Streptophage^® (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Streptophage®

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

Dosage Form, Packaging, and Composition

Solution for oral, topical and external use as a transparent liquid of yellow color of varying intensity, a greenish tint is possible.

* sterile purified filtrate of phage lysates of bacteria of the genus Streptococcus (with activity according to Appelman – not less than 10^-5)

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

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

Clinical-Pharmacological Group

Immunobiological drug – bacteriophage

Pharmacological Action

It has the ability to specifically lyse Streptococcus bacteria.

Indications

Treatment and prevention of diseases caused by Streptococcus bacteria 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, panaritium, 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 streptococci.

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

Administer orally, rectally, topically, or via irrigation. Introduce into wound cavities, nasal passages, sinuses, uterus, vagina, or other drained body spaces.

Determine the dosage based on the patient’s age and the clinical application method. Confirm pathogen susceptibility to the bacteriophage prior to initiating therapy.

For oral administration, take on an empty stomach, 1-2 hours before a meal. For rectal use, administer as an enema after bowel evacuation.

Treat purulent wounds, burns, and infected skin lesions by irrigation and application of a moist gauze dressing soaked in the solution. Introduce into wound cavities, abscesses, and body spaces after pus removal.

In gynecological practice, administer intravaginally or intrauterinely. For otorhinolaryngological conditions, instill into the nose, sinuses, or use for gargling.

For intestinal forms and dysbiosis, use orally and/or rectally. In neonatal practice, apply orally, rectally, or use for irrigation of mucous membranes and wound surfaces.

Adverse Reactions

Not established.

Contraindications

Hypersensitivity to this agent.

Use in Pregnancy and Lactation

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

Pediatric Use

It is used according to indications in accordance with the dosage regimen.

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.