Bifilyz Vigel (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Ferment Firm, LLC (Russia)

ATC Code

A07FA (Antidiarrheal microorganisms)

Active Substances

Lysozyme (DCF adopted for use in France)

Bifidobacterium bifidum (Grouping name)

Dosage Form

Bifilyz (Vigel)

Lyophilizate for the preparation of suspension for oral administration: fl. 5 doses 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of suspension for oral administration in the form of a porous or crystalline mass of various shades of beige or whitish-gray color, with a specific odor.

Excipients: milk – 12-15%, sugar – 5-7%, gelatin – 0.7-2%.

5 doses – bottles (10) – cardboard packs.

* The content of the protective drying medium components in the finished preparation is not determined.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

Combined medicinal product. The therapeutic effect of this combination is due to the presence of bifidobacteria, the action of which is aimed at normalizing the intestinal microflora, and lysozyme as a natural factor in the protection of the gastrointestinal tract.

Live bifidobacteria with high antagonistic activity against a wide range of opportunistic and enteropathogenic microorganisms displace the latter from the intestinal microbiocenosis, creating favorable conditions for normalizing the microflora and improving metabolic processes, preventing the formation of protracted forms of intestinal diseases.

Lysozyme has bifidogenic, immunomodulatory, anti-inflammatory effects, stimulates metabolic, reparative processes and erythropoiesis, improves digestion, increases the body’s anti-infective and antitoxic resistance, has an antibacterial effect and exhibits synergism with many antibiotics.

The optimal combination of bifidobacteria and lysozyme in this combination makes it possible to enhance the therapeutic effect of each component and limit the use of antibiotics for the treatment of intestinal infections and selective decontamination of pathogenic microflora.

Indications

Treatment and prevention of dysbacteriosis and intestinal infections in children and adults.

ICD codes

Dosage Regimen

Administer orally. Prepare the suspension immediately before use.

Open the bottle and add approximately 5 ml (one teaspoon) of chilled, boiled water. Shake thoroughly until a homogeneous suspension is formed.

For adults and children over 14 years, prescribe 5 doses, 2-3 times per day.

For children aged 3 to 14 years, prescribe 5 doses, 1-2 times per day.

For children aged 1 to 3 years, prescribe 3-5 doses once per day.

For infants up to 1 year, prescribe 1-2 doses, 2-3 times per day.

Take 30-40 minutes before a meal.

The duration of treatment is determined by the severity of the condition. For acute intestinal infections, a course of 7-10 days is typical. For correction of dysbiosis, treatment may extend to 14-21 days.

For preventive purposes, use 5 doses once daily for 10-14 days.

Repeat courses are possible on the recommendation of a physician.

Adverse Reactions

Not identified.

Contraindications

Hypersensitivity to chicken egg protein.

Use in Pregnancy and Lactation

Bifidobacteria are representatives of the normal human microflora, therefore, preparations made on their basis can be used during pregnancy and breastfeeding.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Can be used simultaneously with antibacterial, antiviral and immunomodulatory therapy.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.