Pyobacteriophage polyvalent purified (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Active Substance

Pyobacteriophage (Grouping name)

Dosage Forms

	Pyobacteriophage polyvalent purified	Solution for oral administration, topical and external use: 10 ml fl. 4 or 10 pcs.
		Solution for oral administration, topical and external use: 20 ml fl. 4 or 10 pcs.

Dosage Form, Packaging, and Composition

Preservative chinosol 0.0001 g/ml

10 ml – glass bottles (4) – cardboard packs.
10 ml – glass bottles (10) – cardboard packs.
10 ml – glass bottles (4) – contour cell packs (1) – cardboard packs.

20 ml – glass bottles (4) – cardboard packs.
20 ml – glass bottles (10) – cardboard packs.
20 ml – glass bottles (4) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug

Pharmacotherapeutic Group

Other therapeutic products

Pharmacological Action

The drug has the ability to specifically lyse bacteria of Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Escherichia coli.

Indications

Treatment and prevention of various forms of purulent-inflammatory and enteral diseases caused by bacteria of Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Escherichia coli.

• Diseases of the gastrointestinal tract (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbiosis);
• Inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbiosis, omphalitis, pemphigus, pyoderma, septicemia and septicopyemia of various localization);
• Surgical infections (wound suppuration, 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, paranasal sinuses, oral cavity, pharynx, larynx, lungs and pleura (otitis, tonsillitis, pharyngitis, stomatitis, periodontitis, sinusitis, frontal sinusitis, pneumonia, pleurisy);
• Post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcer and iridocyclitis;
• Prevention of nosocomial infections caused by bacteria of Staphylococcus, Streptococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Escherichia coli.

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

ICD codes

Dosage Regimen

Before use, the vial with the bacteriophage must be shaken and inspected. The preparation must be transparent and free from sediment.

Attention! Do not use the preparation if it is cloudy!

Due to the content of a nutrient medium in the preparation, in which bacteria from the environment can develop, causing cloudiness of the preparation, 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 preparation must be drawn with a sterile syringe in a volume of 0.5-1 ml.

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

The preparation is used for oral administration (by mouth), as enemas, applications, irrigations, introduction into wound cavities, vagina, uterus, nose, paranasal sinuses, as well as into drained cavities: abscesses, abdominal, pleural, urinary bladder, renal pelvis.

Orally, the preparation is taken on an empty stomach 0.5-1 hour before meals.

Recommended dosages of the preparation

Treatment of purulent-inflammatory diseases with localized lesions should be carried out simultaneously both locally and by oral administration of the preparation.

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

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

In the treatment of bronchitis, pneumonia, the preparation 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), course of treatment 15-20 days.

In the treatment of otitis, the preparation is used for washing and introduction into the middle ear cavity, 2-5 ml 1-3 times a day. Course of treatment 7-15 days.

In the treatment of sinus inflammation, the preparation is used for washing the nasal cavity, nasopharynx and paranasal sinuses in a dose of 5-10 ml and introduction into the sinuses 2-3 ml. The procedure is repeated once daily for 7-10 days. In addition, the preparation is introduced into the nasal cavity in the form of turundas soaked in bacteriophage, alternately into each nasal passage and left for 0.5-1 hour. The procedure is repeated 3 times a day, course of treatment 7-15 days.

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

In conjunctivitis and keratoconjunctivitis, the preparation is applied 2-3 drops 4-5 times a day, course of treatment 5-7 days; in purulent corneal ulcer – 4-5 drops a day for 7-10 days, in purulent iridocyclitis – 6-8 drops every 3 hours in combination with oral administration in therapeutic dosages for 7-10 days.

In abscess, after opening and removing the purulent contents, the preparation is introduced in an amount less than the volume of removed pus once daily, course of treatment 7-10 days.

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

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

In the treatment of mastitis, wound suppurations and burns, the preparation is used in the form of irrigation, applications, dressings, introduction into drainage in a dose of 5-50 ml depending on the lesion focus at least once a day, course of treatment 10-15 days.

In the treatment of purulent-inflammatory gynecological diseases (wound suppurations, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis) the preparation is used for irrigations, applications, introduced into wound cavities, vagina, uterus, 5-20 ml once a day for 7-10 days.

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

In gastroenterocolitis, pancreatitis, cholecystitis, as well as intestinal dysbiosis, the bacteriophage is taken orally in age-specific dosages 3 times a day 1 hour before meals for 7-15 days (based on clinical indications). In case of uncontrollable vomiting, the preparation is used as high enemas 2-3 times a day, 20-40 ml. In intestinal dysbiosis, the preparation can be used with normoflora preparations.

For the prevention of nosocomial surgical infections, the preparation is used for treating postoperative and freshly infected wounds in a dose of 5-50 ml depending on the lesion focus once daily for 5-7 days.

Use of the preparation in children under 1 year of age (including premature infants)

In gastroenterocolitis, pneumonia and sepsis of newborns, the preparation is applied orally 2-3 times a day, 3-5 ml 30 minutes before feeding. In cases of uncontrollable vomiting, the preparation is used as high enemas (through a gas outlet tube or catheter) once daily in a dose of 5-10 ml. A combination of rectal (as high enemas) and oral administration of the preparation is possible. Course of treatment 7-15 days (based on clinical indications). In case of recurrent disease, repeated courses of treatment are possible.

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

For the prevention of nosocomial infection in newborn children, the bacteriophage is used for epidemiological indications orally, 3-5 ml 3 times a day 30 minutes before feeding for the entire period of stay in the hospital.

Adverse Reactions

Not established.

Contraindications

None.

Pediatric Use

Use is possible according to the dosage regimen.

Drug Interactions

The use of the preparation does not exclude the use of other antibacterial and anti-inflammatory drugs.

Storage Conditions

The preparation should be stored (in a place inaccessible to children) and transported 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.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.