Active substanceThiamineThiamine
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  • Dosage form: & nbspsolution for intramuscular injection
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Thiamine hydrochloride 50 mg

    Excipients:

    Sodium dimercaptopropanesulfonate monohydrate 2 mg

    (unitiol)

    Water for injection up to 1 ml.

    Description:Transparent colorless or slightly colored liquid with a characteristic odor.
    Pharmacotherapeutic group:Vitamin
    ATX: & nbsp

    A.11.D.A.01   Thiamine

    Pharmacodynamics:

    In the body it is converted into an active thiamine pyrophosphate and as a coenzyme is included in the pyruvate decarboxylase and alpha-ketoglutarate decarboxylase complexes,which participate in the oxidative decarboxylation of pyruvic and alpha-ketoglutaric acids; transketolase - an enzyme of the pentose phosphate shunt.

    Pharmacokinetics:

    In the blood, the concentration is relatively low, while the plasma circulates predominantly free thiamine, in erythrocytes and leukocytes - its phosphoric esters. Phosphorylation occurs in the liver. The most active phosphoric ester is thiamine diphosphate, which has coenzyme activity. It accumulates mainly in the liver, heart, brain, kidneys, spleen. 1/2 of the total amount is contained in striated muscles and myocardium and about 40% in internal organs. It is excreted through the intestines and kidneys.

    Indications:

    Hypo-and avitaminosis of thiamine (vitamin B1). Treatment of conditions associated with vitamin deficiency B1: beriberi disease; pathology central (encephalopathy Wernicke) and peripheral (mono- and polyneuropathy) of the nervous, cardiovascular systems; and also, developing against the background of diabetes mellitus, chronic alcoholism, malnutrition, pathology of the gastrointestinal tract with impaired absorption of thiamine, etc.

    The dosage form for intramuscular administration is used in all clinical situations for rapid recovery of vitamin deficiency B1 and when oral administration is not possible.

    Contraindications:

    Increased individual sensitivity to the components of the drug.

    Carefully:

    No data.

    Pregnancy and lactation:

    During pregnancy and breastfeeding are used taking into account the benefit / risk ratio.

    Dosing and Administration:

    A solution of thiamine hydrochloride is administered intramuscularly (deep into the muscle).

    Initiate the drug is recommended with small doses (not more than 0.5 ml of a 5% solution) and Switch to higher doses only with good tolerability.

    Adults appoint 25-50 mg of thiamine hydrochloride (0.5-1 ml of a 5% solution) once a day, daily; children - 12.5 mg (0.25 ml of a 5% solution) once a day. The course of treatment is 10-30 injections.

    Side effects:

    Allergic reactions are possible (itching, hives, Quincke's edema, anaphylactic shock); increased sweating; tachycardia. Soreness at the injection site (due to low pH of the solution).

    Overdose:

    Symptoms of overdose are not recorded.

    Interaction:

    It is not recommended simultaneous parenteral administration of thiamine hydrochloride and pyridoxine (vitamin B6) or cyanocobalamin (vitamin B12). B12 enhances the allergic effect of thiamine. B6 makes it difficult to convert thiamine hydrochloride into a biologically active form. Do not mix in one syringe thiamine hydrochloride and benzylpenicillin or streptomycin (destruction of antibiotics), thiamine and nicotinic acid (destruction of thiamine).

    Thiamine hydrochloride reduces the pharmacological activity of salts of suxamethonium, phentolamine, propranolol, sympatholytics (reserpine), hypnotics (hypnotics and hypotensive effects are reduced).

    A solution of thiamine hydrochloride should not be mixed with solutions containing sulfites, t. in them it completely disintegrates.

    Thiamine hydrochloride is unstable in alkaline and neutral solutions; the appointment with carbonates, citrates, barbiturates, copper preparations is not recommended.

    Special instructions:

    When determining the concentration of theophylline in the blood serum by the spectrophotometric method, urobilinogen can be distorted by Ehrlich's reagent (when taking high doses).More often the anaphylactic reaction develops after intravenous administration of large doses.

    Parenteral administration is recommended only if oral administration (nausea, vomiting, malabsorption syndrome, preoperative and / or postoperative conditions) is not possible. Parenteral administration of the drug should be started with minimal doses and at high doses only when the susceptibility to the first is good.

    With Wernicke encephalopathy, the administration of dextrose should be preceded by the use of thiamine hydrochloride.

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

    Negative impact on the ability to drive vehicles and work with mechanisms is not revealed.

    Form release / dosage:

    Solution for intramuscular injection 50 mg / ml.

    Packaging:

    1 ml per ampoule of colorless or colored glass. By 5 or 10 ampoules in a contoured cell pack of a film of polyvinyl chloride or polyethylene terephthalate and a polymer film or foil of aluminum lacquered or without a polymer film and a foil of aluminum lacquered or in cardboard form with cells for laying ampoules.

    On 1 contour acheikova packing or the form from a cardboard with 10 ampoules or

    2 contour squares or carton shapes with 5 ampoules together with instructions for use and a scapegrator ampoule or without a scarifier ampullum in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004281
    Date of registration:02.05.2017
    Expiration Date:02.05.2022
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.05.2017
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