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Dosage form: & nbspsolution for oral, local and external use
Composition:The preparation is a sterile mixture of purified filtrate filtrates from bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis. 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 varying intensity, a greenish shade is allowed.

Biological properties. The drug causes a specific lysis of bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis.

Pharmacotherapeutic group:MIBP-bacteriophage
ATX: & nbsp
  • Other different drugs
  • Indications:
    Treatment and prevention of diseases caused by bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis as part of complex therapy:
    - ozona, scleroma;
    - 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 septicopyemia of various localization);
    - 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, tonsillitis, 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 a preliminary determination of the phage sensitivity of pathogens
    Contraindications:Hypersensitivity to the components of the drug.
    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 PREPARATION

    AGE OF PATIENT

    DOSE FOR 1 RECEPTION

    with different methods of drug administration

    Inside (ml)

    in enema (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 treatment of the purulent focus cavity with chemical antiseptics, before using the bacteriophage, it must be washed with a sterile 0.9% solution of sodium chloride.

    In the treatment of oes and scleroma, the drug is used to wash the nasal cavity and the mucous membrane of the upper respiratory tract, for administration in the sinus cavity (according to clinical indications), as well as in case of involvement of the pharynx, larynx, trachea in the form of inhalations (without heating and using ultrasound). The dose of the drug for the treatment of nasal mucosa and upper respiratory tract 10-20 ml. After washing the mucous membranes into the nasal cavity, in turn, each of the nasal passages is injected with turuns moistened with the drug and left for 1 hour. The procedure is repeated 2-3 times a day for 20-40 days.Since ozona and scleroma are chronic diseases, for the purpose of prevention of exacerbations it is recommended to carry out 20-40 day-long courses of treatment once a year according to the above scheme.

    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 in the form of aerosols and 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 administered in a 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 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 the introduction into the periodontal pockets of turundas, impregnated with Klebsiella bacteriophage,for 5-10 minutes, the course of treatment is 7-10 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; with a purulent ulcer of the cornea - 4-5 drops per day for 7-10 days; with purulent iridocyclites - according to 6-8 drops every 3 hours in combination with oral administration at therapeutic dosages for 7-10 days.

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

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

    In osteomyelitis, the drug is injected into the wound cavity through the turundas, drains in the amount of 10-30 ml daily once, the course of treatment 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 wounds, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis) 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 that case, if the cavity of the bladder or renal pelvis is drained, the drug is administered through a 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 for 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 dysbiosis intestinal preparation can be used with medications of normoflora.

    For the 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 daily on a single dose 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 disease, it is possible re-holding courses of treatment.

    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 for 30 minutes before feeding, during the entire stay in the hospital.

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

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

    Precautions for use. Before use, the bacteriophage vial must be shaken and scanned. The drug should be clear and free of sediment.

    Attention! 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 place the inner surface of the cork on a table or other objects;

    - do not leave the vial open;

    - Store the vial 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 at observance of storage conditions, the above rules and the absence of turbidity can be used throughout the shelf life.

    Side effects:Not installed.
    Overdose:Not installed.
    Interaction:The use of the drug is possible in combination with other drugs, including antibiotics.
    Effect on the ability to drive transp. cf. and fur:None.
    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:

    Conditions of transportation. 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.

    Storage conditions. The preparation is stored in accordance with SP 3.3.2.1248-03 in a place protected from light and inaccessible to children at a temperature of 2 ° to 8 ° C.

    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-001361
    Date of registration:07.07.2011 / 10.07.2013
    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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