Klebsiella polyvalent bacteriophage purified (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Forms

	Klebsiella polyvalent bacteriophage purified	Solution for oral administration, topical and external use 10 ml: 4 or 10 fl.
		Solution for oral administration, topical and external use 20 ml: 4 fl.

Dosage Form, Packaging, and Composition

Solution for oral administration, 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 administration, 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, Klebsiella ozaenae, Klebsiella rhinoscleromatis bacteria.

Indications

Treatment and prevention of diseases caused by Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis bacteria as part of complex therapy:

• Ozaena, scleroma;
• Gastrointestinal diseases (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbacteriosis);
• Inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbacteriosis, 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), as 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 dosages of the drug

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

If the cavity of the purulent focus is treated with chemical antiseptics before using the bacteriophage, it should be rinsed with a sterile 0.9% sodium chloride solution.

When treating ozaena and scleroma, the drug is used for washing the nasal cavity and the mucous membrane of the upper respiratory tract, for introduction into the cavities of the sinuses (according to clinical indications), as well as for lesions of the pharynx, larynx, trachea in the form of inhalations (without heating and using ultrasound). The dose of the drug for treating the mucous membranes of the nose and upper respiratory tract is 10-20 ml. After washing the mucous membranes, turundas moistened with the drug are inserted into the nasal cavity alternately into each nasal passage and left for 1 hour. The procedure is repeated 2-3 times a day for 20-40 days. Since ozaena and scleroma are chronic diseases, for the purpose of preventing exacerbations, it is recommended to conduct 20-40 day courses of treatment according to the above scheme once a year.

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

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

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

When treating inflammation of the sinuses, the drug is used for washing the nasal cavity, nasopharynx and sinuses at a dose of 5-10 ml and introduction into the sinuses of 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 moistened with bacteriophage, alternately into each nasal passage and left for 0.5-1 hour. The procedure is repeated 3 times a day, the course of treatment is 7-15 days.

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

For conjunctivitis and keratoconjunctivitis, the drug is applied 2-3 drops 4-5 times a day, the course of treatment is 5-7 days; for purulent corneal ulcer – 4-5 drops per 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, the course of treatment is 7-10 days.

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

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

When treating 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 case 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, the course of treatment is 7-15 days.

For gastroenterocolitis, pancreatitis, cholecystitis, as well as intestinal dysbacteriosis, 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 as high enemas 2-3 times a day, 20-40 ml. For intestinal dysbacteriosis, the drug can be used with normoflora preparations.

For prevention of nosocomial surgical infections, the drug is used for treating postoperative and freshly infected wounds at 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, by mouth 2-3 times a day, 3-5 ml 30 minutes before feeding. In cases of uncontrollable vomiting, the drug is used as high enemas (through a gas outlet tube or catheter) once daily at a dose of 5-10 ml. A combination of rectal (as high enemas) and oral administration of the drug is possible: the course of treatment is 7-15 days (according to clinical indications). In case of recurrent disease, repeated courses of treatment are possible.

With the aim 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.

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

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

Adverse Reactions

Not established.

Contraindications

• hypersensitivity to the components of the preparation.

Use in Pregnancy and Lactation

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

Pediatric Use

Can be used in children when indicated.

Special Precautions

Precautionary measures for use

Before use, the vial with the bacteriophage must be shaken and inspected. The preparation must be transparent and not contain any sediment.

Warning! Do not use the preparation if it is cloudy!

Due to the content of a nutrient medium in the preparation, in which bacteria from the environment can develop, causing the preparation to become cloudy, 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 the 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 the storage conditions, the above-mentioned rules are observed, and there is no cloudiness, can be used throughout the shelf life.

Effect on the ability to drive vehicles and mechanisms

None.

Overdose

Not established.

Drug Interactions

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

Storage Conditions

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

Shelf Life

The shelf life is 2 years.

The preparation is transported in accordance with SP 3.3.2.1248-03 at a temperature between 2 and 8°C (46.4°F). Transportation at a temperature between 9 and 25°C (77°F) for no more than 1 month is allowed.

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.