Bifidumbacterin - instructions for use, dose, side effects, contraindications

The preparation is a microbial mass of living antagonistically active strains of bifidobacteria (Bifidobacterium bifidum 1 or Bifidobacterium bifidum 791) lyophilized in a culture medium with the addition of a protective sucrose-gelatin-lactic drying medium

Pharmacotherapeutic group:Eubiotic

ATX: & nbsp

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

Pharmacodynamics:

The therapeutic effect of Bifidumbacterin is caused by the content of live bifidobacteria in it, which have antagonistic activity against a wide range of pathogenic and conditionally pathogenic microorganisms, and thereby normalize the intestinal microflora, improve the activity of the gastrointestinal tract, and prevent the formation of protracted forms of intestinal diseases.

^*The content of the components of the drying protective medium in the finished preparation does not determine

Indications:

Treatment and prevention of dysbacteriosis of various etiologies in children and adults. Children (including premature) drug can be used from the first days of life.

In diseases of the gastrointestinal tract:

- long-term intestinal dysfunction of unknown etiology;

- acute intestinal infections (in the complex treatment of acute dysentery, salmonellosis, escherichiosis, viral diarrhea, etc.), long-term intestinal dysfunctions of staphylococcal etiology, and treatment of convalescents after acute intestinal infections with continuing intestinal 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;

- 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 with 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;

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

- 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, as well as with the goal of preventing dysbiosis;

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

In diseases of the female sexual sphere:

- if the purity of the vaginal secretion is violated to grade III-IV in the pregnant "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:

Hypersensitivity to the components of the drug.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and during lactation during controlled clinical trials has not been investigated.

Dosing and Administration:

Bifidumbacterin in 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 drug dissolves no more than 5 minutes with the formation of a homogeneous opaque suspension), the contents of the vial should be transferred to the sameglass and mix. One teaspoon of the drug dissolved in this way is 1 dose. Dissolved drug may be stored for no more than 12 hours at a temperature of 2 to 25 ° C. The required number of doses (respectively, tea spoons) should be taken 20-30 minutes before meals. Breast children can be given the drug immediately before feeding.

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

Newborn group "risk" it is advisable to begin the use of the drug in the maternity ward from the first day of life to discharge for 2.5 doses per reception 2 times a day.

Children with sepsis, pneumonia and other purulent-infectious diseases prescribe 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 chronic inflammatory diseases of the small and large intestine, colitis and enterocolitis in adults it is recommended to take 5 doses 2-3 times a day.

With intestinal diseases duration of treatment 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.

Treatment of the nipple area and areola of the puerperas: (5 doses) to impregnate 2 sterile swabs and apply them to the mammary gland for 20-30 minutes before feeding. The course of treatment is 5 days.

With intravaginal application soaked sterile swab in the vagina and leave for 2-3 hours.

With inflammatory diseases of the female genitalia and prenatal preparation of the pregnant "risk" Bifidumbacterin is prescribed for 5-10 doses 1 time per day for 5-8 days under the control of the restoration of purity of the vaginal secretion to I-II degree and disappearance of clinical symptoms of inflammation.

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

For preventive purposes prescribe 5 doses 1-2 times a day for 1-2 weeks.

Side effects:

Side effect of the drug is not established.

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

Overdose:

Cases of overdose are not registered.

Interaction:

With simultaneous administration with chemo- and antibacterial drugs, a decrease in therapeutic efficacy is possible.

Special instructions:

Do not dissolve the preparation in hot water (above 40 ° C).

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

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, 12 or 14 bottles in a pack (box) of cardboard with instructions for use.

Storage conditions:

At a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Transportation conditions. At a temperature of 2 to 8 ° C.

Shelf life:

1 year (at maintenance at an output in one dose from 1 х 10⁷ up to 5х10⁷ live bifidobacteria).

2 years (if the content of the release in a single dose of more than 5x10⁷ live bifidobacteria).

The drug is not eligible for use with expired use.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002159

Date of registration:28.10.2011 / 02.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp07.04.2017

Illustrated instructions

Instructions

Bifidumbacterin (Bifidumbacterin)