Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
MESALAZINE (5 - AMINOSALICYLIC ACID)
RAFA LABORATORIES LTD
A07EC02
GRANULES PROLONGED RELEASE GASTRO RESISTANT
MESALAZINE (5 - AMINOSALICYLIC ACID) 1.5 G
PER OS
Required
DR. FALK PHARMA, GERMANY
MESALAZINE
For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.
2019-03-31
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1 Rafassal Granules -DL-Jun 2023-05 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS _RAFASSAL 1 GRAM GRANULES _gastro-resistant prolonged-release granules _RAFASSAL 1.5 GRAM_ _GRANULES _gastro-resistant prolonged-release granules _RAFASSAL 3 GRAM_ _GRANULES _gastro-resistant prolonged-release granules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of _RAFASSAL 1 GRAM GRANULES _contains 1 gram mesalazine. Each sachet of _RAFASSAL 1.5 GRAM GRANULES_ contains 1.5 gram mesalazine. Each sachet of _RAFASSAL 3 GRAM GRANULES_ contains 3 gram mesalazine. Excipients _ _ with known effect: Each sachet of _RAFASSAL 1 GRAM GRANULES_ contains 2.0 mg aspartame and 0.08mg sucrose. Each sachet of _RAFASSAL 1.5 GRAM GRANULES_ contains 3.0 mg aspartame and 0.12mg sucrose. Each sachet of _RAFASSAL 3 GRAM GRANULES_ contains 6.0 mg aspartame and 0.24mg sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant prolonged-release granules. Description: 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 elderly: _ For the treatment of acute episodes of ulcerative colitis: Once daily 1 sachet of _RAFASSAL 3 GRAM GRANULES_, 1 or 2 sachets of _RAFASSAL 1.5 _ _GRAM GRANULES_, or 3 sachets of _RAFASSAL 1 GRAM_ _GRANULES _(equivalent to 1.5- 3 gram 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 _RAFASSAL 1 GRAM GRANULES three_ times daily) if this is more convenient to the patient. For the maintenance of remission of ulcerative colitis: 2 Total dose of 1.5 gram mesalazine per day as a single daily dose. For patients known to be at increased risk for relapse for medical reasons, the dosing schedule can be adapted to 3 gram mesalazine given as a single da Olvassa el a teljes dokumentumot