Vitagamma^® (Solution) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Or

Ferein, CJSC (Republic Of Belarus)

ATC Codes

A11DB (Vitamin B1 in combination with vitamins B6 and/or B12)

N07XX (Other drugs for the treatment of diseases of the nervous system)

Dosage Form

Vitagamma®

Solution for intramuscular injection: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

2 ml – dark glass ampoules (5) – contour plastic packaging (1) – cardboard packs.

Clinical-Pharmacological Group

B complex vitamins

Pharmacotherapeutic Group

B vitamins + other preparations

Pharmacological Action

The pharmacological action is determined by the properties of the components included in the drug.

Vitamins B₁, B₆ and B₁₂ regulate protein, carbohydrate and fat metabolism, contribute to its normalization, and improve the function of motor, sensory and autonomic nerves.

Thiamine (B₁) prevents protein glycation, has antioxidant activity, and is involved in the regulation of nerve impulse conduction.

Pyridoxine (B₆) is involved in the synthesis of neurotransmitters (dopamine, norepinephrine, etc.), decarboxylation, deamination and transamination reactions of amino acids, prevents the accumulation of ammonia and accelerates regenerative processes in nervous tissue.

Cyanocobalamin (B₁₂) is necessary for normal hematopoiesis and is involved in the synthesis of myelin tissue.

Indications

• Neurological diseases caused by proven deficiency of vitamins B₁, B₆ and B₁₂;
• As an auxiliary agent for symptomatic therapy of diseases of the nervous system of various origins: neuritis and polyneuritis (including those accompanied by pain syndrome), including retrobulbar neuritis, peripheral paresis (including facial nerve paresis), neuralgia, polyneuropathies (diabetic, alcoholic and others).

ICD codes

Dosage Regimen

Administer deep intramuscularly only.

For severe cases and acute pain, administer 2 ml daily.

After the acute phase subsides or for mild forms of disease, administer 2 ml 2-3 times per week.

Adjust the frequency of administration based on clinical response and tolerability.

The maximum single dose is 2 ml (one ampoule).

Do not exceed the recommended dosage.

Administer the injection slowly to minimize the risk of adverse reactions.

The treatment duration is determined by the treating physician based on the underlying condition.

For maintenance therapy, a reduced frequency may be employed as clinically indicated.

Discontinue use if severe adverse reactions occur.

Adverse Reactions

In some cases, increased sweating, tachycardia, and acne may occur.

Cases of skin allergic reactions (itching, urticaria and other types of skin rash), as well as systemic reactions (difficulty breathing, Quincke’s edema, anaphylactic shock) have been described.

In case of very rapid administration of the drug, the following may occur: dizziness, headache, vomiting, tachycardia or bradycardia, arrhythmia, convulsions, agitation, cardialgia.

Contraindications

• Pregnancy and breastfeeding period;
• Thrombosis and thromboembolism;
• Severe forms of decompensated heart failure;
• Erythremia;
• Erythrocytosis;
• Severe bleeding;
• Arterial hypotension;
• Shock conditions;
• Childhood;
• Hypersensitivity to the components of the drug.

With caution Wernicke’s encephalopathy, premenopausal and menopausal period in women, severe angina, benign and malignant neoplasms accompanied by megaloblastic anemia and vitamin B₁₂ deficiency, tendency to form blood clots, elderly age (over 65 years).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children.

Geriatric Use

With caution: elderly age (over 65 years).

Overdose

In case of overdose, the symptoms of the drug’s side effects are intensified; symptomatic therapy is carried out.

Drug Interactions

Thiamine is destroyed in solutions containing sulfites.

Therapeutic doses of vitamin B₆ reduce the effect of levodopa.

Copper ions, pH values greater than 3 accelerate the breakdown of thiamine.

Vitamin B₁₂ is incompatible with heavy metal salts.

In solutions containing thiamine, Cyanocobalamin (like other B vitamins) is rapidly destroyed (low concentrations of iron ions present in the drug can prevent this).

Storage Conditions

In a place protected from light, out of reach of children, at a temperature not exceeding 15°C (59°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.