Bificol (Lyophilisate) Instructions for Use
ATC Code
A07FA (Antidiarrheal microorganisms)
Clinical-Pharmacological Group
Drug regulating the balance of intestinal microflora (probiotic)
Pharmacotherapeutic Group
MIBP-eubiotic
Pharmacological Action
It possesses antagonistic activity against many pathogenic and opportunistic microorganisms.
Indications
Gastrointestinal dysbiosis, including against the background of: intestinal infections (dysentery, salmonellosis, viral diarrhea); inflammatory gastrointestinal diseases (colitis, enterocolitis, nonspecific ulcerative colitis); during the convalescence period after chemotherapy.
ICD codes
| ICD-10 code | Indication |
| A02 | Other salmonella infections |
| A03 | Shigellosis |
| A04 | Other bacterial intestinal infections |
| A05 | Other bacterial food poisonings, not elsewhere classified |
| A08 | Viral and other specified intestinal infections |
| A09 | Other and unspecified gastroenteritis and colitis of infectious origin |
| K51 | Ulcerative colitis |
| K52 | Other noninfectious gastroenteritis and colitis |
| K63.8 | Other specified diseases of intestine |
| Z54.2 | Convalescence following chemotherapy |
| ICD-11 code | Indication |
| 1A01 | Intestinal infection caused by other Vibrio species |
| 1A02 | Intestinal infections due to Shigella |
| 1A03.Z | Intestinal infections caused by Escherichia coli, unspecified |
| 1A09.Z | Salmonella infection, unspecified |
| 1A0Z | Bacterial intestinal infections, unspecified |
| 1A1Z | Bacterial foodborne intoxications, unspecified |
| 1A2Z | Viral intestinal infections, unspecified |
| 1A40.Z | Infectious gastroenteritis or colitis, unspecified |
| DA42.81 | Radiation gastritis |
| DA42.8Z | Gastritis due to external causes, unspecified |
| DA51.53 | Radiation duodenitis |
| DA51.5Z | Duodenitis due to external causes, unspecified |
| DA92.1 | Pneumatosis intestinalis of the small intestine |
| DA98.Z | Polyps of small intestine, unspecified |
| DB31.1 | Pneumatosis of the colon |
| DB33.2Z | Allergic or alimentary colitis, unspecified |
| DB33.4Y | Other specified colitis or proctitis caused by external agents |
| DB33.4Z | Colitis or proctitis caused by external agents, unspecified |
| DB36.Z | Certain infections of the colon, unspecified |
| DD71.Z | Ulcerative colitis, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| QB70 | Convalescence following chemotherapy |
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. |
Lyophilisate
Orally, 20-30 minutes before meals: children from 6 months to 1 year — 1 dose 2 times/day, from 1 year to 3 years – 2-5 doses 2 times/day, over 3 years and adults – 3-5 doses 2 times/day. The course of treatment for acute forms is at least 2 weeks, depending on clinical and laboratory parameters — 3-4 weeks; for convalescence — 21-30 days, for post-dysenteric colitis and prolonged intestinal dysfunction — at least 4-6 weeks, for chronic colitis, enterocolitis and nonspecific ulcerative colitis up to 45-60 days. If necessary, repeated courses of treatment or maintenance doses (half the daily dose) can be prescribed for 1-1.5 months.
The drug is dissolved with boiled water at room temperature immediately before use at the rate of 1 teaspoon of water per 1 dose. Persons with high acidity are recommended to drink 1/2 glass of mineral water (Borjomi, Essentuki No. 4 or No. 17) or a sodium bicarbonate solution (1/2 teaspoon per 1 glass of water) 5-10 minutes before taking the drug.
Adverse Reactions
Not described.
Contraindications
Concomitant antibiotic therapy.
Pediatric Use
Use is possible according to the dosing regimen.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Lyophilizate for preparation of oral suspension 5 doses: pkg. 10, 20, 30, 40 or 50 pcs.
Marketing Authorization Holder
Biomed named after I.I.Mechnikov, PJSC (Russia)
Dosage Form
 |
Bificol | Lyophilizate for preparation of oral suspension 5 doses: pkg. 10, 20, 30, 40 or 50 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of suspension for oral administration | 1 dose |
| Bifidobacterium bifidum | Not less than 10 million CFU |
| Escherichia coli | Not less than 10 million CFU |
5 doses – multilayer sachets (10) – cardboard packs.
5 doses – multilayer sachets (20) – cardboard packs.
5 doses – multilayer sachets (30) – cardboard packs.
5 doses – multilayer sachets (40) – cardboard packs.
5 doses – multilayer sachets (50) – cardboard packs.
Lyophilizate for preparation of oral suspension 5 doses: fl. 10 pcs.
Marketing Authorization Holder
Biomed named after I.I.Mechnikov, PJSC (Russia)
Dosage Form
|
Bificol | Lyophilizate for preparation of oral suspension 5 doses: fl. 10 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of suspension for oral administration | 1 dose |
| Bifidobacterium bifidum | Not less than 10 million CFU |
| Escherichia coli | Not less than 10 million CFU |
5 doses – vials (10) – cardboard packs.
Lyophilizate for the preparation of suspension for oral administration: fl. 5 doses 10 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Bificol | Lyophilizate for the preparation of suspension for oral administration: fl. 5 doses 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for preparation of suspension for oral administration in the form of a crystalline or porous mass of beige or whitish-gray color of varying intensity, with a specific odor.
| 1 dose | |
| Live bifidobacteria strain B. bifidum 1 | Not less than 107 |
| Live bacteria of Escherichia coli strain E. coli M-17 | Not less than 107 |
The drug is a microbial mass of live antagonistically active strains of bifidobacteria (Bifidobacterium bifidum 1) and Escherichia coli (Escherichia coli M-17), lyophilized in the cultivation medium with the addition of a protective sucrose-gelatin-milk drying medium.
Excipients: components of the protective drying medium (gelatin, sucrose (sugar), milk).
5 doses – vials (10) – cardboard packs.
Lyophilisate for preparation of solution for oral administration: vial 2, 3, 5 or 10 doses 10 pcs.
Marketing Authorization Holder
Biocom, JSC (Russia)
Dosage Form
|
Bificol siccum | Lyophilisate for preparation of solution for oral administration: vial 2, 3, 5 or 10 doses 10 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilisate for preparation of solution for oral administration | 1 dose |
| Bifidobacterium bifidum | Not less than 10 million CFU |
| Escherichia coli | Not less than 10 million CFU |
2 doses – ampoules (10) – cardboard packs.
3 doses – ampoules (10) – cardboard packs.
5 doses – ampoules (10) – cardboard packs.
10 doses – vials (10) – cardboard packs.
![Bificol [Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Bificol [Lyophilisate] 2")