BIOPHAG

INSTRUCTIONS FOR MEDICAL USE

LIQUID STAPHYLOCOCCAL BACTERIOPHAGE – BIOPHAG

BAKTERIOPHAGUM STAPHYLOCOCCUS FLUIDUM–BIOFAG

 

Trade name of the drug: Staphylococcal bacteriophage liquid – BIOFAG

Active ingredient (INN): staphylococcal bacteriophage (Bakteriophagum staphylococcus)

Dosage form: liquid for oral administration, external use.

Compound:

1 ml of the drug contains

active substance – sterile purified filtrate of phagolysates of Staphylococcusaureus bacteria, not less than 1×106 CFU / ml.

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

Description: clear yellow liquid of varying intensity.

Pharmacotherapeutic group:Bacteriophage

 

Pharmacological properties

Staphylococcal bacteriophage is a drug that has a specific bactericidal effect against strains of staphylococci, the most significant in the etiology of purulent and inflammatory diseases. Bacteriophage specifically lyses Staphylococcus bacteria. Phage particles attach to the membrane of sensitive bacteria, penetrate into the cell and multiply at the expense of its resources. This results in cell death and the release of mature virulent phage particles capable of infecting other sensitive bacterial cells. Staphylococcal bacteriophage does not affect other bacteria, in particular, does not violate the natural microflora.

 

Indications for use

The drug is used for the treatment and prevention of bacterial purulent-inflammatory diseases caused by Staphylococcusaureus in all age groups and high-risk groups.

– surgical infections: purulent wound, burn, abscess, phlegmon, furuncle, carbuncle. Hidradenitis, felon, paraproctitis, mastitis, bursitis and osteomyelitis.

– urogenital infections: urethritis, cystitis, pyelonephritis, colpitis, endometritis and salpingonephritis.

– gastroenterological diseases: enterocolitis, cholecystitis, irritable bowel syndrome (IBS), dysbacteriosis.

– bacterial infections of the upper respiratory tract: inflammation of the sinuses and middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia and pleurisy.

– treatment of fresh wounds

– purulent complications during surgical manipulations and operations

– bacterial complications in acute respiratory viral diseases

– sepsis and enterocolitis in newborns with intrauterine infection

– bacterial contamination and nosocomial infections in medical institutions.

 

Methods of application and doses

An important condition for effective phage therapy is the preliminary determination of phage sensitivity of the pathogen (determination of sensitivity to staphylococcal bacteriophage of strains isolated from the patient). The use of staphylococcal bacteriophage is the most effective at the early stage of the disease, as well as its introduction into the focus of infection.

Taking into account the localization of the focus of infection, the Staphylococcal bacteriophage liquid preparation can be used:

locally – in the form of irrigation, washing, rinsing, instillation, applications, tampons, turundas;

by introducing into the cavities (abdominal, pleural, articular, bladder) through capillary drainage, catheter;

by ingestion (peros);

by introduction into the rectum (perrectum) with an enema.

For the treatment of purulent-inflammatory diseases with local lesions Staphylococcal bacteriophage liquid is prescribed both locally and for oral administration (peros). The duration of the course of treatment with the drug is from 5 to 10 days. The dose of the drug is determined by the nature of the focus of infection and is:

up to 200 ml (taking into account the size of the affected area) – for irrigation, lotions, tampons;

up to 100 ml – for injection into cavities (pleural, articular and other limited cavities) is injected through capillary drainage. Then the cavity is tightly sutured or capillary drainage is left, through which the bacteriophage is re-introduced for several days.

In abscesses, the drug is injected into the cavity of the focus after the removal of pus by puncture. The amount of the injected drug should be slightly less than the volume of the removed pus. Pus can be removed by opening the abscess, followed by the introduction of a tampon richly moistened with bacteriophage into the cavity.

10-20 ml – for infusion into the wound with osteomyelitis (after appropriate surgical treatment).

2-10 ml – for irrigation, rinsing, washing, instillation, wetting turundas with purulent-inflammatory diseases of the ear, throat, nose. The procedure is carried out 1-3 times a day (turunda is left for 1 hour). For children under the age of 11, it is advisable to treat the tonsils with a syringe (or pear) and instill the drug into the nose – to treat the back of the throat; older children can rinse the throat and instill a small amount (2 ml) of the drug into the nose.

With cystitis, pyelonephritis, urethritis, the drug is taken orally. If the cavity of the bladder or renal pelvis is drained, the bacteriophage is injected through a catheter or probe 2 times a day, 20-30 ml into the bladder and 10 ml into the renal pelvis.

With enteral pathologies, IBS (dysbacteriosis) caused by microorganisms Staphylococcus aureus Staphylococcal bacteriophage liquid is used orally and in the form of enemas. The drug is taken on an empty stomach an hour before meals. In the form of enemas, it is prescribed 1 time per day, in the evening, at bedtime, after bowel movements.

 

Recommended dosage of the drug

 

Age Per os Per rectum (by enema)

  1. Up to 6 months 5 ml per dose 1 time per day for 5-7 days 10 ml once a day for 5-7 days
  2. From 6 to 12 months 5 ml per dose 2 times a day for 5-7 days 10 ml once a day for 5-7 days
  3. From 1 year to 3 years 5 ml per dose 3 times a day for 5-7 days 20 ml once a day for 5-7 days
  4. From 3 years to 8 years 10 ml per dose 2-3 times a day for 5-7 days 30 ml once a day for 5-7 days
  5. Above 8 years 20 ml per dose 2-3 times a day for 5-7 days 40-50 ml once a day for 5-7 days

 

Side effects

The drug is non-toxic. No side effects were found.

 

Contraindications

Hypersensitivity to any component of the drug.

 

Drug Interactions

The drug can be used in conjunction with drugs of any group.

 

special instructions

Treatment with bacteriophage should be started as early as possible. Before use, the drug must be shaken. A cloudy preparation should not be used. If chemical antiseptics were used to treat the wound before using the bacteriophage, the wound must be thoroughly washed with a sterile 0.9% sodium chloride solution. Since the preparation contains a nutrient medium in which bacteria from the environment can develop, the following rules must be observed when opening the vial, selecting and storing:

– hands should be thoroughly washed;

– before removing the cap from the bottle, it should be treated with an alcohol solution;

– the cap should be removed without removing the cork;

– the drug from the opened vial should be taken with a sterile syringe (by puncturing the stopper);

– if, when opening the vial, the cork was removed together with the cap, the vial should not be left open;

– The opened vial must be stored in the refrigerator. It is allowed to use the contents of the vial within 24 hours after opening, when stored under appropriate conditions.

Pregnancy and lactation.

Bacteriophage can be used during pregnancy and lactation.

The drug should be kept out of the reach of children and not used after the expiration date.

 

Overdose

Data on overdose are not described.

 

Release form

5 bottles of 10 ml, or 4 bottles of 20 ml, or 1 bottle of 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!

 

Best before date

1 year.

 

Terms of dispensing from pharmacies

Without recipe

Manufacturer

OOO “NIHOL BIOMED”

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

Tel.: +99899 0880000