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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 1 dose: 10, 20, or 30 pcs.
Marketing Authorization Holder
48 TsNII of the Ministry of Defense of Russia FSU (Russia)
Dosage Form
 |
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.
Tablets 2 doses: 10 pcs.
Marketing Authorization Holder
48 TsNII of the Ministry of Defense of Russia FSU (Russia)
Dosage Form
|
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.
Lyophilizate for the preparation of suspension for oral and topical administration 1 dose: vial 10 pcs.
Marketing Authorization Holder
48 TsNII of the Ministry of Defense of Russia FSU (Russia)
Dosage Form
|
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.
Lyophilizate for the preparation of suspension for oral and topical administration 5 doses: fl. 10 pcs.
Marketing Authorization Holder
48 TsNII of the Ministry of Defense of Russia FSU (Russia)
Dosage Form
|
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.
Lyophilizate for the preparation of suspension for oral and topical administration 10 doses: vial 10 pcs.
Marketing Authorization Holder
48 TsNII of the Ministry of Defense of Russia FSU (Russia)
Dosage Form
|
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.
Lyophilizate for the preparation of suspension for oral and topical administration 2 doses: vial 10 pcs.
Marketing Authorization Holder
48 TsNII of the Ministry of Defense of Russia FSU (Russia)
Dosage Form
|
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.
![Biosporin [Tablets, Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Biosporin [Tablets, Lyophilisate] 2")