Intesti^®-bacteriophage (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Intesti®-bacteriophage

Oral and rectal solution: bottle 20 ml 4 or 10 pcs. or bottle 100 ml 1 pc.

Dosage Form, Packaging, and Composition

Excipients: Chinosol 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

Absent

Pharmacological Action

The drug causes specific lysis of bacteria Shigella flexneri serovars 1, 2, 3, 4, 6, Shigella sonnei, Salmonella paratyphi A, Salmonella paratyphi B, Salmonella typhimurium, Salmonella infantis, Salmonella choleraesuis, Salmonella oranienburg, Salmonella enteritidis, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Enterococcus, Staphylococcus, Pseudomonas aeruginosa.

Indications

Treatment and prevention of gastrointestinal diseases caused by bacteria of dysentery, Salmonella spp., Escherichia coli, Proteus spp., Enterococcus spp., Staphylococcus spp., Pseudomonas aeruginosa or their combination

• Bacterial dysentery;
• Salmonellosis;
• Dyspepsia;
• Dysbacteriosis;
• Enterocolitis, colitis.

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 intended for oral and rectal administration. For treatment, the drug is taken orally 4 times a day 0.5-1 hour before meals from the first day of illness for 7-10 days.

For infants in the first months of life, during the first two days of administration, the drug is diluted twice with boiled water; in the absence of adverse reactions (regurgitation, skin rashes), the bacteriophage can subsequently be used undiluted.

The drug is administered orally 3 times a day 30 minutes before feeding. In cases of uncontrollable vomiting, the drug is administered in the form of high enemas (via a gas outlet tube or catheter) daily.

A combination of rectal (in the form of high enemas) and oral administration of the drug is possible. The course of treatment is 7-10 days.

Recommended dosages of the drug

In the absence of colitic syndrome, it is recommended to replace one oral administration with a single rectal administration of a single age dose of the drug in the form of an enema after bowel movement.

For prophylactic purposes, the optimal regimen is daily administration of a single age dose. The duration of the drug administration is determined by the conditions of the epidemic situation.

Adverse Reactions

In infants during the first 2 days of drug administration, regurgitation and skin rashes are possible.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of this medicinal product 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

It is prescribed to infants in the first months of life.

Special Precautions

Do not use the drug if it is cloudy!

Due to the content of a nutrient medium in the drug, in which bacteria from the environment can develop, causing cloudiness of the drug, the following rules must be observed when opening the vial

• Wash hands thoroughly;
• 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 vial open;
• Store the opened vial only in the refrigerator.

When using small doses (2-8 drops), the drug must be drawn with a sterile syringe in a volume of 0.5-1 ml.

The drug from an opened vial, subject to storage conditions, the above rules and the absence of cloudiness, can be used throughout the entire shelf life.

Information on the possible effect of the medicinal product on the ability to drive vehicles and mechanisms.

Absent.

Overdose

Symptoms of overdose have not been established.

Drug Interactions

The use of the drug is possible in combination with other medicinal products, including antibiotics.

Storage Conditions

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Transportation at a temperature of 8 to 25°C (77°F) for no more than 1 month is allowed.

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

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

Dispensing Status

Available without a prescription.

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.