Sextaphage^® Piobacteriophage polyvalent (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03AX (Other therapeutic agents)

Active Substance

Pyobacteriophage (Grouping name)

Dosage Form

Sextaphage® Pyobacteriophage polyvalent

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

Dosage Form, Packaging, and Composition

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

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

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

Clinical-Pharmacological Group

Herbal immunostimulant drug

Pharmacotherapeutic Group

Other medicinal products

Pharmacological Action

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

The study of pharmacodynamic properties for bacteriophages is not provided.

Pharmacokinetics

The 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 the treatment of surgical and freshly infected wounds, as well as for the prevention of nosocomial infections for epidemic indications.

ICD codes

Dosage Regimen

Administer orally, rectally, topically, externally, or via irrigation/introduction into body cavities including wounds, sinuses, and pleural cavity.

Shake the bottle vigorously before each use. Ensure the solution is clear. Do not use if cloudy.

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

Oral dosage for intestinal infections and dysbacteriosis: Children under 6 months: 5 ml per dose. Children 6-12 months: 10 ml per dose. Children 1-3 years: 15 ml per dose. Children 3-8 years: 20 ml per dose. Patients 8 years and older: 20-30 ml per dose. Administer three times daily.

For rectal administration as an enema, use the same age-specific doses and frequency as for oral use.

Topical treatment for purulent-inflammatory conditions: Irrigate, apply compresses, or tamponade with the solution. For abscesses, inject into the cavity after pus evacuation.

Introduce 2-10 ml into body cavities (pleural, articular, other) once daily. For otitis media, instill 1-3 drops into the ear canal 1-3 times daily.

For nasopharyngeal infections, use as a rinse, instillation, or irrigation with 5-10 ml 2-3 times daily. Alternatively, insert soaked turundas for 1 hour.

In urology, administer 20-50 ml into the bladder, and 5-7 ml into the renal pelvis via cystostomy or pyelostomy tubes 1-2 times daily.

In gynecology, administer 5-10 ml intravaginally once daily, or use for cervical irrigation.

For prophylaxis of nosocomial infections, use the solution for irrigation of postoperative wounds and body cavities as indicated.

The typical treatment course is 7-20 days, depending on the clinical indication and response. For recurrent infections, repeat courses are acceptable.

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

Dosage adjustment is not required.

Use in Renal Impairment

Dosage adjustment is not required.

Pediatric Use

It is used in children at recommended doses.

Geriatric Use

Dosage adjustment is not required.

Special Precautions

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

Drug Interactions

It can be used 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.