ENTEROPHAG

INSTRUCTIONS FOR USE OF THE DRUG “ENTEROPHAGE” INTESTIBACTERIOPHAGE.

Trade name of the drug: “ENTEROPHAG” Intestibacteriophage

Active ingredient (INN): Sterile purified filtrates of phagolysates Staphylococcus aureus 10-5, Pseudomonas aeruginosa 10-5, Esherichia coli 10-4, Proteus mirabilis 104, Proteus vulgaris 10-4, Shigella flexneri 10-4, Shigella sonnei 10-4 , Salmonella paratyphi B 10-4, Salmonella enteritidis 10-5, Salmonella typhimurium 10-5, Enterobacter spp. 10-4 “- up to 1 ml.

Dosage form: liquid for oral and rectal administration.

Clinico-pharmacological group: Immunobiological preparation – bacteriophage

Compound:

1 ml of the drug contains

active substance – sterile purified filtrate of phagolysates of bacteria Shigella flexneri Shigella sonnei, Salmonella paratyphi, Salmonella typhimurium, Salmonella enteritidis, enteropathogenic Escherichia coli, Staphylococcus,

Pseudomonas aeruginosa, Proteus vulgaris, Proteus mirabilis, Enterobacter.

excipients: preservative chinosol 0.01% of the volume of liquid phage. water for injections.

Description: clear yellow liquid of varying intensity.

Pharmacotherapeutic group: Bacteriophages

Pharmacological properties: The drug causes a specific lysis of bacteria

Shigella flexneri Shigella sonnei, Salmonella paratyphi, Salmonella typhimurium, Salmonella enteritidis, enteropathogenic Escherichia coli, Proteus vulgaris,

Proteus mirabilis, Enterobacter, Staphylococcus, Pseudomonas aeruginosa.

Indications for use

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

  • bacillary dysentery;
  • salmonellosis;
  • dyspepsia;
  • dysbacteriosis;
  • enterocolitis, colitis.

An important condition for effective phage therapy is the preliminary determination of phage sensitivity of the causative agent of gastrointestinal diseases (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbacteriosis);

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 the disease for 7-10 days.

For children of the first months of life: in the first two days of taking the drug, the drug is diluted with boiled water twice, in the absence of adverse reactions (regurgitation, skin rashes), the bacteriophage can be used undiluted in the future. The drug is used by mouth 3 times a day 30 minutes before feeding. In cases of indomitable vomiting, the drug is used in the form of high enemas (through a gas tube or catheter) daily. Perhaps a combination of rectal (in the form of high enemas) and oral administration of the drug. The course of treatment is 7-10 days.

Recommended dosage of the drug

Age Dose per 1 dose (ml)

orally rectally

0-6 months 5 10

6-12 months 10-15 20

from 1 to 3 years 15-20 20-30

from 3 to 8 years 20-30 30-40

8 years and older 30-40 50-60

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

For preventive purposes, the optimal scheme of use is the daily intake of a single dose of age. The duration of taking the drug is determined by the conditions of the epidemiological situation.

Side effect: In children of the first months of life, regurgitation, rashes on the skin are possible in the first 2 days of taking the drug.

Contraindications for use: hypersensitivity to the components of the drug.

Use during pregnancy and lactation: The use of this medicinal product during pregnancy and lactation is possible in the presence of infections caused by phage-sensitive strains of bacteria (on the recommendation of a doctor).

Use in children: Assign to children in the first months of life.

Special instructions: Do not use the drug in case of turbidity!

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

  • wash your hands thoroughly;
  • treat the cap with an alcohol-containing solution;
  • remove the cap without opening the cork;
  • do not put the cork with the inner surface on the table or other objects;
  • do not leave the vial open;
  • the opened vial should be stored only in the refrigerator.

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

– The drug from the opened vial, subject to the storage conditions, the above rules and the absence of turbidity, can be used during the entire shelf life.

Information about the possible effect of the drug on the ability to drive vehicles, mechanisms: None.

Overdose: Symptoms of overdose have not been established.

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

Release form: 5 bottles of 10 ml, or 4 bottles of 20 ml, or 1 bottle n 100 ml in a cardboard box along with instructions for medical use in the state and Russian languages.

Storage conditions: Store in a dry, dark place at a temperature of +2 to +80C. Keep out of the reach of children!

Shelf life: 2 years.

Terms of dispensing from pharmacies: Without a prescription

Manufacturer

OOO “NIHOL BIOMED”

Republic of Uzbekistan, Tashkent, M. Ulugbek district, Durmon Yuli street, house 40

Tel.: +99893 3823493