Beviplex (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Galenika, a.d. (Serbia)

ATC Code

A11BA (Multivitamins)

Dosage Form

Beviplex

Lyophilized powder for preparation of solution for injection: amp. 5 pcs. incl. with solvent

Dosage Form, Packaging, and Composition

Solvent water for injections – 2 ml.

Ampoules (5) in a set with solvent (amp. 5 pcs.) – cardboard packs.

Clinical-Pharmacological Group

B complex vitamins

Pharmacotherapeutic Group

Multivitamin agent

Pharmacological Action

Beviplex is a complex of B vitamins, which are components of enzymes that regulate the metabolism of carbohydrates, fats, and proteins in the body.

Pharmacokinetics

Each vitamin included in the complex undergoes its own natural transformations.

Indications

Prevention and treatment of B vitamin deficiency

• In the complex treatment of neurological diseases: neuritis, radiculitis, neuralgia, peripheral paralysis, as well as in diabetic polyneuropathies; therapy of disorders caused by chronic alcoholism;
• Primary deficiency of B vitamins associated with unbalanced nutrition;
• Secondary deficiency of B vitamins: in cases of impaired intestinal absorption (sprue, diarrhea, and prolonged antibiotic therapy);
• Hypovitaminosis (beriberi, pellagra, glossitis, cheilitis, stomatitis, ariboflavinosis);
• During or after the use of drugs that impede the absorption or promote the excretion of B vitamins from the body (cytostatics, isoniazid, cycloserine, hydralazine, oral contraceptives);
• Pregnancy and lactation (insufficient dietary intake of B vitamins, as in the case of uncontrollable vomiting of pregnancy);
• In dermatological practice for dermatoses, photodermatoses, pruritus of various etiologies, neurodermatitis, eczema, psoriasis;
• In ophthalmic practice for keratitis, conjunctivitis, corneal opacities;
• As a general tonic for nutritional disorders, liver diseases, asthenia, neurasthenia;
• For spasms of peripheral vessels, in the complex treatment of endarteritis;
• For conditions after X-ray irradiation.

ICD codes

Dosage Regimen

Reconstitute the lyophilisate from one ampoule with 2 ml of the provided water for injections solvent.

Administer the prepared solution by deep intramuscular or slow intravenous injection.

For adults, the typical dosage is 1 to 2 ampoules, administered 1 to 2 times per day.

Adjust the dosage and treatment duration based on the severity of the vitamin deficiency and the clinical response.

For severe deficiency states, initiate therapy with a higher dosage, subsequently reducing it for maintenance.

In cases of peripheral neuropathies or conditions with impaired absorption, a prolonged course of therapy may be necessary.

The maximum daily dose should not exceed the equivalent of 2 ampoules administered twice daily.

Discontinue administration immediately if signs of hypersensitivity occur.

The final treatment regimen, including dosage, route, and duration, must be determined by a physician.

Adverse Reactions

Allergic reactions to the components of the drug are possible.

Contraindications

• Therapy with levodopa;
• Hypersensitivity to B vitamins.

Use in Pregnancy and Lactation

Permitted according to indications.

Overdose

Symptoms nausea, vomiting, drowsiness, pallor of the skin.

Drug Interactions

Pyridoxine (vitamin B₆) reduces the effect of levodopa in the therapy of Parkinson’s disease.

Pyridoxine (vitamin B₆) may reduce the effects of steroid hormones.

Isoniazid increases the excretion of this vitamin in the urine. Cycloserine, hydralazine, and penicillamine are antagonists of vitamin B₆.

Storage Conditions

Store in a dry place, protected from light, at a temperature up to 15°C (59°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 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.