Instructions Linex Baby powder for oral suspension 1000000000 IU package 1.5 g No. 20
Composition
active ingredient: Bifidobacterium animalis subsp. lactis;
1 packet (1.5 g) of powder for oral suspension contains 1,000,000,000 CFU of Bifidobacterium animalis subsp. lactis;
excipient: maltodextrin.
Dosage form
Powder for oral suspension.
Main physicochemical properties: white to light beige powder.
Pharmacotherapeutic group
Antidiarrheal microbial drugs.
ATX code A07F A01.
Pharmacological properties
Pharmacodynamics
Linex Baby® contains Bifidobacterium animalis subsp. lactis, which is part of the normal intestinal microbiota and belongs to the class of lactic acid bacteria. The microflora of breastfed infants mainly consists of these bacteria, which are considered important in the early period of infant development.
There are several potential mechanisms by which the protective and therapeutic effects of Bifidobacterium animalis subsp. lactis are provided.
Inhibition of the growth of pathogenic bacteria occurs by:
lowering the pH level in the intestinal tract (which is a result of the ability of Bifidobacterium animalis subsp. lactis to produce acids); production of metabolites toxic to pathogenic bacteria (production of H2O2); production of antibacterial substances, bacterions; competition with pathogenic bacteria for nutrients; blocking adhesive receptors and, thus, inhibiting the colonization of other potentially pathogenic microorganisms.
This remedy also has a stimulating effect on the immune system.
Disruption of the balance of intestinal microflora (e.g., as a result of viral or gastrointestinal infections (including rotavirus infections), treatment with broad-spectrum antibiotics and drugs intended for chemotherapy) or a delay in the formation of a permanent intestinal microflora in infants can induce digestive disorders (such as colic, flatulence, diarrhea, and constipation) and atopic dermatitis.
Regular intake of Bifidobacterium animalis subsp. lactis effectively reduces the frequency and severity of mild to moderate symptoms of digestive disorders (mainly diarrhea) associated with disruption of the normal intestinal microflora, and ensures regular bowel function.
This drug can also be used to prevent atopic dermatitis and as a supportive agent to stabilize the function of the intestinal immune system.
Pharmacokinetics
Bifidobacterium animalis subsp. lactis acts locally in the gastrointestinal tract. After oral administration, systemic absorption is not observed. Therefore, standard pharmacokinetic studies are not used. The resistance of Bifidobacterium animalis subsp. lactis to gastric acid and bile makes it possible to ensure a high percentage of survival of the strain when passing through the stomach and duodenum. The strain can form a tight bond with the intestinal mucus. Like other microorganisms contained in the gastrointestinal tract, it is gradually excreted due to peristalsis and as a result of defecation.
Indication
For infants from birth and children up to 12 years of age:
to stabilize and maintain the balance and function of intestinal microflora; as a preventive and supportive measure in case of diarrhea, flatulence and other disorders caused by: viral and bacterial infections of the gastrointestinal tract (e.g. rotavirus infections), treatment with antimicrobial drugs (antibiotics and other synthetic antimicrobials).
Contraindication
Hypersensitivity to the active substance or to maltodextrin.
Special safety precautions
Before starting treatment, parents should consult a doctor if their child has the following symptoms:
body temperature above 38°C; blood or mucus in the stool; diarrhea that lasts more than two days; profuse diarrhea with dehydration and weight loss; diarrhea accompanied by severe abdominal pain; diarrhea and another chronic disease (e.g. diabetes, chronic cardiovascular disorders) or immunodeficiency state (in particular HIV infection).
Treatment of diarrhea in children under 6 years of age should be carried out under the supervision of a physician.
When treating diarrhea, it is imperative to replace lost fluids and electrolytes.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted.
Like other bacteria, bifidobacteria are sensitive to antibiotics. Therefore, it is recommended to take Linex Baby® at least 3 hours after taking antibiotics.
Application features
Before starting treatment, parents should consult a doctor if their child has the following symptoms:
body temperature above 38°C; blood or mucus in the stool; diarrhea that lasts more than two days; profuse diarrhea with dehydration and weight loss; diarrhea accompanied by severe abdominal pain; diarrhea and another chronic disease (e.g. diabetes mellitus, chronic cardiovascular disorders) or immunodeficiency state (in particular HIV infection).
Treatment of diarrhea in children under 6 years of age should be carried out under the supervision of a physician.
When treating diarrhea, it is imperative to replace lost fluids and electrolytes.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies on the effect on the ability to drive and use machines have been conducted.
Use during pregnancy or breastfeeding
Linex Baby® is used for infants from birth and children up to 12 years of age.
No adverse effects have been reported with the use of Bifidobacterium animalis subsp. lactis during pregnancy and lactation. However, in case of acute diarrhea during pregnancy and lactation, precautions should be taken to prevent fluid and electrolyte depletion or any other adverse effects that may be harmful to the unborn child or the mother.
Treatment of diarrhea during pregnancy and lactation should be carried out under the supervision of a physician.
Method of administration and doses
Infants from birth and children up to 2 years of age
One packet once a day with meals.
Children aged 2 to 12 years
One packet once or twice a day with meals.
The package should be opened and its contents poured into a glass of water, juice, milk or baby food.
Linex Baby® should not be taken with hot drinks.
Linex Baby® can be taken as long as the corresponding symptoms are present.
Children
Linex Baby® is used for infants from birth and children up to 12 years of age.
Overdose
No cases of overdose have been reported.
Adverse reactions
Adverse reactions are classified by system organ class and listed in order of decreasing frequency: very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1000 - <1/100), rare (≥ 1/10,000 - <1/1000), rare (< 1/10,000, including isolated case reports).
On the part of the immune system
Rare: hypersensitivity reactions (rash, itching).
Expiration date
2 years.
Storage conditions
Store in original packaging. Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
Sachets of aluminum foil laminated on the outside with polyester film and on the inside with polyethylene film, containing 1.5 g of powder for oral suspension. Cardboard box containing 20 sachets.
Vacation category
Without a prescription.
Producer
Lek Pharmaceutical Company Ltd.
Location of the manufacturer and its business address
Verovškova 57, Ljubljana 1526, Slovenia.
