Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LIDOCAINE; tetracaine
MIGRIS LIFE SCIENCES SDN BHD
LIDOCAINE; tetracaine
15 gm mcg/mL; 30 gm mcg/mL
LABORATORIES GALDERMA
1 (11) SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pliaglis 70mg/g + 70mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of cream contains 70mg lidocaine (lignocaine) and 70 mg tetracaine. Excipients with known effect: methyl parahydroxybenzoate (E218) 0.5 mg/g propyl parahydroxybenzoate (E216) 0.1 mg/g For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White to off-white viscous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pliaglis is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For use in adults and elderly: For dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non- ablative laser facial resurfacing, dermal filler injections and vascular access, Pliaglis should be applied onto intact skin at a thickness of approximately 1mm for 30 minutes (approximately 1.3 g of cream 2 (11) per 10 cm2). After the required time, the peel must then be removed from the skin prior to the procedure. For dermatological procedures such as laser-assisted tattoo removal, and laser leg vein ablation, Pliaglis should be applied onto intact skin at a thickness of approximately 1mm for 60 minutes (approximately 1.3 g of cream per 10 cm2). After the required time, the peel must then be removed from the skin prior to the procedure. SURFACE AREA OF TREATMENT SITE (CM2) APPROXIMATE WEIGHT OF PLIAGLIS DISPENSED (G) 10 1.3 2 fingertip units 50 6.5 Half content of a 15g tube 100 13 Full content of a 15g tube 200 26 Full content of a 30g tube 400 52 Full content of two 30g tubes The maximum application area should not exceed 400 cm2. Hepatic, renal and cardiac impairment Pliaglis should be used with caution in patients with hepatic, renal and cardiac impairment (see section 4.4). Paediatric population The safety and efficacy of Pliaglis in children and adolescents aged up to 18 years have not been established. Therefore, the Leggi il documento completo