Active substanceCocarboxylaseCocarboxylase
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    ELLARA, LTD.     Russia
  • Cocarboxylase hydrochloride
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  • Dosage form: & nbsplyophilizate for the preparation of solution for intravenous and intramuscular administration
    Composition:

    Composition (per 1 ampoule)

    Active substance:

    Cocarboxylase hydrochloride - 50.0 mg.

    Excipient:

    Sodium carbonate - 8.0 mg.

    Description:Lyophilized powder or porous compacted mass of white or almost white, color with a characteristic odor.
    Pharmacotherapeutic group:Metabolic means
    ATX: & nbsp

    A.11.D.A   Vitamin B1

    Pharmacodynamics:Cocarboxylase - coenzyme thiamine (vitamin B1, in the body is phosphorylated to form mono-, di- and triphosphate esters, is part of the enzymes that catalyze the carboxylation and decarboxylation of alpha-keto acids,pyruvic acid, promotes the formation of acetyl-coenzyme A, which determines its participation in carbohydrate metabolism. Exogenous vitamin B1 (thiamine) to participate in these processes must be metabolized by phosphorylation into cocarboxylase, a ready-made form of coenzyme. It should be noted that the properties of cocarboxylase are only partially adequate to those of thiamine; kokarboksilazu not used for the prevention and treatment of hypo- and avitaminosis B1. Improves the absorption of glucose, trophic nervous tissue, contributes to the normalization of the function of the cardiovascular system. Deficiency of cocarboxylase causes an increase in the level of pyruvic and lactic acids in the blood, which leads to acidosis and an acidotic coma.
    Indications:

    In the complex therapy of hepatic and renal failurestatisticand, diabetic precoma and coma, diabetic ketoacidosis, chronic heart failure and heart rhythm disturbances, peripheral neuritis. Children prescribe the drug for the same indications. In newborns, the drug is also used in complex therapy of conditions associated with hypoxia and acidosis, including acnewborns, hypoxic encephalopathy, circulatory insufficiency, pneumonia, sepsis, and others..

    Contraindications:Hypersensitivity to the drug.
    Pregnancy and lactation:
    Due to the lack of data on safety of use, do not prescribe the drug Cocarboxylase-Ellara ® during pregnancy and breastfeeding.
    Dosing and Administration:

    Intramuscularly, intravenously (struino or drip).

    The contents of the ampoule (50 mg) are dissolved immediately before injection into 2 ml of water for injection.

    At intravenous jet introduction volume bring up to 10-20 ml, at dropwise introduction to 200-400 ml, adding 0.9% a solution of sodium chloride or a solution of dextrose (glucose).

    Adults

    With violations of the heart rhythm prescribed 100-200 mg per day for 15-30 days.

    In chronic heart failure 50 mg for 2 hours before the use of digitalis preparations 2-3 times a day.

    In diabetes (ketoacidosis, coma), the daily dose is 100 mg.

    In acute renal and hepatic insufficiency intravenously injected 100-150 mg 3 times a day or drip, previously dissolved in a 5% solution of dextrose (glucose), 100-150 mg per day.

    With peripheral neuritis, intramuscularly administered at a dose of 50-100 mg per day for 1-1.5 months.

    Children

    Children are given intramuscularly, intravenously (drip or jet). Depending on the severity of the condition and clinical symptoms, it is prescribed from 25 to 50 mg per day. The course of treatment is from 3-7 to 15-30 days. The newborn is injected intravenously (slowly) 10 mg per 1 kg of body weight once a day.

    Side effects:

    Allergic reactions are possible (hives, itchy skin);when intramuscular injection - hyperemia, itching, swelling (at the injection site).

    Overdose:Cases of overdose are not described.
    Interaction:Kokarboksilaza enhances the effect of cardiac glycosides and improves their tolerability.
    Special instructions:Without features.
    Effect on the ability to drive transp. cf. and fur:Not described.
    Form release / dosage:
    Lyophilizate for the preparation of solution for intravenous and intramuscular injection 50 mg.
    Packaging:

    50 mg of the drug are placed in ampoules of neutral glass or glass with resistance class hydrolysis HGA1 (first hydrolytic).

    5 ampoules are placed in a contour mesh package from a PVC film or from a PET film.

    1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard.

    10 ampoules together with the instructions for use and the ampoule scarifier are placed in a pack of cardboard with a corrugated liner.

    1 circuit cell pack with the preparation complete with the solvent "Water for injection, solvent for the preparation of dosage forms for injection" (1 circuit pack of PVC film or PET film with 5 ampoules of water for injection of 2 ml of neutral glass or glass with class resistance to hydrolysis HGA1) together with the use of the application and the ampoule scapegrator are placed in a pack of cardboard.

    When packing ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

    Packing for hospitals. For 4, 5 or 10 contour mesh packages, together with instructions for use in an amount equal to the number of contour mesh packages, are placed in a pack of cardboard.

    2 KNC with ampoules of the preparation and 2 NLC with ampoules of the solvent or 5 NLC with ampoules of the preparation and 5 NLC with ampoules of the solvent together with an equal number of instructions for use are placed in a pack of corrugated cardboard boxes .50 or 100 contour cell packs with ampoules together with instructions for use in the quantity equal to the number of contour mesh packages is placed in a box of corrugated cardboard.

    25 KNC with ampoules of the preparation and 25 KNU with ampoules of the solvent or 50 NUC with ampoules of the preparation and 50 NUC with ampoules of the solvent together with an equal number of instructions for use are placed in a box of corrugated paperboard.

    Storage conditions:In the dark place at a temperature of no higher than 10 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001365
    Date of registration:05.08.2011 / 16.11.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.01.2018
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