Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CHOLINE SALICYLATE GLYCEROL
SSL International plc
20/12.6 %w/v
Ear Drops Solution
2006-05-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Choline Salicylate 20.0%w/v. Glycerol 12.6%w/v. Excipients: also contains 1.25%w/v ethylene oxide polyoxypropylene glycol and up to 66.6%w/v propylene glycol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops solution Clear, faintly tan solution, with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief of pain in otitis externa and media, furuncles and other local inflammation, softening of earwax and aid to earwax removal. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical into ear. Place the head on one side with the affected ear uppermost. Completely fill the external auditory canal with drops. The ear should be plugged with cotton wool soaked with the eardrops or a wick may be inserted if preferred. Audax Ear Drops should be instilled every 3 to 4 hours until permanent relief of symptoms is obtained. 4.3 CONTRAINDICATIONS 1. Use in patients hypersensitive to salicylates. 2. Perforated ear drum. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. If symptoms persist, the doctor should be consulted. 2. If the patient is under the doctor’s care or is on any medication, the doctor should be consulted before using. 3. Contains propylene glycol and esters which may cause skin irritation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/02/2012_ _CRN 2105686_ _page number: 1_ 4.6 FERTILITY, PREGNANCY AND LACTATION There is no known hazard with the use of this product durin Læs hele dokumentet