Active substanceBifidobacteria bifidumBifidobacteria bifidum
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  • Dosage form: & nbsplyophilizate for solution for oral administration and topical application
    Composition:

    One dose of the drug contains live bifidobacteria of at least 107, auxiliary substance: lactulose - 2%, drying medium components: sucrose, gelatin, skim milk (reverse).

    Description:

    Crystalline or porous mass with possible stratification of biomass in the upper part, beige or whitish-gray color, with a specific odor.

    Pharmacotherapeutic group:Eubiotic
    ATX: & nbsp

    A.07.F.A   Antidiarrhoeal preparations of biological origin regulating the balance of intestinal microflora

    Pharmacodynamics:

    The preparation is a microbial mass of living, antagonistically active bifidobacteria strains Bifidumbacterium bifidum No. 1 or 791, lyophilized.

    The therapeutic effect of bifidumbacterin determines the living bifidobacteria contained in it, which have antagonistic activity against a wide range of pathogenic and conditionally pathogenic microorganisms and thereby normalize the intestinal and vaginal microflora. The high quantitative level of bifidoflora and its predominance in the microbiocenosis, achieved with the use of bifidumbacterin, normalize the activity of the gastrointestinal tract,improve metabolism, prevent the formation of lingering forms of intestinal diseases, improve non-specific resistance of the organism. Bifidumbacterin as a solution applied topically effective in the treatment of inflammatory diseases of female genitalia and prenatal preparation pregnant "at risk".

    Appointment

    Bifidumbacterin, lyophilisate for the preparation of oral solution and topical application for the treatment of acute and chronic diseases of the gastrointestinal tract involving dysbacteriosis in children and adults. Children (including premature) drug can be used from the first days of life. In obstetric practice - locally, for the prevention and treatment of mastitis and dysbiosis vagina.

    Indications:

    In diseases of the gastrointestinal tract:

    - for the treatment of long-term intestinal dysfunctions not established etiology;

    - acute intestinal infections (in treatment of acute dysentery, salmonellosis, ehsherihioza, viral diarrhea, etc...) long intestinal dysfunctions staphylococci, as well as for the treatment of convalescents after acute intestinal infections with continued bowel dysfunction;

    - in the complex treatment of children (including newborns, prematurity), patients with pneumonia, sepsis and other purulent-infectious diseases, for preventing or stopping their bowel function and preventing the development of ulcerative necrotic enterocolitis;

    - for treatment and prevention of dysbacteriosis in children with a burdened premorbid condition, prematurely born or with signs of prematurity receiving antibiotics in the early neonatal period; children whose mothers suffered from severe toxicosis, extragenital diseases, had a long anhydrous period or other pathology; children of mothers who had lactostasis, nipple cracking and resuming breastfeeding after recovery from mastitis; weakened children with anemia, hypotrophy, rickets, diathesis and other manifestations of allergy; with pertussis disease - especially if they have any disorders of bowel function;

    - with early transfer of infants to artificial feeding or feeding with donor milk;

    - for the treatment of acute and chronic inflammatory diseases of the large and small intestine (colitis,enterocolitis) in older children and adults that occur against a background of microflora disorders with deficiency or lack of bifidoflora;

    - with intestinal dysfunctions as a result of intestinal dysbacteriosis, which arose as a result of prolonged antibacterial, hormonal, radiation and other therapy, in stressful situations and staying in extreme conditions, and with the goal of preventing dysbiosis in these individuals.

    In obstetric-gynecological practice:

    - for the purpose of preventing mastitis for the local treatment of the mammary glands of nursing mothers of the "risk" group (in women with a retracted flat nipple, with a decrease in its erection, the presence of cracks) with a burdened epidemiological situation in maternity hospitals;

    - if the purity of the vaginal secretion is violated to grade III-IV in pregnant women of the "risk" group;

    - with bacterial colpitis caused by staphylococcus and E. coli (in monoflora or in associations), as well as senile colpitis of hormonal nature.

    Contraindications:

    There were no reactions to the drug administration.

    Pregnancy and lactation:

    Bifidobacteria are representatives of normal human microflora, therefore, preparations made on their basis, can be used during pregnancy and lactation.

    Dosing and Administration:

    Bifidumbacterin in intestinal diseases is used inside, and in obstetric-gynecological practice: locally (intravaginally).

    1. Treatment and prevention of gastrointestinal diseases:

    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 an opaque homogeneous suspension), the contents of the vial should be transferred to the same beaker and mixed. One teaspoon of the drug dissolved in this way is 1 dose. Dissolved drug is not subject to storage.

    The required number of doses (respectively tea spoons) should be taken 20-30 minutes before meals or 1-1.5 hours after eating. Breast children can be given the drug immediately before feeding.

    In case of intestinal diseases: for children of the first half-year of life, the drug is prescribed 5 doses per reception 2 times a day, children of the second half and older - 5 doses 3 times a day.

    Newborns of the "risk" group should start using the drug in the maternity department from the first day of life to discharge 2.5 doses per reception 2 times a day.

    Children with sepsis, pneumonia and other purulent-infectious diseases are prescribed 5 doses 3 times a day in combination with conventional methods of treating the underlying disease. If this group of children has gastrointestinal tract disorders and the threat of ulcerative necrotic enterocolitis, the dose of bifidumbacterin is increased to 20 doses per day.

    In acute and chronic inflammatory diseases of the small and large intestine, children older than 3 years and adults are advised to take 5 doses 2-3 times a day. In severe cases, the dose can be doubled.

    The duration of treatment with bifidumbacterin is determined by the severity of clinical manifestations, the patient's age and is 2-4 weeks, and in some cases up to 3 months.

    With the preventive purpose, the drug is prescribed for 5 doses 1-2 times a day for 1-2 weeks.

    2. In obstetrics and gynecology practice:

    To treat the nipple area and the areola of the puerperas, the contents of one vial (5 doses) are dissolved in a small amount of cooled boiled water, impregnated with a solution of 2 sterile swabs,which are applied to the nipple and areola for 20-30 minutes before each feeding for 5 days. The tampon impregnated with the drug is left on the surface of the mammary gland before the beginning of the feeding.

    With inflammatory diseases of female genitalia and prenatal preparation of pregnant "risk" groups, bifidumbacterin is prescribed for 5-10 doses once a day for 5-8 days under the control of the restoration of vaginal secretion to grade I-II and disappearance of clinical symptoms of the disease.

    For intravaginal administration, bifidumbacterin is also dissolved by the above method. The resulting suspension of the drug is impregnated with a sterile swab that is not squeezed intravaginally and left for 2-3 hours.

    If necessary, the course of treatment with bifidumbacterin can be repeated.

    Side effects:

    Not identified.

    Interaction:

    Clinically significant interaction of the drug with other drugs has not been established.

    Bifidumbacterin can be used simultaneously with antibacterial, antiviral and immunomodulatory therapy.

    The effect is enhanced by vitamins (especially group B), lowering - antibiotics.

    Corrective therapy with bifidumbacterin can be administered after a course of treatment with specific bacteriophages, intended for the elimination of opportunistic bacteria.

    Special instructions:

    The drug does not affect the performance of activities requiring special attention and quick reactions (management of vehicles, machinery, etc.).

    Form release / dosage:Liofilizate for solution for oral administration and topical application.
    Packaging:

    5, 10 doses per vial; 10 bottles in a pack with instructions for use.

    Storage conditions:

    The preparation is stored in accordance with JV 3.3.2. 1248-03, at a temperature not exceeding 10 ° C, out of the reach of children.

    Transport conditions:

    Transportation is carried out in accordance with SP 3.3.2. 1248-03, at a temperature not exceeding 10 ° ะก.

    Not suitable for use:

    - at expiration of the expiration date, or stored with non-observance of regulated conditions;

    - the integrity of the package is broken (cracked bottles);

    - without labeling on the vial;

    - with altered physical properties (color change, shrinkage of biomass), or in the presence of extraneous inclusions.

    Shelf life:

    2 years.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N002188 / 01
    Date of registration:03.04.2008 / 15.03.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:EKOPOLIS, ZAO EKOPOLIS, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.02.2017
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