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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 Disclaimer

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

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Biomed named after I.I.Mechnikov, PJSC (Russia)

Dosage Form

Bottle OTC Icon 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.

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