all, or they have vomiting, etc. These patients should never skip insulin injections completely.

Mixing insulins

Insuman ® Rapid should NOT be mixed with insulins of animal origin or with insulin analogues.

Insuman ® Rapid GT can be mixed with all Sanofi-Aventis human insulin products, with the exception of insulins intended for use in insulin pumps.

If you need to draw two different insulins into one injection syringe, it is recommended that you draw the shorter-acting insulin first to prevent contamination of the vial with the longer-acting drug. It is advisable to administer immediately after mixing. Do not mix insulins of different concentrations (for example, 100 IU/ml and 40 IU/ml).

Any unused product or waste should be disposed of in accordance with local regulations.

Instructions for use

Insuman® Rapid GT (cartridge) Designed for use in conjunction with insulin pens such as OptiPen and other pens suitable for Insuman cartridges. Directions for use should be strictly followed

handles regarding filling the cartridge, inserting the injection needle and administering the insulin injection.

If an insulin pen is damaged or does not work well (due to a mechanical defect), it should be thrown away and a new insulin pen used. If the pen does not work well (see instructions for use of the pen), you can withdraw the solution from the cartridge using an injection syringe (suitable for 100 IU/ml insulin) and inject it.

Before inserting into the Insuman pen ® Rapid GT should be kept at room temperature for 1-2 hours. The cartridge must be inspected before use. It can only be used if the solution appears clear, colorless, contains no visible solids and has a watery consistency.

Before injection, any air bubbles should be removed from the cartridge. Empty cartridges cannot be refilled.

Insuman Rapida GT cartridges are designed to prevent mixing in the cartridge with any other insulin.

Insuman® Rapid GT (bottle)

It must be remembered that 1 ml of suspension contains 100 IU of insulin, so you must use only injection syringes designed for this insulin concentration (100 IU/ml). The syringe must not contain any other drug or its residues (for example, residues of heparin).

Before taking insulin for the first time, you must remove the plastic protective cap from the vial. Do not shake the bottle vigorously, as this may cause foam to form, which may prevent accurate dosage measurement.

Insuman ® Rapid GT can only be used if the solution is colorless, transparent and free of visible solids and has a consistency similar to an aqueous solution.

Like all insulin preparations, Insuman ® Rapid GT must not be mixed with solutions containing reducing substances such as thiols and sulfites. It must be remembered that neutral regular insulin precipitates at a pH of approximately 4.5-6.6. It is unacceptable for alcohol and other disinfectants to get into the insulin solution.

Pregnancy and lactation

There are no data on the effects of human insulin during pregnancy. Insulin does not cross the placental barrier. When prescribing the drug to pregnant women, caution should be exercised.

In the case of patients with pre-existing or gestational diabetes mellitus, it is important to maintain a good metabolic rate throughout pregnancy. Insulin requirements may decrease during the first trimester of pregnancy and generally increase during the second and third trimesters. Immediately after birth, the need for insulin decreases rapidly (the risk of hypoglycemia increases). In these conditions

Careful monitoring of blood glucose levels is essential.

No effects are expected on breastfed children. Insuman ® Rapid GT can be used during breastfeeding.

However, women who are breastfeeding may need to adjust their insulin dose and diet.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms The patient's ability to concentrate and react may be reduced as a result of hypoglycemia or hyperglycemia, or, for example, as a result of visual impairment. This is dangerous in situations where the above abilities are of particular importance (for example, while driving a car or operating machinery).

Patients should be warned about the need to take precautions to avoid the development of hypoglycemia while driving. This is especially important for those who have mild or absent warning symptoms of hypoglycemia, or frequent episodes of hypoglycemia. Consideration should be given to the appropriateness of driving a vehicle and operating machinery under such circumstances.

Overdose

Symptoms: severe and sometimes prolonged life-threatening hypoglycemia

Treatment: uh episodes of mild hypoglycemia are usually relieved by taking

oral carbohydrates. It is possible to adjust the dosage regimen of the drug, diet or physical activity. Intramuscular or subcutaneous administration of glucagon or intravenous administration of concentrated glucose is possible in more severe cases occurring with coma, seizures or neurological disorders. Long-term administration of carbohydrates and long-term observation of the patient may be required due to possible relapse of hypoglycemia after apparent clinical recovery.

Release forms and packaging

Cartridge

3 ml of solution in a cartridge (colorless glass type I) with a piston (elastomer rubber) and a flange cap (aluminum) with a stopper (elastomer rubber). 5 cartridges are placed in a blister pack. 1 blister pack is placed in a cardboard box along with instructions for medical use in the state and Russian languages.

Bottle

5 ml of solution in a bottle (type I flint glass) with a stopper (aluminum tamper evident flange closure, elastomeric rubber) and a tear-off cap. 5 bottles are placed in a cardboard box along with instructions for medical use in the state and Russian languages.

Storage conditions

Before opening the primary packaging

Store at temperatures from 2° to 8° C.

Do not freeze! Avoid contact with the walls of the refrigerator.

X wound at a temperature not exceeding 25ºС.

Store cartridges and bottles in outer cardboard packaging to protect from light.

After each injection, the pen cap should be placed back on the pen to protect it from light.

Keep out of the reach of children!

Shelf life

Before opening the original packaging 2 years Do not use after the expiration date indicated on the packaging.

After opening the original packaging

Cartridge

After the first use of the cartridge inserted into the pen, the product can be used for 4 weeks.

Bottles

After the first withdrawal of the suspension from the vial, the product can be used for 4 weeks. It is recommended to indicate on the label the date of first use of insulin.

Conditions for dispensing from pharmacies

On prescription

Manufacturer/Marketing Authorization Holder

Sanofi-Aventis Deutschland GmbH, Germany

Address location: Industriepark Hoechst, Brüningstrasse, 50, D-65926 Frankfurt am Main, Germany

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Sanofi-aventis Kazakhstan LLP

Republic of Kazakhstan, 050016, Almaty, st. Kunaeva 21B

phone: 8-727-244-50-96

fax: 8-727-258-25-96

e-mail: [email protected]

Attached files

Some facts about the product:

Price in online pharmacy website: from 1 112

Pharmacological properties

Insuman Rapid GT belongs to the group of hypoglycemic medications. This is an insulin hormone with a short duration of action. The synthetic active substance is structurally identical to the human hormone. It was developed in a genetic engineering laboratory based on the K12 culture of E. coli. Its task is to reduce the density of low-molecular carbohydrates, promote plastic metabolism (anabolism) with the formation of high-molecular compounds and counteract decay processes (catabolism). Insulin Insuman Rapida GT accelerates the transport of carbohydrates into the middle of the cell, the synthesis of the hormone glycogen in muscle tissue and liver structures, promotes the process of excretion of pyruvate, slows down the formation of sugars from non-carbohydrate compounds and the breakdown of glycogen to glucose. Insulin directly accelerates the formation of fatty acid compounds from carbohydrates and prevents their breakdown. The effectiveness of Insuman Rapid GT is observed within half an hour after subcutaneous injection, reaches a maximum after 1-4 hours and lasts up to 9 hours.

Composition and release form

The main active chemical component of the drug is the human hormone insulin in a dosage of 3 mg. It is produced in the form of a transparent and colorless liquid.

Indications for use

The medical product Insuman Rapid GT is prescribed for therapeutic measures in case of complications of the pathology. It is administered in preparation for surgery, during surgery and at the stage of post-surgical recovery to ensure metabolic balance in people suffering from diabetic syndrome.

International Classification of Diseases (ICD-10)

E10 Diabetic pathology type 1. E14.0 Diabetic coma due to hyperglycemia. Z100* CLASS XXII Surgical interventions. Z98.8 Other postoperative conditions.

Side effects

The instructions for use discuss the main incidental manifestations characteristic of insulin. The most common reaction is a decrease in the level of glucose in the blood fluid, especially if the administered dose is exceeded. Repetition of such precedents can cause severe relapses of hypoglycemia with the development of neurological signs, including convulsive symptoms and coma. If such reactions continue for a long time, there is a real threat to human life. In the event of such a development of the situation, the issue of canceling Insuman Rapida GT is being considered. Signs of reflex tone of the sympathetic nervous structure are often observed, which precede neuroglycopenia. Typically, reflex activation occurs when there is a sharp drop in the density of sugars in the blood plasma. In this case, the effect of hypokalemia occurs with the development of undesirable processes in the cardiovascular system and swelling of brain tissue.

The main collateral complications in the case of a rapid decrease in glucose levels as a result of the administration of the drug Insuman Rapid GT are symptoms from:

Contraindications

Instructions for use prohibit the use of the hormone insulin in cases of low levels of low molecular weight sugars and a high degree of sensitivity to the action of the substance. The drug should be used carefully and cautiously for renal and hepatic dysfunction, narrowing of coronary vessels, proliferative retinopathy, and concomitant pathologies caused by insulin use. Particular caution should be exercised in elderly people due to reduced efficiency of the renal structure.

Use during pregnancy

The stage of bearing a child is not a reason to cancel treatment with insulin, since it does not penetrate the placental barrier. At the same time, effective support of metabolic reactions of carbohydrate balance is necessary throughout pregnancy. In the first third of the period, the amount of insulin required may decrease. But in the future it is necessary to adjust the dose of the medicine upward. During the lactoformation process, there are no restrictions on the use of insulin. However, dose and diet adjustments may be required.

Method and features of application

The target density of low-molecular carbohydrates, drug rationing schemes, and types of drugs are set strictly individually by a specialized medical specialist based on glycemic control, in accordance with the patient’s motor capabilities, his lifestyle and nutritional culture. Therefore, there are no standard doses or regimens for insulin administration. Before prescribing the pharmaceutical drug Insuman Rapid GT, the doctor is obliged to consult the person about the repeatability of procedures for determining the density of sugars in the blood fluid, as well as provide recommendations in case of changes in diet and treatment. The administration of insulin in cases of severe forms of hyperglycemia is an integral part of the combined therapeutic regimen. This also includes a number of procedures to protect the patient from the development of side effects due to a sharp drop in blood sugar. To do this, it is necessary to admit a person to a hospital and periodically, as prescribed by a doctor, analyze the metabolic status, determine the balance of acid-base reactions, and keep basic vital parameters under control. Changing the type of medication requires dosage adjustment. Thus, when switching from insulin material from representatives of the animal world to Insuman Rapid GT, a decrease in the norm is necessary. This applies to those patients who had low glucose density, who are prone to the formation of hypoglycemia, who took large amounts of material due to detected antibodies to the hormone. Patients in the older age group should clearly understand that their body needs less insulin. Therefore, they themselves or their relatives are obliged to control the dose level of the administered drug in order to avoid a sharp decrease in the glucose substance in the blood substance with serious consequences. The same applies to people with kidney and liver destruction. Insuman Rapid GT is introduced under the skin to a sufficient depth 20 minutes before eating.

Interaction with other drugs

Combination of the drug with other hypoglycemic agents, liver enzyme inhibitors, anabolic steroids, propoxyphene, phentolamine, tetracycline and other dosage forms may lead to increased hypoglycemia. The chemical product in combination with glucocorticosteroids, diuretics, somatotropin, barbiturates, and micronutrient PP weakens the effect of the insulin hormone. This is also facilitated by lithium salts, β-blockers and clonidine.

Overdose

The instructions contain a warning that the introduction of an excessive dose of the active component can cause such a serious complication that there may be a question of immediately saving a person’s life. Hypoglycemia is easily eliminated by adjusting the dose of the drug. In cases of complex forms of decreased glucose levels in the blood substance, immediate injections of concentrated dextrose are performed. All these measures apply to children at any age. The dose of the drug is determined taking into account the child’s weight.

Analogues

Products alternative to the Insuman Rapid GT product include: Ryzodeg, Vozulim-R, Insuran R and others.

Terms of sale

The medication, according to the instructions for use, is sold only with a prescription.

Storage conditions

The medicine Insuman Rapid GT must be kept in a room with normal humidity. Storage period – 2 years at temperatures in the range of 2-8°C.

Solution for injection, Aventis Pharma Deutschland GmbH

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instructions for use

Release form and composition

Solution for injection 1 ml active substance: human insulin (100% soluble human insulin) 3.571 mg (100 IU) excipients: metacresol; sodium dihydrogen phosphate dihydrate; glycerol (85%); sodium hydroxide (used to adjust pH); hydrochloric acid (used to adjust pH); water for injections

Active substance

Soluble insulin [human genetically engineered]

Pharmakinetics

Insuman® Rapid GT is an insulin with a rapid onset of action and a short duration of action. After subcutaneous administration, the hypoglycemic effect occurs within 30 minutes and reaches a maximum within 1-4 hours. The effect lasts for 7-9 hours.

Pharmadynamics

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

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.

Indications

diabetes mellitus requiring treatment with insulin;

treatment of diabetic coma and ketoacidosis;

achieving metabolic compensation in patients with diabetes mellitus during surgical interventions (before surgery, during surgery and in the postoperative period).

Contraindications

hypersensitivity reaction to insulin or to any of the auxiliary components of the drug;

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); 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); severe stenosis of the coronary and cerebral arteries (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 who have not received treatment 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.

Use during pregnancy and breastfeeding

Treatment with Insuman® Rapid GT should be continued if pregnancy occurs. 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 in 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 are planning a pregnancy, 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.

Side effects

Hypoglycemia. The most common side effect of insulin therapy can develop if the dose of insulin administered exceeds the need for it (see “Special Instructions”). Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma, seizures (see “Overdose”). 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<1/10); нечастые (≥1/1000 и <1/100); редкие (≥1/10000 и <1/1000); очень редкие (<1/10000); частота неизвестна (по имеющимся данным определить частоту встречаемости побочного действия не представляется возможным).

From the immune system: 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 (infrequent reactions) and may threaten the patient's life. Allergic reactions require the immediate adoption of appropriate emergency measures. 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.

On the part of the organ of vision: significant changes in glycemic control can 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), urticaria at the injection site (frequency unknown), swelling at the injection site (frequency unknown), or inflammation reaction at the injection site (frequency unknown).

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

Interaction

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, phenolphthalein, phenytoin derivatives, doxazosin can weaken the hypoglycemic effect of insulin.

Beta-blockers, clonidine, and lithium salts can either potentiate or weaken the hypoglycemic effect 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 amounts of alcohol consumed 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 drugs, such as beta-blockers, clonidine, guanethidine and reserpine, symptoms of reflex (in response to hypoglycemia) activation of the sympathetic nervous system may be weakened or completely absent.

Overdose

Symptoms: Insulin overdose, such as administering excess insulin relative to food intake or energy expenditure, can lead to severe and sometimes prolonged and 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 the possible development of severe hyperglycemia.

special instructions

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 (see “Interaction”) can weaken or enhance the hypoglycemic effect of the drug Insuman® Rapid GT, when using it, you should not take any other drugs without the special permission of your 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, fear, depression, irritability, unusual behavior, anxiety, paresthesia in the 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 diabetic patient receiving insulin must learn to recognize the 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. Poor diet, skipping insulin injections, increased need for insulin as a result of infectious or other diseases, and decreased physical activity can lead to increased blood glucose concentrations (hyperglycemia), possibly with increased levels 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 medications (see “Interactions”). 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, you should think about the possibility of developing repeated, unrecognized (especially nocturnal) episodes of hypoglycemia.

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 (see “Interaction”).

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, even if they can only eat small amounts of food or if they are vomiting, and they should never stop taking insulin completely.

Cross immunological reactions. In a fairly large number of patients with hypersensitivity to insulin of animal origin, the transition to human insulin is difficult due to the cross-immunological reaction of human insulin and insulin of animal origin. If the patient is hypersensitive to insulin of animal origin, as well as to m-cresol, the tolerability of the drug Insuman® Rapid GT should be assessed in the clinic using intradermal tests. If the intradermal test reveals hypersensitivity to human insulin (immediate reaction, Arthus type), then further treatment should be carried out under clinical supervision.

Impact on the ability to drive vehicles or other machinery. The patient's ability to concentrate and the speed of psychomotor reactions may be impaired as a result of hypoglycemia or hyperglycemia, as well as as a result of visual disturbances. This may pose a certain risk in situations where these abilities are important (driving vehicles or other machinery).

Patients should be advised to exercise caution and avoid hypoglycemia while driving. This is especially important in patients who have reduced or absent awareness of symptoms indicating the development of hypoglycemia, or who have frequent episodes of hypoglycemia. In such patients, the question of whether they can drive vehicles or other machinery should be decided individually.

A.10.A.B.01 Insulin (human)