Linex baby®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LINEX BABY® (LINEXBABY®)

Composition:

Active substance: Bifidobacterium animalis subsp. lactis;

1 sachet (1.5 g) of powder for oral suspension contains 1,000,000,000 CFU of Bifidobacterium animalis subsp. lactis;

Excipient: maltodextrin.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical characteristics: powder from white to light beige in color.

Pharmacotherapeutic group. Microbial anti-diarrheal agents.

ATC code A07FA01.

Pharmacological Properties

Pharmacodynamics

Linex Baby® contains Bifidobacterium animalis subsp. lactis, a bacterium naturally present in the intestinal microbiota and belonging to the class of lactic acid bacteria. The gut flora of breastfed infants is predominantly composed of these bacteria, which are considered important during early infant development.

There are several potential mechanisms through which Bifidobacterium animalis subsp. lactis exerts protective and therapeutic effects.

Inhibition of pathogenic bacterial growth occurs through:

• Lowering the pH level in the gastrointestinal tract (as a result of the ability of Bifidobacterium animalis subsp. lactis to produce acids);
• Production of metabolites toxic to pathogenic bacteria (such as H₂O₂);
• Production of antibacterial substances and bacteriocins;
• Competition with pathogenic bacteria for nutrients;
• Blocking of adhesion receptors, thereby inhibiting colonization by other potentially pathogenic microorganisms.

This product also exerts a stimulatory effect on the immune system.

Disruption of intestinal microbial balance (e.g., due to viral or gastrointestinal infections, including rotavirus infections, treatment with broad-spectrum antibiotics, or chemotherapy agents), or delayed establishment of stable gut microbiota in infants, may lead to gastrointestinal 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 gastrointestinal symptoms (primarily diarrhea) associated with intestinal microbial imbalance and supports regular bowel function.

This preparation may also be used for the prevention of atopic dermatitis and as a supportive agent to stabilize intestinal immune system function.

Pharmacokinetics

Bifidobacterium animalis subsp. lactis acts locally within the gastrointestinal tract. After oral administration, systemic absorption is not observed. Therefore, standard pharmacokinetic studies are not applicable. The strain's resistance to gastric acid and bile ensures high survival rates as it passes through the stomach and duodenum. The strain can form a close association with intestinal mucus. Like other microorganisms present in the gastrointestinal tract, it is gradually eliminated through peristalsis and defecation.

Clinical characteristics.

Indications.

For newborns and children up to 12 years of age:

• for stabilization and maintenance of intestinal microflora balance and function;

• as a prophylactic and supportive agent in cases of diarrhea, flatulence, and other disturbances caused by:

  * viral and bacterial infections of the gastrointestinal tract (e.g. rotavirus infections),

  * treatment with antimicrobial agents (antibiotics and other synthetic antimicrobial agents).

Contraindications.

Hypersensitivity to the active substance or to maltodextrin.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

As with other bacteria, bifidobacteria are sensitive to antibiotics. Therefore, it is recommended to take Linex baby® at least 3 hours after taking antibiotics.

Special precautions for use.

Before starting treatment, parents should consult a physician if the child has any of the following symptoms:

• body temperature above 38 °C;
• blood or mucus in stools;
• diarrhea lasting more than two days;
• severe diarrhea with dehydration and weight loss;
• diarrhea accompanied by severe abdominal pain;
• diarrhea and any chronic disease (e.g. diabetes mellitus, chronic cardiovascular disorders) or immunodeficiency state (including HIV infection).

Treatment of diarrhea in children under 6 years of age should be carried out under medical supervision.

When treating diarrhea, it is essential to restore fluid and electrolyte losses.

Use during pregnancy or breastfeeding.

Linex Baby® is indicated for infants from birth up to children aged 12 years.

No adverse effects associated with the use of Bifidobacterium animalis subsp. lactis during pregnancy and lactation have been reported. However, in case of acute diarrhea during pregnancy and lactation, precautionary measures should be taken to prevent development of fluid and electrolyte deficiency or any other adverse effects that could endanger the mother or the unborn child.

Treatment of diarrhea during pregnancy and lactation should be carried out under medical supervision.

Ability to affect reaction rate when driving or operating machinery.

No studies on the influence on the ability to drive vehicles or operate machinery have been conducted.

Dosage and Administration.

Infants from birth and children up to 2 years of age

One sachet once daily during a meal.

Children from 2 to 12 years of age

One sachet one or two times daily during a meal.

The sachet should be opened and its contents poured into a glass of water, juice, milk, or infant formula.

Linex Baby® should not be taken with hot beverages.

Linex Baby® may be taken for as long as the appropriate symptoms persist.

Children.

Linex Baby® is used in infants from birth and in children up to 12 years of age.

Overdose.

Cases of overdose have not been reported.

Side effects.

Adverse events are classified by organ systems and listed in decreasing order of frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000, including single case reports).

Immune system disorders

Rare: hypersensitivity reactions (rash, pruritus).

Shelf life. 2 years.

Storage conditions.

Store in original packaging. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. Pouches made of aluminum foil, laminated on the outer side with polyester film and on the inner side with polyethylene film, containing 1.5 g of powder for oral suspension. A cardboard box containing 10 or 20 pouches.

Prescription status. Over-the-counter (without prescription).

Manufacturer.

Lek Pharmaceuticals d.d.

Manufacturer's address and place of business.

Verovškova 57, Ljubljana 1526, Slovenia.