The B1B6B12 complex solution for injections No. 5
Producer: CJSC Lekhim-Kharkiv Ukraine
Code of automatic telephone exchange: A11D B
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active ingredients: thiamin hydrochloride (B1 vitamin), pyridoxine hydrochloride (B6 vitamin), cyanocobalamine (B12 vitamin);
1 ml of solution contains thiamin a hydrochloride of 50 mg, a pyridoxine a hydrochloride of 50 mg, cyanocobalamine of 500 mkg; excipients: lidocaine a hydrochloride, benzyl alcohol, sodium polyphosphate, potassium ferricyanide, sodium hydroxide, water for injections. Main physical and chemical properties: transparent liquid of red color.
Pharmacological properties:
Pharmacodynamics. The combined vitamin drug containing a complex of vitamins of group B (thiamin a hydrochloride, a pyridoxine a hydrochloride, cyanocobalamine).
Vitamins of group B possess neurotropic action, make favorable impact on inflammatory and degenerative diseases of nerves and the motive device. Along with participation in regulation of carbohydrate, protein and lipidic metabolism in a cell thiamin (B1 vitamin), a pyridoxine (B6 vitamin) and cyanocobalamine (B12 vitamin) regulate carrying out nervous impulse, are cofactors of many enzymes operating in cells of nervous tissue; participate in decarboxylation, in a misinformation - and interamination of amino acids, in synthesis of neurotransmitters (a dopamine, noradrenaline, adrenaline, a histamine, piperidic acid). Drug stimulates a neuranagenesis, improves blood supply, in high doses possesses analgetichesky action.
Pharmacokinetics. After intramuscular introduction thiamin (B1) quickly comes to blood. In 15 min. after introduction in a dose of 50 mg concentration of thiamin in blood makes 484 ng/ml. In fabrics it is distributed unevenly: contents in leukocytes makes 15%, in erythrocytes – 75%, in plasma – 10%. Passes through a blood-brain barrier and a placenta, it is found in breast milk. The main metabolites of thiamin are tiaminokarbonovy acid, pyramine and some unknown metabolites. From all vitamins remains in an organism in the smallest quantities, contents at adults makes about 30 mg: 80% - in the form of thiamin of a pyrophosphate, 10% - thiamin of triphosphate, 10% - monophosphate thiamin. The semi-removal period three-phase is removed with urine, in general makes 2 days.
The pyridoxine (B6) after intramuscular introduction quickly joins in a system blood stream, is distributed in all organism and after phosphorylation joins in metabolism. Passes through a placenta and it is found in breast milk. It is deposited in a liver and is oxidized to 4-pyridoxynew acid which is removed with urine at most in 2-5 hours after introduction. The organism of the adult contains 40-150 mg of a pyridoxine, its daily speed of elimination makes about 1,7-3,6 mg at a speed of completion of 2,3-2,4%.
Cyanocobalamine (B12) after intramuscular introduction forms transport proteinaceous complexes which are quickly absorbed by a liver, marrow and other bodies. Comes to bile, takes part in enterohepatic circulation, gets through a placental barrier.
Pharmaceutical characteristics.
Indications to use:
Symptomatic therapy of diseases of a nervous system of various origin: neuritis, neuralgia, polyneuropathy (diabetic, alcoholic), mialgiya, radicular syndromes, retrobulbar neuritis, herpetic defeats (the surrounding herpes), the paresis of a facial nerve, general neurologic diseases caused by the proved vitamin deficiency of B1, B6 and B12.
Route of administration and doses:
The drug is administered slowly deeply in a muscle. In hard cases of a disease and at an acute pain for bystry increase in level of vitamins B of blood appoint 2 ml of 1 times a day. After subsiding of an aggravation and at easy forms of a disease appoint 2 ml 2-3 times a week. The course of treatment proceeds not less than 1 month.
Features of use:
Ability to influence speed of response at control of motor transport or work with other mechanisms. There are no cautions about appointment to drivers of vehicles.
Use during pregnancy or feeding by a breast. Safety of use of a complex of vitamins B in high doses at pregnancy and during feeding by a breast is not proved. In order to avoid a possible adverse effect on a fruit or the child it is not recommended to appoint drug during pregnancy; in need of use in the period of a lactation feeding by a breast should be stopped.
Children. Safety of use of drug for children is not proved. As solution contains benzyl alcohol, drug cannot be used at children.
Side effects:
Drug is well transferred, side reactions develop seldom. At very bystry introduction passing system reactions (dizziness, nausea, arrhythmia, bradycardia, the increased perspiration, spasms) are possible.
Allergic reactions: skin rash and/or an itch, the complicated breath, a Quincke's edema, an acute anaphylaxis.
Interaction with other medicines:
The effect of a pyridoxine can decrease at simultaneous use with Cycloserinum, Penicillaminum, Epinephrinum, Norepinephrinum, streptocides.
The pyridoxine is incompatible with the drugs containing a levodopa as at simultaneous use peripheral decarboxylation of a levodopa amplifies and, thus, its antiparkinsonichesky action decreases.
Incompatibility. Thiamin completely breaks up in solutions with рН more than 3 or in the solutions containing sulfites; iron-ammonium-citrate, sodium phenobarbital, Riboflavinum, benzylpenicillin, a dextrose is incompatible with the oxidizing and recovering substances, mercury chloride, iodides, carbonates, acetates, tannin acid. Copper accelerates thiamin disintegration.
Cyanocobalamine is incompatible with salts of heavy metals. Other vitamins are inactivated in the presence of decomposition products of vitamins B.
Contraindications:
The increased individual sensitivity to drug components, severe and acute forms of noncompensated heart failure; period of pregnancy and feeding by a breast, children's age.
Overdose:
Symptoms: strengthening of manifestations of side effect - the expressed dizziness, nausea, arrhythmia, bradycardia, the increased perspiration, spasms.
Treatment: symptomatic therapy.
Storage conditions:
To store in the unavailable to children, protected from light place, at a temperature not over 15 ºС.
Period of validity - 2 years.
Issue conditions:
According to the recipe
Packaging:
On 2 ml in ampoules, on 5 ampoules in a pack.