Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
RETINOL PALMITATE ERGOCALCIFEROL CHOLINE CHLORIDE CYANOCOBALAMIN
Paines and Byrne Limited
Oral Solution
1987-11-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketovite Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains: Excipients: also includes methyl parahydroxybenzoate (E218) 7.5mg/5ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution (oral liquid) Pale pinkish clear to opalescent liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a sugar-free therapeutic supplement for the prevention of vitamin deficiency in conditions such as galactosaemia, disaccharide intolerance, phenylketonuria and other disorders of carbohydrate or amino acid metabolism, as well as in patients who are on restricted, specialised or synthetic diets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults, children and the elderly: 5 ml daily, by oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the product. Hypercalcaemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The recommended dose should not be exceeded without medical advice. No other vitamin supplement containing Vitamins A and D should be taken with Ketovite Liquid except under medical supervision. The methyl parahydroxybenzoate (E218) in Ketovite Liquid may cause allergic reactions which can be delayed. Prolonged excessive ingestion of Vitamin A and Vitamin D can lead to hypervitaminosis states which may occur if foods high in this vitamin, (for example liver), are ingested in association with the recommended doses of this product. Vitamin A (as palmitate) 2500 IU Ergocalciferol (Vitamin D 2 ) 400 IU Cyanocobalamin 12.5 micrograms Choline chloride 150.0 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/01/2011_ _CRN 2094199_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND Lestu allt skjalið