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Dosage form: & nbsp

solution for oral, local and external use

Composition:

The preparation is a sterile filtrate of phagolysates of strains Streptococcus. Excipient: 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.

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

    The drug has the ability to specifically lyse bacteria Streptococcus.

    Indications:

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

    - Diseases of the ear, throat, nose, respiratory tract and lungs (inflammation of the sinuses of the nose, middle ear, sore throat, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleurisy);

    - surgical infections (suppuration of wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis);

    - urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis);

    - enteral infections (gastroenterocolitis, cholecystitis), intestinal dysbiosis;

    - generalized septic diseases;

    - purulent-inflammatory diseases of the newborn (omphalitis, pyoderma, conjunctivitis, gastroenterocolitis, sepsis, etc.);

    - other diseases caused by streptococci.

    With the preventive purpose the preparation is used for processing postoperative and freshly infected wounds, as well as for the prevention of nosocomial infections due to epidemic indications.

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

    Contraindications:

    Hypersensitivity to the components of the drug.

    Pregnancy and lactation:

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

    Dosing and Administration:The drug is used for oral administration (through the mouth), rectal administration, applications, irrigation, insertion into the wound cavity, vagina, uterus, nose, sinuses and drained cavities.

    Recommended dosage of the drug.

    AGE OF PATIENT

    DOSE FOR 1 RECEPTION (ml)

    inwards

    in the enema

    0-6 months

    5

    5-10

    6-12 months

    10

    10-20

    from 1 year to 3 years

    15

    20-30

    from 3 to 8 years

    15-20

    30-40

    from 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 within 7-20 days (according to clinical indications).

    In the event that chemical antiseptics were used before the bacteriophage was used to treat wounds, the wound should be thoroughly washed with a sterile 0.9% solution of sodium chloride.

    Depending on the source of infection, the bacteriophage is used:

    1. In the form of irrigation, lotion and tamponization in a volume of up to 200 ml, depending on the size of the affected area. In the abscess after removal of purulent contents with puncture, the drug is administered in an amount less than the volume of the removed pus. When osteomyelitis after appropriate surgical treatment, a bacteriophage 10-20 ml is poured into the wound.
    2. When inserted into the cavity (pleural, articular and other limited cavities) up to 100 ml, capillary drainage is left through which the bacteriophage is administered for several days.
    3. With cystitis, pyelonephritis, urethritis, the drug is taken orally. In case of bladder cavity or kidney. the pelvis is drained, the bacteriophage is injected through the cystostomy or nephrostomy 1-2 times a day for 20-50 ml in the bladder and 5-7 ml in the renal pelvis.
    4. With purulent-inflammatory gynecological diseases, the drug is injected into the cavity of the vagina, the uterus in a dose of 5-10 ml once daily; with colpitis - 10 ml irrigation or tamponing 2 times a day. Tampons are pawned for 2 hours.
    5. With purulent-inflammatory diseases of the ear, throat, nose, the drug is administered in a dose of 2-10 ml 1-3 times a day. Bacteriophage, used to rinse, rinse, instill, inject wetted turund (leaving them for 1 hour).
    6. When enteral infections, intestinal dysbacteriosis, the drug is taken orally 3 times a day for 1 hour before meals for 7-20 days according to clinical indications. A combination of a double oral administration with a single rectal administration of a single age-related dose of a bacteriophage in the form of an enema after bowel evacuation is possible.

    Use of bacteriophage in children (up to 6 months).

    With sepsis, enterocolitis newborn, including premature babies, the bacteriophage is used in the form of high enemas (through the gas outlet tube or catheter) 2-3 times a day in a dose of 5-10 ml. In the absence of vomiting and regurgitation, the use of the drug through the mouth is possible. In this case, it is mixed with breast milk.Perhaps a combination of rectal (in the form of high enemas) and oral (through the mouth) application of the drug. The course of treatment is 5-15 days. With a recurring course of the disease, repeated courses of treatment are possible. In order to prevent sepsis and enterocolitis with intrauterine infection or the danger of nosocomial infection in newborns, the bacteriophage is used as an enema 2 times a day for 5-7 days.

    In the treatment of omphalitis, pyoderma, infected wounds, the drug is applied twice daily (the gauze cloth is moistened with a bacteriophage and applied to the umbilical wound or the affected area of ​​the skin).

    Side effects:

    Not installed.

    Overdose:

    Symptoms of overdose, measures to provide assistance for overdose are not established.

    Interaction:

    The use of a bacteriophage does not exclude the use of other antibacterial drugs.

    Special instructions:

    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.

    Opening the vial and extracting the required volume of the drug can be performed with a sterile syringe by puncturing the plug.

    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 on the possible effects of the drug on the ability to drive vehicles are absent.

    Form release / dosage:Solution for oral, local and external use.
    Packaging:To 20, 100 ml in the bottles. 4 or 10 bottles of 20 ml or 1 bottle of 100 ml in a pack of cardboard.
    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.

    Conditions of transportation. In accordance with SP 3.3.2.1248-03 with temperature from 2 to 8 ° С. Transportation at a temperature of 8 to 25 ° C is allowed for not more than 1 month.

    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:P N001974 / 01
    Date of registration:19.01.2009 / 02.07.2013
    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: & nbsp15.01.17
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