Active substanceInsulin soluble [human genetic engineering]Insulin soluble [human genetic engineering]
Similar drugsTo uncover
  • Actrapid® HM
    solution for injections 
    Novo Nordisk A / S     Denmark
  • Actrapid® HM Penfill®
    solution for injections 
    Novo Nordisk A / S     Denmark
  • Biosulin® R
    solution for injections 
  • Vozulim-R
    solution for injections 
    Vokhard Ltd     India
  • Gensulin R
    solution for injections 
    BIOTEK MFPDK, CJSC     Russia
  • Insuman Rapid GT
    solution for injections 
  • Insuran R
    solution for injections 
  • Monoinsulin CR
    solution for injections 
    VIAL, LLC     Russia
  • Rinsulin® R
    solution for injections 
    GEROPHARM-BIO, JSC     Russia
  • Rinsulin® R
    solution for injections 
    GEROPHARM-BIO, JSC     Russia
  • Rosinsulin R
    solution for injections 
  • Humodar® R 100 Rivers
    solution for injections 
  • Humulin Regular
    solution for injections 
    Eli Lilly East SA     Switzerland
  • Dosage form: & nbspinjection
    Composition:

    1 ml of the 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 the pH) 0.576 mg, hydrochloric acid (used to adjust the pH) 0.232 mg, water for injection up to 1 , 0 ml.

    Description:A clear, colorless liquid.
    Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin
    ATX: & nbsp

    A.10.A.B.01   Insulin (human)

    Pharmacodynamics:

    Insuman Rapid HT contains insulin, identical in structure to human insulin and obtained by genetic engineering with use of 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 muscles and liver and improves the utilization of pyruvate, inhibits glycogenolysis and glycoeogenesis;

    - increases lipogenesis in the liver and adipose tissue and inhibits lipolysis;

    - promotes the introduction of amino acids into cells and protein synthesis;

    - increases the flow of potassium into the cells.

    Insuman Rapid HT 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;

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

    Contraindications:

    - Hypoglycemia;

    - a hypersensitivity reaction to insulin or to any of the auxiliary components of the drug.

    Carefully:

    - With renal insufficiency (there may be a decrease in insulin requirements due to a decrease in insulin metabolism);

    - in elderly patients (a gradual decrease in renal 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 the metabolism of insulin);

    - in patients with severe stenosis of the coronary and cerebral arteries (hypoglycemic episodes can be of particular clinical significance, since there is an increased risk of cardiac or cerebral complications of hypoglycemia);

    - in patients with proliferative retinopathy, especially those who have not been treated with photocoagulation (laser therapy), since they have hypoglycemia risk of transient amaurosis - complete blindness;

    - in patients with intercurrent diseases (as in intercurrent diseases, insulin is often increased).

    Pregnancy and lactation:

    Treatment of Insuman Rapid HT in pregnancy should be continued. Insulin does not penetrate the placental barrier.

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

    The need for insulin during pregnancy can decrease during the first trimester of pregnancy and usually rises during the second and third trimester of pregnancy. Immediately after delivery, the need for insulin rapidly decreases (an increased risk of developing hypoglycemia). In pregnancy and especially after childbirth, careful monitoring of the concentration of glucose in the blood is mandatory.

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

    During breastfeeding, there are no restrictions on insulin therapy, but dosage, insulin and diet may need to be adjusted.

    Dosing and Administration:

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

    There are no strictly regulated dosing rules for insulin. However, the average daily dose of insulin is 0.5-1.0 ME per kg of body weight per day, and the share of human insulin prolonged action accounts for 40-60% of the required daily dose of insulin.

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

    In the treatment of severe hyperglycemia or, in particular, ketoacidosis, the introduction of insulin is part of a comprehensive treatment regimen that includes measures to protect patients from possible serious complications due to a relatively rapid decrease in blood glucose.This treatment regimen requires careful monitoring in the intensive care unit (definition of metabolic status, acid-base balance and electrolyte balance, control 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, it may be necessary to adjust the dosage regimen of insulin: for example, when switching from animal insulin to human insulin, or from one preparation of human insulin to another, or from the treatment with soluble human insulin to regimen , which includes longer-acting insulin.

    After switching from animal insulin to human insulin, a reduction in the insulin dose may be required, especially in patients who had previously been administered at low enough blood glucose levels; 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 can 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 following first weeks, careful monitoring of the concentration of glucose in the blood is recommended. In patients who required high doses of insulin because of the presence of antibodies, it is recommended to switch to another type of insulin under medical supervision in the hospital.

    Additional change in the dose of insulin

    Improved metabolic control can lead to an increase in insulin sensitivity, which may reduce the body's need for insulin.

    A dose change may also be required when:

    - changing the patient's body weight;

    - lifestyle changes (including diet, level of physical activity, etc.);

    - other circumstances that may contribute to an increase in susceptibility to hypo- or hyperglycemia (see section "Special instructions").

    Dosing regimen in special patient groups

    Elderly people

    In elderly people, the need for insulin can decrease (see Fig.sections "With caution", "Special instructions"). It is recommended that initiation of treatment, increasing doses and selection of maintenance doses in elderly patients with diabetes mellitus be carried out with caution in order 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 administered by deep subcutaneous 15-20 minutes before meals. Injection site within a region of the introduction of each time it is necessary to change. Change the area of ​​insulin administration (for example, from the abdomen to the thigh area) should only be done after consultation with the doctor, since the absorption of insulin and, accordingly, the effect of lowering blood glucose concentration may vary depending on the area of ​​administration.

    Insuman® Rapid HT can be administered intravenously. Intravenous insulin therapy should be performed in a hospital setting or in settings in which similar monitoring and treatment conditions can be provided.

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

    Insuman® can not mix with insulin Rapid ADT different concentrations with animal insulins, insulin analogues, or other lmedicines.

    Insuman® GT Rapid may be mixed with all insulin preparations of human sanofi-aventis Group. Insuman® Rapid GT should not be mixed with insulin, designed specifically for use in insulin pumps.

    It must be remembered that the concentration of insulin in the formulation Insuman® Rapid ADT is 100 mg / ml (5 ml for a vial or cartridge 3 ml), therefore it is necessary to use only plastic syringes designed for a given concentration of insulin in the case of vials, or syringe grips OptiPen Pro1 or ClickSTAR in case of using cartridges. A plastic syringe should not contain any other drug or its residual quantities.

    Before the first set of insulin from the vial, it is necessary to 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 dialing insulin from the vial, a volume of air equal to the prescribed dose of insulin is sucked into the syringe and injected into the vial (not into the liquid). Then the vial with the syringe is turned with a syringe down and the necessary amount of insulin is collected. Before injection, it is necessary to remove air bubbles from the syringe.

    At the injection site, a skin fold is taken, the needle is inserted under the skin and insulin is slowly injected. After 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 written on the label of the vial.

    After opening, the vials can be stored at a temperature of no higher than 25 ° C for 4 weeks in a place protected from light and heat.

    Before installing the cartridge (100 MN / ml) into the Optiphen Pro1 and ClickSTAR syringe pen, hold it for 1-2 hours at room temperature (chilled insulin injections are more painful). Remove any air bubbles from the cartridge before injecting (see the OPTIPEN Pro1 or the CLAITING INSTRUCTION manual).

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

    In the event that the syringe pen has failed, you can enter the required dose from the cartridge using a conventional syringe.It should be remembered that the concentration of insulin in the cartridge is 100 IU / ml, so it is necessary to use only plastic syringes, calculated for this concentration of insulin. The syringe should not contain any other drug or its residual quantities.

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

    It is recommended to store a syringe pen with an installed cartridge at a temperature of no higher than + 25 ° C in a place protected from light and heat, but not in the refrigerator (since injections of cooled insulin are more painful).

    After installing a new cartridge, check that the syringe pen is operating correctly before the first dose is injected (see the instructions for using the Optiphen Pro1 syringe pen or the ClickStar). Insuman® Rapid GT, injection solution in the disposable syringe pen SoloStar® is intended only for subcutaneous administration.

    Side effects:

    Hypoglycaemia

    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, convulsions (see section "Overdose").Prolonged or severe episodes of hypoglycemia can endanger the lives of patients.

    In many patients, the symptoms and manifestations of neuroglycopenia can be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Usually, with a more pronounced or faster decrease in the concentration of glucose in the blood, 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 may develop hypokalemia (complications of the cardiovascular system) or the development of cerebral edema.

    The undesirable phenomena observed in clinical studies that are classified according to the system-organ classes and in order of decreasing incidence are listed below: very frequent (≥1 / 10); Frequent (≥1 / 100 and <1/10); infrequent (≥1 / 1000 and <1/100); Rare (≥1 / 10000 and <1/1000); very rare (<1/10000); the frequency is unknown (it is not possible to determine the incidence of side effects from the available data).

    Immune system disorders

    Allergic reactions of immediate type to insulin or to auxiliary substances of the drug (the frequency is unknown),may be manifested as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (unknown frequency), lowering blood pressure (frequency unknown) and anaphylactic shock (infrequent reactions) and may endanger the patient's life: Allergic reactions require immediate admission appropriate emergency assistance.

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

    Disorders from the metabolism and nutrition

    Insulin can cause sodium retention (frequency is unknown) and swelling (often), especially when improving previously inadequate metabolic control through the use of more intensive insulin therapy.

    Disturbances on the part of the organ of sight

    Significant changes in glycemic control can cause transient visual disorders (the frequency is unknown) due to a temporary change in the turgor of the lens 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 sharp improvement in glycemic control may be associated with a temporary deterioration in the course of diabetic retinopathy (the frequency is unknown). In patients with proliferative retinopathy, especially if they do not receive treatment with photocoagulation (laser therapy), severe hypoglycemic episodes can cause a transient amaurosis (complete loss of vision) (the frequency is unknown).

    Disturbances from the skin and subcutaneous tissues

    As with any insulin therapy, it is possible to develop lipodystrophy at the injection site (the frequency is unknown) and slow the local absorption of insulin. Continuous injection site changes within the recommended area of ​​administration may help to reduce or eliminate these reactions.

    General disorders and disorders at the site of administration

    Frequent moderate reactions occur at the site of administration. These include redness at the injection site (frequency unknown), pain at the injection site (frequency unknown), itching in the area of ​​injection (frequency unknown),urticaria at the injection site (frequency unknown), swelling at the injection site (frequency unknown), or an inflammatory reaction at the injection site (frequency unknown).

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

    Symptoms

    An overdose of insulin, for example, the introduction of excessive amounts of insulin compared to consumed food or energy expenditure, can lead to severe and sometimes prolonged and life-threatening hypoglycemia

    Treatment

    Light episodes of hypoglycemia (the patient is conscious) can be stopped by ingesting carbohydrates. You may need to adjust the dose of insulin, the diet and physical activity.

    Severe episodes of hypoglycemia with coma, convulsions or neurologic disorders can be stopped by intramuscular or subcutaneous administration of glucagon or by intravenous administration of a concentrated dextrose solution. In children, the amount of dextrose administered is proportional to the body weight of the child. After increasing the concentration of glucose in the blood, it may be necessary to maintain carbohydrate intake andobservation, since after a seeming clinical elimination of symptoms of hypoglycemia, its re-development is possible. In cases of severe or prolonged hypoglycemia, following injection of glucagon or the administration of dextrose, it is recommended that infusion be administered with a less concentrated dextrose solution in order to prevent the re-development of hypoglycemia. Young children should 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 monitoring of the therapy.

    Interaction:

    Joint use with hypoglycemic agents for oral administration, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cibenzolin, cyclophosphamide; fenfluramine, guanethidine, ifosfamide, phenoxybenzamine, phentolamine, somatostatin and its analogs; sulfonamides, tetracyclines, tritokvaline or trophosphamide can increase the hypoglycemic action of insulin and increase the predisposition to the development of hypoglycemia.

    Joint use with corticotropin, glucocorticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (eg, present in combination 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 action of insulin.

    With ethanol

    Ethanol can either potentiate or weaken the hypoglycemic action of insulin. The use of ethanol can cause hypoglycemia or reduce the already low blood glucose to a dangerous level. The tolerance of ethanol in patients receiving insulin is reduced. The permissible quantities of alcohol consumed must be determined by the doctor.

    With pentamidine

    With simultaneous admission, it is possible to develop hypoglycemia, which can sometimes turn into hyperglycemia.

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

    Special instructions:

    In case of insufficient glucose control or a tendency to the appearance of hyper- or hypoglycemia episodes before deciding whether the correction of insulin dose should be sure to verify that the prescribed regimen of insulin administration, to make sure that the insulin is injected into the recommended area, check the correct injection technique and all other factors , which can affect the effect of insulin.

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

    Hypoglycaemia

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

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

    As with all insulins, special care should be taken and intensive monitoring of blood glucose in patients for whom hypoglycemic episodes may be of particular clinical importance, such as patients with severe stenosis of the coronary or cerebral arteries (risk of cardiac or cerebral complications of hypoglycemia) is recommended. , as well as in patients with proliferative retinopathy, especially if they did not undergo photocoagulation (laser therapy), since they have the risk of transient amaurosis (full blindness) with the development of hypoglycemia.

    There are certain clinical signs and signs that should indicate to the patient or others about developing hypoglycemia. These include: increased sweating, skin moisture, tachycardia, heart rhythm disturbances, increased blood pressure, chest pain, tremor, anxiety, hunger,drowsiness, sleep disturbances, feelings of fear, depression, irritability, unusual behavior, anxiety, paresthesia in the mouth and around the mouth, pallor of the skin, headache, movement coordination disorders, and transient neurological disorders (speech and vision impairment, paralytic symptoms) and unusual sensations. With an increasing decrease: the glucose concentration of the patient may lose self-control and even consciousness. In such cases, coldness and moisture of the skin can be observed, and convulsions may also appear.

    Therefore, every patient with diabetes who receives insulin should learn to recognize symptoms that are a sign of developing hypoglycemia. Patients who regularly monitor the concentration of glucose in the blood are less likely to develop hypoglycemia. The patient himself can correct the observed decrease in blood glucose concentration by taking sugar or food with a high carbohydrate content. For this purpose, the patient should always carry 20 g of glucose. In more severe conditions of hypoglycemia, a glucocaine injection is indicated (which can be done by a doctor or average medical personnel).After enough improvement, the patient should eat. If hypoglycemia can not be immediately remedied, then it is urgent to call a doctor. It is necessary to inform the doctor immediately about the development of hypoglycemia, so that he makes a decision about the need to correct the dose of insulin. Failure to comply with a diet, insulin injection, increased insulin requirements due to infectious or other diseases, decreased physical activity may 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 within a few 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 a doctor changes (for example, during hospitalization for an accident, illness during a vacation), the patient should inform the doctor that he has diabetes mellitus.

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

    - with a significant improvement in glycemic control;

    - with gradual development of hypoglycemia;

    - in elderly patients;

    - in patients with autonomic neuropathy;

    - patients with a long history of diabetes mellitus;

    - in patients who are simultaneously receiving treatment with certain medications (see section "Interaction with other drugs").

    Such situations can lead to the development of severe hypoglycemia (and possibly with loss of consciousness) earlier than the patient realizes that he develops hypoglycemia.

    In case of detection of normal or reduced values ​​of glycosylated 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 accurately follow the prescribed dosing regimen and diet, properly administered insulin injections and be warned about the symptoms of developing hypoglycemia.

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

    These factors include:

    - change in the area of ​​insulin administration;

    - increased sensitivity to insulin (eg, elimination of stress factors);

    - unusual (increased or prolonged physical activity);

    - intercurrent pathology (vomiting, diarrhea);

    - inadequate intake of food;

    - skipping meals;

    - alcohol consumption;

    - Some uncompensated endocrine diseases (such as hypothyroidism and insufficiency of the anterior lobe of the pituitary gland or insufficiency of the adrenal cortex);

    - simultaneous administration of certain drugs (see section "Interaction with other drugs").

    Intercurrent diseases

    Intercurrent diseases require intensive metabolic control. In many cases, urine tests for the presence of ketone bodies are shown, and often a correction of the insulin dose is necessary. The need for insulin is often increased. Patients with type 1 diabetes must continue to regularly consume at least a small amount of carbohydrates, even if they can take only a small amount of food or if they have vomiting and they should never completely stop the introduction of insulin.

    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 cross-immunological reaction of human insulin and insulin of animal origin. With increased sensitivity of the patient to insulin of animal origin, as well as to m-cresol, tolerability of the drug Insuman Rapid HT should be evaluated in the clinic with the help of intradermal tests. If a hypersensitivity to human insulin (an immediate reaction, such as Arthus) is detected during the intradermal test, further treatment should be carried out under clinical control.

    Instructions for use and circulation in advance filled with SoloStar® pen

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

    Before use, inspect the cartridge inside the syringe pen. It should be used only if the insulin solution is absolutely transparent, colorless, without visible foreign particles.

    Empty SoloStar® pen need not be reused and must be destroyed.

    To prevent infection, a pre-filled syringe pen should only be used by one patient and not transferred to another person.

    Handling of the SoloStar® syringe handle

    Carefully read the usage information before using the SoloStar® pen.

    Important information on using the SoloStar® pen

    Before each use, it is necessary to carefully connect a new needle to the syringe pen and conduct a safety test.

    Only needles that are compatible with SoloStar® should be used.

    It is necessary to take special precautions to avoid accidents involving the use of a needle and the possibility of transfer of infection.

    Do not use the SoloStar® pen when it is damaged or if you are not sure that it will work properly.

    Always have a spare SoloStar® pen in case you lose or damage your copy of the SoloStar® pen.

    Storage Instruction

    Please read the "Storage conditions" section for the storage rules for the SoloStar® pen.

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

    The used SoloStar® pen must be destroyed.

    Exploitation

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

    The outer side 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® syringe, as this can damage it.

    The syringe handle SoloStar® accurately doses insulin and is safe to work with. It also requires careful handling. Avoid situations in which the SoloStar® pen can be damaged. If you suspect that your copy of the SoloStar® pen can be damaged, use a new syringe pen.

    Stage 1. Insulin control

    It is necessary to check the label on the SoloStar® syringe pen to ensure that it contains the appropriate insulin. For Insuman Rapid GT, a SoloStar® white syringe pen with a yellow button for injection with a relief ring on it.After removing the cap of the syringe-pen, monitor the appearance of the insulin contained in it: the insulin solution must be absolutely transparent, colorless, without visible foreign particles.

    Stage 2. Connecting the needle

    Use only needles that are compatible with the SoloStar® syringe handle.

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

    Stage 3. Performance of the safety test

    Before each injection, a safety test must be carried out and make sure that the syringe pen and needle work well and air bubbles are removed.

    Measure the dose equal to 2 units.

    The outer and inner needle caps must be removed.

    With the needle pen up, gently tap the cartridge with the insulin finger so that all air bubbles are directed toward the needle.

    Fully press the injection injection button.

    If insulin appears at the tip of the needle, it means that the pen and needle work correctly.

    If no insulin appears on the tip of the needle, stage 3 can be repeated until insulin appears on the tip of the needle.

    Stage 4. Dose selection

    The dose can be set to an accuracy of 1 unit from a minimum dose of 1 unit to a maximum dose of 80 units. If it is necessary to enter a dose exceeding 80 units, two or more injections should be given.

    The dosage window should indicate "O" after the safety test is completed. After this, the required dose can be set.

    Stage 5. Dosing Introduction

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

    The needle must be inserted under the skin.

    The injection button must be pressed completely. It is held in this position for another 10 seconds until the needle is removed. Thus, the introduction of a selected dose of insulin is fully ensured.

    Stage 6. Extraction and ejection of a needle

    In all cases, the needle after each injection should be removed and discarded. This ensures the prevention of contamination and / or infection, air entering the insulin tank and leakage of insulin.

    When removing and discarding the needle, special precautions must be taken. Observe the recommended safety measures for removing and disposing of needles (for example,the technique of putting the cap on with one hand) in order to reduce the risk of accidents involving the use of a needle, and prevention of infection.

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

    Effect on the ability to drive transp. cf. and fur:

    The patient's ability to concentrate and the speed of psychomotor reactions can be compromised by hypoglycemia or hyperglycemia, as well as by visual disorders. This can pose a certain risk in situations where these capabilities are important (driving or other mechanisms).

    Patients should be advised to use caution and avoid hypoglycemia while driving. This is especially important in patients who have reduced or lack of awareness of symptoms that indicate development hypoglycemia, or there are frequent episodes of hypoglycemia. Such patients should individually decide whether they can be managed by vehicles or other mechanisms.

    Form release / dosage:Solution for injection, 100 IU / ml.
    Packaging:

    For 5 ml of the drug in a bottle of clear and colorless glass (type 1).The bottle is sealed with a cork, crimped with an aluminum cap and covered with a protective plastic lid. 5 vials with instructions for use in a cardboard box.

    For 3 ml of the drug in a cartridge of transparent and colorless glass (type I). The cartridge is sealed on one side with a cork and crimped with an aluminum cap, on the other hand - by a plunger. 5 cartridges per contour cell box made of PVC film and aluminum foil. 1 contour pack together with instructions for use in a cardboard box.

    For 3 ml of the drug in a cartridge of transparent and colorless glass (type I). The cartridge is sealed on one side with a cork and crimped with an aluminum cap, on the other hand - by a plunger. The cartridge is mounted in a disposable syringe pen SoloStar®.

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

    Storage conditions:

    Store in a dark place at a temperature of 2 to 8 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011995 / 01
    Date of registration:03.03.2011
    The owner of the registration certificate:Sanofi-Aventis Deutschland GmbHSanofi-Aventis Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
    Information update date: & nbsp28.10.2015
    Illustrated instructions
      Instructions
      Up