Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
CHOLINE SALICYLATE CETALKONIUM CHLORIDE
SSL International plc
CHOLINE SALICYLATE CETALKONIUM CHLORIDE
8.7/0.01 %v/v
Oromucosal Gel
Product not subject to medical prescription
Withdrawn
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teejel Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The gel contains 8.7 % w/w Choline Salicylate and 0.01 % w/w of Cetalkonium Chloride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oromucosal Gel Clear, colourless gel with an odour of alcohol/aniseed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical analgesic and antiseptic in the management of pain and minor infections in and around the mouth, including oral ulcers, infant teething, stomatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and older children: Approximately 1cm ( ½ inch) of gel should be massaged onto the affected area. Children (aged 4 months to 2 years): Approximately 0.5cm ( ¼ inch) of gel should be massaged onto the affected area. The hands should be cleansed before applying the cream. The treatment may be repeated every 3 to 4 hours as required. 4.3 CONTRAINDICATIONS Use in persons hypersensitive to salicylates. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. If under the doctor’s care or taking other medication, consult a doctor before using this product. 2. If there is no response to treatment, consult the doctor. 3. Avoid excessive use in infants and young children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/07/2006_ _CRN 2025816_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Safe provided recommended dose is not exceeded. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Overdose with choline salicylate Mild overdose: Symptoms include dizziness, sweating, nausea and vom Διαβάστε το πλήρες έγγραφο