Piofag^® (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03AX (Other therapeutic agents)

Active Substance

Pyobacteriophage (Grouping name)

Dosage Form

Piofag®

Solution for oral, external and topical use

Dosage Form, Packaging, and Composition

Solution for oral, topical and external use

100 ml – bottles – cardboard packs – Over-the-counter
20 ml – bottles (8 pcs.) – cardboard packs – Over-the-counter

Pharmacotherapeutic Group

Other therapeutic products

Pharmacological Action

It has the ability to specifically lyse bacteria of Staphylococcus, Streptococcus, Enterococcus, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Klebsiella oxytoca, Escherichia coli.

Study of pharmacodynamic properties for bacteriophages is not provided.

Pharmacokinetics

Study of pharmacokinetic properties for bacteriophages is not provided.

Indications

Treatment and prevention of purulent-inflammatory and intestinal diseases caused by staphylococci, enterococci, streptococci, Pseudomonas aeruginosa, Klebsiella, pathogenic Escherichia coli of various serogroups, Proteus when used internally, rectally and externally: diseases of the ear, throat, nose, respiratory tract and lungs, inflammation of the sinuses, middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleurisy; surgical infections – wound suppuration, burns, abscess, phlegmon, boils, carbuncles, hidradenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis; urogenital infections – urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis; post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcers and iridocyclitis; enteral infections – gastroenterocolitis, cholecystitis, dysbacteriosis; generalized septic diseases;
Purulent-inflammatory diseases of newborns – including omphalitis, pyoderma, conjunctivitis, gastroenterocolitis, sepsis; other diseases caused by bacteria of staphylococci, streptococci, enterococci, Proteus, Klebsiella pneumoniae and oxytoca, Pseudomonas aeruginosa and Escherichia coli.

For prophylactic purposes – for treatment of surgical and freshly infected wounds, as well as for prevention of nosocomial infections for epidemic indications.

ICD codes

Dosage Regimen

Administer orally, topically, externally, or into body cavities.

Determine the dose based on the patient’s age, specific indication, and method of application.

For oral administration, take on an empty stomach, 1-2 hours before a meal.

For treatment of purulent-inflammatory diseases with localized lesions, use both orally and topically.

Irrigate wounds, ulcers, and burns directly. Introduce into drained cavities: pleural, articular, and other confined spaces.

Apply for peritonitis and pleurisy by introducing into drained cavities after removal of pus.

For osteomyelitis, instill the solution into the wound after surgical treatment.

For urogenital infections, administer via cystostomy or capillary drainage.

For ENT infections, use for rinsing, instilling, or introducing turundas soaked in the solution.

For intestinal infections and dysbiosis, administer orally or rectally as an enema.

For newborns, administer orally, mixed with breast milk, or as high enemas.

For prophylactic purposes, treat postoperative and freshly infected wounds with the solution.

Before use, shake the bottle vigorously. Ensure the solution is clear and the packaging is intact.

Use a sterile syringe to withdraw the solution, piercing the cap without opening the bottle.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to pyobacteriophage.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is considered appropriate.

Use in Hepatic Impairment

Correction of the dosage regimen is not required.

Use in Renal Impairment

Correction of the dosage regimen is not required.

Pediatric Use

Used in children at recommended doses.

Geriatric Use

Correction of the dosage regimen is not required.

Special Precautions

An important condition for effective phage therapy is the preliminary determination of the pathogen’s sensitivity to the bacteriophage and the early use of this agent.

Drug Interactions

It is possible to use in combination with other medicines, including antibiotics.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.