Transcription of NEW ZEALAND DATA SHEET - Medsafe
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NEW ZEALAND DATA SHEET - Medsafe
NEW ZEALAND data SHEET ASACOL data SHEET 15 January 2018 Page 1 of 14 Emerge Health NZ Ltd 1 ASACOL Asacol 400mg enteric coated tablet Asacol 800mg enteric coated tablet Asacol w/w suppository 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Asacol 400mg enteric coated tablet: Mesalazine (5-aminosalicylic acid, 5-ASA) 400mg in each enteric coated (gastro-resistant) tablet. Excipient with known effect: lactose, see section Asacol 800mg enteric coated tablet: Mesalazine (5-aminosalicylic acid, 5-ASA) 800mg in each enteric coated (gastro-resistant) tablet. Excipient with known effect: lactose, see section Asacol w/w (500mg) suppository: Mesalazine (5-aminosalicylic acid, 5-ASA) w/w (500mg) in each suppository. For the full list of excipients, see section 3 PHARMACEUTICAL FORM Enteric coated tablets (gastro-resistant [GR]) tablets coated red/brown oblong tablets. Suppository light grey-brown, torpedo-shaped suppositories.
NEW ZEALAND DATA SHEET ASACOL Data Sheet 15 January 2018 Page 2 of 14 Emerge Health NZ Ltd Crohn's ileo-colitis Maintenance of remission: 2.4g (6 of the 400mg tablets, or 3 of the 800mg tablets) in divided doses.
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