Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
RETINOL PALMITATE ERGOCALCIFEROL THIAMINE HYDROCHLORIDE RIBOFLAVIN SODIUM PHOSPHATE PYRIDOXINE HYDROCHLORIDE NICOTINAMIDE ASCORBIC ACID
LTT Pharma Limited
RETINOL PALMITATE ERGOCALCIFEROL THIAMINE HYDROCHLORIDE RIBOFLAVIN SODIUM PHOSPHATE PYRIDOXINE HYDROCHLORIDE NICOTINAMIDE
Oral Drops Solution
Product not subject to medical prescription
Withdrawn
2014-02-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Abidec Multivitamin Oral Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Abidec Multivitamin Drops contains 1333 IU retinol (as vitamin A palmitate), 400 IU ergocalciferol, 0.4 mg thiamine hydrochloride, 0.8 mg riboflavin sodium phosphate, 0.8 mg pyridoxine hydrochloride, 8 mg nicotinamide, and 40 mg ascorbic acid in each 0.6 ml dose. Excipients - contains sucrose and arachis oil (refined peanut oil) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral drops, solution _Product imported from the UK:_ A yellow to orange brown oral drops, solution which darkens upon storage, with some cloudiness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abidec Multivitamin Drops is indicated for the prevention of vitamin deficiencies and for the maintenance of normal growth and health during the early years of infancy and childhood; multivitamin supplement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 12 YEARS: Not appropriate. CHILDREN AGED 1 TO 12 YEARS: Oral. One 0.6ml dose taken daily. Maximum daily dose: 0.6ml. CHILDREN UNDER 1 YEAR: Oral. One 0.3ml dose taken daily. Maximum daily dose: 0.3ml. THE ELDERLY: Not appropriate. HEPATIC/RENAL DYSFUNCTION: Normal dosage is appropriate. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/09/2011_ _CRN 2105463_ _page number: 1_ 4.3 CONTRAINDICATIONS Abidec Multivitamin Drops is contra-indicated in individuals with known hypersensitivity to the product or any of its components including peanut oil. Vitamin A palmitate contains refined peanut oil (Arachis oil) and should not be taken by patients known to be allergic to peanut. As there is a possible Lue koko asiakirja