Bifiliz (VIGEL) lyophilisate for preparation of suspension for oral administration 5 doses., No. 10

The drug is intended for the treatment and prevention of dysbacteriosis and intestinal infections in children of all age groups and adults.

Applicable:

- for the treatment and prevention of dysbiosis of various origins and intestinal dysfunctions: in newborns and infants with early artificial and mixed feeding; in patients with secondary immunodeficiency states, including after cytostatic therapy; with severe infectious-inflammatory and purulent-septic diseases against the background and after the use of broad-spectrum antibiotics;

- for the treatment of acute intestinal infections of bacterial etiology, including dysentery, salmonellosis of food toxicoinfections, especially with pronounced symptoms of intoxication and with intolerance to antibiotics;

- for the treatment of acute and chronic nonspecific diseases of the digestive tract, accompanied by inhibition of reparative processes in the intestinal mucosa (gastroduodenitis, proctosigmoiditis, colitis, including ulcerative colitis);

- to prevent infectious and destructive complications (including ulcerative necrotizing colitis) in neonatal intensive care units in premature infants with a burdened premorbid background in mixed pathology (infectious and inflammatory diseases, the threat of sepsis, hypotrophy, anemia, atopic dermatitis, etc.) against a background of intense therapy.

The drug is intended for oral administration 20-30 minutes before meals. Young children can be given the drug immediately before meals or with the first portions of food.

The drug is dissolved in boiled water at room temperature immediately before use.

The bottle with the drug should be opened, filled to the top with water, closed again with a rubber stopper and left for 2-3 minutes at room temperature; after shaking, the preparation is ready for use.

Do not dissolve the drug in hot water and store it dissolved.

For therapeutic purposes, the drug is prescribed to children of the first six months, 5 doses (1 bottle) 1-2 times a day; children from 6 months to 1 year, 5 doses 2 times a day; adults and older children - 5 doses (1 bottle) 2-3 times a day.

In acute intestinal infections, the drug is prescribed in short courses (5-7 days), sometimes up to 10 days; in the presence of concomitant diseases of the digestive tract, pronounced changes in the microbiocenosis and intestinal mucosa, it is advisable to lengthen the course of treatment to 20 days.

In case of dysbiosis and persistent intestinal dysfunctions, the drug is used for 10-20 days, depending on the severity of the course of the disease.

For the prevention of dysbiosis and intestinal infections, the drug is used for 10 days: for children of the first six months of life, 1 dose per reception 1 time per day, children of other age groups and adults - 5 doses 2 times a day.

If necessary, it is possible to repeat the courses of using the drug with an interval of 2-3 months.

1 dose:

Active ingredients: live bifidobacteria Bifidobacterium bifidum 1 - not less than 107, lysozyme hydrochloride - (10 ± 1) mg.

Excipients *: milk 12-15%, sugar 5-7%, gelatin 0.7-2.0%.

* The content of the components of the protective drying medium in the finished product is not determined

Allergic reactions to chicken egg protein.

Trade name of the drug

Bifilis (VIGEL)

International non-proprietary name

Bifidobacterium bifidum + Lysozyme

Dosage form

lyophilisate for preparation of oral suspension

Composition

1 dose:

Active ingredients: live bifidobacteria Bifidobacterium bifidum 1 - not less than 107, lysozyme hydrochloride - (10 ± 1) mg.

Excipients *: milk 12-15%, sugar 5-7%, gelatin 0.7-2.0%.

* The content of the components of the protective drying medium in the finished product is not determined

Description

A porous or crystalline mass of various shades of beige or whitish-gray, with a specific odor.

Pharmacotherapeutic group

MIBP-eubiotic

ATX code

A07FA

Pharmacodynamics:

The therapeutic effect of the drug is due to the presence of bifidobacteria in its composition, the action of which is aimed at normalizing the intestinal microflora and lysozyme as a natural factor in the protection of the gastrointestinal tract.

Live bifidobacteria with high antagonistic activity against a wide range of opportunistic and enteropathogenic microorganisms displace the latter from intestinal microbiocenosis, creating favorable conditions for normalizing microflora and improving metabolic processes, preventing the formation of protracted forms of intestinal diseases. Lysozyme has a bifidogenic immunomodulatory anti-inflammatory effect, stimulates metabolic reparative processes and erythropoiesis improves digestion, increases anti-infectious and antitoxic resistance of the body, has an antibacterial effect and exhibits synergism with many antibiotics.

The optimal combination of bifidobacteria and lysozyme in the composition of the drug makes it possible to enhance the therapeutic effect of each component and to limit the use of antibiotics for the treatment of intestinal infections and the selective decontamination of pathogenic microflora.

Indications:

The drug is intended for the treatment and prevention of dysbacteriosis and intestinal infections in children of all age groups and adults.

Applicable:

- for the treatment and prevention of dysbiosis of various origins and intestinal dysfunctions: in newborns and infants with early artificial and mixed feeding; in patients with secondary immunodeficiency states, including after cytostatic therapy; with severe infectious-inflammatory and purulent-septic diseases against the background and after the use of broad-spectrum antibiotics;

- for the treatment of acute intestinal infections of bacterial etiology, including dysentery, salmonellosis of food toxicoinfections, especially with pronounced symptoms of intoxication and with intolerance to antibiotics;

- for the treatment of acute and chronic nonspecific diseases of the digestive tract, accompanied by inhibition of reparative processes in the intestinal mucosa (gastroduodenitis, proctosigmoiditis, colitis, including ulcerative colitis);

- to prevent infectious and destructive complications (including ulcerative necrotizing colitis) in neonatal intensive care units in premature infants with a burdened premorbid background in mixed pathology (infectious and inflammatory diseases, the threat of sepsis, hypotrophy, anemia, atopic dermatitis, etc.) against a background of intense therapy.

Contraindications:

Allergic reactions to chicken egg protein.

Pregnancy and lactation:

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

Method of administration and dosage: