Bifidumbacterin forte^® (Capsules) Instructions for Use

Marketing Authorization Holder

Avan, LLC (Russia)

Or

Avan-Bio, LLC (Russia)

Manufactured By

Probiofarm, LLC (Russia)

Or

Avan-Bio, LLC (Russia)

ATC Code

A07FA (Antidiarrheal microorganisms)

Active Substance

Bifidobacterium bifidum (Grouping name)

Dosage Forms

	Bifidumbacterin forte®	Capsules 50 million CFU (5 doses): 10, 18 or 30 pcs.
	Bifidumbacterin Forte®	Powder for oral administration 50 million CFU (5 doses): pkg. 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, white body, blue cap; capsule contents – powder from light gray to dark gray with black charcoal particles and possible beige inclusions, with a faint fermented milk odor.

Excipients : lactose monohydrate – up to 0.2 g.

10 pcs. – polymer jars (1) – cardboard packs.
18 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Powder for oral administration from light gray to dark gray with black charcoal particles and possible beige inclusions, with a faint fermented milk odor.

Excipients : lactose.

50 million CFU – combined material bags (10) – cardboard packs.
50 million CFU – combined material bags (30) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

A biological agent that regulates the balance of intestinal microflora, a probiotic.

The action is due to the high concentration of bifidobacteria sorbed on activated charcoal particles, which are antagonists of a wide range of pathogenic (including Shigella spp., Salmonella spp., Staphylococcus aureus) and opportunistic microorganisms (including Proteus spp., Klebsiella spp.).

Bifidobacteria sorbed on a specially prepared carrier provide increased clinical efficacy and rapid restoration of normal microflora. The microflora, being a natural biosorbent, accumulates a significant amount of toxic substances entering from outside or formed in the body and decomposes them into non-toxic components. Sorbed bifidobacteria, forming microcolonies, intensively activate restorative and metabolic processes, parietal digestion, synthesis of vitamins and amino acids, and the body’s immune defense.

Indications

As monotherapy or as part of complex therapy

• Intestinal dysbiosis;
• Acute intestinal infections of established (shigellosis, salmonellosis, staphylococcal enterocolitis, rotavirus infection) and unspecified etiology;
• Food toxicoinfections;
• Acute respiratory viral infections (ARVI);
• Chronic diseases with gastrointestinal tract involvement (gastric and duodenal ulcer, pancreatitis, cholecystitis, liver and biliary tract diseases), accompanied by intestinal dysbiosis;
• Chronic constipation;
• Malabsorption syndrome;
• Allergic diseases accompanied by intestinal dysbiosis;
• Pneumonia, acute and chronic bronchitis, inflammatory diseases of the urogenital tract, accompanied by intestinal dysbiosis;
• Intestinal dysbiosis caused by the intake of antibiotics, antibacterial drugs, hormones, NSAIDs;
• Diarrhea in patients receiving long-term treatment with antibiotics and other antibacterial drugs;
• Correction of intestinal microbiocenosis and prevention of purulent-inflammatory diseases in surgical patients during preoperative preparation and after operations on the intestines, liver, pancreas.

For prophylaxis

• Nosocomial infections in maternity hospitals and hospitals;
• Dysbiosis in children and adults frequently ill with ARVI.

ICD codes

Dosage Regimen

Take orally during meals, if necessary – regardless of meals.

Depending on the severity of the diseases, this agent is used in usual or increased doses.

For treatment this agent in usual doses is used in patients of all age groups.

The usual dose for adults is 2 capsules or 2 sachets 2-3 times/day; for children aged 3 years and older – 1 capsule 3-4 times/day, aged 1 year and older – 1 sachet 3-4 times/day, aged under 1 year – 1 sachet 2-3 times/day.

The course of treatment for acute intestinal infections and food toxicoinfections is 5-7 days, for other diseases – 15-21 days, depending on the nature and severity of the disease. If necessary, treatment courses can be repeated 2-3 times, each course is conducted one month after the end of the previous treatment course.

For surgical pathology use for 3-5 days before surgery and for 10-15 days after surgery : adults – 2 capsules or 2 sachets 3 times/day; children aged 3 years and older – 1 capsule 3-4 times/day, aged 1 year and older – 1 sachet 3-4 times/day, aged under 1 year – 1 sachet 3 times/day.

For treatment this agent in increased doses is used in adults and children aged 1 year and older.

For acute intestinal infection and acute respiratory viral infection this agent is used from the first day of the disease: adults – 10 capsules or 10 sachets 3 times/day; children aged 3 years and older – 3-5 capsules every 2 hours up to 6 times/day, aged 1 year and older – 5 sachets 6 times/day. The course of treatment is 1-3 days, depending on the severity of the condition.

For chronic gastrointestinal diseases use in adults 10 capsules or 10 sachets 1-3 times/day; children aged 3 years and older – 5 capsules 1-3 times/day, aged 1 year and older – 5 sachets 1-3 times/day. The course of treatment is 10-14 days.

For prophylaxis this agent is used in adults and children over 3 years old 1-2 capsules or 1-2 sachets 1-2 times/day; children aged under 1 year – 1 sachet 1 time/day. The prophylactic course is 10-15 days 2-3 times/year. For the prevention of nosocomial infections in maternity hospitals and hospitals, the drug is used for 5-10 days.

Adverse Reactions

When used according to the indications in the recommended doses, no adverse effects have been established.

Contraindications

• Individual intolerance.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is permitted.

Use in Hepatic Impairment

Dosage adjustment is not required.

Use in Renal Impairment

Dosage adjustment is not required.

Pediatric Use

Used in children in dosage forms and doses appropriate for age.

Geriatric Use

Dosage adjustment is not required.

Special Precautions

Should be used with caution in lactase deficiency.

Drug Interactions

When taken simultaneously with vitamins (especially B group), the effect of this agent is enhanced.

When taken with antibiotics, a decrease in the therapeutic efficacy of this agent is possible.

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.