Bifidumbacterin lyophilisate for preparation of suspension for oral administration and topical administration 5 doses, No. 10

For diseases of the gastrointestinal tract:

- for the treatment of long-term intestinal dysfunctions of unknown etiology;

- in acute intestinal infections (in the complex treatment of acute dysentery, salmonellosis, Escherichiosis, viral diarrhea, etc.), prolonged intestinal dysfunctions of staphylococcal etiology, as well as for the treatment of convalescents after acute intestinal infections with continuing intestinal dysfunction;

- in the complex treatment of children (including premature newborns) patients with pneumonia, sepsis and other purulent-infectious diseases for the prevention or relief of intestinal dysfunction and prevention of the development of necrotizing ulcerative enterocolitis;

- for the treatment and prevention of dysbiosis in children with aggravated premorbid condition born prematurely 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 with lactostasis of cracked nipples and resuming breastfeeding after recovery from mastitis; weakened children with anemia, hypotrophy of rickets diathesis and other manifestations of allergies; with whooping cough - 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 occurring against the background of microflora disorders with a deficiency or absence of bifidoflora;

- with intestinal dysfunctions as a result of intestinal dysbiosis arising as a result of prolonged antibacterial hormonal radiation and other therapy in stressful situations and in extreme conditions, as well as for the prevention of dysbiosis in these persons.

In obstetric and gynecological practice:

- in order to prevent mastitis for local treatment of the mammary glands of nursing mothers of the 'risk' group (in women with an inverted flat nipple with a decrease in its erection, the presence of cracks) with a burdened epidemiological situation in maternity hospitals;

- in case of violation of the purity of the vaginal secretion up to III-IV degree in pregnant women of the 'risk' group;

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

Bifidumbacterin for intestinal diseases is used internally and in obstetric and gynecological practice: locally (intravaginally).

1. Treatment and prevention of gastrointestinal diseases:

Dissolve the contents of the bottle with 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 into a glass (in accordance with the number of doses indicated on the bottle); open the bottle by removing the cap and stopper; transfer a small amount of water from a glass into a bottle; after dissolution (the drug dissolves for no more than 5 minutes with the formation of an opaque homogeneous suspension), transfer the contents of the vial to the same glass and mix. One teaspoon of the drug dissolved in this way is 1 dose. The dissolved preparation cannot be stored.

The required number of doses (respectively, teaspoons) should be taken 20-30 minutes before meals or 1-15 hours after meals. The drug can be given to infants just before feeding.

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

It is advisable for newborns of the 'risk' group to start using the drug in the maternity ward from the first day of life until discharge, 25 doses per dose 2 times a day.

Children with sepsis of 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 develops disturbances in the function of the gastrointestinal tract and the threat of necrotizing enterocolitis, the dosage of bifidumbacterin is increased to 20 doses per day.

For acute and chronic inflammatory diseases of the small and large intestines, children over 3 years of age and adults are recommended to take 5 doses 2-3 times a day. In severe cases of the disease, the dose can be doubled.

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

For prophylactic purposes, the drug is prescribed in 5 doses 1-2 times a day for 1-2 weeks.

2. In obstetric and gynecological practice :

To treat the area of ??the nipple and areola of puerperas, the contents of one bottle (5 doses) are dissolved in a small amount of cooled boiled water, soaked with a solution of 2 sterile tampons that are applied to the nipple and areola for 20-30 minutes before each feeding for 5 days. The swab soaked in the drug is left on the surface of the breast until feeding begins.

In inflammatory diseases of the female genitals and prenatal preparation of pregnant women of the 'risk' group, bifidumbacterin is prescribed 5-10 doses 1 time per day for 5-8 days under the control of restoring the purity of the vaginal secretion to I-II degrees and the disappearance of the clinical symptoms of the disease.

For intravaginal administration, bifidumbacterin is also dissolved in the above manner. The resulting suspension of the drug is impregnated with a sterile swab, which, without squeezing, is injected intravaginally and left for 2-3 hours.

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

Active substance:

Live bifidobacteria Bifidobacterium bifidum - not less than 107 CFU.

Excipients:

Components of a protective drying medium * (gelatin; sucrose (sugar); milk).

Hypersensitivity to the components of the drug.

Trade name of the drug

Bifidumbacterin

International non-proprietary name

Bifidobacterium bifidum

Dosage form

lyophilisate for preparation of oral and topical solution

Composition

Active substance:

Live bifidobacteria Bifidobacterium bifidum - not less than 107 CFU.

Excipients:

Components of a protective drying medium * (gelatin; sucrose (sugar); milk).

Description

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

Pharmacotherapeutic group

Eubiotic

ATX code

A07FA

Pharmacodynamics:

The drug is a microbial mass of live antagonistically active bifidobacteria strains Bifidumbacterium bifidum No. 1 or 791 lyophilized.

The therapeutic effect of bifidumbacterin is determined by the live bifidobacteria contained in it, which have antagonistic activity against a wide range of pathogenic and opportunistic 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 metabolic processes, prevent the formation of protracted forms of intestinal diseases, increase the nonspecific resistance of the organism. Bifidumbacterin in the form of a topically applied solution is effective in the treatment of inflammatory diseases of the female genitals and in the prenatal preparation of pregnant women at risk.

Appointment

Bifidumbacterin lyophilisate for the preparation of a solution for oral administration and local use is intended for the treatment of acute and chronic diseases of the gastrointestinal tract accompanied by dysbiosis in children and adults. For children (including premature babies), the drug can be used from the first days of life. In obstetric and gynecological practice - topically for the prevention and treatment of mastitis and vaginal dysbiosis.

Indications:

For diseases of the gastrointestinal tract:

- for the treatment of long-term intestinal dysfunctions of unknown etiology;

- in acute intestinal infections (in the complex treatment of acute dysentery, salmonellosis, Escherichiosis, viral diarrhea, etc.), prolonged intestinal dysfunctions of staphylococcal etiology, as well as for the treatment of convalescents after acute intestinal infections with continuing intestinal dysfunction;

- in the complex treatment of children (including premature newborns) patients with pneumonia, sepsis and other purulent-infectious diseases for the prevention or relief of intestinal dysfunction and prevention of the development of necrotizing ulcerative enterocolitis;

- for the treatment and prevention of dysbiosis in children with aggravated premorbid condition born prematurely 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 with lactostasis of cracked nipples and resuming breastfeeding after recovery from mastitis; weakened children with anemia, hypotrophy of rickets diathesis and other manifestations of allergies; with whooping cough - 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 occurring against the background of microflora disorders with a deficiency or absence of bifidoflora;

- with intestinal dysfunctions as a result of intestinal dysbiosis arising as a result of prolonged antibacterial hormonal radiation and other therapy in stressful situations and in extreme conditions, as well as for the prevention of dysbiosis in these persons.

In obstetric and gynecological practice:

- in order to prevent mastitis for local treatment of the mammary glands of nursing mothers of the 'risk' group (in women with an inverted flat nipple with a decrease in its erection, the presence of cracks) with a burdened epidemiological situation in maternity hospitals;

- in case of violation of the purity of the vaginal secretion up to III-IV degree in pregnant women of the 'risk' group;

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

Contraindications:

Hypersensitivity to the components of the drug.

Pregnancy and lactation:

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

Method of administration and dosage: