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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder: sachets 1.5 g 10 or 20 pcs.
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Lek Pharmaceuticals, d.d. (Slovenia)
Dosage Form
| 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.
Oral solution: 8 ml bottle with a dropper-dispenser
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Biofarma, S.r.l. (Italy)
For
CHR. HANSEN, A/S (Denmark)
Dosage Form
| 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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