Bacteriophagum proteus (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Bacteriophagum proteus

Solution for oral, topical and external use: bottle 20 ml 4 or 10 pcs. or 100 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for oral, topical and external use in the form of a clear liquid of yellow color of varying intensity, a greenish tint is possible.

Excipients : preservative – 8-hydroxyquinoline sulfate / 8-hydroxyquinoline sulfate monohydrate in terms of 8-hydroxyquinoline sulfate – 0.0001 g/ml (calculated content).

20 ml – bottles (4) – cardboard packs.
20 ml – bottles (10) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Immunobiological drug – bacteriophage

Pharmacotherapeutic Group

Other therapeutic products

Pharmacological Action

It has the ability to specifically lyse Proteus bacteria.

Indications

Treatment and prevention of purulent-inflammatory and enteral diseases caused by bacteria P. vulgaris, P. mirabilis as part of complex therapy: 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, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); enteral infections (gastroenterocolitis, cholecystitis), intestinal dysbiosis; generalized septic diseases; purulent-inflammatory diseases of newborns (including omphalitis, pyoderma, conjunctivitis, gastroenterocolitis, sepsis); other diseases caused by Proteus bacteria.

For prophylactic purposes, it is used for the treatment of postoperative and freshly infected wounds, as well as for the prevention of nosocomial infections for epidemic indications.

ICD codes

Dosage Regimen

Determine the dosage regimen individually based on the patient’s age and the specific clinical indication.

Administer the solution orally on an empty stomach, 1 hour before a meal.

For rectal administration, use the drug in the form of enemas after bowel evacuation.

Apply topically for irrigation, lotions, and tamponage of affected areas and wound cavities.

Introduce into body cavities such as the pleural, articular, and other drained spaces.

Use for instillation into the nose, sinuses, vagina, and uterus.

For oral administration in adults and children over 8 years old, use a single dose of 20-30 ml.

For children aged 3 to 8 years, administer 15-20 ml per dose.

For children from 1 to 3 years old, use 10-15 ml per dose.

For infants 6 to 12 months old, administer 10 ml per dose.

For infants under 6 months old, use 5 ml per dose.

Administer the drug orally twice daily for the treatment of enteral infections and intestinal dysbiosis.

For other indications, administer orally three times daily.

For high rectal administration in adults and children over 8 years old, use a single dose of 40-60 ml.

For children aged 3 to 8 years, administer 30-40 ml per rectal dose.

For children from 1 to 3 years old, use 20-30 ml per rectal dose.

For infants 6 to 12 months old, administer 10-20 ml per rectal dose.

For infants under 6 months old, use 10 ml per rectal dose.

Administer rectally once daily. The standard treatment course is 7 to 10 days based on clinical response.

For purulent-inflammatory diseases with localized lesions, apply the solution topically in addition to oral or rectal administration.

Irrigate, rinse, or apply moistened gauze pads to affected areas 2-3 times daily.

Introduce into drained cavities 10 to 200 ml once daily.

For purulent otitis, instill 2-5 drops into the ear or insert turundas soaked in the solution 1-3 times daily.

For tonsillitis, pharyngitis, or laryngitis, gargle with 10-20 ml of solution 2-3 times daily.

For conjunctivitis, instill 4-5 drops into each eye 2-3 times daily.

For styes, apply a moistened gauze pad to the affected eyelid 2-3 times daily.

For sinusitis or rhinitis, instill 5-10 drops into each nasal passage 2-3 times daily.

For cystitis, pyelonephritis, and urethritis, administer the solution into the bladder or renal pelvis via cystostomy or ureteral catheter, 20-50 ml once daily.

For colpitis and endometritis, administer 5-10 ml intravaginally once daily or use for irrigation with 10-20 ml.

For intestinal dysbiosis, administer orally or rectally for 7 to 10 days.

For prophylactic purposes in treated surgical wounds, apply the solution once daily throughout the risk period.

Adverse Reactions

Not established.

Contraindications

Hypersensitivity to the components of the bacteriophage.

Use in Pregnancy and Lactation

The use of the bacteriophage during pregnancy and breastfeeding is possible in the presence of infections caused by phage-sensitive strains of bacteria (as recommended by a doctor).

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Special Precautions

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

Drug Interactions

The use of the bacteriophage does not exclude the use of other antibacterial drugs.

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.