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Dosage form: & nbspsolution for oral, local and external use
Composition:

The preparation is a sterile purified filtrate of bacterial phagolysates Klebsiella pneumoniae. Auxiliary substance: preservative - 8-hydroxyquinoline sulfate monohydrate - 0.0001 g / ml (in terms of 8-hydroxyquinoline sulfate, the calculated content).

Description:

It is a transparent liquid of yellow color of various, intensity levels, a greenish shade is allowed. Determine visually.

Pharmacotherapeutic group:MIBP bacteriophage
ATX: & nbsp
  • Other different drugs
  • Pharmacodynamics:

    The drug causes a specific bacterial lysis Klebsiella pneumoniae.

    Indications:

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

    - diseases of the gastrointestinal tract (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbacteriosis);

    - inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbacteriosis, omphalitis, pemphigus, pyoderma, septicemia and septicopiaemia of various locations);

    - surgical infections (suppuration of wounds, 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 of the nose, mouth, pharynx, larynx, bronchi, lungs and pleura (otitis, angina, pharyngitis, laryngitis, stomatitis, periodontitis, sinusitis, frontalitis, 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 pathogenicity of the pathogen.

    Contraindications:

    Hypersensitivity to components preparation.

    Pregnancy and lactation:

    The use of this drug during pregnancy and during breast-feeding is possible in the presence of infections caused by phage-sensitive strains of Klebsiella (on the recommendation of a doctor).

    Dosing and Administration:

    The drug is used for oral administration (through the mouth), in the form of enemas, applications, irrigation, insertion into the wound cavity, vagina, uterus, nose, sinuses of the nose, and also into the drained cavities: abscesses, abdominal, pleural, bladder, renal pelvis.

    Inside, the drug is taken on an empty stomach for 0.5-1 hour before meals.

    Recommended dosage of the drug.


    DOSE FOR 1 RECEPTION

    AGE OF PATIENT

    with different methods of drug administration

    inwards

    in the enema


    (ml)

    (ml)

    0-6 months

    5

    10

    6-12 months

    10

    20

    From 1 to 3 years

    15

    20-30

    From 3 to 8 years

    20

    30-40

    8 years and older

    20-30

    40-50

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

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

    In the treatment of angina, pharyngitis, laryngitis, the drug is used to rinse the mouth and throat 3 times a day for 10-20 ml, the course of treatment is 7-10 days.

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

    In the treatment of otitis drug is used to wash and insert into the middle ear cavity 2-5 ml 1-3 times a day. The course of treatment is 7-15 days.

    In the treatment of sinus inflammation, the drug is used to wash the nasal cavity, nasopharynx and sinuses in a dose of 5-10 ml and the introduction of 2-3 ml in the sinuses. The procedure is repeated once daily for 7-10 days.In addition, the drug is injected into the nasal cavity in the form of turundas moistened with a bacteriophage, alternately in 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.

    In the treatment of stomatitis or chronic generalized periodontitis preparation is used as a rinse oral 3-4 times a day at a dose of 10-20 ml, and the introduction into periodontal pockets turundae impregnated bacteriophage Klebsiella, 5-10 min, 7-10 treatment days.

    With conjunctivitis and keratoconjunctivitis, the drug is used 2-3 drops 4-5 times a day, the course of treatment is 5-7 days; in purulent corneal ulcer - 4-5 drops daily for 7-10 days in purulent iridotsiklitah - 6-8 drops every 3 hours combined with ingestion of therapeutic doses for 7-10 days.

    When abscesses after opening and removal of pus preparation is administered in an amount less than the amount of remote pus once daily, 7-10 days treatment.

    When peritonitis and pleurisy preparation is administered in oral drained - peritoneal and pleural drainage tube through a single daily dose of 20-70 ml, 10-15 days of treatment.

    When osteomyelitis preparation is administered into the cavity through turundy wounds, drains in an amount of 10-30 ml once daily, the treatment course is 15-20 days.

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

    In the treatment of purulent-inflammatory gynecological diseases (suppuration of wounds, endometritis, vulvitis, bartholinitis, colpitis, salpingoophoritis), the drug is used for irrigation, applications, injected into the wound cavity, vagina, uterus 5-20 ml once a day for 7-10 days.

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

    With gastroenterocolitis, pancreatitis, cholecystitis, and intestinal dysbacteriosis, the bacteriophage is taken orally at age dosages 3 times a day 1 hour before meals for 7-15 days (according to clinical indications). With indomitable vomiting, the drug is used in the form of high enemas 2-3 times a day for 20-40 ml. With dysbacteriosis of the intestine, the drug can be used with preparations of normoflora.

    For prophylaxis of intrahospital surgical infections, the drug is used to treat postoperative and freshly infected wounds in a dose of 5-50 ml, depending on the lesion site, once daily for 5-7 days.

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

    With gastroenterocolitis, pneumonia and sepsis of newborns, the drug is administered through the mouth 2-3 times a day for 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) daily once 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. The course of treatment is 7-15 days (according to clinical indications). With a recurring course of the disease, repeated courses of treatment are possible.

    In order to prevent the emergence of nosocomial infection in newborns, the bacteriophage is used for epidemiological indications inside by 3-5 ml 3 times a day 30 minutes before feeding during the entire period of stay in the hospital.

    In the treatment of omphalitides, pyoderma, infected wounds bacteriophage is used in the form of applications of 5-10 ml 2-3 times a day (moistened with a gauze wipe bacteriophage and superimposed on the umbilical wound or affected area skin) for 7-15 days.

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

    Side effects:Not installed.
    Overdose:Not installed.
    Interaction:

    The use of the drug is possible in combination with other drugs, including antibiotics.

    Special instructions:

    In case of turbidity, do not use the drug!

    Due to the content of the nutrient medium in which the bacteria can develop from the environment, causing the drug to cloud, it is necessary to observe the following rules when opening the vial:

    - Wash hands thoroughly;

    - treat the cap with an alcohol-containing solution;

    - remove the cap without opening the plug;

    - Do not put a stopper on the inner surface of the table or other objects;

    - do not leave the vial open;

    - The opened vial should be stored only in the refrigerator.

    When using - small doses (2-8 drops) the drug should be taken with a sterile syringe in a volume of 0.5-1 ml.

    The preparation from the opened bottle under observance of storage conditions, the above rules and absence of turbidity can be used during the whole shelf life.

    Effect on the ability to drive transp. cf. and fur:

    Information about the possible effect of the drug on the ability to manage vehicles, mechanisms are absent.

    Form release / dosage:Solution for oral, local and external use.
    Packaging:

    Solution for oral, topical and topical use in vials of 10 or 20 ml. For 4 or 10 bottles with instructions for use in a pack of cardboard. 4 bottles in a contour acrylic packing from a film of polyvinylchloride.

    1 contour pack with instructions for use in a pack of cardboard.

    Storage conditions:

    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. It is allowed to transport at a temperature of 9 to 25 ° C not more than 1 month.

    The drug preservesin accordance with JV 3.3.2.1248-03 in protected from light and inaccessible to children at a temperature of 2 ° to 8 ° C.
    Shelf life:

    Shelf life 2 years. The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-001297
    Date of registration:10.06.2011 / 17.07.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.01.17
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