Bifidumbacterin 5 doses 20 capsules

The drug is intended for the treatment of acute and chronic gastrointestinal diseases accompanied by dysbiosis in children and adults. It can be used in children (including premature infants) from the first days of life. In obstetric and gynecological practice - locally (in the form of a solution of the capsule contents), for the prevention and treatment of mastitis and vaginal dysbiosis.
In gastrointestinal diseases:

• for the treatment of prolonged intestinal dysfunctions of unknown etiology;

• in acute intestinal infections (as part of the complex treatment of acute dysentery, salmonellosis, escherichiosis, viral diarrhea, etc.), prolonged intestinal dysfunctions of staphylococcal etiology, as well as treatment of convalescents after acute intestinal infections with ongoing intestinal dysfunction;

• as part of the complex treatment of children (including newborns, premature infants) suffering from pneumonia, sepsis, and other purulent-infectious diseases to prevent or alleviate intestinal dysfunctions and prevent the development of ulcerative-necrotic enterocolitis;

• for the treatment and prevention of dysbiosis in children with a complicated premorbid condition, born prematurely or with signs of prematurity, receiving antibiotics in the early neonatal period; children whose mothers suffered from severe toxemia, extragenital diseases, had a prolonged period of amniotic fluid loss, or other pathologies; children of mothers who had lactostasis, nipple cracks, and resumed breastfeeding after recovery from mastitis; weakened children with anemia, hypotrophy, rickets, diathesis, and other manifestations of allergies; in cases of whooping cough accompanied by intestinal dysfunctions;

• when transitioning breastfed infants to artificial feeding or 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 a background of microflora disturbances with a deficiency or absence of bifidoflora;

• in cases of intestinal dysfunctions resulting from intestinal dysbiosis caused by prolonged antibacterial, hormonal, radiation, and other therapies, staying in extreme conditions, as well as for the prevention of dysbiosis in these individuals.
In obstetric and gynecological practice (in the form of a solution of the capsule contents):

• for the prevention of mastitis for local treatment of the mammary glands of breastfeeding mothers in the "risk" group (in women with retracted flat nipples, with reduced erection, presence of cracks) in a complicated epidemiological situation in maternity hospitals;

• in cases of vaginal secretion purity disturbances up to III-IV degree in pregnant women of the "risk" group;

• in bacterial vaginitis caused by staphylococcus and Escherichia coli (in monoflora or in associations), as well as in senile vaginitis of hormonal nature.

Method of Application and Dosage

1. Treatment and prevention of gastrointestinal diseases.
The drug "Bifidumbacterin" is taken orally by swallowing whole capsules with a sufficient amount of room temperature liquid or by taking a suspension obtained by dissolving the contents of an opened capsule in a small amount of cooled boiled water. When dissolved in water, it forms an opaque suspension with a specific sour-milk smell and taste. It is unacceptable to dissolve the drug in hot water and to store it in dissolved form.
Children under three years old are not recommended to be given whole capsules to avoid them entering the respiratory tract - the drug should be used in the form of a solution.
The drug is taken 20-30 minutes before meals or 1-1.5 hours after eating.
For infants, the drug can be given immediately before feeding.
In cases of acute intestinal diseases, infants in the first year of life are prescribed 5 doses (the contents of one capsule) per dose 2 times a day. For children over 1 year old - 5 doses (the contents of one capsule) 3 times a day.
In cases of sepsis, pneumonia, and other purulent-septic diseases, children are prescribed 5 doses 3 times a day in conjunction with standard treatment methods for the underlying disease. If gastrointestinal function disturbances and the threat of ulcerative-necrotic enterocolitis occur in this group of children, the dosage of Bifidumbacterin is increased to 20 doses per day.
For newborns in the "risk" group, it is advisable to start using the drug in the maternity ward from the first days of life until discharge at 2.5 doses per dose 2 times a day. The contents of 1 capsule are dissolved in a small amount of boiled water or milk.
Method of dissolution. In a clean container, pour the contents of one capsule (carefully separating the capsule cap from the body of the capsule) and add cooled boiled water, 1 teaspoon per one dose of the drug, mixing until a homogeneous suspension of whitish-gray or various shades of beige color is obtained. One teaspoon of the prepared solution constitutes one dose.
Attention! For preparing the drug solution, especially for young children, only clean containers should be used. The drug solution is not subject to storage.
For children over 3 years old and adults with acute and chronic inflammatory diseases of the small and large intestine (enterocolitis and colitis), it is recommended to take 1 capsule (5 doses) 2-3 times a day. In severe cases of the disease, the dose may be doubled.
The duration of the treatment course with Bifidumbacterin in capsules is determined by the severity of clinical manifestations, the age of the patient, and is 2-4 weeks, and in some cases - up to 3 months.
For preventive purposes, the drug is prescribed at 1 capsule (5 doses) 1-2 times a day for 1-2 weeks.
Clinical experience with the drug: a high clinical (95%) efficacy of Bifidumbacterin in capsules has been identified in the treatment of intestinal infections. Good tolerance of the drug and practically no side reactions have been observed.
2. In obstetric and gynecological practice, the drug is used locally in the form of a solution of the capsule contents. For treating the area of the nipple and areola in postpartum women, the contents of 1 capsule are dissolved in a small amount of boiled water, and 2 sterile tampons are soaked with the solution, which are applied to the nipple and areola 20-30 minutes before feeding for 5 days. The tampon soaked with the drug is left on the surface of the mammary gland until feeding begins.
In cases of inflammatory diseases of the female genitalia and prenatal preparation of pregnant women in the "risk" group, the drug in the form of a solution for soaking a tampon or douching is prescribed at 5-10 doses (the contents of 1-2 capsules) once a day for 5-8 days under the control of restoring the purity of vaginal secretions to I-II degree and the disappearance of clinical symptoms of the disease.
For intravaginal administration, Bifidumbacterin is also dissolved in the indicated manner. The resulting suspension of the drug is used to soak a sterile tampon, which is then inserted intravaginally and left for 2-3 hours.
If necessary, the course of treatment with Bifidumbacterin can be repeated.

In 1 capsule of the preparation contains:
Active ingredient:
Live bifidobacteria Bifidobacterium bifidum - not less than 5x107 CFU
Excipients: Lactulose or Lactose - not more than 17.5 %.

•

• calculated content, not determined in the finished preparation
Composition of capsule shell No. 3
Body:
Titanium dioxide (white color) - 2%
Gelatin (forming agent) - up to 100 %
Cap:
Gelatin (forming agent) - up to 100 %
Titanium dioxide (white color) - 1%
Indigo carmine (blue) - 0.1333 %

Description of the dosage form

Hard gelatin capsules No. 3, cylindrical in shape with hemispherical ends; the body of the capsule is white, and the cap of the capsule is blue. The body fits into the cap without forming gaps. The body and cap have special grooves to ensure a "lock." The contents of the capsule are a powder of various shades of beige with a specific odor.

Contraindications

The drug contains lactose, so it should not be prescribed to patients with hereditary lactose intolerance, lactase deficiency, or malabsorption syndrome.

Special instructions

Use during pregnancy and breastfeeding: bifidobacteria are representatives of the normal human microflora, therefore, preparations made on their basis can be used during pregnancy and breastfeeding.

Dissolving the preparation in hot water (above 40 °C) is not allowed. The preparation is unsuitable for use if the integrity of the packaging is compromised (the jar is cracked or the first opening control is violated), if the preparation is unmarked, if the preparation is expired, or if it has been stored under inappropriate conditions.

Effect on the ability to drive vehicles and operate machinery: the preparation does not affect the performance of activities that require special attention and quick reactions (driving vehicles, operating machinery, etc.).

Side effects

not identified.

Overdose cases have not been reported.

Section: Interaction

Clinically significant interaction of the drug with other medicinal products has not been established. Bifidumbacterin can be used simultaneously with antibacterial, antiviral, and immunomodulatory therapy. The effect is enhanced by vitamins (especially group B), and reduced by antibiotics. Corrective therapy with bifidumbacterin can be prescribed after a course of treatment with specific bacteriophages designed to eliminate conditionally pathogenic bacteria.

Pharmacodynamics

Characteristics.

“Bifidumbacterin” is a microbial mass of live, antagonistically active bifidobacteria of the Bifidobacterium bifidum 791 strain, lyophilized and placed in capsules.

Pharmacological properties.

The therapeutic effect of bifidumbacterin is determined by the live bifidobacteria it contains, which have antagonistic activity against a wide range of pathogenic and opportunistic microorganisms, thereby normalizing intestinal and vaginal microflora. A high quantitative level of bifidoflora and its predominance in the microbiocenosis, achieved through the use of bifidumbacterin, normalize the functioning of the gastrointestinal tract, improve metabolic processes, prevent the formation of chronic forms of intestinal diseases, and increase the nonspecific resistance of the body. Bifidumbacterin in the form of a solution applied locally is effective in treating inflammatory diseases of the female genitalia and in the prenatal preparation of pregnant women in the "risk group." Oral administration of bifidumbacterin in capsules allows for increased bioavailability of the drug, thereby enhancing the therapeutic effect of bifidobacteria.

Description

Bifidumbacterin 5 doses 20 pcs. capsules is a medicinal product that consists of a microbial mass of live, antagonistically active bifidobacteria of the Bifidobacterium bifidum 791 strain, lyophilized and placed in capsules. The high quantitative level of bifidoflora and its predominance in the microbiocenosis, achieved through the use of Bifidumbacterin in capsules, normalizes the activity of the gastrointestinal tract, improves metabolic processes, prevents the formation of chronic forms of intestinal diseases, and increases the nonspecific resistance of the body. Oral administration of Bifidumbacterin in capsules allows for increased bioavailability of the drug, thereby enhancing the therapeutic effect of bifidobacteria. The drug is intended for the treatment of acute and chronic gastrointestinal diseases accompanied by dysbiosis in children and adults. The drug can be used in children (including premature infants) from the first days of life. In obstetric and gynecological practice, it is used locally (in the form of a solution of the capsule contents) for the prevention and treatment of mastitis and vaginal dysbiosis. Each capsule contains 5 doses of probiotic. The "Bifidumbacterin capsules" are taken orally by swallowing whole capsules with a sufficient amount of room temperature liquid or by taking an internal suspension obtained by dissolving the contents of an opened capsule in a small amount of cooled boiled water. When dissolved in water, it forms an opaque suspension with a specific sour-milk smell and taste. It is unacceptable to dissolve the drug in hot water and to store it in dissolved form. In obstetric and gynecological practice, the drug is used locally in the form of a solution of the capsule contents. It is recommended to consult a doctor before use.