Medivitan® (Medivitan)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePyridoxine + Cyanocobalamin + Folic acidPyridoxine + Cyanocobalamin + Folic acid
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  • Medivitan®
    solution w / m in / in 
    Meditsa Artznamittel Pütter GmbH & Co. KG. KG     Germany
    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Solution I. 4 ml of solution contains:

    Active substances:

    Pyridoxine hydrochloride

    5 mg

    Cyanocobalamin

    1 mg

    Excipients:

    Sodium chloride

    34 mg

    Water for injections

    up to 4 ml

    Solution II. 1 ml of the solution contains:

    Active substances:

    Folic acid

    1.05 mg

    Excipients:

    Sodium chloride

    8.75 mg

    Water for injections

    before 1,0 ml
    Description:

    Solution I: PThe red liquid is red.

    Solution II: Transparent liquid of yellow color.

    Pharmacotherapeutic group:Vitamins of group B
    ATX: & nbsp

    A.11.E.A   B vitamins

    Pharmacodynamics:

    The drug contains a complex of B vitamins, which take part in the process of hematopoiesis, are necessary for the normal functioning of the nervous and other tissues, organs and systems of the body.

    Included in the composition of vitamins: pyridoxine (AT6), cyanocobalamin (AT12) and folic acid (AT9) regulate protein, carbohydrate and fat metabolism, promote their normalization, improve the function of motor, sensory and autonomic nerves.

    Pyridoxine (vitamin B6) entering the body, phosphorylated, converted to pyridoxal-5-phosphate and is part of the 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 (participation in the reaction of biosynthesis of serotonin). Isolated deficiency of pyridoxine is very rare, mainly in children who are on special artificial nutrition.

    Cyanocobalamin (vitamin B12) in the body (mainly in the liver) is converted to methylcobalamin and 5-deoxyadenosylcobalamin. Methylcobalamin participates in the homocysteine ​​conversion reaction in methionine and S-adenosylmethionine are key reactions of the metabolism of pyrimidine and purine bases, and consequently, deoxyribonucleic (DNA) and ribonucleic (RNA) acids. If the vitamin is deficient in this reaction, it can be replaced by methyltetrahydrofolic acid, with folic acid reactions of metabolism being disturbed. 5-deoxyadenosyl cobalamin serves as a cofactor in the isomerization of L-methylmalonyl-CoA in succinyl-CoA, an important carbohydrate and lipid metabolism reaction.Vitamin B deficiency12 leads to a violation of the proliferation of rapidly dividing cells of the hematopoietic tissue and epithelium, as well as to the violation of the formation of the myelin sheath of neurons.

    Folic acid (vitamin B9) in the human body is not synthesized; comes with food and is produced by normal intestinal microflora. It is a precursor of tetrahydrofolic acid, which takes part as a cofactor of enzyme systems that carry the transfer of single-carbon fragments (in the form of methyl, methylene, formyl or methenyl groups) in a number of nucleotide and amino acid exchange reactions. It plays an important role in the regulation of proliferation, differentiation and maturation of cells, including in erythropoiesis and embryogenesis.

    Pharmacokinetics:

    Cyanocobalamin

    In blood cyanocobalamin binds to trans-balamines I and II, which transport it into tissues. It is deposited mainly in the liver. The connection with plasma proteins is 90%. The maximum concentration in the blood plasma after subcutaneous and intramuscular injection is achieved after 1 hour.

    From the liver is excreted with bile into the intestine and again absorbed into the blood. It is excreted at normal kidney function - 7-10% by kidneys, about 50% - by the intestine.From 50 to 90% of cyanocobalamin, administered intramuscularly or intravenously at a dosage of 0.1 to 1 mg, are excreted by the kidneys for 48 hours.

    Penetrates through the placental barrier into breast milk.

    Folic acid

    After administering 1.5 mg of folic acid intramuscularly, the concentration of monosodium salt in blood plasma reaches a maximum within the first hour. Subsequent decrease in concentration occurs very quickly, as a result of which the baseline level is reached after 12 hours. The maximum concentration in plasma of 80-87%, after intramuscular injection, is reached after approximately 1 hour.

    Intensively binds to plasma proteins. It is deposited and metabolized in the liver with the formation of tetrahydrofolic acid. It is excreted by the kidneys mainly in the form; metabolites.

    Penetrates through the blood-brain barrier, into the placenta and into breast milk.

    Pyridoxine

    Pyridoxine is metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). Pyridoxalphosphate 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.The half-life is 15-20 days. It is excreted by the kidneys (with intravenous injection - with bile 2%), as well as during hemodialysis.

    Penetrates through the placenta, is secreted with breast milk.

    Indications:

    Combined deficiency of vitamins - pyridoxine, cyanocobalamin and folic acid, if it is not possible to make up the deficit in alimentary ways.

    Contraindications:

    Hypersensitivity to the components of the drug; skin inflammatory reactions at the injection site; megaloblastic anemia; thrombosis and thromboembolism; children under 18 years of age (efficacy and safety of use not established).

    Pregnancy and lactation:

    During pregnancy and lactation (breastfeeding), the use of the drug is not recommended due to the lack of reliable clinical data confirming the safety of the drug during these periods.

    Dosing and Administration:

    The drug is administered intramuscularly or intravenously. It is recommended to inject intramuscularly deep and slowly; it is necessary to alternate the injection site.

    Ampoule contents (solution I and solution II) must be successively dialed into the syringe and mixed immediately before use.

    The use of the drug in prefilled two-chamber syringes requires preliminary preparation.

    Introduce a single dose of the drug (5 ml) intramuscularly or intravenously 2 times a week, the course of treatment - 4 weeks (only 8 injections).

    In case of impaired intestinal absorption, one dose of the drug is recommended to be administered intramuscularly with an interval of 4 weeks.

    In the interval between injections it is recommended to take folic acid daily orally.

    Side effects:

    The frequency of side effects noted when taking the drug is given in accordance with the WHO classification: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100) , rarely (> 1/10000 and <1/1000), very rarely (<1/10000), including individual messages.

    Very rarely (<0.01%): allergic reactions (skin reactions in the form of pruritus, urticaria), increased sweating, tachycardia, possibly the appearance of acne, difficulty breathing, angioedema, anaphylactic shock.

    In cases of very rapid administration of the drug, systemic adverse reactions (dizziness, headache, arrhythmia, convulsions) may occur, and may also result from an overdose.

    If any of the side effects listed in the manual are aggravated, you will notice any other side effects not listed in the instructions, inform your doctor.

    Overdose:

    Symptoms: increased symptoms of side effects of the drug.

    Treatment: symptomatic therapy.

    Interaction:

    Cyanocobalamin is pharmaceutically incompatible with ascorbic acid, heavy metal salts (inactivation of cyanocobalamin), thiamine, riboflavin. Pyridoxine strengthens the action of diuretics; weakens the activity of levodopa. Isoniazid, penicillamine, cycloserine and estrogen-containing oral contraceptives weaken the effect of pyridoxine.

    At simultaneous application with chloramphenicol, neomycin, polymyxins, tetracyclines, absorption of folic acid decreases. Analgesics (long-term therapy), anticonvulsants (including phenytoin and carbamazepine), estrogen-containing oral contraceptives increase the need for folic acid. The use of folic acid can reduce the concentration in the blood plasma of phenobarbital, phenytoin or primidon and cause an epileptic fit. Antacids, cholestyramine, sulfonamides (including sulfasalazine) reduce the absorption of folic acid.

    Medivitan® should not be taken in combination with methotrexate, pyrimethamine, triamterene, trimethoprim, because they act as antagonists of folic acid, inhibiting tetrahydrofolate reductase.

    Special instructions:

    It should be borne in mind that antibiotics can distort (give low results) the results of analysis of the concentration of folic acid in blood plasma and erythrocytes. 5 ml of the ready-to-use medivitan® preparation contains - 23 mg (less than 1 mmol) of sodium (minimum content). This should be taken into account when it is necessary to follow a diet with a limited salt content (with chronic heart failure, with kidney dysfunction).

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

    The drug does not affect the ability to drive vehicles and other mechanisms.

    Form release / dosage:

    Solution for intravenous and intramuscular injection.

    Packaging:

    4 ml into 5 ml ampoules (solution I) and 1 ml each into 2 ml (solution II) ampoules of dark glass of hydrolytic class 1 with technical ring marks and a white point on the fracture side.

    By 4 ampules of solution I and solution II into one contour-cell package. 2 contour-cell packs along with instructions for use in a cardboard pack.

    For 4 ml of solution I and 1 ml of solution II separately in a syringe of a two-chamber dark glass of hydrolytic class 1 with a separating membrane and a safety cap made of PVC, sealing the nozzle of the syringe bulb. A syringe complete with a disposable needle and a piston in the blister. For 4 or 8 blisters together with instructions for use in a pack of cardboard.

    Storage conditions:

    In the dark place 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 expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001881
    Date of registration:16.10.2012 / 29.05.2017
    Expiration Date:16.10.2017
    The owner of the registration certificate:Meditsa Artznamittel Pütter GmbH & Co. KG. KGMeditsa Artznamittel Pütter GmbH & Co. KG. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspKOSMOFARM LLCKOSMOFARM LLC
    Information update date: & nbsp26.04.2018
    Illustrated instructions
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