Probifor^® (Capsules) Instructions for Use

Marketing Authorization Holder

Avan-Bio, LLC (Russia)

Manufactured By

Probiofarm, LLC (Russia)

ATC Code

A07FA (Antidiarrheal microorganisms)

Active Substance

Bifidobacterium bifidum (Grouping name)

Dosage Forms

	Probifor®	Capsules 500 million CFU: 6, 10, 18 or 30 pcs.
		Powder for oral administration 500 million CFU/sachet: 6, 10 or 30 sachets.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 3, cylindrical in shape with hemispherical ends, white opaque body, yellow opaque cap; capsule contents – powder from light gray to dark gray with black charcoal particles, with a faint fermented milk odor.

Excipients : lactose monohydrate – up to 0.2 g.

6 pcs. – polymer jars (1) – cardboard packs.
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 monohydrate – up to 0.85 g.

0.85 g – sachets made of multilayer metal-polymer material (6) – cardboard packs.
0.85 g – sachets made of multilayer metal-polymer material (10) – cardboard packs.
0.85 g – sachets made of multilayer metal-polymer material (30) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

Probiotic

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), 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.

Long-term intestinal dysfunctions of unspecified etiology; acute intestinal infections (as part of complex treatment of acute dysentery, salmonellosis, escherichiosis, viral diarrhea), long-term intestinal dysfunctions of staphylococcal etiology, as well as treatment of convalescents after acute intestinal infections with persistent intestinal dysfunction; as part of complex treatment of children (including newborns, premature infants) with pneumonia, sepsis and other purulent-infectious diseases, for the prevention or relief of intestinal function disorders in them 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, especially in the presence of any intestinal function disorders; during 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 disturbances with deficiency or absence of bifidoflora; intestinal dysfunctions resulting from intestinal dysbiosis arising as a consequence of long-term antibacterial, hormonal, radiation and other therapy, during stressful situations and stay 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 up to III-IV degree in pregnant women at risk; in bacterial colpitis caused by staphylococcus and Escherichia coli (in mono-flora or in associations), as well as in senile colpitis of hormonal nature.

ICD codes

Dosage Regimen

Administer orally or topically.

Select the dosage form and regimen based on the patient’s age and clinical indication.

For oral administration of capsules to adults and children over 3 years: take 2-3 capsules two or three times daily.

For children aged 1 to 3 years: administer 1 capsule three or four times daily.

For infants under 1 year: use the powder for oral administration.

To administer the powder to infants: open the sachet and mix the contents with 25-50 ml of liquid (breast milk, infant formula, or boiled water cooled to no more than 40°C).

Give the prepared suspension immediately; do not store it.

For infants 0-6 months: use 1 sachet two times daily.

For infants 6-12 months: use 1 sachet three or four times daily.

For children aged 1-3 years: use 1 sachet three or four times daily.

For children over 3 years and adults: use 2 sachets two or three times daily.

The standard course of treatment is 7-10 days; for persistent conditions, extend the course to 14-21 days.

For acute intestinal infections: use for the first 2-3 days at the maximum frequency and dose, then transition to standard maintenance doses.

For topical prevention of mastitis in nursing mothers: apply the contents of one sachet, dissolved in 10-15 ml of boiled water at room temperature, to the nipple area and areola 20-30 minutes before feeding.

For intravaginal use in gynecological practice: insert the contents of one sachet, dissolved in 15-20 ml of boiled water, into the vagina once or twice daily for 7-10 days.

Take oral doses 20-30 minutes before a meal.

Do not take oral forms concurrently with antibiotics; maintain a 2-3 hour interval.

Adverse Reactions

Possible allergic reactions, nausea.

Contraindications

Individual intolerance.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible according to indications in the 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

Use in elderly patients is permitted.

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

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.