Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Lidocaine hydrochloride monohydrate 21.3 mg/mL equivalent to 20 mg Lignocaine hydrochloride anhydrous
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Lidocaine hydrochloride monohydrate 21.3 mg/mL (=20 mg Lignocaine hydrochloride anhydrous)
2% w/v
Oral solution
Active: Lidocaine hydrochloride monohydrate 21.3 mg/mL equivalent to 20 mg Lignocaine hydrochloride anhydrous Excipient: Carmellose sodium Cherry Extract Fache 5913G Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Saccharin sodium Sodium hydroxide
Bottle, plastic, Tampertel cap, 1x200mL, 200 mL
Pharmacy only
Pharmacy only
Cambrex Karlskoga AB
Xylocaine Viscous solution is indicated for the relief of pain and discomfort associated with: · irritated or inflamed mucous membranes of the mouth, pharynx and upper gastrointestinal tract, e.g. post-tonsillectomy sore throat, dumping syndrome · introduction of instruments and catheters into the respiratory and gastrointestinal tract.
Package - Contents - Shelf Life: Bottle, plastic, Tampertel cap, child resistant - 200 mL - 36 months from date of manufacture stored at or below 25°C
1994-12-06
X YLOCAINE V ISCOUS Data Sheet NEW ZEALAND DATA SHEET 1. PRODUCT NAME Xylocaine ® Viscous solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Xylocaine Viscous contains lignocaine hydrochloride monohydrate 21.4 mg (equivalent to lignocaine hydrochloride 20 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Xylocaine Viscous solution is a clear to almost clear slightly coloured viscous liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xylocaine Viscous solution is indicated for the relief of pain and discomfort associated with: • irritated or inflamed mucous membranes of the mouth, pharynx and upper gastrointestinal tract, e.g. post-tonsillectomy sore throat, dumping syndrome; • introduction of instruments and catheters into the respiratory and gastrointestinal tract. 4.2 DOSE AND METHOD OF ADMINISTRATION As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated, acutely ill or elderly patients and children should be given doses commensurate with their age and physical condition. Shake the bottle well before use. For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around the mouth for approximately 30 seconds and spat out. For use on the pharynx, the solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours. MAXIMUM DOSAGE Although the incidence of adverse effects with lignocaine is quite low, caution should be exercised when using large amounts. X YLOCAINE V ISCOUS Data Sheet Copyright 2 ADULTS: No more than 15 mL (300 mg lignocaine HCl) every 3 hours or 120 mL in a 24 hour period. CHILDREN OVER 3 YEARS OF AGE: No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 5 mL (100 mg lignocaine HCl), whichever is lower. No more than 4 doses should be given in a 24 hour period. The dose should not be a Đọc toàn bộ tài liệu