Bacteriophage klebsiella pneumoniae purified (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Bacteriophage klebsiella pneumoniae purified

Oral, topical and external solution 20 ml: bottle 4 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: 8-hydroxyquinoline sulfate monohydrate 0.0001 g/ml

10 ml – glass bottles (4) – cardboard packs.
10 ml – glass bottles (10) – cardboard packs.
10 ml – glass bottles (4) – contour cell packs (1) – cardboard packs.

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

Excipients: 8-hydroxyquinoline sulfate monohydrate 0.0001 g/ml

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

Clinical-Pharmacological Group

Immunobiological drug – bacteriophage

Pharmacotherapeutic Group

MIBP-bacteriophage

Pharmacological Action

The drug causes specific lysis of Klebsiella pneumoniae bacteria.

Indications

Treatment and prevention of diseases caused by Klebsiella pneumoniae bacteria as part of complex therapy

• Diseases of the gastrointestinal tract (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbiosis);
• Inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbiosis, omphalitis, pemphigus, pyoderma, septicemia 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, salpingoophoritis);
• 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.

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

ICD codes

Dosage Regimen

The drug is used for oral administration (by mouth), in the form of enemas, applications, irrigations, introduction into wound cavities, vagina, uterus, nose, sinuses, as well as into drained cavities: abscesses, abdominal, pleural, bladder, renal pelvis.

The drug is taken orally on an empty stomach 0.5-1 hour before meals.

Recommended doses of the drug

Treatment of purulent-inflammatory diseases with localized lesions should be carried out simultaneously both locally and by taking the drug orally.

In case of treatment of a purulent focus cavity with chemical antiseptics before using the bacteriophage, it should be washed with a sterile 0.9% sodium chloride solution.

For treatment of tonsillitis, pharyngitis, laryngitis, the drug is used for rinsing the mouth and throat 3 times a day, 10-20 ml, course of treatment 7-10 days.

For treatment of bronchitis, pneumonia, the drug is taken orally 3 times a day, 10-20 ml, and also used in the form of inhalations (without heating and using ultrasound), course of treatment 15-20 days.

For treatment of otitis, the drug is used for washing and introduction into the middle ear cavity, 2-5 ml 1-3 times a day. Course of treatment 7-15 days.

For treatment of sinus inflammation, the drug is used for washing the nasal cavity, nasopharynx and sinuses in a dose of 5-10 ml and introduction into the sinuses 2-3 ml. The procedure is repeated once daily for 7-10 days. In addition, the drug is introduced into the nasal cavity in the form of turundas soaked in bacteriophage, alternately into each nasal passage and left for 0.5-1 hour. The procedure is repeated 3 times a day, course of treatment 7-15 days.

For treatment of stomatitis and chronic generalized periodontitis, the drug is used in the form of mouth rinses 3-4 times a day in a dose of 10-20 ml, as well as by introducing turundas soaked in klebsiella bacteriophage into periodontal pockets for 5-10 minutes, course of treatment 7-10 days.

For conjunctivitis and keratoconjunctivitis, the drug is applied 2-3 drops 4-5 times a day, course of treatment 5-7 days; for purulent corneal ulcer – 4-5 drops a day for 7-10 days, for purulent iridocyclitis – 6-8 drops every 3 hours in combination with oral administration in therapeutic dosages for 7-10 days.

For abscesses after opening and removal of purulent contents, the drug is introduced in an amount less than the volume of removed pus once daily, course of treatment 7-10 days.

For peritonitis and pleurisy, the drug is introduced into drained cavities – abdominal and pleural through drainage tubes once daily 20-70 ml, course of treatment 10-15 days.

For osteomyelitis, the drug is introduced into the wound cavity through turundas, drainages in an amount of 10-30 ml once daily, course of treatment 15-20 days.

For treatment of wound suppurations, the drug is used in the form of irrigation, applications, dressings, introduction into drainage in a dose of 5-50 ml depending on the lesion focus at least once a day, course of treatment 10-15 days.

For treatment of purulent-inflammatory gynecological diseases (wound suppurations, endometritis, vulvitis, bartholinitis, colpitis, salpingoophoritis), the drug is used for irrigations, applications, introduced into wound cavities, vagina, uterus 5-20 ml once a day for 7-10 days.

For cystitis, pyelonephritis, urethritis, the drug is taken orally in a therapeutic dose 3 times a day 1 hour before meals for 10-20 days. In the case when the bladder cavity or renal pelvis is drained, the drug is administered through a cystostomy or nephrostomy 1-3 times a day, 20-50 ml into the bladder and 5-7 ml into the renal pelvis, course of treatment 7-15 days.

For gastroenterocolitis, pancreatitis, cholecystitis, as well as intestinal dysbiosis, the bacteriophage is taken orally in age-specific dosages 3 times a day 1 hour before meals for 7-15 days (according to clinical indications). In case of uncontrollable vomiting, the drug is used in the form of high enemas 2-3 times a day, 20-40 ml. For intestinal dysbiosis, the drug can be used with normoflora preparations.

For prevention of nosocomial surgical infections, the drug is used for treatment of postoperative and freshly infected wounds in a dose of 5 -50 ml depending on the lesion focus once daily for 5-7 days.

Use of the drug in children under 1 year of age (including premature infants).

For gastroenterocolitis, pneumonia and sepsis of newborns, the drug is applied orally 2-3 times a day, 3-5 ml 30 minutes before feeding. In cases of uncontrollable vomiting, the drug is used in the form of high enemas (through a gas outlet tube or catheter) once daily in a dose of 5-10 ml. A combination of rectal (in the form of high enemas) and oral administration of the drug is possible. Course of treatment 7-15 days (according to clinical indications). In case of recurrent disease, repeated courses of treatment are possible.

For the purpose of preventing the occurrence of nosocomial infection in newborn children, the bacteriophage is used according to epidemic indications orally, 3-5 ml 3 times a day 30 minutes before feeding for the entire period of stay in the hospital.

For treatment of omphalitis, pyoderma, infected wounds, the bacteriophage is used in the form of applications, 5-10 ml 2-3 times a day (a gauze napkin is moistened with bacteriophage and applied to the umbilical wound or affected area of the skin) for 7-15 days.

The use of the drug does not exclude the use of other antibacterial and anti-inflammatory drugs.

Adverse Reactions

Not established.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

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

Pediatric Use

Use in children is possible according to indications.

Special Precautions

Precautions for use

Do not use the preparation if it becomes cloudy!

Due to the content of the nutrient medium in the preparation, in which bacteria from the environment can develop, causing cloudiness of the preparation, the following rules must be observed when opening the vial

• Wash hands thoroughly;
• Treat the cap with an alcohol-containing solution;
• Remove the cap without opening the stopper;
• Do not place the stopper with the inner surface on a table or other objects;
• Do not leave the vial open;
• Store the opened vial only in the refrigerator.

When using small doses (2-8 drops), the preparation must be drawn up with a sterile syringe in a volume of 0.5-1 ml.

The preparation from an opened vial, if storage conditions and the above rules are observed and there is no cloudiness, can be used throughout the entire shelf life.

Effect on ability to drive vehicles and machinery

Absent.

Overdose

Not established.

Drug Interactions

The use of the preparation is possible in combination with other medicines, including antibiotics.

Storage Conditions

The preparation should be stored in accordance with SP 3.3.2.1248-03 in a dry place, protected from light and out of the reach of children, at a temperature between 2°C and 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

Without a prescription.

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.