Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
IMATINIB MESYLATE
20Tablet Tablets; 60Tablet Tablets; 120 Tablet Tablets; 60 Tablet Tablets
NOVARTIS PHARMA PRODUKTIONS GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ GLIVEC ® TABLET Imatinib Mesylate (100mg, 400mg) 1 WHAT IS IN THIS LEAFLET 1. What Glivec is used for 2. How Glivec works 3. Before you use Glivec 4. How to use Glivec 5. While you are using Glivec 6. Side effects 7. Storage and Disposal of Glivec 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT GLIVEC IS USED FOR Glivec is a medicine to treat cancer. Glivec is a treatment for adults and children for: - chronic myeloid leukemia (CML) - acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positive (Ph-positive ALL). Leukemia is cancer of white blood cells. These white blood cells usually help the body to fight infections. CML and ALL are cancers of the blood which makes the body produce too many abnormal white blood cells. Glivec is also a treatment for adults for: • Certain types of gastrointestinal stromal tumors (GIST). GIST are cancers of the stomach and the bowels. • Certain types of dermatofibrosarcoma protuberans (DFSP). They arise from uncontrolled cell growth. • Certain types of myelodysplastic/myeloproliferativ e diseases (MDS/MPD), a group of blood diseases which make the body produce too many abnormal blood cells. • Certain types of aggressive systemic mastocytosis (ASM). • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL), blood diseases which make the body produce too many blood cells. HOW GLIVEC WORKS Glivec works by slowing the growth of abnormal cells. Glivec kills the abnormal cells while leaving normal cells alone in the diseases listed above. If you have any questions about how Glivec works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE GLIVEC Your Glivec treatment will be prescribed by a doctor with experience in the use of anticancer therapies. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. - _When you must not use it _ Les hele dokumentet
Novartis Page 2 Malaysian Package Insert 10-Mar-2022 Glivec film-coated tablets GLIVEC Protein-tyrosine kinase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS FILM-COATED TABLETS GLIVEC 100 and 400 mg film-coated tablets Note: Glivec is known as Gleevec ® (imatinib mesilate) tablets in the US, Canada and Israel. 100 MG TABLETS, DIVISIBLE Very dark yellow to brownish orange film-coated tablets, biconvex with debossed “NVR” on one side and “SA” and score on the other side. 400 MG TABLETS, DIVISIBLE Very dark yellow to brownish orange, ovaloid, biconvex with beveled edges. De-bossed with “400” on one side and score on the other side and “SL” on each side of the score. ACTIVE SUBSTANCE FILM-COATED TABLETS Each film-coated tablet contains 100 or 400 mg imatinib (as mesilate beta crystals). EXCIPIENTS 100 AND 400 MG (DIVISIBLE OR NON-DIVISIBLE) FILM-COATED TABLETS Tablet content: Cellulose microcrystalline, Crospovidone, Hypromellose, Magnesium stearate, Silica colloidal anhydrous. Coating content: Hypromellose, Macrogol, Talc, Iron oxide, red (E 172), Iron oxide, yellow (E 172). Pharmaceutical formulations may vary between countries. INDICATIONS • Glivec is indicated for the treatment of adult and pediatric patients with newly diagnosed chronic myeloid leukemia (CML) as well as for the treatment of adult and pediatric patients with CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon- alpha therapy. • adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). Novartis Page 3 Malaysian Package Insert 10-Mar-2022 Glivec film-coated tablets • adjuvant treatment of adult patients following resection of GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. • adult and pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. • adult patients with relapsed or refractory Les hele dokumentet