Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Mesalazine
DCH AURIGA SINGAPORE
A07EC02
1000mg/ sachet
GRANULE, DELAYED RELEASE
Mesalazine 1000mg/ sachet
ORAL
Prescription Only
Losan Pharma GmbH
ACTIVE
2013-11-08
Salofalk Granu-Stix Gebrauchsinformation (Outsert) für Singapur Format: 528 x 157 mm Druckfarben: 2/2 (Schwarz + Pant. 644) inkl. Klebefläche Mat.-Nr.: Mock-up (Losan Pharma) Falk-Datumscode: SG/03.12 Grammatur: 40g/m 2 Laetuscode: XXX PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCTS Salofalk ® Gastro-resistant Prolonged-release granules 500mg/sachet Salofalk ® Gastro-resistant Prolonged-release granules 1g/sachet Salofalk ® Gastro-resistant Prolonged-release granules 1.5g/sachet Salofalk ® Gastro-resistant Prolonged-release granules 3g/sachet Mesalazine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Salofalk ® granules 500mg contains 500 mg mesalazine. Each sachet of Salofalk ® granules 1g contains 1000 mg mesalazine. Each sachet of Salofalk ® granules 1.5g contains 1.5 g mesalazine. Each sachet of Salofalk ® granules 3g contains 3 g mesalazine. Excipients: Each sachet of Salofalk ® granules 500mg contains 1.0 mg aspartame. Each sachet of Salofalk ® granules 1g contains 2.0 mg aspartame. Each sachet of Salofalk ® granules 1.5g contains 3.0 mg aspartame. Each sachet of Salofalk ® granules 3g contains 6.0 mg aspartame. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant prolonged-release granules Description: stick-formed or round, greyish white granules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acute episodes and the maintenance of remission of ulcerative colitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Adults and the elderly_ For the treatment of acute episodes of ulcerative colitis: Once daily, 1 sachet of Salofalk ® granules 3g, 1-2 sachets of Salofalk ® granules 1.5g, 3 sachets of Salofalk ® granules 1g or 3 sachets of Salofalk ® granules 500mg (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement. It is also possible to take the prescribed daily dose in three divided Read the complete document
salofalk gastro resistant pr granules pi 1 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCTS Salofalk ® Gastro-resistant Prolonged-release granules 500mg/sachet Salofalk ® Gastro-resistant Prolonged-release granules 1g/sachet Salofalk ® Gastro-resistant Prolonged-release granules 1.5g/sachet Salofalk ® Gastro-resistant Prolonged-release granules 3g/sachet Mesalazine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Salofalk granules 500mg contains 500 mg mesalazine. Each sachet of Salofalk granules 1g contains 1000 mg mesalazine. Each sachet of Salofalk granules 1.5g contains 1.5 g mesalazine. Each sachet of Salofalk granules 3g contains 3 g mesalazine. Excipients with known effect Each sachet of Salofalk granules 500mg contains 1.0 mg aspartame and 0.02 mg sucrose. Each sachet of Salofalk granules 1g contains 2.0 mg aspartame and 0.04 mg sucrose. Each sachet of Salofalk granules 1.5g contains 3.0 mg aspartame and 0.06 mg sucrose. Each sachet of Salofalk granules 3g contains 6.0 mg aspartame and 0.12 mg sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant prolonged-release granules Description: stick-formed or round, greyish white granules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acute episodes and the maintenance of remission of ulcerative colitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and the elderly _ For the treatment of acute episodes of ulcerative colitis Once daily, 1 sachet of Salofalk granules 3g, 1-2 sachets of Salofalk granules 1.5g, 3 sachets of Salofalk granules 1g or 3 sachets of Salofalk granules 500mg (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement. It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk granules 500mg 3 times daily or 1 sachet of Salofalk granules 1g 3 times daily) if this is more convenient to the patient. For the maintenance of remission of ulcerat Read the complete document