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Linex for kids® (Liquid, Powder) Instructions for Use

Properties

Dietary supplement, a source of probiotic microorganisms. The probiotic contains bifidobacteria Bifidobacterium Animalis subsp. lactis (BB-12), which are important for a child.

Bifidobacteria are present in breast milk and begin to colonize the newborn’s intestine from the first hours of life. The strain Bifidobacterium Animalis subsp. lactis (BB-12) has a high safety profile, good tolerability, and clinical efficacy in children from the neonatal period.

Bifidobacteria contribute to the natural formation of normal intestinal microflora and function, and also create an optimal environment in the intestine for the action of digestive enzymes. Furthermore, bifidobacteria ensure the proper formation of immunity and help reduce the risk of infectious diseases, the possibility of atopic dermatitis and food allergy manifestation in young children. In breastfed children, bifidobacteria constitute 60-91% of the microflora.

Scope of Application

Establishment and maintenance of the balance of the composition and functional state of the intestinal microflora, including in infants under one year of age, with digestive disorders such as colic, gas formation, stool disorders (constipation, diarrhea) and other digestive disorders; maintenance of the balance of the composition and functional state of the intestinal microflora during antibiotic therapy and after its completion; reduction of the risk of diarrhea caused by viral or bacterial gastrointestinal infections (including rotavirus infection); support for the formation and functioning of the immune system; prevention of atopic dermatitis in children.

ICD codes

ICD-10 code Indication
A04.9 Unspecified bacterial intestinal infection
A08.0 Rotaviral enteritis
A08.4 Viral intestinal infection, unspecified
K59.0 Constipation
K59.1 Functional diarrhea
K59.8 Other specified functional intestinal disorders
K63.8 Other specified diseases of intestine
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
R10.4 Other and unspecified abdominal pain (colic)
R14 Flatulence and related conditions (including abdominal bloating, belching)
Y40 Systemically acting antibiotics
ICD-11 code Indication
1A0Z Bacterial intestinal infections, unspecified
1A22 Gastroenteritis due to Rotavirus
1A2Y Other specified viral intestinal infections
1A2Z Viral intestinal infections, unspecified
9A06.70 Atopic eczema of the eyelids
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB32.1 Slow-transit constipation
DB32.3 Acquired hypoganglionosis of the colon
DB32.Z Colonic motility disorders, unspecified
DB36.Z Certain infections of the colon, unspecified
DD90.2 Functional heartburn
DD91.1 Functional constipation
DD91.2 Functional diarrhea
DD91.Y Other specified irritable bowel syndrome or functional bowel disorders
DD93.1 Infantile colic
DD93.Y Other specified functional gastrointestinal disorders in infants, toddlers and school-age children
DD9Z Functional gastrointestinal disorders, unspecified
DE2Z Diseases of the digestive system, unspecified
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA85.20 Atopic hand eczema
MD81.4 Other and unspecified abdominal pain
ME08 Flatulence and related conditions
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Powder, Liquid

Take orally, with meals, once a day. The frequency of use depends on the child’s age.

The recommended duration of administration is 20-30 days. If necessary, the course can be repeated after 1 month.

Contraindications

Individual intolerance to the components of the dietary supplement.

Special Instructions

Consult a pediatrician before use.

If a course of antibiotic therapy is necessary, it should be taken no earlier than 3 hours after taking antibiotics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Lek Pharmaceuticals, d.d. (Slovenia)

Dosage Form

Bottle OTC Icon Linex for kids® Powder: sachets 1.5 g 10 or 20 pcs.

Dosage Form, Packaging, and Product Composition

Powder 1 sachet
Lyophilized bifidobacteria 100 mg,
Including Bifidobacterium Animalis subsp. lactis (BB-12) (strain DSM No. 15954)* 1.5×109 CFU

Excipients: maltodextrin (filler) – 1400 mg.

1.5 g – sachets (10) – cardboard boxes.
1.5 g – sachets (20) – cardboard boxes.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Biofarma, S.r.l. (Italy)

For

CHR. HANSEN, A/S (Denmark)

Dosage Form

Bottle OTC Icon Linex for kids® drops Oral solution: 8 ml bottle with a dropper-dispenser

Dosage Form, Packaging, and Product Composition

Liquid for oral administration 1 daily dose
Bifidobacterium animalis subsp. lactis (BB-12) Not less than 1.0×109 CFU

Composition: sunflower oil (sunflower oil, antioxidants DL-alpha tocopherol and citric acid), lyophilized bifidobacteria (Bifidobacterium animalis subsp. lactis (BB-12)), sucrose, maltodextrin, antioxidant sodium ascorbate.

8 ml – bottles with a dropper-dispenser (1) – cardboard boxes.

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