TEMAVIT-B [vitamin B complex] 100/100/1 mg/3 ml Solution for intramuscular injection

TEMAVIT-B

instructions for medical use of the medicinal product

Tradename

Temavit-B, Темавит-В

International non-proprietary name

Vitamin B complex.

Compound

Each 3 ml ampoule contains:

active substances : thiamine hydrochloride (vitamin B1) 100 mg, pyridoxine hydrochloride (vitamin B6) 100 mg, cyanocobalamin (vitamin B12) 1 mg

excipients: water for injections.

Dosage form

Injection.

Pharmacotherapeutic group

Vitamins.

Pharmacological properties

Pharmacodynamics

The drug contains a combination of neurotropic B vitamins. The vitamins contained: thiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6) and cyanocobalamin (vitamin B12) play a special role as coenzymes in the intermediate metabolism that occurs in the central and peripheral nervous system.

A special role in the metabolic processes of the nervous system is played by the combined action of vitamins B1, B6 and B12, which justifies their combined use. The combined use of B vitamins accelerates the regeneration of damaged nerve fibers. The effectiveness of the combination has been proven to be superior to that of the single component.

Like other vitamins, they are essential nutrients that the body cannot synthesize on its own. The therapeutic introduction of vitamins B1, B6 and B12 into the body makes up for the often existing insufficient intake of vitamins from food, which ensures the presence in the body of the necessary amounts of coenzymes. The therapeutic use of these vitamins in various diseases of the nervous system is aimed at, on the one hand, compensating for the existing deficiency (possibly due to the increased need of the body, caused directly by the disease) and, on the other hand, to stimulate natural mechanisms aimed at restoring function. nervous tissues.

At the same time, the indirect analgesic effect of the vitamin B complex has a beneficial effect on the therapeutic result.

Pharmacokinetics

Thiamine hydrochloride
The half-life is about 4 hours. The human body contains about 30 mg of thiamine hydrochloride. Given the rapid metabolism, it is excreted in 4-10 days.
Pyridoxine hydrochloride

The human body contains about 40-150 mg of pyridoxine hydrochloride. The kidneys excrete 1.7-3.6 mg per day.
cyanocobalamin
Excess cyanocobalamin mainly accumulates in the liver. The daily requirement for a vitamin is 1 mcg. The metabolic rate of cyanocobalamin per day is 2.5 mcg, or 0.05% of the amount in the liver. From the liver, it is excreted in the bile to the intestine and is largely reabsorbed in the enterohepatic circulation.

Indications for use

With a proven deficiency of B vitamins, polyneuropathy of various origins. In the complex therapy of the following neurological diseases: trigeminal neuralgia, neuritis of the facial nerve, pain syndrome caused by diseases of the spine (intercostal neuralgia, lumboischalgia, lumbar syndrome, cervical syndrome, cervicobrachial syndrome, radicular syndrome caused by degenerative changes in the spine).

Contraindications

Hypersensitivity to any component of the drug, children's age.

Use during pregnancy or lactation

It is contraindicated to use during pregnancy and lactation.

Interaction with other drugs

A solution of thiamine hydrochloride is incompatible with solutions of dopamine, methoxantrone, pyridoxal phosphate. With the simultaneous administration of L-dopa, pyridoxine hydrochloride may reduce its effect. Pyridoxine hydrochloride weakens the antitumor effect of altretamine, enhances the hypoglycemic effect of glimepiride, insulin and the combination of glibenclamide + metformin. Cyanocobalamin is incompatible with ascorbic acid, heavy metal salts and pyridoxal phosphate. Lansoprazole slows down the absorption of cyanocobalamin, mesalazine slows down its absorption. Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations - reduce the absorption of cyanocobalamin. The combination of thiamine hydrochloride + pyridoxine hydrochloride + cyanocobalamin is incompatible with ascorbic acid, benzylpenicillin, dextrose, riboflavin, phenobarbital. When combined with epinephrine and norepinephrine, it is possible to increase their side effects on the heart.

Special instructions and precautions

Temavit-B injection solution must not be mixed with other medicinal products. Do not administer in acute thromboembolic diseases. Use with caution in gastric ulcer and duodenal ulcer, coronary heart disease. In severe liver damage, it can cause a deterioration in its function.

Dosage and administration

The drug is usually administered intramuscularly, less often intravenously slowly at a dose of 3 ml per day or every other day. The dosage and duration of treatment is determined by the attending physician, depending on the severity of the disease and the tolerability of the drug.
As soon as possible, switching to dosage forms for oral administration is recommended.

Side effect

In most cases, the drug is well tolerated. In rare cases, skin reactions may occur, especially in patients predisposed to allergic reactions. Adverse reactions disappear when treatment is stopped.

If you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

An overdose may occur only after extremely large doses have been administered for a prolonged period.

Symptoms: neuropathy with ataxia, impaired sensory function, convulsions with EEG changes, hypochromic anemia, dermatitis.

Treatment is symptomatic.

Storage conditions

Store in a cool and dark place, at a temperature not exceeding 30 ⁰ C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

5 ampoules of 3 ml together with instructions for medical use in a cardboard box.