Bacteriophagum coli (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Coli bacteriophage

Solution for oral, topical and external use: bottle 20 ml or 100 ml

Dosage Form, Packaging, and Composition

Solution for oral, topical and external use yellow in color, transparent.

* sterile filtrate of phage lysates of pathogenic strains of Escherichia coli.

Excipients : 8-hydroxyquinoline sulfate monohydrate (preservative) – 0.0001 g/ml.

20 ml – bottles (4) – cardboard packs.
20 ml – bottles (10) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Immunobiological drug – bacteriophage

Pharmacotherapeutic Group

Other therapeutic products

Pharmacological Action

The drug has the ability to specifically lyse bacteria of enteropathogenic Escherichia coli.

Indications

Treatment and prevention of diseases caused by Escherichia coli bacteria, as part of complex therapy

• Diseases of the ear, throat, nose, respiratory tract and lungs (inflammation of the sinuses, middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleurisy);
• Surgical infections (wound suppuration, burns, abscess, phlegmon, furuncles, carbuncles, hidradenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis);
• Urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis);
• Enteral infections (gastroenterocolitis, cholecystitis), intestinal dysbiosis;
• Generalized septic diseases;
• Purulent-inflammatory diseases of newborns (omphalitis, pyoderma, conjunctivitis, gastroenterocolitis, sepsis, etc.);
• Other diseases caused by Escherichia coli.

For prophylactic purposes, the drug is used for the treatment of postoperative and freshly infected wounds, as well as for the prevention of nosocomial infections for epidemic indications.

An important condition for effective phage therapy is the preliminary determination of the phage sensitivity of the pathogen.

ICD codes

Dosage Regimen

The drug is used for oral administration (by mouth), rectal administration, applications, irrigations, introduction into wound cavities, vagina, uterus, nose, sinuses and drained cavities.

Recommended dosages of the drug

Treatment of purulent-inflammatory diseases with localized lesions should be carried out simultaneously both locally and by taking the drug orally for 7-20 days (according to clinical indications).

In case chemical antiseptics were used to treat the wound before applying the bacteriophage, the wound must be thoroughly washed with a sterile 0.9% sodium chloride solution.

Depending on the focus of infection, the bacteriophage is used:

1. In the form of irrigation, lotions and tamponage in a volume of up to 200 ml depending on the size of the affected area. In case of an abscess, after removal of purulent contents by puncture, the drug is administered in an amount less than the volume of removed pus. In case of osteomyelitis, after appropriate surgical treatment, 10-20 ml of bacteriophage is poured into the wound.

2. When introduced into cavities (pleural, articular and other limited cavities) up to 100 ml, a capillary drainage is left, through which the bacteriophage is administered for several days.

3. For cystitis, pyelonephritis, urethritis, the drug is taken orally. In case the cavity of the bladder or renal pelvis is drained, the bacteriophage is administered through a cystostomy or nephrostomy 1-2 times a day, 20-50 ml into the bladder and 5-7 ml into the renal pelvis.

4. For purulent-inflammatory gynecological diseases, the drug is administered into the cavity of the vagina, uterus in a dose of 5-10 ml once daily, for colpitis – 10 ml by irrigation or tamponage 2 times a day.
Tampons are placed for 2 hours.

5. For purulent-inflammatory diseases of the ear, throat, nose, the drug is administered in a dose of 2-10 ml 1-3 times a day. The bacteriophage is used for rinsing, washing, instillation, introduction of moistened turundas (leaving them for 1 hour).

6. For enteral infections, intestinal dysbiosis, the drug is taken orally 3 times a day 1 hour before meals for 7-20 days according to clinical indications. A combination of double oral administration with a single rectal administration of a single age dose of bacteriophage in the form of an enema after bowel movement is possible.

Use of bacteriophage in children (up to 6 months). For sepsis, enterocolitis of newborns, including premature infants, the bacteriophage is used in the form of high enemas (through a gas outlet tube or catheter) 2-3 times a day in a dose of 5-10 ml. In the absence of vomiting and regurgitation, the drug can be used by mouth. In this case, it is mixed with breast milk. A combination of rectal (in the form of high enemas) and oral (by mouth) administration of the drug is possible. The course of treatment is 5-15 days. In case of recurrent disease, repeated courses of treatment are possible. For the prevention of sepsis and enterocolitis in case of intrauterine infection or risk of nosocomial infection in newborn children, the bacteriophage is used in the form of enemas 2 times a day for 5-7 days.

In the treatment of omphalitis, pyoderma, infected wounds, the drug is used in the form of applications twice daily (a gauze napkin is moistened with bacteriophage and applied to the umbilical wound or affected area of the skin).

Precautions for use. Before use, the bottle with bacteriophage must be shaken and inspected. The preparation must be transparent and not contain sediment.

Attention! Do not use the preparation if it is cloudy!

Due to the content of a nutrient medium in the preparation, in which bacteria from the environment can develop, causing cloudiness of the preparation, it is necessary to observe the following rules when opening the bottle

• Thoroughly wash hands;
• Treat the cap with an alcohol-containing solution;
• Remove the cap without opening the stopper;
• Do not place the stopper with the inner surface on the table or other objects;
• Do not leave the bottle open;
• Store the opened bottle only in the refrigerator.

Opening the bottle and extracting the required volume of the preparation can be done with a sterile syringe by puncturing the stopper.

The preparation from an opened bottle, if storage conditions, the above rules are observed and there is no cloudiness, can be used throughout the shelf life.

Adverse Reactions

Not established.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of this medical drug during pregnancy and breastfeeding is possible in the presence of infections caused by phage-sensitive strains of bacteria (as recommended by a doctor).

Pediatric Use

Used according to indications in accordance with the dosage regimen

Special Precautions

Effect on ability to drive vehicles and mechanisms

None.

Overdose

Not established.

Drug Interactions

The use of bacteriophage does not exclude the use of other antibacterial drugs.

Storage Conditions

The drug is stored in accordance with SP 3.3.2.1248-03 in a dry place, protected from light and out of reach of children, at a temperature of 2 to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

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.