Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE
DCH AURIGA (MALAYSIA) SDN. BHD.
5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE
30 Pieces Pieces
VIFOR AG
Consumer Medication Information Leaflet (RiMUP) SALOFALK ® SUPPOSITORIES Mesalazine 500 mg 1 What is in this leaflet 1. What Salofalk Suppositories are used for 2. How Salofalk Suppositories work 3. Before you use Salofalk Suppositories 4. How to use Salofalk Suppositories 5. While you are using it 6. Side effects 7. Storage and Disposal of Salofalk Suppositories 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision What Salofalk Suppositories are used for Salofalk Suppositories are used for the treatment of acute episodes of inflammatory disease at the large intestine, rectum and anal canal. How Salofalk Suppositories work Salofalk Suppositories contain the active substance mesalazine, an anti- inflammatory agent used to treat inflammatory bowel disease. Before you use Salofalk Suppositories - When you must not use it Do not use Salofalk Suppositories - if you are or have been told you are hypersensitive (allergic) to mesalazine, salicylic acid, salicylates such as Aspirin or any of the other ingredients of this medicine. - if you have a serious liver and/or kidney disease. Pregnancy and breast-feeding If you are pregnant or breast- feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should only use Salofalk Suppositories during pregnancy if your doctor tells you to. You should only use Salofalk Suppositories during breast-feeding if your doctor tells you to, as this medicine and its metabolites may pass into breast milk. If the infant develops diarrhoea, the breastfeeding should be discontinued. - Before you start to use it Before you start using this medicine you should tell your doctor - if you have a history of problems with your lungs, particularly if you suffer from bronchial asthma. - if you have a history of allergy to sulphasalazine, a substance related to mesalazine. - if you suffer with problems of your liver. - if you suffer with problems of your kidney. - if you have ever de সম্পূর্ণ নথি পড়ুন
D3 Package insert_SAS500_Nov20-CLN PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Salofalk ® 500 Suppositories Mesalazine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One suppository contains 500 mg mesalazine as the medically active ingredient. Excipient with known effect: cetyl alcohol (Ph.Eur.) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories Appearance: white to cream-coloured, torpedo-shaped suppositories 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute episodes of ulcerative colitis, proctitis and inflammation of the anal canal. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly _ One Salofalk 500 suppository three times daily (equivalent to 1500 mg mesalazine daily) inserted into the rectum, according to the individual clinical requirement. As soon as remission has occurred, Salofalk 500 mg gastro-resistant tablets can be used. _ _ _Children and adolescents_ There is little experience and only limited documentation for an effect in children. Method of administration When used three times daily, Salofalk 500 Suppositories should be inserted into the rectum in the morning, at midday and at bedtime. Treatment with Salofalk 500 Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved. The duration of use is determined by the physician. 2 / 7 d3 package insert_sas500_nov20-cln 4.3 CONTRAINDICATIONS Salofalk 500 Suppositories are contraindicated in patients with: - known hypersensitivity to salicylates or any of the excipients. - severe impairment of hepatic or renal function 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count; liver function parameters like ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of সম্পূর্ণ নথি পড়ুন