Insulin Rapid: time of action and instructions for use. From the side of the skin

Manufacturer– Sanofi-Aventis (France), Sanofi

Name: Insuman® Rapid GT, Insuman® Rapid GT

Compound: 1 ml of neutral solution for injection contains 100 IU of human insulin.
Excipients: m-cresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid, water for injection.

Pharmachologic effect: Insuman Rapid GT contains insulin, identical in structure to human insulin and obtained by the method genetic engineering. The hypoglycemic effect occurs quickly, within 30 minutes, and reaches a maximum within 1-4 hours after subcutaneous administration of the drug. The effect persists for 7-9 hours. Insuman Rapid GT can be mixed with all Hoechst Marion Roussel human insulins, with the exception of pump insulins.

Indications for use: insulin dependent diabetes. Insuman Rapid HT is indicated for the treatment diabetic coma and ketoacidosis, as well as to achieve metabolic compensation in patients with diabetes mellitus in the pre-, intra-, and postoperative periods.

Mode of application: Insuman Rapid GT is usually injected deep subcutaneously 15-20 minutes before a meal. Intramuscular administration of the drug is allowed. The injection site must be changed each time. Insuman Rapid GT can be administered intravenously in the treatment of hyperglycemic coma and ketoacidosis, as well as to achieve metabolic compensation in the pre-, intra- and postoperative periods in patients with diabetes mellitus. Insuman Rapid GT is not used in various types of insulin pumps (including implanted ones), where a silicone coating is used.

Side effects: Sometimes at the injection site, atrophy or hypertrophy of adipose tissue may occur, which can be avoided by constantly changing the injection site.

In rare cases, there may be slight redness at the injection site, which disappears with continued therapy. If a significant erythema is formed, accompanied by itching and swelling, and its rapid spread beyond the boundaries of the injection site, as well as other severe adverse reactions to the components of the drug (insulin, m-cresol), it is necessary to immediately inform the doctor about this, since in some cases such reactions can pose a threat to the life of the patient.

Severe hypersensitivity reactions are quite rare. They may also be accompanied by the development of angioedema, bronchospasm, a drop in blood pressure, and, very rarely, anaphylactic shock. Hypersensitivity reactions require immediate correction in ongoing insulin therapy and the adoption of appropriate emergency measures.

The formation of antibodies to insulin is possible, which may require adjustment of the dose of insulin administered. Sodium retention with subsequent tissue swelling is also possible, especially after an intensive course of insulin treatment.

Contraindications: Hypersensitivity reaction to insulin or any of the auxiliary components drug, unless insulin therapy is life-saving. In such cases, the use of Insuman Rapid GT is possible only with careful medical supervision and, if necessary, in combination with antiallergic therapy.

Drug interaction: Weakening of insulin action can be observed with the simultaneous administration of insulin and corticotropin, corticosteroids, diazoxide, heparin, isoniazid, barbiturates, nicotinic acid, phenolphthalein, phenothiazine derivatives, phenytoin, diuretics, danazol, doxazosin, glucagon, estrogens and progestogens, somatotropin, sympathomimetic agents and thyroid gomons. In patients simultaneously receiving insulin and clonidine, reserpine or lithium salts, both weakening and potentiation of insulin action can be observed. Pentamidine can cause hypoglycemia followed by hyperglycemia. Drinking alcohol can cause hypoglycemia or lower already low blood sugar levels to dangerous levels. Tolerance to alcohol in patients receiving insulin is reduced. Permissible amounts of alcohol consumed should be determined by a doctor. Chronic alcoholism, as well as chronic overuse of laxatives, can affect glycemic levels. Beta-blockers increase the risk of hypoglycemia and, along with other sympatholytic agents (clonidine, guanethidine, reserpine), may reduce or even mask the manifestation of hypoglycemia.

Pregnancy and lactation: Treatment with Insuman Rapid HT should be continued during pregnancy. During pregnancy, especially after the first trimester, an increase in insulin requirements should be expected. However, immediately after delivery, the need for insulin usually falls, which entails a significant risk of hypoglycemia. During the period breastfeeding There are no restrictions on insulin therapy. However, dosage and dietary adjustments may be required.

Storage conditions: Store at temperatures from +2° C to +8° C. Avoid freezing, avoiding direct contact of the vial with the walls of the freezer compartment or the cold store.

Additionally: With caution, the dosage regimen is selected for patients with pre-existing cerebrovascular accidents of the ischemic type and with severe forms of coronary artery disease. The need for insulin may change when switching to another type of insulin (when replacing insulin of animal origin with Insuman Rapid, the dose is usually reduced), with a change in diet, diarrhea, vomiting; changes in the usual volume of physical activity, diseases of the kidneys, liver, pituitary gland, thyroid gland, changing the injection site. The patient should be informed about the symptoms of a hypoglycemic state, about the first signs of a diabetic coma and about the need to inform the doctor about all changes in his condition.

Dosage form:  injection Compound:

1 ml of solution contains:

active substance : human insulin (100% soluble human insulin) 3.571 mg (100 ME);

Excipients: metacresol (m-cresol) 2.700 mg, sodium dihydrogen phosphate dihydrate 2.100 mg, glycerol (85%) 18.824 mg, sodium hydroxide (used to adjust pH) 0.576 mg, hydrochloric acid (used to adjust pH) 0.232 mg, water for injection to 1 .0 ml

Description: Clear, colorless liquid. Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin ATX:  

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

Pharmacodynamics:

Insuman® Rapid GT contains insulin identical in structure to human insulin and obtained by genetic engineering using the K12 strain E. coli.

Mechanism of action of insulin:

Reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects;

Increases the transfer of glucose into cells and the formation of glycogen in the muscles and liver and improves the utilization of pyruvate, inhibits glycogenolysis and gluconeogenesis;

Increases lipogenesis in the liver and adipose tissue and inhibits lipolysis;

Promotes the entry of amino acids into cells and protein synthesis;

Increases the intake of potassium into cells.

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 persists for 7-9 hours.

Indications:

Diabetes mellitus requiring insulin treatment;

Treatment of diabetic coma and ketoacidosis;

Achieving metabolic compensation in diabetic patients with surgical interventions(before surgery, during surgery and in the postoperative period).

Contraindications:

hypoglycemia;

Hypersensitivity reaction to insulin or to any of the auxiliary components of the drug.

Carefully:

With renal insufficiency (possibly reduced need for insulin due to a decrease in insulin metabolism);

In elderly patients ( gradual decline kidney function can lead to an ever-increasing decrease in insulin requirements);

In patients with liver failure(the need for insulin may decrease 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(hypoglycemic episodes may have a special clinical significance, since there is increased risk cardiac or cerebral complications hypoglycemia);

In patients with proliferative retinopathy, especially those who have not received photocoagulation treatment ( laser therapy), since they have a risk of transient amaurosis with hypoglycemia - complete blindness;

In patients with intercurrent diseases (because intercurrent diseases often increase the need for insulin).

Pregnancy and lactation:

Treatment with Insuman® Rapid HT should be continued when pregnancy occurs. Insulin does not cross the placental barrier.

Effective maintenance metabolic control throughout pregnancy is mandatory for women who had diabetes before pregnancy or women who develop gestational diabetes.

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 delivery, the need for insulin decreases rapidly (increased risk of hypoglycemia). During pregnancy and especially after childbirth, careful monitoring of blood glucose concentrations is mandatory.

When pregnancy occurs or when planning a pregnancy, it is imperative to inform the doctor.

During the period of breastfeeding, there are no restrictions on insulin therapy, however, dose, insulin and dietary adjustments may be required.

Dosage and administration:

The target blood glucose concentration, the insulin preparations to be used, the insulin dosing regimen (doses and timing of administration) should be determined and adjusted individually to suit the diet, physical activity level and lifestyle of the patient.

There are no precisely regulated rules for dosing insulin. However, the average daily dose of insulin is 0.5-1.0 IU per kg of body weight per day, with long-acting human insulin accounting for 40-60% of the required daily dose of insulin.

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

In the treatment of severe hyperglycemia, or in particular ketoacidosis, insulin administration is part of a comprehensive treatment regimen that includes measures to protect patients from possible serious complications due to the relatively rapid decrease in blood glucose concentration. This treatment regimen requires careful monitoring in the intensive care unit (determination of metabolic status, acid-base balance and electrolyte balance, monitoring of vital signs of the body).

Switching from another type of insulin to Insuman® Rapid GT

When transferring patients from one type of insulin to another, adjustment of the insulin dosing regimen may be required: for example, when switching from animal-derived insulin to human insulin, or when switching from one human insulin preparation to another, or when switching from a regimen of treatment with soluble human insulin to a regimen , which includes longer-acting insulin.

After switching from animal-derived insulin to human insulin, a reduction in insulin dose may be required, especially in patients who have previously been managed on sufficiently low blood glucose concentrations; in patients with a tendency to develop hypoglycemia; in patients who previously required high doses of insulin due to the presence of antibodies to insulin.

The need for correction (reduction) of the dose may occur 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 concentration is recommended. In patients who require 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 change in insulin dose

Improved metabolic control may lead to increased insulin sensitivity, which may result in a decrease in the body's need for insulin.

A dose change may also be required if:

Change in body weight of the patient;

Lifestyle changes (including diet, physical activity level, etc.);

Other circumstances that may increase the predisposition to hypo- or hyperglycemia (see section " special instructions").

Dosing regimen in special patient groups

The elderly

In the elderly, the need for insulin may decrease (see sections "With caution", "Special instructions"). It is recommended that the initiation of treatment, dose escalation and maintenance dose selection in elderly patients with diabetes mellitus be carried out with caution to avoid hypoglycemic reactions.

Patients with hepatic or renal insufficiency

In patients with hepatic or renal insufficiency, the need for insulin may decrease.

Introduction of Insuman® Rapid GT

Insuman® Rapid GT usually injected deep subcutaneously 15-20 minutes before a meal. The injection site within the same injection area must be changed each time. Changing the area of ​​insulin injection (for example, from the abdomen to the thigh area) should be done only after consulting a doctor, since the absorption of insulin and, accordingly, the effect of lowering blood glucose concentrations may vary depending on the area of ​​\u200b\u200badministration.

Insuman® Rapid GT can be administered intravenously. Intravenous insulin therapy should be administered in a hospital setting or in a setting that can provide similar conditions for monitoring and treatment.

Insuman® Rapid G"T is not used in various types of insulin pumps (including implanted ones), where silicone tubes are used.

Do not mix Insuman® Rapid GT with other concentrations of insulin, with insulins of animal origin, insulin analogues or other l medicinal means.

Insuman® Rapid GT can be mixed with all sanofi-aventis group human insulin preparations. Insuman® Rapid GT must not be mixed with insulin intended specifically for use in insulin pumps.

It must be remembered that the concentration of insulin in the Insuman® Rapid GT preparation is 100 MG / ml (for 5 ml vials or 3 ml cartridges), therefore, it is necessary to use only plastic syringes designed for this concentration of insulin in the case of using vials, or OptiPen syringe pens Pro1 or ClickSTAR if cartridges are used. The plastic syringe must not contain any other drug or its residues.

Before the first set of insulin from the vial, you must remove the plastic cap (the presence of a cap is evidence of an unopened vial).

The injection solution must be absolutely clear and colorless without visible foreign particles.

Before taking 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 a liquid). Then the vial, together with the syringe, is turned upside down with the syringe and the required amount of insulin is drawn up. Before injection, air bubbles must be removed 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 a few seconds. The date of the first set of insulin from the vial should be recorded on the vial label.

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

Before installing the cartridge (100 MN / ml) in the OptiPen Pro1 and ClickSTAR syringe pen, keep it at room temperature for 1-2 hours (chilled insulin injections are more painful). Remove any air bubbles from the cartridge before injection (see Instructions for Use for OptiPen Pro1 or ClickSTAR).

The cartridge is not designed to mix Insuman® Rapid GT with other insulins. Empty cartridges cannot be refilled.

If the syringe pen breaks down, you can enter the required dose from the cartridge using a conventional syringe. It must be remembered that the concentration of insulin in the cartridge is 100 IU / ml, so only plastic syringes designed for this concentration of insulin should be used. The syringe must not contain any other drug or its residual amounts.

After installing the cartridge, it can be used within 4 weeks.

It is recommended to store the syringe pen with the installed cartridge at a temperature not exceeding +25°C in a place protected from light and heat, but not in the refrigerator (since chilled insulin injections are more painful).

After installing a new cartridge, check the correct operation of the syringe pen before injecting the first dose (see Instructions for using the OptiPen Pro1 or ClickSTAR syringe pens). Insuman® Rapid GT, solution for injection in a disposable syringe pen SoloStar® is intended for subcutaneous administration only.

Side effects:

hypoglycemia

Hypoglycemia, the most common side effect insulin therapy, may 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, convulsions (see section "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. Usually with more pronounced or more rapid decline 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 may develop hypokalemia (complications from the cardiovascular system) or the development of cerebral edema.

The following are adverse events observed in clinical research, which are classified according to system-organ classes and in decreasing order of frequency of occurrence: very frequent (≥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).

Immune System Disorders

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), lowering blood pressure (frequency unknown) and anaphylactic shock (infrequent reactions) and may threaten the life of the patient: Allergic reactions require the immediate adoption of appropriate emergency measures.

The use of insulin can cause the formation of antibodies to insulin (frequency unknown). In rare cases, the presence of such insulin antibodies may require a change in insulin dose to correct a tendency to hyper- or hypoglycemia.

Metabolic and nutritional disorders

Insulin can cause sodium retention (frequency unknown) and edema (common), especially when previously poor metabolic control improves with more intensive insulin therapy.

Violations of the organ of vision

Significant changes in glycemic control can cause transient visual disturbances (frequency unknown) due to temporary changes 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 a dramatic improvement in glycemic control may be associated with a temporary worsening of diabetic retinopathy (frequency unknown). In patients with proliferative retinopathy, especially if they are not treated with photocoagulation (laser therapy), severe hypoglycemic episodes can cause transient amaurosis (complete loss of vision) (frequency unknown).

Skin and subcutaneous tissue disorders

As with any insulin therapy, it is possible to develop lipodystrophy at the injection site (frequency unknown) and slow local absorption of insulin. Constantly changing injection sites within the recommended injection site may help reduce or stop these reactions.

General disorders and disorders at the injection site

Mild reactions at the injection site often occur. 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 inflammatory reaction at the injection site (frequency unknown).

Mild reactions to insulin at the injection site usually disappear after a few days or a few weeks. Overdose:

Symptoms

Insulin overdose, for example, administering an excess amount of insulin compared 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 ingestion of carbohydrates. Adjustment of insulin dose, food intake and physical activity may be required.

More severe episodes of hypoglycemia with coma, seizures, or neurologic deficits may be treated with intramuscular or subcutaneous glucagon or intravenous administration of concentrated dextrose. In children, the amount of dextrose administered is set in proportion to the child's body weight. After an increase in blood glucose concentration, maintenance carbohydrate intake and observation may be required, since after the apparent clinical resolution of the symptoms of hypoglycemia, its re-development is possible. In cases of severe or prolonged hypoglycemia following glucagon injection or dextrose administration, 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.

Interaction:

Combined use with oral hypoglycemic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cibenzoline, cyclophosphamide; fenfluramine, guanethidine, ifosfamide, phenoxybenzamine, phentolamine, somatostatin and its analogues; sulfonamides, tetracyclines, tritoqualin or trophosfamidemay enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia.

Co-administration with corticotropin, glucocorticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (eg, those present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthalein, phenytoin derivatives, doxazosinmay weaken the hypoglycemic effect of insulin.

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

With ethanol

Ethanol can either potentiate or weaken the hypoglycemic action of insulin. Drinking ethanol can cause hypoglycemia or lower an already low blood glucose to dangerous levels. Ethanol tolerance in patients receiving insulin is reduced. Permissible amounts of alcohol to be consumed must be determined by a doctor.

With pentamidine

With simultaneous administration, hypoglycemia may develop, which can sometimes turn into hyperglycemia.

When used together with sympatholytic agents, such as beta-blockers, guanethidine and, possible weakening or complete absence of symptoms of reflex (in response to hypoglycemia) activation of the sympathetic nervous system.

Special instructions:

In case of insufficient glycemic control or a tendency to episodes of hyper- or hypoglycemia, before making a decision to adjust the dose of insulin, it is imperative to check the prescribed regimen of insulin administration, make sure that insulin is injected into the recommended area, check the correct injection technique and all other factors. , which may interfere with the effect of insulin.

Since the simultaneous administration of a number of drugs (see the section "Interaction with other drugs") can weaken or enhance the hypoglycemic effect of the drug Insuman® Rapid GT, when using it, no other drugs should be taken without the special permission of the doctor.

hypoglycemia

Hypoglycemia occurs when the dose of insulin exceeds the need for it.

The risk of hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin preparation, in patients with a low maintenance blood glucose concentration.

As with all insulins, special care should be taken 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 stenosis of the coronary or cerebral arteries (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 (total 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, retrosternal 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 (disturbances in speech and vision, paralytic symptoms) and unusual sensations. With an increasing decrease in: the concentration of glucose, the patient may lose self-control and even consciousness. In such cases, cooling and moisture of the skin may occur, and convulsions may also occur.

Therefore, every diabetic patient receiving insulin must learn to recognize the symptoms that are a sign of developing hypoglycemia. Patients who regularly monitor their blood glucose levels are less likely to develop hypoglycemia. The patient himself can correct the decrease in the concentration of glucose in the blood he noticed by eating 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 a sufficient improvement in the condition, the patient should eat. If hypoglycemia cannot be immediately eliminated, then you should immediately call a doctor. It is necessary to immediately inform the doctor about the development of hypoglycemia in order for him to decide on the need to adjust the dose of insulin. Poor diet, missed insulin injections, increased need for insulin due to infectious or other diseases, reduced physical activity can lead to an increase in blood glucose (hyperglycemia), possibly with an increase in the level of ketone bodies in the blood (ketoacidosis). Ketoacidosis can develop over 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, hospitalization due to an accident, sickness while on vacation), the patient must tell the doctor that he has diabetes.

Patients should be warned about conditions that may change, be less pronounced, or completely absent symptoms that warn of the development of hypoglycemia, for example:

With a significant improvement in glycemic control;

With the 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 drugs (see section "Interaction with other drugs").

Such situations can lead to the development of severe hypoglycemia (and possibly loss of consciousness) before the patient realizes that he is developing hypoglycemia.

In the case of detection of normal or reduced values ​​of glycated hemoglobin, one should think about the possibility of developing recurring, unrecognized (especially nocturnal) episodes of hypoglycemia.

To reduce the risk of hypoglycemia, it is required that the patient strictly follow the prescribed dosing regimen and diet, correctly administer insulin injections, and be warned about the symptoms of developing hypoglycemia.

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

These factors include:

Changing the area of ​​insulin injection;

Increased insulin sensitivity (for example, elimination of stress factors);

Unaccustomed (increased or prolonged physical activity);

Intercurrent pathology (vomiting, diarrhea);

Insufficient food intake;

skipping meals;

Alcohol consumption;

Certain uncompensated endocrine diseases (such as hypothyroidism and anterior pituitary insufficiency or adrenal insufficiency);

Simultaneous reception of certain drugs (see section "Interaction with other drugs").

Intercurrent diseases

Intercurrent diseases require intensive metabolic control. Urinalysis for the presence of ketone bodies is indicated in many cases, and insulin dose adjustment is often necessary. The need for insulin often increases. Patients with type 1 diabetes should continue to consume at least a small amount of carbohydrate regularly, even if they can only take small amounts of food or if they vomit, and they should never completely stop insulin administration.

Cross immunological reactions

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

Instructions for use and handling filled syringe pen SoloStar®

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

Before use, inspect the cartridge inside the syringe pen. It should only be used if the insulin solution is completely clear, colorless, with no visible foreign particles.

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

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

Handling the SoloStar® pen

Before using the SoloStar® syringe pen, carefully read the information for use.

Important information on using the SoloStar® syringe pen

Before each use, carefully connect a new needle to the pen and carry out a safety test.

Only SoloStar® compatible needles should be used.

Special precautions must be taken to avoid needle accidents and the possibility of transmission of infection.

Never use the SoloStar® pen if it is damaged or if you are not sure that it will work properly.

Always have a spare SoloStar® pen available in case your copy of the SoloStar® pen is lost or damaged.

Storage instructions

Please read the "Storage Conditions" section regarding the rules for storing the SoloStar® syringe pen.

If the SoloStar® syringe pen is stored in the refrigerator, remove it from there 1-2 hours before the intended injection so that the solution reaches room temperature. The introduction of chilled insulin is more painful.

The used syringe pen SoloStar® must be destroyed.

Exploitation

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

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

Do not immerse in liquid, do not rinse and do not lubricate the SoloStar® pen, as this may damage it.

The SoloStar® pen syringe accurately doses insulin and is safe to use. It also requires careful handling. Avoid situations in which damage to the SoloStar® syringe pen may occur. If you suspect that your copy of the SoloStar® pen may have been damaged, use a new pen.

Stage 1. Insulin control

The label on the SoloStar® pen should be checked to make sure it contains the correct insulin. For Insuman® Rapid GT, the SoloStar® syringe pen is white with a yellow injection button with a relief ring on it. After removing the cap of the syringe pen, the appearance of the insulin contained in it is controlled: the insulin solution must be absolutely transparent, colorless, without visible foreign particles.

Stage 2. Connecting the needle

It is necessary to use only needles 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: Performing a safety test

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

Measure the dose equal to 2 units.

The outer and inner needle caps must be removed.

Positioning the syringe pen with the needle up, 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 needle tip, the pen and needle are working properly.

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

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

The dosing window should show “O” after completion of the safety test. After that, the required dose can be set.

Stage 5. Dosing

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 fully depressed. It is held in this position for another 10 seconds until the needle is withdrawn. Thus, the introduction of the selected dose of insulin is ensured completely.

Stage 6. Removal and ejection of the needle

In all cases, the needle must be removed and discarded after each injection. This ensures that contamination and/or infection is prevented, air enters the insulin container, and insulin leaks.

Special precautions must be taken when removing and discarding the needle. Follow recommended safety precautions for removing and discarding needles (e.g., one-handed capping technique) to reduce the risk of needle-related accidents, and preventing infection.

After removing the needle, close the SoloStar® pen with a cap.

Influence on the ability to drive transport. cf. and fur.:

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 present a certain risk in situations where these abilities are important (driving motor vehicles or other mechanisms).

Patients should be advised to exercise caution and avoid hypoglycemia while driving. This is especially important in patients who have reduced or no awareness of symptoms that indicate the development of hypoglycemia, or who have frequent episodes of hypoglycemia. In such patients, the question of the possibility of driving motor vehicles or other mechanisms should be individually decided.

Release form / dosage:Solution for injections, 100 IU/ml. Package:

5 ml of the drug in a bottle of transparent and colorless glass (type 1). The bottle is stoppered, crimped with an aluminum cap and covered with a protective plastic cap. 5 bottles with instructions for use in a cardboard box.

3 ml of the drug in a transparent and colorless glass cartridge (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. 5 cartridges in a blister pack of PVC film and aluminum foil. 1 blister pack along with instructions for use in a cardboard box.

3 ml of the drug in a transparent and colorless glass cartridge (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. The cartridge is mounted in a SoloStar® disposable syringe pen.

5 syringe pens SoloStar® together with instructions for use in a cardboard box.

Storage conditions:

To store in the place protected from light at a temperature from 2 to 8 °C. Do not freeze.

Keep out of the reach of children.

Best before date:

Do not use after the expiry date stated on the packaging.

Conditions for dispensing from pharmacies: On prescription Registration number: P N011995/01 Date of registration: 03.03.2011 Registration certificate holder:Sanofi-Aventis Deutschland GmbH Germany Manufacturer:   Representation:  Sanofi AventisGroup JSC Information update date:   28.10.2015 Illustrated Instructions

Insuman Rapid GT is a short-acting human insulin drug used to treat diabetes mellitus or its complications.

What is the composition and form of release of Insuman Rapid GT?

The active substance is represented by human insulin, obtained by genetic engineering. The content of this component is 100 IU per milliliter. Auxiliary drug compounds: sodium dihydrophosphate dihydrate, metacresol, water for injection, glycerol 85%, sodium hydroxide, in addition, hydrochloric acid.

The drug Insuman Rapid GT is produced in the form of a clear solution. Supplied in cartridges, syringe pens or vials. Sale is subject to a prescription from a doctor.

What is the effect of Insuman Rapid GT?

Insuman Rapid GT is a short acting insulin. The active substance of the drug is identical to the human hormone synthesized by the islet apparatus of the pancreas. Under industrial conditions, the active component of the drug is produced by introducing special genes in the BK12 strain of a very common bacterium - Escherichia coli.

Insulin, synthesized in the human body, as well as genetically engineered, is able to stimulate anabolic reactions, as well as inhibit catabolic processes. Under the action of this substance, the transport of glucose into tissues is enhanced, which leads to the formation of glycogen in muscle fibers or liver cells. In addition, the processes underlying the production of adipose tissue (lipogenesis) are activated.

Secondly, insulin suppresses the reactions that underlie the processes of synthesizing glucose from other substances, in particular from adipose tissue (gluconeogenesis), which reduces blood sugar levels.

You can not ignore the effect on protein metabolism. Under the action of insulin, the entry of amino acids into the cell increases, which triggers the anabolic processes that underlie protein synthesis.

After subcutaneous administration, the hypoglycemic effect develops after 30 minutes. The maximum therapeutic effect is formed after 1 - 4 hours after use. The effect of the drug lasts for 7-9 hours.

What are the indications for Insuman Rapid GT?

The appointment of Insuman Rapid GT is possible in the presence of the following diseases:

Any form of diabetes mellitus requiring the use of insulin preparations;
Treatment of complications of diabetes in the form of ketoacidosis or coma;
Stabilization of the conditions of patients suffering from diabetes mellitus after surgical interventions.

I remind you that effective treatment of diabetes mellitus is impossible without constant monitoring by an experienced specialist. Only an endocrinologist should prescribe such drugs and evaluate the effectiveness of treatment.

What are the contraindications for Insuman Rapid GT?

The use of the drug is unacceptable in the presence of the following conditions:

Any hypoglycemic conditions;
Individual intolerance to any component of the remedy.

Relative contraindications: advanced age, severe liver and kidney disease, coronary artery stenosis, acute cerebrovascular accident, proliferative retinopathy.

What is Insuman Rapid HT use and dosage?

The mode of administration, as well as the exact dose of the drug, is determined by a specialist, and depends on a large number of factors: blood glucose levels, diet and physical activity, type of activity, age, body weight, and so on.

The introduction of the drug should be carried out deep subcutaneously 10-15 minutes before a meal. The place for injection should be constantly changed, otherwise the formation of painful infiltrates (seals) or dystrophic phenomena is possible.

For the introduction of the drug, the anterior surface of the abdominal wall or the lateral region of the thigh is most often chosen. Points of administration of the drug should be agreed with a specialist, since the localization of the injection can change the rate of onset of the therapeutic effect.

Overdose from Insuman Rapid GT

In case of an overdose, rapid breathing and palpitations, weakness, tinnitus, “flies” before the eyes, nausea, vomiting, severe anxiety, a feeling of hunger are noted, sometimes convulsive seizures, respiratory arrest, as well as paralysis of the heart muscle, coma and even death .

Treatment depends on the condition of the patient. With mild severity, it is possible to adjust the glucose level with foods high in simple sugars.

In severe cases, drug therapy is required in the form of the introduction of glucose solutions and other symptomatic measures.

What are the side effects of Insuman Rapid GT?

Most often, allergic manifestations occur in the form of bronchospastic phenomena, angioedema, anaphylactic reactions, skin manifestations are characteristic.

Other side effects: edema, lowering blood pressure, various visual disturbances, dystrophic manifestations in the injection area.

How to replace Insuman Rapid GT, what analogues?

The drug Actrapid HM, Rinsulin R, Biosulin R, Human insulin, Rayzodeg, Rosinsulin R, Humulin Regular, Gensulin R, Gansulin R, in addition, Human insulin, Actrapid, Vozulim-R, and Insuran R are analogues.

Conclusion

We have reviewed the medicine Insuman Rapid GT, instructions for use of the drug. Diabetes mellitus, to a large extent, is a special way of life, an integral part of which, in addition to the use of drugs, is the restriction of carbohydrate intake from food, dosed physical activity, periodic visits to a specialist and constant monitoring of blood glucose levels.

Release form: Liquid dosage forms. Injection.



General characteristics. Compound:

Active substance: human insulin (100% soluble human insulin) - 3.571 mg (100 IU);
excipients: metacresol (m-cresol), sodium dihydrogen phosphate dihydrate, glycerol (85%), sodium hydroxide (used to adjust pH), hydrochloric acid (used to adjust pH), water for injection.
Description: clear colorless liquid.


Pharmacological properties:

Pharmacodynamics. Insuman® Rapid GT contains insulin identical in structure to human insulin and obtained by genetic engineering using the K12 strain of E. Coli. Mechanism of action of insulin:
- reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects;
- increases the transfer of glucose into cells and the formation of glycogen in the muscles and liver and improves the utilization of pyruvate, inhibits glycogenolysis and gluconeogenesis;
- 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® 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 persists for 7-9 hours.

Indications for use:

Diabetes mellitus requiring insulin treatment.
- Treatment of diabetic coma and.
- Achievement of metabolic compensation in patients with diabetes mellitus during surgical interventions (before surgery, during surgery and in the postoperative period).


Important! Get to know the treatment

Dosage and administration:

The selection of the dose of insulin in the patient is carried out by the doctor individually, depending on the diet, level of physical activity and lifestyle. The dose of insulin is determined based on the level of sugar in the blood, as well as on the basis of the planned level of physical activity and the state of carbohydrate metabolism. Read more about calculating dosages for type 1 and type 2 diabetes. Treatment with insulin requires appropriate self-preparation of the patient. The doctor should give the necessary instructions on how often to check the level of sugar in the blood and, possibly, in the urine, as well as give appropriate recommendations in case of any changes in the diet or in the regimen of insulin therapy.
The average daily dose of insulin is from 0.5 to 1.0 IU per kg of body weight of the patient, with 40-60% of the dose accounted for by long-acting human insulin.
When switching from animal-derived insulins to human insulin, it may be necessary to reduce the dose of insulin. Switching from other types of insulin to this drug can only be done under medical supervision. Particularly frequent monitoring of the state of carbohydrate metabolism is necessary in the first weeks after such a transition.
Insuman Rapid GT is usually injected deep subcutaneously 15-20 minutes before a meal. Intramuscular administration of the drug is allowed. The injection site must be changed each time. Changing the injection site (for example, from the abdomen to the thigh) should be done only after consulting a doctor.
Insuman Rapid GT can be administered intravenously in the treatment of hyperglycemic coma and ketoacidosis, as well as to achieve metabolic compensation in the pre-, intra- and postoperative periods in patients with diabetes mellitus.
Insuman Rapid GT is not used in various types of insulin pumps (including implanted ones), where a silicone coating is used.
Do not mix Insuman Rapid GT with insulins of other concentrations (for example, 40 IU / ml and 100 IU / ml), with insulins of animal origin or other drugs. Only clear, colorless solutions of Insuman Rapid GT without visible mechanical inclusions should be used.
It must be remembered that the concentration of insulin in the vial is 100 IU / ml, so only plastic syringes designed for this concentration of insulin should be used. The syringe must not contain any other drug or its residual amounts.
Before the first set of insulin from the vial, you must remove the plastic cap (the presence of a cap is evidence of an unopened vial). The injection solution must be absolutely transparent and colorless.
Before taking 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 a liquid). Then the vial, together with the syringe, is turned upside down with the syringe and the required amount of insulin is drawn up. Before injection, air bubbles must be removed 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 a few seconds. The date of the first set of insulin from the vial should be recorded on the vial label.
After opening, the vials can be stored at a temperature not exceeding +25°C for 4 weeks in a place protected from light and heat.

Application Features:

In case of insufficient glycemic control or a tendency to episodes of hyper- or hypoglycemia, before making a decision to adjust the dose of insulin, it is imperative to check the prescribed regimen of insulin administration, make sure that insulin is injected into the recommended area, check the correct injection technique and all other factors. , which may interfere with the effect of insulin.
Since the simultaneous use of a number of drugs (see section "Interaction with other drugs") can weaken or enhance the hypoglycemic effect of the drug Insuman® Rapid GT, when using it, no other drugs should be taken without the special permission of the doctor.
Hypoglycemia occurs when the dose of insulin exceeds the need for it. The risk of hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin preparation, in patients with a low maintenance blood glucose concentration.
As with all insulins, special care should be taken 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 stenosis of the coronary or cerebral arteries (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 (total 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, heart rhythm disturbances, increased blood pressure, retrosternal pain, anxiety, hunger, drowsiness, fear, irritability, unusual behavior, anxiety, paresthesia in and around the mouth, pallor of the skin , impaired coordination of movements, as well as transient neurological disorders (disturbances in speech and vision, paralytic symptoms) and unusual sensations. With an increasing decrease in the concentration of glucose, the patient may lose self-control and even consciousness. In such cases, cooling and moisture of the skin may occur, and may also appear.
Therefore, every diabetic patient receiving insulin must learn to recognize the symptoms that are a sign of developing hypoglycemia. Patients who regularly monitor their blood glucose levels are less likely to develop hypoglycemia. The patient himself can correct the decrease in the concentration of glucose in the blood he noticed by eating 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 a sufficient improvement in the condition, the patient should eat. If hypoglycemia cannot be immediately eliminated, then you should immediately call a doctor. It is necessary to immediately inform the doctor about the development of hypoglycemia in order for him to decide on the need to adjust the dose of insulin. Poor diet, missed insulin injections, increased need for insulin due to infectious or other diseases, reduced physical activity can lead to an increase in blood glucose (hyperglycemia), possibly with an increase in the level of ketone bodies in the blood (ketoacidosis). Ketoacidosis can develop over hours or days. At the first symptoms (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.
Patients should be warned about conditions that may change, be less pronounced, or completely absent symptoms that warn of the development of hypoglycemia, for example:
- with a significant improvement in glycemic control;
- with the 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 drugs (see section "Interaction with other drugs"). Such situations can lead to the development of severe hypoglycemia (and possibly loss of consciousness) before the patient realizes that he is developing hypoglycemia.
In the case of detection of normal or reduced values ​​of glycated hemoglobin, one should think about the possibility of developing recurring, unrecognized (especially nocturnal) episodes of hypoglycemia.
To reduce the risk of hypoglycemia, it is required that the patient strictly follow the prescribed dosing regimen and diet, correctly administer insulin injections, and be warned about the symptoms of developing hypoglycemia.
Factors that increase the susceptibility to the development of hypoglycemia require careful monitoring and may require dose adjustment. These factors include:
- changing the area of ​​insulin injection;
- increased sensitivity to insulin (for example, elimination of stress factors);
- unusual (increased or prolonged physical activity);
- intercurrent pathology (vomiting,);
- insufficient food intake;
- skipping meals
- alcohol consumption;
- some uncompensated endocrine diseases (such as insufficiency of the anterior pituitary gland or insufficiency of the adrenal cortex);
- concomitant use of certain drugs (see section "Interaction with other drugs"). Intercurrent diseases
Intercurrent diseases require intensive metabolic control. Urinalysis for the presence of ketone bodies is indicated in many cases, and insulin dose adjustment is often necessary. The need for insulin often increases. Patients with type 1 diabetes should continue to consume at least a small amount of carbohydrates regularly, even if they can only take small amounts of food or if they have, and they should never completely stop insulin administration. Cross immunological reactions
In a fairly large number of patients with hypersensitivity to animal insulin, the transition to human insulin is difficult due to the immunological cross-reaction of human insulin and animal insulin. With increased sensitivity of the patient to insulin of animal origin, as well as to m-cresol, the tolerability of the drug Insuman® Rapid GT should be evaluated in the clinic using intradermal tests. If an intradermal test reveals hypersensitivity to human insulin (immediate reaction, Arthus type), then further treatment should be carried out under clinical supervision.
Influence on the ability to drive vehicles or other mechanisms
The patient's ability to concentrate and the speed of psychomotor reactions may be impaired as a result of hypoglycemia or, as well as as a result of visual disorders. This may present a certain risk in situations where these abilities are important (driving motor vehicles or other mechanisms).
Patients should be advised to exercise caution and avoid hypoglycemia while driving. This is especially important in patients who have reduced or no awareness of symptoms that indicate the development of hypoglycemia, or who have frequent episodes of hypoglycemia. In such patients, the question of the possibility of driving motor vehicles or other mechanisms should be individually decided.

Side effects:

Hypoglycemia, the most common side effect, may develop if the dose of insulin administered exceeds the need for it (see "Precautions and special instructions").
Significant fluctuations in blood sugar levels can cause short-term visual disturbances. Also, especially with intensive insulin therapy, a short-term worsening of the course is possible. In patients with proliferative retinopathy, without the use of a course of laser therapy, severe hypoglycemic conditions can lead to blindness.
Sometimes at the injection site, or hypertrophy of adipose tissue may occur, which can be avoided by constantly changing the injection site. In rare cases, there may be slight redness at the injection site, which disappears with continued therapy. If a significant erythema is formed, accompanied by itching and swelling, and its rapid spread beyond the boundaries of the injection site, as well as other severe adverse reactions to the components of the drug (insulin, m-cresol), it is necessary to immediately inform the doctor about this, since in some cases such reactions can pose a threat to the life of the patient. Severe hypersensitivity reactions are quite rare. They may also be accompanied by the development of angioedema, bronchospasm, a drop in blood pressure, and, very rarely, anaphylactic shock. Hypersensitivity reactions require immediate correction in ongoing insulin therapy and the adoption of appropriate emergency measures.
The formation of antibodies to insulin is possible, which may require adjustment of the dose of insulin administered. Sodium retention with subsequent tissue swelling is also possible, especially after an intensive course of insulin treatment.
With a sharp decrease in blood sugar levels, development (complications from the cardiovascular system) or development of cerebral edema is possible.
Since some side effects can be, under certain conditions, life-threatening, it is necessary to inform the attending physician when they occur.
If you notice any side effects, please see your doctor!

Interaction with other drugs:

Combined use with oral hypoglycemic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors,
pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cibenzoline, cyclophosphamide, fenfluramine, guanethidine, ifosfamide, phenoxybenzamine, phentolamine, somatostatin and its analogs, sulfonamides, tetracyclines, tritoqualin, or trophosfamide may increase the predisposition to insulin development of hypoglycemia.
Co-administration with corticotropin, glucocorticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (eg, those present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthalein, phenytoin derivatives, doxazosin can weaken the hypoglycemic effect of insulin.
Beta-blockers, clonidine, lithium salts can either potentiate or weaken the hypoglycemic effect of insulin.
With ethanol
Ethanol can either potentiate or weaken the hypoglycemic action of insulin. Drinking ethanol can cause hypoglycemia or lower an already low blood glucose to dangerous levels. Ethanol tolerance in patients receiving insulin is reduced. Permissible amounts of alcohol to be consumed must be determined by a doctor. With pentamidine
With simultaneous administration, hypoglycemia may develop, which can sometimes turn into hyperglycemia.
When used together with sympatholytic agents, such as beta-blockers, clonidine, guanethidine and reserpine, it is possible to weaken or completely lack symptoms of reflex (in response to hypoglycemia) activation of the sympathetic nervous system.

Contraindications:

Hypoglycemia.
- Hypersensitivity reaction to insulin or to any of the auxiliary components of the drug.
If you have one of these diseases or conditions, before using the drug, be sure to consult your doctor. Carefully
- With (possible decrease in insulin requirements due to a decrease in insulin metabolism).
- In elderly patients (gradual decline in kidney function may
lead to an ever-increasing decrease in insulin requirements).
- In patients with hepatic insufficiency (the need for insulin may decrease 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 (hypoglycemic episodes may be of particular clinical importance, since there is an increased risk of cardiac or cerebral complications of hypoglycemia).
- In patients with proliferative retinopathy, especially those who have not received photocoagulation (laser therapy) treatment, since they have a risk of transient amaurosis - total blindness with hypoglycemia.
- In patients with intercurrent diseases (because intercurrent diseases often increase the need for insulin).
If you have one of these diseases or conditions, before using the drug, be sure to consult your doctor. Pregnancy and lactation
Treatment with Insuman® Rapid HT should be continued when pregnancy occurs. Insulin does not cross the placental barrier. Effective maintenance of metabolic control throughout pregnancy is mandatory for women who had diabetes before pregnancy or women who develop gestational diabetes.
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 delivery, the need for insulin decreases rapidly (increased risk of hypoglycemia). During pregnancy and especially after childbirth, careful monitoring of blood glucose concentrations is mandatory.
When pregnancy occurs or when planning a pregnancy, it is imperative to inform the doctor.
There are no restrictions on insulin therapy during breastfeeding.
available, but insulin dose and dietary adjustments may be required.

Overdose:

Symptoms
Insulin overdose, for example, administering an excess amount of insulin compared 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 ingestion of carbohydrates. Adjustment of insulin dose, food intake and physical activity may be required.
More severe episodes of hypoglycemia with coma, seizures, or neurologic deficits may be treated with intramuscular or subcutaneous glucagon or intravenous administration of concentrated dextrose. In children, the amount of dextrose administered is set in proportion to the child's body weight. After an increase in blood glucose concentration, maintenance carbohydrate intake and observation may be required, since after the apparent clinical resolution of the symptoms of hypoglycemia, its re-development is possible. In cases of severe or prolonged hypoglycemia following glucagon injection or dextrose administration, 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.
Under certain conditions, hospitalization of patients in intensive care units is recommended for more careful monitoring of their condition and control over ongoing therapy.

Storage conditions:

To store in the place protected from light at a temperature from 2 °C to 8 °C. Do not freeze! Keep out of the reach of children! Shelf life 2 years. Do not use after the expiry date stated on the packaging.

Leave conditions:

On prescription

Package:

Solution for injections 100 IU/ml.
5 ml of the drug in a bottle of transparent and colorless glass (type I). The bottle is stoppered, crimped with an aluminum cap and covered with a protective plastic cap. 5 bottles with instructions for use in a cardboard box. 3 ml of the drug in a transparent and colorless glass cartridge (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. 5 cartridges in a blister pack of PVC film and aluminum foil. 1 blister pack along with instructions for use in a cardboard box.
3 ml of the drug in a transparent and colorless glass cartridge (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. The cartridge is mounted in a SoloStar® disposable syringe pen. 5 syringe pens SoloStar® together with instructions for use in a cardboard box.


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