Order of the Ministry of Health
as of 06.04.11 No. 193
State Registration Certificate
No. 838/11-300200000 as of 06.04.11
For Application of Drug
Main properties of the drug.
Effects of Lactomun are caused by bacteria which produce lactic acid and possess antagonist activity against pathogenic and opportunistic pathogenic microorganisms, and create favourable conditions for normal intestinal biocenosis. Lactic and bifidus bacteria perform enzymatic breakdown of proteins, fats and complex carbohydrates, and stimulate processes of reparation of mucous membrane of intestine.
Lactomun is a powder of white to beige colour; red impregnations are allowed.
One sachet contains:
Active substances: Bifidobacterium bifidum, Bifidobacterium lactis, Lactococcus lactis not less than 1.0×109 CFU/g.
Adjuvants: rice starch – 2.34 g, maltodextrin – 0.60 g.
Dosage Form. Powder for oral suspension.
ATC Code. Lactic acid producing organisms. A07FA01.
Immunologic and Biological Properties
Lactomun is a combined microbial drug which contains high-efficient combination of live bacteria: Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium lactis. These probiotic bacteria are the normal component of natural intestinal microflora and are contained in digestive tract of a new-born baby. These bacteria have large biochemical significance for human organism:
- lactic fermentation changes pH factor to acidic. Acidic medium inhibits growth of pathogenic and opportunistic pathogenic bacteria and ensures optimum activity of digestive enzymes;
- participate in synthesis of vitamins of group B, vitamin K, ascorbic acid, increasing resistance of organism to unfavourable environmental factors;
- take part in metabolism of bile pigments and bile acids;
- synthesize substances with anti-bacterial activity;
- increase immune reactivity of organism.
Lactic bacteria and bifidus bacteria of Lactomun maintain and regulate physiological balance of intestinal microflora, favour quick colonisation with commensal bacteria and simultaneously prevent colonisation and growth of pathogenic bacteria. Intestinal barrier is strengthened by probiotics by means of several mechanisms of action, including by means of restoration of structure of impermeable protein membrane, which stimulates regulation of mucin genes and secretion of defensins. Immunostimulating properties of probiotic bacteria of Lactomun are caused by their ability to reduce reactivity of type 1 T-helpers and T-suppressors, which is particularly important for immunity strengthening and prevention of allergy development in pregnant women and babies.
Indications for Application
- Prevention and treatment of intestinal dysbacteriosis in premature new-borns and babies that were born by means of caesarean section;
- Prevention and treatment of intestinal dysbacteriosis in babies that are artificially fed or take antibiotics;
- Prevention of allergic diseases (atopic dermatitis, diathesis, urticaria, food allergy) in babies form the first day of life (if one or both parents have allergic diseases in past history);
- Treatment of allergic diseases in babies from the first day of life (atopic dermatitis, diathesis, urticaria, food allergy) in course of combined treatment;
- Prevention of allergic diseases in pregnant (if one or both parents of future baby have complicated allergic history);
- Treatment of allergic diseases in pregnant women in course of combined treatment.
Method of Application and Dosage
New-borns and infants aged under 2: ½ sachet once a day;
Pregnant and children aged 2 and above: 1 sachet once a day.
Unused contents of sachet should be stored in refrigerator for not longer than 24 hours.
Dissolve contents of 1 sachet in 100 ml of water, milk or fruit juice of room temperature, leave for 10 minutes, stir thoroughly and drink, preferably with meals. Mixture received is a white-colour suspension.
Duration of treatment depends on the cause of disease and individual properties of organism.
Drug is well-tolerated; any reports of side effects are absent.
Hypersensitivity to drug components or dairy products.
Peculiarities of Application
Lactic and bifidus bacteria, as other bacteria, are sensitive to action of antibiotics, therefore, it is recommended to take Lactomun 3 hours after taking the antibiotics.
Information about overdosage cases is absent.
Store in original packaging under the temperature below 25°C out of reach of children.
14 sachets in cardboard box with application instructions.
Winclove Bio Industries B.V., Hulstweg 11, 1032 LB Amsterdam, Netherlands.
Variopack Lohnfertigungen GmbH, Kolberger Str. 13-15, 63667 Nidda-Harb, Hesse, Germany.