Bifidumbacterium
Producer: Federal state unitary enterprise NPO Mikrogen Russia
Code of automatic telephone exchange: A07FA
Release form: Liquid dosage forms. Lyophilisate for suspension preparation.
General characteristics. Structure:
Active ingredient: from 1х107 to 5х107 live bifidobacteria or more than 5х107 live bifidobacteria.
Excipients: components of the protective environment of drying * (gelatin, sucrose (sugar), milk).
Structure of the protective environment of drying: edible gelatin, the P-11 or K-13 brand, lumpy white sugar or granulated sugar, or sucrose, powdered milk the fat-free or drinking milk pasteurized fat-free, or the milk fat-free - the raw materials pasteurized (in terms of dry matter).
Pharmacological properties:
Pharmacodynamics. The therapeutic effect of Bifidumbacterium is caused by contents in it live bifidobacteria which have antagonistic activity against a wide range of pathogenic and opportunistic microorganisms and by that normalize intestinal microflora, improve activity of digestive tract, interfere with formation of long forms of intestinal diseases.
* The maintenance of components of the protective environment of drying in ready drug is not defined
Indications to use:
Treatment and prevention of dysbacterioses of various etiology at children and adults. Children (including premature) can use drug from the first days of life.
At digestive tract diseases:
- long intestinal dysfunctions of an unspecified etiology;
- acute intestinal infections (in complex treatment of acute dysentery, salmonellosis, esherikhioz, viral diarrheas, etc.), long intestinal dysfunctions of a staphylococcal etiology, and also treatment of convalescents after acute intestinal infections at the proceeding intestines dysfunction;
- in complex treatment of children (including newborn, premature), patients with pneumonia, sepsis and others it is purulent - infectious diseases, for prevention or stopping of disorders of function of intestines at them and prevention of development of an ulcer and necrotic coloenteritis;
- children with the burdened premorbidal state: been born prematurely or with signs of prematurity, receiving antibiotics in the early neonatal period; children whose mothers had heavy toxicoses, extragenital diseases had the long anhydrous period or other pathology; children of mothers having лактостаз, a nipple crack and resuming feeding by a breast after recovery from mastitis; the weakened children with anemia, a hypotrophy, rickets, diathesis and other displays of an allergy; at a disease of whooping cough, especially in the presence they any frustration have functions of intestines;
- at early transfer of children of chest age into artificial feeding;
- acute and chronic inflammatory diseases of a large and small intestine (colitis, coloenterites) at children of advanced age and adults proceeding against the background of disturbances of microflora with deficit or absence bifidoflor;
- intestinal dysfunctions as a result of the intestinal dysbiosis which arose as a result of long antibacterial, hormonal, radiation and other therapy at stressful situations and stay in extreme conditions, and also for the purpose of prevention of dysbacteriosis;
- for the purpose of prevention of mastitis for local processing of mammary glands of nursing mothers of group of "risk" (at women with the pulled-in flat nipple, decrease in its erection, existence of cracks) at a difficult epidemiological situation in maternity hospitals.
At diseases of a female genital:
- at disturbance of purity of a vaginal secret to the III-IV degree at pregnant women of group of "risk",
- at the bacterial colpitises caused by staphylococcus and colibacillus (in monoflora or in associations), and also at senile colpitises of the hormonal nature.
Route of administration and doses:
Bifidumbacterium at intestinal diseases is applied inside, and in obstetric gynecologic practice intravaginalno.
To dissolve contents of a bottle boiled water of room temperature at the rate of 5 ml (teaspoon) of water on 1 dose of drug.
To carry out dissolution as follows: in a glass to pour a necessary amount of water (according to quantity of the doses specified on a bottle); to open a bottle, having removed a cap and a stopper; from a glass to transfer a small amount of water to a bottle; after dissolution (drug is dissolved no more than 5 min. with formation of homogeneous opaque suspension) to transfer contents of a bottle to the same glass and to mix. One teaspoon of the drug dissolved thus makes 1 dose. The dissolved drug is allowed to store no more 12th hour at a temperature from 2 to 25 °C. To accept necessary quantity of doses (according to teaspoons) in 20-30 min. prior to food. Babies can give drug just before feeding.
At intestinal diseases: to children of the first half of the year of life drug is appointed on 5 doses to reception by 2 times a day, to children of the second half of the year and are more senior - on 5 doses 3 times a day. It is reasonable to newborn of group of "risk" to begin use of drug in delivery room from first days of life to an extract on 2,5 doses on reception 2 times a day.
To children at sepsis, pneumonia and others it is purulent - infectious diseases appoint 5 doses 3 times a day in a complex with the standard methods of treatment of a basic disease. At emergence at this group of children of dysfunctions of digestive tract and threat of an ulcer and necrotic coloenteritis the dosage of Bifidumbacterium is increased to 20 doses a day.
At acute chronic inflammatory diseases of a small and large intestine, colitis and coloenterites at adults about 5 doses 2-3 times a day are recommended to accept.
At intestinal diseases duration of a course of treatment of Bifidumbacterium is defined by weight of clinical manifestations, age of the patient and makes 2-4 weeks, and in some cases - up to 3 months.
Processing of area of a nipple and areola of women in childbirth: to impregnate with the dissolved drug (5 doses) 2 sterile tampons and to put them to a mammary gland for 20-30 min. before feeding. A course of treatment - 5 days.
At intravaginalny use to enter the sterile tampon impregnated with drug into a vagina and to leave for 2-3 hours.
At inflammatory diseases of female genitalias and prenatal training of pregnant women of group of "risk" Bifidumbacterium is appointed till 5-10 doses within 5-8 days under control of recovery of purity of a vaginal secret to the I-II degree and disappearance of clinical symptoms of an inflammation once a day.
If necessary the course of treatment Bifidumbacterium can be repeated.
With the preventive purpose appoint 5 doses 1-2 times a day within 1-2 weeks.
Features of use:
Pregnancy and lactation. Safety of use of this medical supply at pregnancy and during feeding by a breast in the course of controlled clinical tests was not investigated.
Dissolution of drug in hot water (above 40 °C) is not allowed.
Drug which integrity of packaging is broken (the burst bottles), drug not marked, in the presence of foreign inclusions is unsuitable for use.
Influence on ability to manage vehicles and mechanisms. It was not studied.
Side effects:
Side effect of drug is not established.
Interaction with other medicines:
At a concomitant use with himio-and antibacterial drugs decrease in a therapeutic effectiveness is possible.
Contraindications:
No.
Overdose:
It is not registered.
Storage conditions:
According to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. To store in the place, unavailable to children. A period of validity - 1 year (at contents at release in one dose from 1х107 to 5х107 live bifidobacteria). 2 years (at contents at release in one dose more than 5х107 live bifidobacteria). Drug is not subject to expired use.
Issue conditions:
Without recipe
Packaging:
Lyophilisate for preparation of suspension for intake and topical administration. Packaging: on 3 or 5 doses in a bottle. On 10, 12 or 14 bottles in a pack (box) from a cardboard with the application instruction.