PUROFAG

INSTRUCTIONS FOR USE OF THE PREPARATION “PUROPHAG” PYOBACTERIOPHAGE COMPLEX LIQUID.

Trade name of the drug: “PUROFAG” Purified polyvalent pyobacteriophage.

Active ingredient (INN): Sterile purified filtrates of Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli bacteria phagolysates.

Dosage form: liquid for oral administration, local and external use.

Clinico-pharmacological group: Immunobiological preparation – bacteriophage

Composition: 1 ml of the drug contains

active substance – sterile purified filtrate of Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli phagolysates, not less than 1×104 CFU / ml.

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

Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli

Indications for use

Treatment and prevention of various forms of pyoinflammatory and enteric diseases caused by bacteria Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli:

  • diseases of the gastrointestinal tract (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbacteriosis);
  • inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbacteriosis, omphalitis, pemphigus, pyoderma, septicemia and septicopyemia of various localization);
  • surgical infections (suppuration of wounds, purulent skin lesions, burns, peritonitis, pleurisy, mastitis, osteomyelitis);
  • urogenital infections (cystitis, pyelonephritis, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis);
  • purulent-inflammatory diseases of the ear, throat, nose, sinuses, oral cavity, pharynx, larynx, lungs and pleura (otitis media, tonsillitis, pharyngitis, stomatitis, periodontitis, sinusitis, sinusitis, pneumonia, pleurisy);
  • post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcer and iridocyclitis;
  • prevention of nosocomial infections caused by bacteria Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli.

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

Use during pregnancy and during breastfeeding. Application

this drug during pregnancy and lactation is possible in the presence of infections caused by phage-sensitive strains of Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli.

(on

doctor’s advice).

 

 

 

Methods of application and doses

Before use, the bacteriophage vial must be shaken and viewed. The drug should be clear and free of sediment.

Attention! 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 bottle, subject to the storage conditions, the above rules and the absence of turbidity, can be used during the entire shelf life.

The drug is used for oral administration (through the mouth), in the form of enemas, applications, irrigation, injection into the cavity of wounds, vagina, uterus, nose, sinuses, as well as into drained cavities: abscesses, abdominal, pleural, bladder, renal pelvis.

Inside the drug is taken on an empty stomach 0.5-1 hour before a meal.

Recommended dosage of the drug

Age of the patient Dose per 1 dose for various routes of drug administration

by mouth (ml) by enema (ml)

0-6 months 5 10

6-12 months 10 20

From 1 year to 3 years 15 20-30

From 3 to 8 years 20 30-40

From 8 years and older 20-30 40-50

Treatment of purulent-inflammatory diseases with localized lesions should be carried out simultaneously both locally and by taking the drug orally.

If the cavity of the purulent focus is treated with chemical antiseptics, it must be washed with a sterile 0.9% sodium chloride solution before using the bacteriophage.

In the treatment of tonsillitis, pharyngitis, laryngitis, the drug is used for rinsing the mouth and throat 3 times a day, 10-20 ml, the course of treatment is 7-10 days.

In the treatment of bronchitis, pneumonia, the drug is taken orally 3 times a day, 10-20 ml, and also used in the form of aerosols and inhalations (without heating and using ultrasound), the course of treatment is 15-20 days.

In the treatment of otitis media, the drug is used for washing and introducing into the  middle ear cavity 2-5 ml 1-3 times a day. The course of treatment is 7-15 days.

In the treatment of inflammation of the sinuses, the drug is used to wash the nasal cavity, nasopharynx and sinuses at a dose of 5-10 ml and inject 2-3 ml into the sinuses. The procedure is repeated once daily for 7-10 days. In addition, the drug is injected into the nasal cavity in the form of turundas moistened with bacteriophage, in turn into each nasal passage and left for 0.5-1 hour. The procedure is repeated 3 times a day, the course of treatment is 7-15 days.

In the treatment of stomatitis and chronic periodontitis, the drug is used in the form of mouth rinses 3-4 times a day at a dose of 10-20 ml, as well as the introduction of bacteriophage-impregnated turundas into periodontal pockets for 5-10 minutes, the course of treatment is 7-10 days.

With conjunctivitis and keratoconjunctivitis, the drug is used 2-3 drops 4-5 times a day, the course of treatment is 5-7 days; with a purulent corneal ulcer – 4-5 drops per day for 7-10 days, with purulent iridocyclitis – 6-8 drops every 3 hours in combination with ingestion in therapeutic dosages for 7-10 days.

In case of an abscess after opening and removing the purulent contents, the drug is administered in an amount less than the volume of the removed pus once a day, the course of treatment is 7-10 days.

In case of peritonitis and pleurisy, the drug is injected into the drained cavities – abdominal and pleural through the drainage tubes once daily 20-70 ml, the course of treatment is 10-15 days.

In osteomyelitis, the drug is injected into the wound cavity through turundas, drainages in the amount of 10-30 ml once daily, the course of treatment is 15-20 days.

In the treatment of mastitis, suppuration of wounds and burns, the drug is used in the form of irrigation, applications, dressings, injection into the drainage at a dose of 5-50 ml, depending on the lesion at least 1 time per day, the course of treatment is 10-15 days.

In the treatment of purulent-inflammatory gynecological diseases (suppuration of wounds, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis), the drug is used for irrigation, applications, injected into the cavity of wounds, vagina, uterus, 5-20 ml once a day for 7-10 days.

For cystitis, pyelonephritis, urethritis, the drug is taken orally at a therapeutic dose 3 times a day 1 hour before meals for 10-20 days. In the event that the cavity of the bladder or renal pelvis is drained, the drug is administered through a cystostomy or nephrostomy 1-3 times a day, 20-50 ml into the bladder and 5-7 ml into the renal pelvis, the course of treatment is 7-15 days.

With gastroenterocolitis, pancreatitis, cholecystitis, as well as intestinal dysbacteriosis, the bacteriophage is taken orally in age dosages 3 times a day 1 hour before meals for 7-15 days (according to clinical indications). With indomitable vomiting, the drug is used in the form of high enemas 2-3 times a day, 20-40 ml each. With intestinal dysbacteriosis, the drug can be used with normoflora preparations.

For the prevention of nosocomial surgical infections, the drug is used to treat postoperative and freshly infected wounds at a dose of 5-50 ml, depending on the lesion, once daily for 5-7 days.

The use of the drug in children under 1 year (including premature babies)

With gastroenterocolitis, pneumonia and sepsis of newborns, the drug is used by mouth 2-3 times a day, 3-5 ml 30 minutes before feeding. In cases of indomitable vomiting, the drug is used in the form of high enemas (through a gas outlet tube or catheter) once a day at a dose of 5-10 ml. Perhaps a combination of rectal (in the form of high enemas) and oral administration of the drug. The course of treatment is 7-15 days (according to clinical indications). With a recurrent course of the disease, repeated courses of treatment are possible.

In the treatment of omphalitis, pyoderma, infected wounds, the bacteriophage is used in the form of applications of 5-10 ml 2-3 times a day (a gauze cloth is moistened with a bacteriophage and applied to the umbilical wound or the affected area of the skin) for 7-15 days.

In order to prevent the occurrence of nosocomial infection in newborns, the bacteriophage is used according to epidemic indications orally, 3-5 ml 3 times a day 30 minutes before feeding during the entire stay in the hospital.

Side effects Not established.

Contraindications for use None.

 

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

Special instructions Start treatment with bacteriophage should be 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 piercing the cork);

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

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, 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