Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TEMOZOLOMIDE
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
TEMOZOLOMIDE
5Capsule Capsules; 5 Capsule Capsules
ORION CORPORATION, ORION PHARMA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TEMODAL ® CAPSULE Temozolomide (20 mg, 100 mg) _______________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What TEMODAL is used for 2. How TEMODAL works 3. Before you take TEMODAL 4. How to take TEMODAL 5. While you are taking TEMODAL 6. Side effects 7. Storage and Disposal of TEMODAL 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT TEMODAL IS USED FOR TEMODAL is used for the treatment of specific forms of brain tumours: • in people with newly-diagnosed brain tumour concomitantly with radiotherapy and then as adjuvant treatment. • in people with malignant brain tumour, showing recurrence or progression after standard therapy. HOW TEMODAL WORKS TEMODAL contains a medicine called temozolomide. This medicine is an antitumour agent. It works by killing cancer cells and stopping cancer cells from growing and multiplying. BEFORE YOU TAKE TEMODAL - _When you must not take it _ DO NOT TAKE TEMODAL • if you are allergic to ‘temozolomide dacarbazine’ (DTIC) or any of the other ingredients of this medicine (listed in “ PRODUCT DESCRIPTION ”). Signs of allergic reaction include hives, itchy or skin rash, swelling of the face, lips, tongue or throat, breathlessness, wheezing, or a tight feeling in your chest. • if you or your partner are pregnant or intend to become pregnant. • if you are breastfeeding. • if you have a very low level of white blood cells, red blood cells or platelets. - _Before you start to take it _ Talk to your doctor, pharmacist or nurse before taking TEMODAL, • if you vomit frequently. Your doctor may give you medicine to control the vomiting. • if you are anaemic or have blood clotting problems. • if you intend to have children. TEMODAL may cause infertility in men. • if you have liver or kidney problems. TEMODAL could cause hepatitis B to become active again, which can be fatal in some cases. • if you have aller Lees het volledige document
TEMODAL CAPSULES S-CCDS -MK7365 -MTL -01201 7 TEMODAL ® Capsules Brand of temozolomide This insert contains basic prescribing information only . For more comprehensive information, a Professional Brochure is available to physicians on request. FOR ORAL A DMINISTRATION DESCRIPTION : TEMODAL Capsules for oral administration contain temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3, 4 -dihydro -3-methyl -4-oxoimidazo[5,1 - d]-as -tetrazine -8-carboxamide. The structural formula i s: Temozolomide The material is a white to light tan/light pink powder with a molecular formula of C 6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (7, hence can be administered orally. The prodrug, te mozolomide, is rapidly hydrolysed to the active 5 -(3-methyltriazen -1-yl) imidazole -4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Each capsule contains either 20 mg or 100 mg of temozolomid e. The inactive ingredients for TEMODAL Capsules are lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. Gelatin capsule shells contain titanium dioxide. The capsules are imprinted with pharmaceutical ink . Lees het volledige document