מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
PARACETAMOL
G & A Licensing Limited
120 MG/5ml
Oral Suspension
2010-11-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calpol Sugar Free Infant Oral Suspension contains 120mg paracetamol in each 5ml. Excipients: also includes the following substances in each 5ml: Maltitol liquid Sorbitol solution (E420) Ethyl parahydroxybenzoate (E214) Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Carmoisine (E122) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension _Product imported from _the UK: A pink suspension with a strawberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CALPOL Sugar Free Infant Suspension is indicated for the treatment of pain (including teething pain), and as an antipyretic. Calpol Sugar Free Infant Suspension is indicated for the relief of headache, migraine, neuralgia, toothache and teething pains, sore throat, rheumatic aches and pains, influenza, feverishness and feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 POSOLOGY _CHILDREN AGED 6 YEARS TO 12 YEARS:_ Oral. 10 to 20 ml (240 mg to 480 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. _CHILDREN AGED 1 TO UNDER 6 YEARS:_ Oral. 5 to 10ml (120 mg to 240 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/10/2011_ _CRN 2107054_ _page number: 1_ _INFANTS 3 MONTHS TO UNDER 1 YEAR:_ Oral. 2.5 to 5 ml (60 mg to 120 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. _INFANTS 2-3 MONTHS (>3KG BODY WEIGHT):_ Oral 2.5ml (60mg para קרא את המסמך השלם