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Biosporin (Tablets, Lyophilisate) Instructions for Use

ATC Code

A07FA (Antidiarrheal microorganisms)

Clinical-Pharmacological Group

Drug regulating the balance of intestinal and vaginal microflora

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

The bacteria that are part of the drug have high antagonistic activity against pathogenic and opportunistic microorganisms and do not affect representatives of the normal microflora.

They synthesize a complex of enzymes that stimulate and regulate digestion.

Indications

Acute intestinal infections caused by pathogenic and opportunistic microorganisms (Salmonella, Shigella, enteropathogenic Escherichia coli, Proteus, Staphylococcus, Candida), including antibiotic-resistant ones: in mild and moderate diseases; in severe forms in persons with contraindications to antibiotics; isolation of pathogenic and opportunistic microorganisms or gastrointestinal dysfunction after acute intestinal infections; intestinal dysbiosis of various etiologies, including against the background of antibiotic therapy; prevention of postoperative infections, including purulent-septic complications; vulvovaginal candidiasis, bacterial vaginosis in women of reproductive age, including pregnant women (after completion of a course of antibacterial therapy).

ICD codes

ICD-10 code Indication
A02 Other salmonella infections
A03 Shigellosis
A04.0 Enteropathogenic Escherichia coli infection
A05.0 Staphylococcal food poisoning
A09 Other and unspecified gastroenteritis and colitis of infectious origin
B37.3 Candidiasis of vulva and vagina
B37.8 Candidiasis of other sites (including candidal enteritis)
K63 Other diseases of intestine
N76 Other inflammatory diseases of vagina and vulva
N89 Other noninflammatory disorders of vagina
O23 Infections of genitourinary tract in pregnancy
T79.3 Posttraumatic wound infection, not elsewhere classified
Y40 Systemically acting antibiotics
Z29.8 Other specified prophylactic measures
ICD-11 code Indication
1A02 Intestinal infections due to Shigella
1A03.0 Infection due to enteropathogenic strains of Escherichia coli
1A09.Z Salmonella infection, unspecified
1A10 Staphylococcal food poisoning
1A40.Z Infectious gastroenteritis or colitis, unspecified
1F23.10 Candidiasis of vulva and vagina
1F23.Z Candidiasis, unspecified
DB31.Z Other acquired anatomical changes of the colon, unspecified
DE2Z Diseases of the digestive system, unspecified
GA00 Vulvitis
GA02.Z Unspecified vaginitis
GA0Z Inflammatory diseases of female genital tract, unspecified
JA62.Z Infections of genitourinary tract in pregnancy, unspecified
NF0A.3 Posttraumatic wound infection, not elsewhere classified
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use
QC05.Z Prophylactic measures, unspecified
GA1Z Unspecified noninflammatory disorders of female genital tract
XA1LK7 Vagina

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Lyophilisate

Orally, with boiled water, 30-40 minutes before meals. Crushing the tablet is allowed.

In children: for treatment of acute intestinal infections (including dysentery, salmonellosis, food toxicoinfection) 1 dose 2 times/day for 5-7 days; for follow-up treatment of convalescents after acute intestinal infections – 1 dose 2 times/day for 5 days, if necessary, the course of treatment can be extended to 2 weeks; for intestinal dysbiosis – 1 dose 2 times/day for 10-14 days; for prevention of purulent-septic complications in the postoperative period 1 dose 2 times/day for 5-7 days before surgery and for 10 days after surgery.

In adults: acute intestinal infections – 2 doses 3 times/day for 5-7 days; for follow-up treatment of convalescents after acute intestinal infections – 2 doses 3 times/day for 5 days, if necessary, the course of treatment can be extended to 2 weeks; for intestinal dysbiosis – 2 doses 2 times/day for 10-14 days; for prevention of purulent-septic complications in the postoperative period – 2 doses 2 times/day for 5-7 days before surgery and for 10 days after surgery; vulvovaginal candidiasis and bacterial vaginosis – 2 doses 2 times/day for 7-10 days. If necessary, the course of treatment can be repeated.

Adverse Reactions

Not established.

Contraindications

Hypersensitivity to the components of the drug.

Pediatric Use

Use is possible according to the dosing regimen.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

Dosage Form

Bottle OTC Icon Biosporin Tablets 1 dose: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Lyophilized bacteria Bacillus licheniformis From 100 million to 2 billion
Lyophilized bacteria Bacillus subtilis From 1 billion to 8 billion

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – vials (1) – cardboard packs.
20 pcs. – vials (1) – cardboard packs.
30 pcs. – vials (1) – cardboard packs.

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

Dosage Form

Bottle OTC Icon Biosporin Tablets 2 doses: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab. (2 doses)
Lyophilized bacteria Bacillus licheniformis From 200 million to 4 billion
Lyophilized bacteria Bacillus subtilis From 2 billion to 16 billion

10 pcs. – vials (1) – cardboard packs.

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

Dosage Form

Bottle OTC Icon Biosporin Lyophilizate for the preparation of suspension for oral and topical administration 1 dose: vial 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of suspension for oral and topical administration 1 vial
Lyophilized bacteria Bacillus subtilis 3 From 1×109 to 8×109 microbial cells
Lyophilized bacteria Bacillus licheniformis 31 From 1×108 to 2×109 microbial cells

1 dose – vials (10) – cardboard packs.

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of suspension for oral and topical administration 1 vial
Lyophilized bacteria Bacillus subtilis 3 From 1×109 to 8×109 microbial cells
Lyophilized bacteria Bacillus licheniformis 31 From 1×108 to 2×109 microbial cells

5 doses – vials (10) – cardboard packs.

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

Dosage Form

Bottle OTC Icon Biosporin Lyophilizate for the preparation of suspension for oral and topical administration 10 doses: vial 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of suspension for oral and topical administration 1 vial
Lyophilized bacteria Bacillus subtilis 3 From 1×109 to 8×109 microbial cells
Lyophilized bacteria Bacillus licheniformis 31 From 1×108 to 2×109 microbial cells

10 doses – vials (10) – cardboard packs.

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

Dosage Form

Bottle OTC Icon Biosporin Lyophilizate for the preparation of suspension for oral and topical administration 2 doses: vial 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of suspension for oral and topical administration 1 vial
Lyophilized bacteria Bacillus subtilis 3 From 1×109 to 8×109 microbial cells
Lyophilized bacteria Bacillus licheniformis 31 From 1×108 to 2×109 microbial cells

2 doses – vials (10) – cardboard packs.

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