Colibacterin (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 exhibits antagonism against a broad spectrum of pathogenic and opportunistic microorganisms, including Shigella, Salmonella, Proteus, Staphylococcus, Klebsiella, and other species, and thereby normalizes the intestinal microflora.
The mechanism of action consists of suppressing the vital activity of pathogenic microorganisms, competitively displacing opportunistic and other non-physiological bacteria; normalizing immunological processes by enhancing the synthesis of immunoglobulins, lysozyme, interferon, activating macrophages, etc.; producing a complex of enzymes (protease, amylase, lipase, cellulase, etc.) that improve digestion; synthesizing B vitamins (B1, B6, B12, etc.) and amino acids; binding, neutralizing, and eliminating from the body toxic products of the vital activity of putrefactive and other bacteria, products of incomplete metabolism, which provides an anti-allergic effect; improving the absorption of macro- and microelements, including iron, calcium, and phosphorus.
Indications
Dysbacteriosis of various etiologies (including during radiation cytotoxic therapy; after taking antimicrobial drugs or corticosteroids; during stress and exposure to extreme conditions); acute infectious diarrhea; diarrhea against the background of chronic diseases of the gastrointestinal tract.
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 |
| K52 | Other noninfectious gastroenteritis and colitis |
| K59.1 | Functional diarrhea |
| K63.8 | Other specified diseases of intestine |
| K73 | Chronic hepatitis, not elsewhere classified |
| R10.4 | Other and unspecified abdominal pain (colic) |
| R14 | Flatulence and related conditions (including abdominal bloating, belching) |
| Y40 | Systemically acting antibiotics |
| Y42.0 | Glucocorticoids and their synthetic analogues |
| Y43.1 | Antineoplastic antimetabolites |
| Y43.2 | Antineoplastic natural products |
| Y43.3 | Other antineoplastic drugs |
| Y84.2 | Radiological procedure and radiotherapy |
| 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 |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| DD91.2 | Functional diarrhea |
| DD93.1 | Infantile colic |
| DD93.Y | Other specified functional gastrointestinal disorders in infants, toddlers and school-age children |
| DD9Z | Functional gastrointestinal disorders, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| MD81.4 | Other and unspecified abdominal pain |
| ME08 | Flatulence and related conditions |
| PK81.C | Radiotherapy causing injury or harm in the course of therapeutic use |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
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, mixed with water (50-100 ml), natural juices, vegetable and fruit decoctions, compote, and other liquid products, 30 minutes before or 1.5 hours after meals.
For adults with acute diarrhea – 10-15 doses (2-3 dessert spoons) every 3 hours for 1-2 days, then 5-10 doses (1-2 dessert spoons) 3 times/day for 3-5 days.
For chronic diarrhea, dysbacteriosis, post-radiation colitis, chronic enterocolitis, gastrointestinal dysfunction (excessive gas formation, intestinal pain), chronic hepatitis – 5 doses (1 dessert spoon) 3 times a day for 1-3 months; for metabolic disorders, reduced immunity, after antibiotic therapy – 5 doses (1 dessert spoon) 2-3 times a day for 1-3 months.
For prevention in infection foci, as well as in the initial stages of diseases, during stress, exposure to extreme conditions – 5 doses (1 dessert spoon) 3 times/day throughout the incubation period and for another 2-3 days. In individual cases, an increase in dosage is possible.
For children under 1 year – 1-1.5 doses (from a few drops to 1/2 teaspoon) 2-3 times/day until recovery; 1-3 years – 1/4 of the adult dose; 6-10 years – 1/2 of the adult dose; from 11 years – adult dose.
If the patient has a pronounced allergic reaction, administration begins with a small amount – 1-1.5 doses (1 teaspoon) 1 time/day, and in the absence of allergic reactions, the dose is gradually increased. In rare cases, the use of the drug in the first days may increase gas formation and the associated intestinal pain. In this case, it is recommended to administer the drug via microenema, and after 1-2 weeks, switch to oral administration, starting with 1-1.5 doses (1 teaspoon) 1 time/day with its further gradual increase.
Adverse Reactions
In the first days of administration in diseases of the small intestine – flatulence and intestinal pain.
Contraindications
Hypersensitivity.
Pediatric Use
Use is possible according to the dosing regimen.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Lyophilisate for the preparation of suspension for oral administration 10×109 CFU/1 dose: vial 3 doses 10 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
| Colibacterin | Lyophilisate for the preparation of suspension for oral administration 10×109 CFU/1 dose: vial 3 doses 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilisate for the preparation of solution for oral administration in the form of a crystalline or porous mass of yellowish or beige, or whitish-gray color of varying intensity, with a specific odor.
| 1 dose | |
| Live bacteria of Escherichia coli strain E. coli M-17 | Not less than 10×109 CFU |
Excipients: protective drying medium (gelatin, sucrose (sugar)).
3 doses – vials (10) – cardboard packs.
Lyophilisate for preparation of solution for oral administration 10×109 CFU/1 dose: fl. 5 doses 10 pcs.
Marketing Authorization Holder
Biomed named after I.I.Mechnikov, PJSC (Russia)
Dosage Form
| Colibacterin siccum | Lyophilisate for preparation of solution for oral administration 10×109 CFU/1 dose: fl. 5 doses 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilisate for the preparation of solution for oral administration in the form of a crystalline or porous mass of various shades of beige or whitish-gray color, with a specific odor.
| 1 dose | |
| Live Escherichia coli bacteria* | Not less than 10×109 CFU |
* the preparation is a microbial mass of live Escherichia coli bacteria of strain Escherichia coli M-17*, lyophilized in the culture medium with the addition of a protective drying medium – sucrose 9%.
5 doses – vials (10) – cardboard packs.
