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APPROVED by:
Order of the Ministry of
Health of Ukraine
____________ No.__________
Registration Certificate
No.___________________
PATIENT LEAFLET
Medical use of the drug
LACTOBACTERINUM-BIOPHARMA
Content:
Active substance: living strains of lactic bacteria (Lactobacillus fermentum of Lactobacillus
plantarum). One dose contains at least 2•109 CFU of lactic bacteria;
Excipients: sucrose or fine-crystalline sugar, gelatin, low-fat or low-fat condensed sterilized milk.
Pharmaceutical form. Powder for oral and local administration.
Main physical and chemical properties: the drug is a live lacto bacteria microbial mass, freeze-dried;
powder (crystalline or porous mass) of yellowish-beige color with fermented smell and taste. Forms a
homogeneous a yellowish-beige suspension when adding water.
Pharmacotherapeutic group.
Antidiarrheal microbial drugs. Organisms producing lactic acid.
ATC code: A07F А01.
Pharmacological properties.
Therapeutic effect of the drug is determined by lacto bacteria that have antagonistic activity against
pathogenic and opportunistic microorganisms and create favorable conditions for development of
useful intestinal microflora. These properties of lactic bacteria associated with the accumulation by
them (in production process) of lactic acid - a strong antiseptic that determines the activity of the
drug to the pathogenic and opportunistic microorganisms (which are activated and detected in terms
of long bowel dysfunction).
Lactic acid is involved in the metabolism of calcium in the body, converting calcium contained in
food to calcium lactate which is better absorbed by the body (helps to prevent rickets in children).
The drug is also involved in the formation of vitamins and protein cleavage to form digestible amino
acids including essential ones synthesized by the body.
Clinical characteristics.
Indications.
The drug shall be used for therapeutic and prophylactic purposes in adults and children (from the first
months of life).
Lactobacterinum-Biopharma is intended for:
- prevention of development and treatment of impaired intestinal biocenosis of various etiologies;
- obstetric and gynecological procedures related to readjustment of the genital tract in case of
nonspecific inflammatory diseases of genitals and prenatal preparation of pregnant women with
disturbances of vaginal secretion purity up to III-IV risk degree.
Contraindications.
Hypersensitivity to the drug components.
Special precautions.
It is not recommended to use the drug in case of impaired integrity of the package, expiration of
shelf-life, changes in physical and chemical properties (dried mass of dark brown color sharply
reduced in volume).
Interaction with other medicinal drugs and other forms of interactions. Treatment with the drug is
recommended to be provided on the basis of vitamin therapy. Due to high stability of lacto bacteria to
antibiotics the drug application is possible in combination with antibiotic therapy. In case of specific
bacteriophages correcting therapy, Lactobacterinum-Biopharma should be administered after
treatment with bacteriophage.
Administration details.
It is unacceptable to dissolve the drug in hot water and store it after dissolution. The drug is desirable
to be washed down with milk.
Infants’ drug may be given the drug immediately before feeding. Patients who have intolerance to
some sugars installed should consult a doctor regarding the use of this drug.
Pregnancy and lactation.
Ref. to Section “Dosage and administration”.
Effects on driving or operating other mechanisms. Not studied.
Dosage and administration.
The drug shall be used as a solution; in obstetric practice – intravaginal administration. Drug
dissolution shall be only using boiled water of a room temperature (20-25 ºC).
Dissolution method:
1. The glass shall be filled with water at the rate of 1 teaspoon per 1 dose of the drug (number of
doses is indicated on the label).
2. The drug dissolution shall assume filling of water (1-2 teaspoons) from the glass to the bottle and
shaking. The drug is dissolving no more than 5 minutes forming a homogeneous mixture with sour
milk smell.
3. The dissolved drug shall be refilled from the bottle to the glass with water and mixed thoroughly.
1 teaspoon of the solution prepared in the glass represents 1 dose.
The required number of the drug solution teaspoons (doses) shall be taken for 40 minutes – 1 hour
before meal.
Daily doses for adults and children are the following depending on the age:
- children: up to 6 months – 1-2 doses (1-2 teaspoons);
- 6 months - 1 year – 2-3 doses (2-3 teaspoons);
- 1 to 3 years – 3-4 doses (3-4 teaspoons);
- above 3 years – 4-10 doses (4-10 teaspoons);
- adults: 6-10 doses (6-10 teaspoons);
Daily dose shall be divided into 2-3 administrations.
Administration duration:
- prevention of intestine biocenosis development – 3-4 weeks;
- treatment of intestine biocenosis dysorders – 4-6 weeks.
In obstetric practice, Lactobacterinum-Biopharma administration shall be intravaginal.
Soak a cotton or gauze sterile swab with a solution and insert it vaginally, leave for 2-3 hours.
In case of genitals inflammatory diseases, Lactobacterinum Biopharma shall be taken in 3 doses, 2-3
times a day for 10-12 days (starting with 10-12 day of the menstrual cycle).
In case of prenatal preparation of pregnant women with a risk group, Lactobacterinum-Biopharma
shall be used in 5-6 doses, once a day for 5-8 days. Treatment shall be carried out under control until
restoration of vaginal secretion purity to I-II degree, appearance of lactoflora and disappearance of
clinical symptoms.
Children.
The drug may be used in pediatric practice (ref. to Section “Dosage and administration”).
Overdose. Not detected.
Adverse effects. Possible development of hypersensitivity reactions.
Shelf life. 2 years.
Storage conditions. Store in a dry place protected from light at the temperature 2 to 8 ºС.
Keep away from children.
Package. 2, 3 or 5 doses in the bottle. 10 bottles in a package.
Release category. No prescription.
Manufacturer. PJSC "BIOFARMA".
Manufacturer’s address. 9 ul. N.Amosova, 03680 Kyiv, Ukraine.
Last revision date.
In the case of side effects (complications) after the application of medicinal immunobiological preparations the urgent
message shall be sent to:
Medicines & Medical Products Administration of the Ministry of Health of Ukraine (7 ul. Grushevskogo, 01021 Kiev,
phone: (044) 200-07-93);
Government Company “State Expert Centre of the Ministry of Health of Ukraine” (40 ul. Ushinskogo, 03151 Kiev,
Ukraine, phone (044) 393-75-86) and to the Manufacturer.