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Dosage form: & nbsplyophilizate for the preparation of a suspension for oral administration and topical application
Composition:

1 dose of the drug contains:

Active components: not less than 2 х 109 live lactobacilli;

Excipients: components of the protective environment of drying (gelatin, sucrose (sugar), milk).

Composition of the protective environment of drying (per 1 liter of medium): gelatin food - from 3 to 8.5%; sugar white lump or sucrose - from 8 to 28%; skimmed milk or pasteurized milk, skimmed milk, or skimmed milk, or milk, natural cow-raw materials (in terms of dry matter) - from 6 to 14%.

The content of the components of the protective environment of drying in the finished product is not determined.

Description:

The crystalline or porous mass is yellowish-beige or whitish-gray in color, with a specific odor.

Pharmacotherapeutic group:eubiotic
ATX: & nbsp
  • Microorganisms that produce lactic acid
  • Pharmacodynamics:

    Characteristics of the preparation

    The preparation is a microbial mass of a living, antagonistically active strain of lactobacilli (Lactobacillus plantarum 8P-A3 or Lactobacillus fermentum 90T-C4) lyophilized in a culture medium with the addition of a protective sugar-gelatin-lactic drying medium.

    Pharmacological properties

    Lactobacterin has a high antagonistic activity against pathogenic and conditionally pathogenic microbes,including staphylococci, enteropathogenic coliforms, proteins, shigella, which determines the corrective effect of the drug in cases of bacteriocenosis. The drug improves metabolic processes, prevents the formation of protracted forms of intestinal diseases, increases the nonspecific resistance of the body.

    Indications:

    Treatment of diseases of the gastrointestinal tract and female genitalia, accompanied by violations of normal microflora.

    The drug is used for adults and children, regardless of age.

    With diseases of the gastrointestinal tract:

    - convalescences that have passed acute intestinal infections, in the presence of bowel dysfunctions or the isolation of pathogenic and opportunistic bacteria;

    - somatic diseases, accompanied by dysbacteriosis, resulting from the use of antibiotics, chemotherapy and other causes;

    - complex treatment of weakened children with diseases of infectious and non-infectious etiology, accompanied by dysbiosis, atopic dermatitis;

    - chronic colitis of various etiologies, including nonspecific ulcerative colitis.

    In diseases of the female sexual sphere:

    - for the sanation of the genital tract with nonspecific inflammatory diseases of the genitals and prenatal preparation of pregnant women "at risk" with impaired purity of the vaginal secretion up to III-IV degree.

    Due to the lack of age restrictions for prescribing the drug, the possibility of use in adolescents and young children is assessed by the doctor, taking into account the possible benefit, risk and age characteristics of the patient.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

    Contraindicated topical application with vulvovaginal candidiasis.

    The safety and therapeutic effectiveness of oral administration of the drug in vulvovaginal candidiasis has not been clinically investigated.

    Pregnancy and lactation:

    Allowed.

    Dosing and Administration:

    Lactobacterin for intestinal diseases is used inside, and in obstetric-gynecological practice - intravaginally.

    The contents of the vial to dissolve boiled water at room temperature at the rate of 5 ml (teaspoon) of water per 1 dose of the drug.

    Dissolve as follows: pour the required amount of water in a glass (according to the number of doses indicated on the vial); open the bottle by removing the cap and stopper; from the glass to transfer a small amount of water into the bottle; after dissolution (the preparation dissolves no more than 5 minutes with the formation of a homogeneous suspension of yellowish-beige or whitish-gray color), transfer the contents of the vial into the same beaker and mix. One teaspoon of the drug dissolved in this way is 1 dose. To children, the contents of the vial are dissolved at a rate of 1 ml per 1 dose of the drug.

    For intestinal diseases, the drug should be taken 40-60 minutes before meals and preferably washed down with milk. Treatment is recommended to accompany the use of vitamins.

    The daily dose and duration of treatment is determined by the doctor depending on the clinical form of the disease and the severity of dysbiosis.

    At intestinal diseases Lactobacterin is used in the following daily doses:

    Age

    Dose

    Up to 6 months

    3 doses 2 times a day

    From 6 months to 1 year

    3 doses 3 times a day

    1 to 3 years

    5 doses 2 times a day

    Older than 3 years and adults

    5 doses 2-3 times a day

    The course of treatment with Lactobacterin for various diseases is:

    a) with prolonged and chronic course of dysentery, post-dysenteric colitis, after-treatment of convalescent congenital cysts, and long-term intestinal dysfunction of unknown etiology - at least 4 weeks;

    b) with nonspecific ulcerative colitis, as well as chronic colitis and enterocolitis - up to 2 months;

    c) with dysbacteriosis of different etiology - 3-4 weeks.

    In the absence of effect from the use of the drug for 2 weeks, it is necessary to re-examine the microflora of the gastrointestinal tract and correct it with other drugs, depending on the result obtained.

    To fix the obtained clinical effect or in the absence of complete normalization of microflora after the end of the course of treatment, in diseases that occur with relapses, repeated courses of treatment are advisable. In these cases, prior to the appointment of the drug, a re-examination of the microflora is necessary.

    With inflammatory diseases of the genitals Lactobacterin is prescribed for 5 doses 2 times a day intravaginally for 10-12 days, starting from 10-12 days of the menstrual cycle.

    For prenatal preparation of pregnant "risk groups" Lactobacterin is prescribed for 5 doses 1 time per day for 5-8 days.

    For intravaginal application, the contents of the vial should be dissolved in 5-10 ml of boiled water at room temperature, a sterile swab should be soaked with a dissolved preparation, insert a swab into the vagina and leave for 2-3 hours. In adolescents and young children, douches can be used (irrigation).

    Treatment is carried out under the control of restoring purity of the vaginal secretion to I-II degree, the appearance of lactoflora and the disappearance of clinical symptoms of the disease.
    Side effects:

    Side effect of the drug is not established.

    In individuals with altered reactivity, allergic reactions to the drug components may develop.

    If side effects occur that are not mentioned in the instructions, you should contact your doctor.

    Overdose:

    Cases of overdose are not registered.

    Interaction:

    In view of the high antibiotic resistance of lactobacilli, Lactobacterin can be used for antibiotic therapy.

    Special instructions:

    Before using the drug, you should consult your doctor.

    A drug whose package integrity is broken (cracked bottles), a drug with a changed appearance of biomass, in the presence of foreign inclusions, a drug without labeling is unsuitable for use.

    It is not recommended to dissolve the drug in hot water (above 40 ° C). Dissolved drug is not subject to storage.

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

    Not studied.

    Form release / dosage:Liofilizate for the preparation of a suspension for oral administration and topical application.
    Packaging:

    For 3 or 5 doses in a vial.

    For 10 bottles in a pack (box) with instructions for use.

    Storage conditions:

    At a temperature of 2 to 8 ° C. Keep out of the reach of children.

    Conditions of transportation. At a temperature of 2 to 8 ° C.

    Shelf life:

    1 year.

    The drug is not eligible for use with expired use.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002098
    Date of registration:25.10.2011 / 01.07.2014
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp15.03.2016
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