Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Mesalazine 2 g; ; Mesalazine 2 g
Pharmaco (NZ) Ltd
Mesalazine 2 g
2 g
Modified release granules
Active: Mesalazine 2 g Excipient: Ethylcellulose Microcrystalline cellulose Active: Mesalazine 2 g Excipient: Ethylcellulose Povidone
Sachet, aluminium foil, Polyester/aluminium/LD foil 60 sachets, 60 dose units
Prescription
Prescription
Syntese A/S
Treatment of mild to moderate ulcerative colitis
Package - Contents - Shelf Life: Sachet, aluminium foil, Polyester/aluminium/LD foil 2g - 60 dose units - 24 months from date of manufacture stored at or below 25°C - Sachet, laminate, Polyester/aluminium/LD foil 2g - 10 dose units - 24 months from date of manufacture stored at or below 25°C
2006-02-17
PENTASA® (sachets) 1 PENTASA® SACHETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI (see from next page) has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING PENTASA? PENTASA contains the active ingredient, mesalazine. PENTASA is taken to treat Crohn's disease and ulcerative colitis: diseases associated with inflammation, ulcers and sores in the bowel causing bleeding, stomach pain, and diarrhoea. For more information, see Section 1. Why am I taking PENTASA? in the full CMI (see from next page), starting from page 2. 2. WHAT SHOULD I KNOW BEFORE I TAKE PENTASA? Do not take PENTASA if you have ever had an allergic reaction to mesalazine or any of the ingredients listed at the end of the CMI (Section 7 Product details). TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take PENTASA? in the full CMI, starting from page 2. 3. WHAT IF I AM TAKING OTHER MEDICINES? Care may be needed when you are also taking other medicines. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI, starting from page 2. 4. HOW DO I TAKE PENTASA? • Tear or cut to open the sachet along the dotted line. • Empty the content of the sachet (granules) onto the tongue and wash down with water or juice to swallow without chewing or crushing the granules. • Alternatively, mix the entire content of the sachet (granules) with yoghurt and consume immediately without chewing or crushing the granules. More instructions can be found in Section 4. How do I take PENTASA? in the full CMI, starting from page 2. 5. WHAT SHOULD I KNOW WHILE TAKING PENTASA? THINGS YOU SHOULD DO • Tell any doctor, dentist or pharmacist you visit that you are taking PENTASA • Have all blood tests recommended by your doctor • IF YOU BECOME PREGNANT WHILE TAKING THIS MEDICINE, TELL YOUR Baca dokumen lengkapnya
NEW ZEALAND DATA SHEET PENTASA – PENTASA020 March 2023 Page 1 of 12 PENTASA mesalazine 1 PENTASA PENTASA 500mg Prolonged release tablet PENTASA 1g Prolonged release tablet PENTASA 10mg/mL Enema PENTASA 1g Suppository PENTASA 1g, 2g or 4g Granules, prolonged-release 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prolonged release tablet 500mg: Contains 500mg mesalazine Prolonged release tablet 1g: Contains 1g mesalazine Enema: Contains 10mg/mL mesalazine Suppository 1g: Contains 1g mesalazine Granules, prolonged-release: Contains 1g, 2g or 4g mesalazine For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM _PROLONGED RELEASE TABLET 500MG_: white grey to pale brown speckled round tablet with a break-mark. Embossed 500mg on one side, PENTASA on the other side. The score line is not intended for breaking the tablet. _PROLONGED RELEASE TABLET 1G:_ white-grey to pale brown, speckled, oval tablet. Embossed on both sides with PENTASA. _ENEMA_: a white to slightly yellow suspension in purified water with a pH value between 4.4 and 5.0. Added buffering agents result is a slightly acidic suspension. Sodium metabisulphite is added as an antioxidant. _SUPPOSITORY_: a white to light tan spotted oblong compressed suppository, average weight 1580mg, 1cm diameter and 2.8cm long. _GRANULES, PROLONGED-RELEASE:_ white-grey to pale white brown cylindrical shaped granules, containing 1g, 2g or 4g mesalazine. NEW ZEALAND DATA SHEET PENTASA – PENTASA020 March 2023 Page 2 of 12 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ _PROLONGED RELEASE TABLETS 500MG AND 1G, AND GRANULES 1G, 2G AND 4G: _ Treatment of mild to moderate ulcerative colitis or Crohn’s disease._ _ _ENEMAS: _ Treatment of ulcerative proctosigmoiditis and left-sided colitis._ _ _SUPPOSITORIES: _ Treatment of ulcerative proctitis._ _ 4.2 DOSE AND METHOD OF ADMINISTRATION _ _ _PROLONGED RELEASE TABLETS 500MG AND 1G / PROLONGED RELEASE GRANULES 1G, 2G, 4G _ _ULCERATIVE COLITIS _ _TREATMENT OF ACTIVE DISEASE: _ _Adults: _Individual dosage, up to 4g o Baca dokumen lengkapnya