Vozulim-R (Vozulim-R)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInsulin soluble [human genetic engineering]Insulin soluble [human genetic engineering]
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    • Dosage form: & nbspinjection
    Composition:

    In 1 ml of the drug contains:

    Active substance: human insulin (recombinant) - 100 ME (4,000 mg);

    Excipients: metacresol - 2.50 mg, glycerol (98%) - 16.32 mg, sodium hydroxide - 0.40 mg. hydrochloric acid 0.001 ml, zinc oxide 0.031 mg, citric acid monohydrate 0,0021 mg sodium citrate dihydrate 0,19 mg water for injection up to 1 ml.

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

    A.10.A.B.01   Insulin (human)

    Pharmacodynamics:

    Vozulim-P is a short-acting human recombinant insulin product produced by the biotechnology of recombinant DNA using a producer strain Hansenula polymorpha. It interacts with specific receptors of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.).

    Reduction of glucose in the blood due to an increase of intracellular transport, absorption and assimilation tissue enhancement, stimulation of lipogenesis, glikogenogeneza decreased hepatic glucose rate and other products.

    The duration of action of insulin preparations is mainly due to the rate of absorption, which depends on several factors (for example, on the dose, method and place of administration, the thickness of the subcutaneous fatty layer, such as diabetes mellitus), and therefore the insulin profile is subject to considerable fluctuations as for different people, and for the same person.

    The beginning of the drug - 30 minutes after the injection, the maximum effect - between 1 and 3 hours, the duration of action - 5-7 hours.

    Pharmacokinetics:

    Suction

    The maximum concentration (CmOh) of insulin in plasma is achieved within 1.5-2.5 h after subcutaneous injection.

    Distribution

    Expressed binding to plasma proteins is not observed, with the exception of circulating antibodies to insulin (if any). It does not penetrate the placental barrier and into breast milk.

    Metabolism

    Human insulin is cleaved by the action of insulin protease or insulinase, and possibly also by the action of protein disulfide isomerase. It is assumed that in the human insulin molecule there are several cleavage sites (hydrolysis); however, none of the metabolites formed as a result of the cleavage is active.

    Excretion

    It is excreted by the kidneys (30-80%).The half-life (T1/2) is determined by the rate of absorption from the subcutaneous tissues. Thus, T1/2 rather, it is a measure of absorption, and not actually a measure of insulin release from the plasma (T1/2) of insulin from the bloodstream is only a few minutes). Studies have shown that T1/2 is about 2-5 hours.

    Indications:

    Diabetes mellitus, requiring insulin therapy.

    Urgent conditions in patients with diabetes mellitus, accompanied by a violation of glycemic control.

    Contraindications:

    Hypersensitivity to insulin or other components of the drug.

    Hypoglycemia.

    Carefully:

    In patients with renal insufficiency, hepatic insufficiency, severe stenosis of coronary and cerebral vessels, proliferative retinopathy, intercurrent diseases; in elderly patients.

    Pregnancy and lactation:

    Pregnancy

    Limitations on the use of insulin during pregnancy does not exist, because insulin does not penetrate the placental barrier.

    Both hypoglycemia and hyperglycemia, which can develop in cases of insufficiently accurately adjusted insulin dose, increase the risk of fetal malformation and intrauterine fetal death.Pregnant women with diabetes throughout the pregnancy should be monitored, they need to exercise increased control of the concentration of glucose in the blood; the same recommendations apply to women who are planning a pregnancy.

    The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the II and III trimesters.

    After delivery, the need for insulin, as a rule, quickly returns to the level that was noted before pregnancy.

    Breastfeeding period

    There are no restrictions for the use of Vozulim-R during breast-feeding. Carrying out insulin therapy for women in the period of breast feeding does not pose a danger to the child. However, it may be necessary to adjust the dose of the drug and / or diet.

    Dosing and Administration:

    The drug Vazulim-R is intended for subcutaneous, intramuscular and intravenous administration.

    The dose and time of administration of the drug are determined by the physician individually in each case based on the concentration of blood glucose. On average, the daily dose of the drug ranges from 0.3 to 1 IU / kg body weight (depends on the individual characteristics of the patient and the concentration of blood glucose).The daily requirement for insulin may be higher in patients with insulin resistance (for example, during puberty, as well as in obese patients), and lower in patients with residual endogenous insulin production.

    The drug is administered 30 minutes before a meal or a light snack containing carbohydrates. The temperature of the insulin should be appropriate at room temperature.

    When monotherapy with the drug, the frequency of administration is 3 times a day (if necessary, up to 5-6 times a day). At a daily dose exceeding 0.6 IU / kg, the drug Vozulim-P should be administered as 2 or more injections in various areas of the body.

    The drug is usually injected subcutaneously into the anterior abdominal wall. Injections can also be done in the thigh, buttock or shoulder area in the projection of the deltoid muscle. It is necessary to constantly change the injection site within the anatomical area to prevent the development of lipodystrophy.

    With subcutaneous administration of insulin, care must be taken so that when injected do not enter the blood vessel. After injection, do not massage the injection site.

    Intramuscularly the drug can be administered only as directed by the doctor.

    Intravenous administration of the drug can be performed only by a medical professional with careful monitoring of the concentration of glucose and potassium in the blood to avoid hypoglycemia and hypokalemia.

    Vozulim-P is a short-acting insulin and is usually used in combination with a medium-duration insulin medication (Vozulim-H).

    The cartridge should only be used with a syringe pen.

    Patients should be trained in the correct use of the insulin delivery device.

    Correction of dose

    Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin.

    Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver; a violation of the adrenal glands, pituitary gland or thyroid gland.

    The need for dose adjustment can also occur when the physical load or the patient's normal diet changes.

    Correction of the dose may be required when transferring a patient from one type of insulin to another.

    Side effects:

    The most common undesirable reaction with insulin is hypoglycemia.The incidence of hypoglycemia varies depending on the patient population, the dosage regimen of the drug and the control of glycemia (see "Description of individual adverse reactions").

    At the initial stage of insulin therapy, refractive disorders, peripheral edema and reactions at the injection site (including pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur.

    These symptoms are usually temporary. Rapid improvement in glycemic control can lead to a state of "acute pain neuropathy," which is usually reversible. Intensification of insulin therapy with a sharp improvement in carbohydrate metabolism control may lead to a temporary deterioration in the state of diabetic retinopathy, while a prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy.

    The list of undesirable reactions is presented in the table.

    All the undesirable reactions presented below are grouped according to the frequency of development in accordance with MedDRA and organ systems.

    The frequency of unwanted reactions is defined as: Often (> 1/10); often (> 1/100 to <1/10); infrequently (> 1 / 1,000 to <1/100); rarely (> 1 / 10,000 to <1 / 1,000); rarely (<1 / 10,000) and unknown (it is impossible to estimate on the basis of available data).

    Immune system disorders

    Infrequently - urticaria, skin rash

    Rarely - Anaphylactic reactions*

    Unknown - formation of antibodies to insulin

    Disorders from the metabolism and nutrition

    Often - hypoglycemia *

    Disturbances from the nervous system

    Rarely - peripheral neuropathy ("acute pain neuropathy")

    Disturbances on the part of the organ of sight

    Rarely refractive failure

    Infrequently - diabetic retinopathy

    Disturbances from the skin and subcutaneous tissues

    Infrequently - lipodystrophy *

    General disorders and disorders at the site of administration

    Infrequently - reactions at the site of administration

    Infrequently - peripheral edema

    *Cm. "Description of individual adverse reactions"

    Description of individual adverse reactions

    Anaphylactic reactions

    There are very rare reactions of generalized hypersensitivity, including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heart rate, lowering blood pressure,as well as fainting / unconsciousness, which are potentially life-threatening.

    Hypoglycaemia

    Hypoglycemia is the most common undesirable reaction. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function or even fatal outcome. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include increased sweating, pale skin, increased fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, impairment orientation, decreased concentration, drowsiness, severe hunger, visual impairment, headache, nausea and heart palpitations.

    Lipodystrophy

    There were reports of infrequent cases of development of lipodystrophy. Lipodystrophy can develop at the site of injection.

    Overdose:

    Overdose may develop hypoglycemia.

    A certain dose required for an insulin overdose has not been established, but hypoglycemia can develop gradually if too high doses of insulin are administered relative to the patient's need.

    Easy patient hypoglycemia can be eliminated by taking glucose or sugar-containing foods. Therefore, patients with diabetes are encouraged to constantly carry with them sugar-containing foods (sugar, sweets, biscuits or sweet fruit juice).

    In case of severe hypoglycemia, when the patient is unconscious, 0.5 mg to 1 mg glucagon should be injected intramuscularly or subcutaneously (can be administered by a trained person) or intravenously with a 40% solution of dextrose (glucose) (can be administered only by a medical professional). It is also necessary to introduce intravenous dextrose in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After restoration of consciousness, the patient is recommended to take a carbohydrate-rich food to prevent the recurrence of hypoglycemia.

    Interaction:

    There are a number of drugs that affect the need for insulin.

    Hypoglycemic action of insulin enhances nonselective beta-blockers, quinidine, quinine, chloroquine, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

    Hypoglycemic action of insulin weakens glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, preparations of iodine-containing thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, sulfinpyrazone, epinephrine, blockers H1-gistaminovyh receptors, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

    Beta-blockers can mask symptoms of hypoglycemia and slow recovery after hypoglycemia.

    Octreotide / lanreotide can both increase and decrease the body's need for insulin.

    Ethanol (alcohol) can enhance or reduce the hypoglycemic effect of insulin.

    Incompatibility

    The drug Vozulim-P can be added only to those solutions with which it is known to be compatible. Some drugs (for example, containing thiols or sulfites) can be dehydrated if insulin is added to the solution.

    Special instructions:

    The drug Vazulim-P should always remain transparent and colorless.

    Do not use the drug if a precipitate appears in the solution.

    On the background of insulin therapy, a constant control of the concentration of glucose in the blood is necessary.

    In case of insufficient glycemic control or a tendency to episodes of hypo- or hyperglycemia, before making a decision to correct the dose of insulin, it should be checked that the prescribed mode of insulin administration has been fulfilled; make sure that insulin is injected into the recommended area; to check the correctness of the injection technique and all other factors that may affect the action of insulin. Since the simultaneous administration of a number of drugs can weaken or intensify the hypoglycemic effect of the drug Vozulim-R (see the section "Interaction with other drugs"), it can not be taken with other drugs without special permission from the doctor.

    Hypoglycaemia

    Hypoglycemia can develop if too high a dose of insulin is administered relative to the patient's need.

    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.

    The causes of hypoglycemia, in addition to an overdose of insulin, can be: switching to another preparation of insulin; skipping meals; vomiting; diarrhea; increased physical activity; diseases that reduce the need for insulin (violations of liver and kidney function, hypofunction of the adrenal cortex, pituitary gland or thyroid gland); change of injection site; alcohol consumption; as well as interaction with other drugs.

    As with all insulin preparations, special care should be taken and careful monitoring of blood glucose concentrations should be carried out in cases where episodes of hypoglycemia may be of particular clinical significance in patients with severe coronary artery stenosis or cerebral vessels (risk of developing cardiac or cerebral complications of hypoglycemia), as well as in patients with proliferative retinopathy, especially if they did not undergo photocoagulation (the risk of transient loss of vision (amaurosis) due to ipoglikemii).

    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.

    Under certain circumstances, the symptoms-precursors of hypoglycemia may change, become less pronounced or absent. Such situations occur in patients with significant improvement in glycemic control; patients with gradual development of hypoglycemia; elderly patients; patients with mental disorders; in the presence of neuropathy; with a long course of diabetes mellitus; with concomitant therapy with other medications (see section "Interaction with Other Drugs"). Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before the patient realizes that he is developing hypoglycemia.

    Patient compliance with the dosing regimen and diet, proper insulin administration and knowledge of hypoglycaemic precursors contribute to a significant reduction in the risk of developing hypoglycemia.

    Hyperglycaemia

    Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes, non-compliance with diet, increased need for insulin as a result of infectious or other diseases, decreased physical activity may lead to increased blood glucose (hyperglycemia).Typically, the first symptoms of hyperglycemia appear gradually, within a few hours or days.

    Symptoms of hyperglycemia are a feeling of thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the appearance of an odor of acetone in the exhaled air. Without proper treatment, hyperglycemia in patients with type 1 diabetes mellitus can lead to the development of life-threatening diabetic ketoacidosis. When the first signs of ketoacidosis appear, urgent medical intervention is necessary.

    When a doctor changes (for example, during hospitalization for an accident, a sickness during a vacation), the patient should inform the doctor that he has diabetes mellitus.

    In patients with renal insufficiency, the need for insulin can be reduced as a result of changes in its metabolism.

    In patients with severe impairment of liver function, the need for insulin can also be reduced as a result of changes in its metabolism and a decrease in gluconeogenesis.

    The dose of insulin must also be corrected in case of thyroid dysfunction, hypofunction of the adrenal cortex and pituitary gland; in elderly patients.

    Correction of the dose of insulin may also be required if the intensity of physical activity increases or the usual diet changes.

    Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

    The transfer of patients to another type of insulin or to the insulin of another manufacturer must be carried out only under medical supervision. If the concentration, producer, type, species (human insulin, human insulin analog) and / or manufacturing method changes, a change in the insulin dose may be required.

    Patients switching to treatment with the drug Vozulim-P may need a dose change or an increase in the frequency of injections compared to previously used insulin preparations. If you need to adjust the dose for the treatment of patients with Vozulim-P, this can be done already with the introduction of the first dose or in the first weeks or months of therapy.

    The transition from one type of insulin to another should be carried out under the control of the concentration of glucose in the blood.

    As with other insulin preparations, reactions can occur at the site of administration, which is manifested by pain, redness, hives, inflammation, bruising, swelling and itching.Regular injection site changes within the same anatomy will help reduce symptoms or prevent the development of these reactions. Reactions usually disappear for a few days to several weeks. In rare cases, it may be necessary to cancel the drug Vozulim-P due to reactions at the site of administration.

    Before the trip associated with the change of time zones, the patient should consult with his attending physician, as changing the time zone means that the patient should take food and inject insulin at another time.

    Simultaneous use of insulin preparations and preparations of the thiazolidinedione group Cases of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for developing chronic heart failure. This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations. When using such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic cardiacdeficiency, weight gain and the presence of peripheral edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

    The drug reduces tolerance to alcohol.

    When Vosulim-P is added to infusion solutions, the amount of insulin absorbed by the infusion system is not predictable, so the use of Vozulim-P for long-term subcutaneous insulin infusions (PPII) is not allowed.

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

    The ability of patients to concentrate and respond to the reaction may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are particularly necessary (for example, when driving vehicles or working with machines and mechanisms).

    Patients should be advised to take measures to prevent the development of hypoglycemia in the management of vehicles. This is especially important for patients with absence or reduction in the severity of symptoms-harbingers of developing hypoglycemia or frequent episodes of hypoglycaemia.In these cases, the expediency of driving vehicles and performing such work should be considered.

    Form release / dosage:

    Solution for injection, 100 IU / ml.

    Packaging:

    3 ml in neutral glass cartridges (type I). A sticker is attached to the cartridge.

    For 1 or 5 cartridges are placed in a blister of PVC / aluminum foil.

    10 ml in bottles of colorless neutral glass, sealed with rubber stoppers and crimped with aluminum caps with a plastic safety cap.

    Each vial or each blister with a cartridge No. 1 or No. 5 is placed in a cardboard box together with an instruction for use.

    Storage conditions:

    Store in a dark place at a temperature of +2 ° C to +8 ° C. Do not freeze. Keep away from children.

    The drug in use should be stored at a temperature of 15-25 ° C not more than 6 weeks.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000293
    Date of registration:17.02.2011 / 13.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Vokhard LtdVokhard Ltd India
    Manufacturer: & nbsp
    Representation: & nbspVokhard Ltd., IndiaVokhard Ltd., India
    Information update date: & nbsp25.03.2017
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