Bifinorm (Lyophilisate) Instructions for Use

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

A07FA (Antidiarrheal microorganisms)

Active Substance

Bifidobacterium bifidum (Grouping name)

Dosage Form

Bifinorm

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

Dosage Form, Packaging, and Composition

5 doses – bottles (10) – carton packs.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

Live bifidobacteria possess high antagonistic activity against a wide range of pathogenic and opportunistic microorganisms of the intestine (including staphylococci, Proteus, enteropathogenic Escherichia coli, Shigella, some yeast-like fungi).

They restore the balance of intestinal and vaginal microflora, normalize the digestive and protective functions of the intestine, activate metabolic processes, and increase the body’s nonspecific resistance.

Indications

Treatment and prevention of dysbiosis of various etiologies in children and adults.

Prolonged intestinal dysfunctions of unspecified etiology; acute intestinal infections (as part of the complex treatment of acute dysentery, salmonellosis, escherichiosis, viral diarrheas), prolonged intestinal dysfunctions of staphylococcal etiology, as well as treatment of convalescents after acute intestinal infections with persistent intestinal dysfunction; as part of the complex treatment of children (including newborns, premature infants) with pneumonia, sepsis and other purulent-infectious diseases, for the prevention or relief of their intestinal function disorders and prevention of the development of ulcerative-necrotizing enterocolitis; children with a burdened premorbid state: born prematurely or with signs of prematurity, receiving antibiotics in the early neonatal period; children whose mothers suffered from severe toxicosis, extragenital diseases, had a long waterless period or other pathology; children of mothers who have lactostasis, cracked nipples and are resuming breastfeeding after recovery from mastitis; weakened children with anemia, hypotrophy, rickets, diathesis and other manifestations of allergy; in whooping cough disease, especially in the presence of any intestinal function disorders; with early transfer of infants to artificial feeding; acute and chronic inflammatory diseases of the large and small intestine (colitis, enterocolitis) in older children and adults, occurring against the background of microflora disorders with a deficiency or absence of bifidoflora; intestinal dysfunctions as a result of intestinal dysbiosis arising from long-term antibacterial, hormonal, radiation and other therapy, during stressful situations and staying in extreme conditions, as well as for the purpose of preventing dysbiosis.

For the prevention of mastitis for local treatment of the mammary glands of nursing mothers at risk (in women with inverted flat nipple, reduced erection, presence of cracks) in a complex epidemiological situation in maternity hospitals.

In diseases of the female genital area: in case of violation of the purity of vaginal secretion to III-IV degree in pregnant women at risk; in bacterial colpitis caused by staphylococcus and Escherichia coli (in monoflora or in associations), as well as in senile colpitis of hormonal nature.

ICD codes

Dosage Regimen

For oral and topical administration.

Prepare the suspension immediately before use. Open the vial and add chilled boiled water. Use approximately 5 ml of water per one dose. Shake until a homogeneous suspension is obtained.

For oral administration, take the prepared suspension 20-30 minutes before a meal.

For intestinal dysbiosis in adults, administer 5 doses orally 2-3 times per day. The treatment course is typically 14-21 days.

For children, the dose is 5 doses orally 2-3 times per day. The duration of treatment is determined individually.

For infants, administer 2.5 doses orally 2 times per day. For premature and low birth weight infants, use 1.25 doses orally 2 times per day.

For acute intestinal infections, use the drug for 5-7 days.

For topical use in gynecological practice, apply 5-10 doses, diluted in 15-20 ml of water, for vaginal irrigation or tampons once daily for 8-10 days.

For mastitis prevention, treat the nipple area and areola with a swab moistened with the prepared suspension from 2.5 doses for 5-10 minutes before feeding. Continue for 5 days.

Do not dissolve the lyophilisate in water with a temperature exceeding 40°C. Do not store the prepared suspension.

Adverse Reactions

Possible allergic reactions, nausea.

Contraindications

Individual intolerance.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications in appropriate dosage forms.

Use in Hepatic Impairment

The drug is approved for use in hepatic impairment.

Use in Renal Impairment

The drug is approved for use in renal impairment.

Pediatric Use

In children (including premature infants) it can be used from the first days of life in dosage forms intended for this category of patients according to age.

Geriatric Use

Approved for use in elderly patients.

Special Precautions

Simultaneous use of oral forms with antibiotics is not recommended, as well as dissolving the drug in hot water (above 40°C) and storing it in dissolved form.

The use of suppositories can be combined with the simultaneous administration of antibacterial, antiviral, and immunostimulating drugs.

Drug Interactions

When taken simultaneously with chemo- and antibacterial drugs, a decrease in therapeutic efficacy is possible.

The action of drugs containing Bifidobacterium bifidum is enhanced by vitamins (especially B vitamins).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.