Humodar® R 100 (Humodar® R 100)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInsulin soluble [human semisynthetic]Insulin soluble [human semisynthetic]
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  • Humodar® R 100
    solution for injections 
    Indar, Inc. for the production of insulin     Ukraine
    • Dosage form: & nbspinjection
    Composition:

    In 1 ml of the drug contains:

    active substance: insulin human semisynthetic 100 ME;

    Excipients: m-cresol, hydrochloric acid, sodium hydroxide, sodium chloride, sodium phosphate monosubstituted 2-water, glycerin, water for injection.

    Description:

    A clear, colorless liquid.

    Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin
    ATX: & nbsp

    A.10.A.B.01   Insulin (human)

    Pharmacodynamics:

    Humodar® P 100 is a short-acting human semisynthetic insulin. It interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase, 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 site of administration), and therefore the profile of insulin activity is subject to significant fluctuations in both different people and the same person . On average, the onset of action of the drug after subcutaneous injection occurs in 30 minutes, the maximum effect is in the interval between 1 and 2 hours, the duration of action is 5-7 hours.

    Pharmacokinetics:

    Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (subcutaneously, intramuscularly), the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Distributed in tissues unevenly; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. The half-life is a few minutes. It is excreted by the kidneys (30-80%).

    Indications:

    Diabetes mellitus in adults.

    Contraindications:

    Hypersensitivity to insulin or other components of the drug.

    Hypoglycemia.

    Pregnancy and lactation:

    There are no restrictions on the treatment of diabetes mellitus with insulin, since insulin does not penetrate the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes. The need for insulin usually decreases in the first trimester of pregnancy and gradually rises in II and III trimesters. During and immediately after delivery, the need for insulin can dramatically decrease. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

    There are no restrictions on the treatment of diabetes mellitus with insulin during breastfeeding. However, it may be necessary to reduce the dose of insulin, so careful monitoring is necessary before stabilizing the need for insulin.

    Dosing and Administration:

    The drug 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 specific case based on the blood glucose level. On average, the daily dose of the drug ranges from 0.5 to 1 IU / kg body weight (depending on the individual characteristics of the patient and blood glucose level).

    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, 5-6 times a day). At a daily dose exceeding 0.6 IU / kg, Humodar® P 100 should be administered as 2 or more injections in various areas of the body.

    The drug is usually administered subcutaneously in the anterior abdominal wall. Injections can be do the same in the thighabout, IgthelNumber of casesgenerous muscles of the shoulder. Notaboutwe areo Change the injection site within the anatomical area to prevent the development of lipodystrophy.

    Intramuscular and intravenous drug can be administered only under the supervision of a doctor.

    Humodar® R 100 is a short-acting insulin and is usually used in combination with insulin of medium duration (Humodar® B 100).

    Side effects:

    Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, agitation, paresthesia in the mouth, headache).Pronounced hypoglycemia can lead to the development of hypoglycemic coma.

    Allergic reactions: rarely - skin rash, angioedema; extremely rare - anaphylactic shock.

    Local reactions: hyperemia, puffiness and itching at the injection site; with prolonged use - lipodystrophy at the injection site.

    Other: edema, transient refractive disorders (usually at the beginning of therapy).

    Overdose:

    Overdose may develop hypoglycemia.

    Treatment: the patient can eliminate mild hypoglycemia himself by taking sugar or carbohydrate-rich foods. Therefore, patients with diabetes are encouraged to always carry sugar, sweets, cookies or sweet fruit juice.

    In severe cases, if the patient lost consciousness, intravenously administered 40% solution of dextrose (glucose); intramuscularly, subcutaneously, intravenously - glucagon. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

    Interaction:

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

    Hypoglycemic effect of Humodara® P 100 enhances oral hypoglycemic agents, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, quinidine, quinine, chloroquine, preparations containing ethanol.

    The hypoglycemic effect of the drug weakens oral contraceptives, glucocorticosteroids, thyroid hormones, loop and thiazide diuretics, glucagon, somatotropin, estrogens, sulfinpyrazone, marijuana, epinephrine, blockers H1-gistamine receptors, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine. Under the influence of reserpine and salicylates, both weakening and enhancement of the action of the drug are possible. Pentamidine can both enhance and weaken the hypoglycemic action of insulin.

    Against the background of alcohol consumption, the need for insulin decreases, which requires correction of the dose of the drug.

    Special instructions:

    The drug should always remain clear and colorless.

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

    On the background of insulin therapy, nare permanentth level control blood glucose.

    Causes hypoglycemia In addition to an overdose of insulin, there may be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), injection site change, and interaction with other drugs.

    Incorrect dosing or breaks in the introduction of insulin can lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually, over a period of several hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite.

    The dose of insulin must be corrected in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and kidney dysfunction and diabetes mellitus in persons over 65 years of age.

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

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

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

    The drug lowers tolerance to alcohol.

    Instructions to be given to the patient

    The technique of injection with the use of insulin in vials

    If the patient uses only one type of insulin

    1. Disinfect the rubber membrane on the vial.

    2. Insert the air in the syringe in the amount corresponding to the required dose of insulin. Insert air into the vial with insulin.

    3. Turn the bottle with the syringe upside down and type the desired dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check the correctness of the dose of insulin.

    4. Immediately inject.

    If the patient needs to mix two types of insulin

    1. Disinfect the rubber membranes on the vials.

    2. Directly before typing, roll a vial of long-acting insulin ("cloudy") between the palms until the insulin becomes evenly white and cloudy.

    3.Type in the syringe air in an amount corresponding to the dose of "turbid" insulin. Enter the air into the bottle with a "cloudy" insulin and remove the needle from the bottle.

    4. Insert the air in the syringe in the amount corresponding to the dose of insulin of short action ("transparent"). Insert air into the bottle with "transparent" insulin. Turn the bottle with the syringe upside down and type the desired dose of "transparent" insulin. Remove the needle and remove air from the syringe. Check the correctness of the dialed dose.

    5. Insert the needle into the vial with "cloudy" insulin, flip the bottle with the syringe upside down and type the desired dose of insulin. Remove air from the syringe and check the correctness of the dialed dose. Immediately inject the dialed mixture of insulin.

    6. Always take the insulin in the same sequence described above.

    The technique of injection with the use of insulin in cartridges

    The cartridge with Humodar® R 100 is intended only for use in syringe pens. Care should be taken to follow the instructions in the instructions for using the syringe pen for insulin administration.

    Before use, make sure that there is no damage to the Humodar® P 100 cartridge (for example, cracks).Do not use the cartridge if there are any visible damage. After the cartridge is inserted into the syringe pen, a colored strip should be visible through the cartridge holder window.

    After the injection, the needle should remain under the skin for a minimum of 6 seconds. Keep the button depressed until the needle is completely removed from the skin, thus ensuring the correct dose administration and limiting the possibility of blood or lymph flow into the needle or the insulin cartridge.

    The cartridge with Humodar® R 100 is intended for individual use only and can not be refilled.

    Injection procedure

    - With two fingers, take the fold of the skin, insert the needle into the base of the fold at an angle of about 45 ° and insert insulin under the skin.

    - After the injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is injected completely.

    - If blood disappears after removing the needle at the injection site, gently press the injection site with your finger.

    It is necessary to change the injection site.

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

    In connection with the primary purpose of insulin, a change in its type or in the presence of significant physical or mental stress,it is possible to reduce the ability to drive a car or to manage various mechanisms, as well as to engage in other potentially dangerous activities that require increased attention and speed of mental and motor reactions.

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

    1) In bottles of transparent colorless glass of 10 ml. One bottle together with the instruction for use is placed in an individual pack of cardboard.

    2) In cartridges of transparent colorless glass of 3 ml. Three or five cartridges, together with instructions for use, are packed in a pack of cardboard.

    Storage conditions:

    At a temperature of 2 to 8 ° C. Do not freeze.

    The vial of insulin that is used, can be stored for 6 weeks, and cartridge with insulin - for 3 weeks, at room temperature (not above 25 ° C), provided protection against direct exposure to heat and light. The drug should always remain clear and colorless.

    Keep out of the reach of children.
    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010479/08
    Date of registration:24.12.2008
    The owner of the registration certificate:Indar, Inc. for the production of insulin Indar, Inc. for the production of insulin Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp30.10.2015
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