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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ml of the solution contains:

    active ingredients: thiamine hydrochloride 100 mg, pyridoxine hydrochloride 50 mg;

    Excipients: tartaric acid 1.6 mg, water for injection up to 1 ml.

    Description:

    Transparent solution with a slight yellowish-green hue.

    Pharmacotherapeutic group:Multivitamins
    ATX: & nbsp

    A.11.B.A   Multivitamins

    Pharmacodynamics:

    Neutropic vitamins of group B have a beneficial effect on inflammatory and degenerative diseases of the nerves and motor apparatus. They help to increase blood flow and improve the work of the nervous system.

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

    Pyridoxine, entering the body, is phosphorylated, converted to pyridoxal-5-phosphate and is part of enzymes that carry out decarboxylation, transamination and racemization of amino acids, as well as enzymatic conversion of sulfur-containing and hydroxylated amino acids. Participates in the exchange of tryptophan (biosynthesis of serotonin). Isolated pyridoxine deficiency is very rare, mainly in children who are on special artificial nutrition; it is manifested by diarrhea, convulsions, anemia, peripheral neuropathy can develop.

    Pharmacokinetics:

    After intramuscular injection thiamine quickly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of dosing in 50 mg) and is distributed unevenly in the body, its content in leukocytes is 15%, erythrocytes are 75% and in plasma is 10%.

    In connection with the lack of significant reserves in the body thiamine must enter the body daily. Thiamine penetrates the blood-brain and placental barriers and is found in breast milk. Thiamine is excreted in the urine in the alpha phase after 0.15 hours, in the beta phase after 1 hour and in the terminal phase for 2 days. The main metabolites are: thiaminic acid, pyramine and some unknown metabolites.

    Of all vitamins thiamine remains in the body in the smallest amount. The adult body contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate, 10% thiamine triphosphate, and the rest in the form of thiamine monophosphate.

    After intramuscular injection pyridoxine quickly absorbed into the bloodstream and distributed in the body, performing the role of coenzyme after phosphorylation of the group. CH2OH in the 5th position.About 80% of thiamine binds to blood plasma proteins.

    Pyridoxine is absorbed rapidly throughout the small intestine, more is absorbed in the jejunum. Metabolised in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate). Pyridoxal phosphate with plasma proteins binds to 90%. It penetrates well into all tissues; accumulates mainly in the liver, less in the muscles and central nervous system. Penetrates through the placenta, is secreted with breast milk. The half-life is 15-20 days. It is excreted by the kidneys (with intravenous injection with bile 2%), as well as during hemodialysis.

    Indications:

    The established deficiency of vitamins B1 and B6, which leads to diseases of the nervous system (systemic neurological diseases).

    Contraindications:

    The period of pregnancy and lactation, hypersensitivity to thiamine hydrochloride, pyridoxine hydrochloride or other components of the drug, decompensated heart failure, children's age.

    Carefully:

    Allergic reactions with shock states after administration of solution B1 are the rare, but their appearance is possible.In rare cases, there may be a shortage breathing, tachycardia, the formation of itchy blisters or circulatory collapse.

    With prolonged use of vitamin B6 in daily doses greater than 50 mg may signs of peripheral sensory neuropathy or paresthesia (tingling and formation in the hands and feet).

    Pregnancy and lactation:Not recommended.
    Dosing and Administration:

    Intravenous or intramuscularly at the beginning of treatment, 1 ml daily (1 ampoule), for subsequent treatment of 1-2 ml (1-2 ampoules) weekly.

    Side effects:

    The frequency of side effects of the drug is classified as follows: very often (≥1 / 10); often (from ≥1 / 100 to <1/10); sometimes (from ≥1 / 1000 to <1/100); rarely (from ≥1 / 10000 to <1/1000); very rarely (<1/10000).

    From the immune system: very rarely - allergic reactions (shock with circulatory collapse, shortness of breath, tachycardia, sweating, skin reactions with pruritus and the formation of itchy blisters.

    From the nervous system: frequency is unknown - when daily doses of vitamin B are exceeded6 over 50 mg may show signs of peripheral sensory neuropathy or paresthesia (tingling and formation in the hands and feet).

    Overdose:

    With an overdose of vitamin B1 nerve palsy (similar to curare) can occur.

    With an overdose of vitamin B6 observe sensory polyneuropathy, with a lack of coordination of muscle movement (ataxia).

    Extremely high doses can lead to seizures.

    In cases of very rapid administration of the drug may occur dizziness, arrhythmia, convulsions, they can also be the result of an overdose.

    Specific methods of treatment for drug overdose are not available, but if the administered dose exceeds 150 mg per 1 kg of body weight, then intensive symptomatic therapy is needed.

    Interaction:

    The solution of thiamine chloride should not be mixed with solutions containing sulfites, because in them it completely disintegrates. Do not mix in one syringe thiamine from benzylpenicillin or streptomycin (destruction of antibiotics), thiamine and nicotinic acid (destruction of thiamine). Thiamine weakens the effect of depolarizing muscle relaxants (suxamethonium iodide and others). 5-fluorouracil weakens the effect of thiamine. Thiamine is unstable when administered intravenously concurrently with solutions containing sodium hydrosulfite as an antioxidant or preservative. Thiamine is incompatible with oxidizing substances, mercury chloride, iodide, carbonate, acetate, tannic acid, iron-ammonium citrate, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose and metabisulphite. Copper accelerates the destruction of thiamine; Besides, thiamine Loses its effect when pH values ​​increase (pH more than 3).

    Pyridoxine enhances the action of diuretics; weakens the activity of levodopa. Isoniazid, penicillamine, cycloserine and estrogen-containing oral contraceptives, weaken the effect of pyridoxine. Pyridoxine combined with cardiac glycosides (promotes synthesis of contractile proteins in the myocardium), with glutamic acid, with potassium and magnesium asparaginate.

    Special instructions:

    Pyridoxine is found in plants and animal organs, especially in unrefined grains of cereal crops, in vegetables, meat, fish, milk, cod liver and cattle, egg yolk. Relatively a lot of pyridoxine in yeast.

    The need for vitamin B6 satisfied with food; it is also partially synthesized by the intestinal microflora. With severe liver damage pyridoxine in large doses can cause a deterioration in its function.

    When determining urobilinogen using Ehrlich's reagent pyridoxine can distort results.

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

    There is no data on the effect of the drug on the ability to manage transport means and mechanisms used in therapeutic doses.

    Form release / dosage:

    Solution for intravenous and intramuscular injection.

    Packaging:

    By 1.0 ml in ampoules of brown hydrolytic glass type I, a white dot is applied to the ampoule with a paint, 5 ampoules per each in a contour cellular box of cardboard or polyvinyl chloride, 1 or 2 contour mesh packaging together with instructions for use in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of 2-8 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001325
    Date of registration:02.08.2011 / 28.12.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspVEVWAG PHARMA GmbH & Co. KG VEVWAG PHARMA GmbH & Co. KG Germany
    Information update date: & nbsp27.06.2018
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