Bifilis (Suppositories) Instructions for Use

Marketing Authorization Holder

Ferment Firm, LLC (Russia)

ATC Codes

A07FA (Antidiarrheal microorganisms)

G02CC (Anti-inflammatory preparations for intravaginal use)

Active Substances

Lysozyme (DCF accepted for use in France)

Bifidobacterium bifidum (Group Grouping name)

Dosage Form

Bifilis

Vaginal and rectal suppositories: 10 pcs.

Dosage Form, Packaging, and Composition

5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal and vaginal microflora

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

The therapeutic effect of Bifilis suppositories is due to the high antagonistic activity of bifidobacteria against opportunistic and a number of pathogenic microorganisms, which, in combination with the antibacterial and anti-inflammatory action of lysozyme, creates favorable conditions for the normalization of the intestinal and vaginal microflora.

Indications

Treatment of dysbiosis and inflammatory processes of the vagina. Increasing the nonspecific resistance of the body in children of all age groups and adults. Used as part of complex therapy.

Rectally for adults and children of all age groups

• In acute intestinal infections of established (bacterial, viral) and unknown etiology during the convalescence period, to prevent bacterial carriage and the transition of the disease to a chronic form;
• After foodborne toxic infections;
• In intestinal dysbiosis of various etiologies;
• To increase the effectiveness of complex treatment of nonspecific inflammatory bowel diseases (chronic colitis, enterocolitis, proctitis, etc.);
• To improve tolerance to antibacterial, cytostatic and other types of therapy.

Vaginally for adults

• In vaginal dysbiosis of various etiologies (bacterial vaginosis, nonspecific vaginitis, etc.). The drug is used to restore normal microflora in combination with or after specific antimicrobial, antiviral and immunomodulatory therapy;
• For the treatment of gynecological diseases complicated by vaginal pathology (chronic salpingo-oophoritis, colpitis of various etiologies);
• For preoperative preparation in planned operations in surgical practice in order to prevent postoperative infectious complications.

ICD codes

Dosage Regimen

Before use, cut the cell packaging of the suppository. The drug is applied rectally after defecation or after a cleansing enema (if necessary), intravaginally – after performing hygiene procedures.

For intestinal diseases, suppositories are used rectally for adults 3 times a day, 1-2 suppositories per dose. The duration of treatment for acute intestinal infections is 7-10 days, for protracted and chronic forms of the disease, intestinal dysbiosis 10-14 days or more. It is possible to use the drug 1 suppository 2-3 times a day in combination with oral administration of the drug Bifilis lyophilisate 5 doses 2-3 times a day for 10-14 days, if necessary, treatment can be continued for up to 3 weeks. For children, the drug is prescribed 1 suppository 2-3 times a day for 7 days.

In gynecological practice for vaginal dysbiosis and treatment of diseases complicated by vaginal pathology, the drug is prescribed vaginally, 1 suppository 3 times a day for 10-15 days.

For the prevention of postoperative infectious complications during planned operations, 1 suppository is used 1-2 times a day for 5-10 days before the intended operation.

Adverse Reactions

Not identified.

Contraindications

• Childhood (for intravaginal use).

With caution allergy to chicken egg proteins (the drug can be used against the background of desensitizing therapy).

Use in Pregnancy and Lactation

No information available.

Pediatric Use

Contraindicated in children (intravaginal use).

Special Precautions

The drug does not affect the performance of activities requiring special attention and quick reactions (driving vehicles, operating machinery, etc.).

Overdose

Cases of drug overdose have not been observed.

Drug Interactions

Clinically significant interaction of the drug with other drugs has not been established. The drug can be used simultaneously with antibacterial, antiviral and immunomodulatory therapy.

Storage Conditions

The drug is stored in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 10°C (50°F) in a dry place protected from light.

Shelf Life

Shelf life – 1 year.

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.