Bacteriophage dysentericum polyvalentus (Tablets, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

V03A (Other therapeutic agents)

Clinical-Pharmacological Group

Antibacterial drug

Pharmacotherapeutic Group

Absent

Pharmacological Action

The drug causes specific lysis of bacteria that are the causative agents of bacterial dysentery.

Indications

Treatment and prevention of bacterial dysentery caused by Shigella flexneri serovars 1, 2, 3, 4, 6 and Shigella sonnei.

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

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A03	Shigellosis

ICD-11 code	Indication
1A02	Intestinal infections due to Shigella

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.

Tablets

Treatment and prevention of bacterial dysentery in adults and children from one year of age.

An important condition for effective phage therapy is the preliminary determination of the phage sensitivity of the pathogen and the early use of the drug.

The drug is intended for oral administration.

For treatment, the drug is taken 3 times a day 1 hour before meals from the first day of illness for 7-10 days.

Recommended dosages of the drug

Age	Dose per dose
From 1 year to 3 years	1 tablet
From 3 years to 8 years	1-2 tablets
From 8 years and older	2-3 tablets

For dysentery characterized by a mild colitic syndrome and during the convalescence period, a combination of a double oral administration of tablets with a single rectal administration of a single age dose of liquid bacteriophage (Dysentery bacteriophage polyvalent, solution for oral administration and rectal administration) is recommended in accordance with its instructions for use in the form of an enema after bowel movement.

For prophylactic purposes, the drug is recommended for use during group diseases in organized groups and families.

The optimal regimens for use are daily intake of a single age dose.

The duration of drug administration is determined by the conditions of the epidemic situation.

Solution

The drug is intended for oral administration and rectal administration.

For treatment, the drug is taken orally 3 times a day on an empty stomach 1 hour before meals from the first day of illness for 7-10 days.

Recommended dosages of the drug

Age	Dose per dose (ml)
Age	orally	rectally
0-6 months	5	10
6-12 months	10-15	20
From 1 year to 3 years	15-20	20-30
From 3 to 8 years	20-30	30-40
From 8 years and older	30-40	50-60

For dysentery characterized by a mild colitic syndrome and during the convalescence period, a combination of a double oral administration with a single rectal administration of a single age dose of the drug in the form of an enema after bowel movement is recommended.

For prophylactic purposes, the drug is recommended for use during group diseases in organized groups and families.

The optimal regimen for use is daily intake of a single age dose.

The duration of drug administration is determined by the conditions of the epidemic situation.

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.

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 up 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.

Effect on ability to drive vehicles, machinery

Absent.

Overdose

Not established.

Drug Interactions

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

Storage Conditions

The drug should be stored in accordance with SP 3.3.2.1248-03 in a place inaccessible to children at a temperature of 2 to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

Transportation conditions

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 9 to 25°C (77°F) for no more than 1 month is allowed.

Dispensing Status

The drug is 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.

Medical Disclaimer

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

Bacteriophage dysentericum polyvalentus [Microgen NPO, JSC (Russia)]
Tablets 72 mg: 50 pcs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Manufactured By

ImBio Nizhny Novgorod State Enterprise for the Production of Bacterial Preparations (Russia)

Dosage Form

Dysentery bacteriophage polyvalent

Tablets 72 mg: 50 pcs.

Dosage Form, Packaging, and Composition

*Tablets*	1 tab.
Dysentery bacteriophage	72 mg

* concentrated lyophilized phagolysate filtrate of bacterial dysentery.

10 pcs. – blister packs (5) – cardboard packs.
50 pcs. – vials (10) – cardboard packs.

Bacteriophage dysentericum polyvalentus [Microgen NPO, JSC (Russia)]
Oral and rectal solution: fl. 20 ml 4 or 10 pcs.
Oral and rectal solution: fl. 100 ml

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Forms

	Dysentery bacteriophage polyvalent	Oral and rectal solution: fl. 20 ml 4 or 10 pcs.
		Oral and rectal solution: fl. 100 ml

Dosage Form, Packaging, and Composition

Solution for oral administration or rectal administration in the form of a transparent liquid of yellow color of varying intensity, a greenish tint is possible.

	1 fl
Dysentery bacteriophage*	20 ml

* 1 ml of the drug contains: sterile purified filtrate of phagolysates of bacteria (with activity according to Appelman): S. flexneri 1, 2, 3, 4 serotypes not less than 10^-8, S. flexneri 6 serotype not less than 10^-6; S. sonnei not less than 10^-7; excipients : preservative – 8-hydroxyquinoline sulfate – 0.0001 g/ml (calculated content); or 8-hydroxyquinoline sulfate monohydrate in terms of 8-hydroxyquinoline sulfate – 0.0001 g/ml (calculated content).

20 ml – glass vials (4) – cardboard packs.
20 ml – glass vials (10) – cardboard packs.

Solution for oral administration or rectal administration in the form of a transparent liquid of yellow color of varying intensity, a greenish tint is possible.

	1 fl
Dysentery bacteriophage*	100 ml

100 ml – glass vials (1) – cardboard packs.

Medixlife (Author)

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