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Dosage form: & nbsp

solution for oral and rectal administration

Composition:

The preparation is a mixture of sterile filagenate filtrates Shigella flexneri 1, 2, 3, 4 and 6 serovars and Shigella sonnei.

Excipients: Preservative - 8-hydroxyquinoline sulfate - 0.0001 g / ml (calculated content);

or 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. Determine visually.

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

    The drug causes a specific lysis of the bacteria of the causative agents of bacterial dysentery.

    Indications:

    Treatment and prevention of bacterial dysentery caused by Shigella flexneri serovars 1, 2, 3, 4, 6 and Shigella sonnei.

    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 medication during pregnancy and during breast-feeding is possible in the presence of infections caused by phagosensitive strains of bacteria (on the recommendation of a doctor).

    Dosing and Administration:

    The drug is intended for oral and rectal administration. For treatment, the drug is taken orally 3 times a day on an empty stomach 1 hour before meals from the first day of the disease for 7-10 days.

    Recommended dosages of the drug:

    Age

    Dose for 1 admission (ml)

    orally

    rectally

    0-6 months.

    5

    10

    6-12 months.

    10-15

    20

    from 1 year to 3 years

    15-20

    20-30

    from 3 to 8 years

    20-30

    30-40

    from 8 years and older

    30-40

    50-60

    In dysentery, characterized by a weakly expressed colitis syndrome, and in the period of convalescence, a combination of a double oral administration with a single rectal administration of a single age dose of the drug in the form of an enema after bowel movement is recommended.

    For preventive purposes, the drug is recommended for use during group diseases in organized groups and families. The optimal scheme of use is a daily intake of a single age-related dose. The duration of the drug is determined by the conditions of the epidemiological situation.

    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:

    Absent.

    Form release / dosage:

    Solution for oral and rectal administration.

    Packaging:Solution for oral administration and rectal administration in vials of 20 or 100 ml. For 4 or 10 bottles of 20 ml or 1 bottle of 100 ml 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 preparation is stored in accordance with SP 3.3.2.1248-03 in a place 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-002033
    Date of registration:10.11.2011 / 14.08.2013
    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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