Klebsiphage^® (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Klebsiphage®

Solution for oral, topical and external use: 20 ml bottles 4 pcs.

Dosage Form, Packaging, and Composition

Solution for oral, topical and external use is clear, yellow of varying intensity, a greenish tint is allowed.

* (with activity according to Appelman – not less than 10^-4).

Excipients : 8-hydroxyquinoline sulfate / 8-hydroxyquinoline sulfate monohydrate calculated as 8-hydroxyquinoline sulfate – 0.0001 g (content is calculated).

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

Clinical-Pharmacological Group

Immunobiological drug – bacteriophage

Pharmacotherapeutic Group

Other therapeutic products

Pharmacological Action

Causes specific lysis of bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis.

Indications

Treatment and prevention of diseases caused by bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis as part of complex therapy in adults and children: ozena, rhinoscleroma; gastrointestinal diseases (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbiosis); inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbiosis, omphalitis, pemphigus, pyoderma, sepsis and septicopyemia of various localization); surgical infections (wound suppuration, purulent skin lesions, burns, peritonitis, pleurisy, mastitis, osteomyelitis, abscess); urogenital infections (cystitis, pyelonephritis, urethritis, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis); purulent-inflammatory diseases of the ear, throat, nose, sinuses, oral cavity, pharynx, larynx, bronchi, lungs and pleura (otitis, tonsillitis, pharyngitis, laryngitis, stomatitis, periodontitis, sinusitis, frontal sinusitis, bronchitis, pneumonia, pleurisy); post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcer and iridocyclitis; prevention of nosocomial infections caused by Klebsiella.

ICD codes

Dosage Regimen

Determine bacterial susceptibility to the bacteriophage prior to initiating therapy.

For oral administration, take on an empty stomach, 1 hour before a meal.

For rectal administration as an enema, administer after defecation.

When treating purulent lesions, perform mechanical removal of necrotic tissue and pus prior to application.

If the cavity was treated with antiseptic solutions, rinse it thoroughly with sterile 0.9% sodium chloride solution before administering the bacteriophage.

Dosage is determined by the nature of the infection, the patient’s age, and the route of administration.

For oral use in adults and children over 8 years, administer 20-30 ml. For children aged 3 to 8 years, administer 15-20 ml. For children aged 1 to 3 years, administer 10-15 ml. For infants aged 6 to 12 months, administer 10 ml. For neonates and infants up to 6 months, administer 5 ml.

For rectal use as an enema in adults and children over 8 years, administer 40-60 ml. For children aged 3 to 8 years, administer 30-40 ml. For children aged 1 to 3 years, administer 20-30 ml. For infants aged 6 to 12 months, administer 10-20 ml. For neonates and infants up to 6 months, administer 10 ml.

Apply the solution topically for irrigation, rinsing, wetting tampons, and lotions, using an adequate volume based on the affected area size.

Introduce into cavities (e.g., pleural, articular, abdominal, bladder) up to 100 ml, leaving capillary drainage for subsequent administration.

For ENT applications, instill 2-10 ml into the nose, sinus, or ear, or use for gargling.

In gynecological practice, administer intravaginally or intrauterinely in doses of 5-20 ml.

The typical treatment course is 7 to 20 days, depending on the clinical response. For recurrent infections, repeat courses as necessary.

Adverse Reactions

From the immune system very rarely – allergic reactions.

Contraindications

Hypersensitivity to this agent.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible in the presence of infections caused by phage-sensitive strains of Klebsiella.

Pediatric Use

Used in children according to indications.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

An important condition for effective phage therapy is the preliminary determination of the pathogen’s sensitivity to the bacteriophage.

Drug Interactions

It is possible in combination with other drugs, 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.