Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
DKSH MALAYSIA SDN BHD
IMATINIB MESYLATE
60tablet Tablets; 120tablet Tablets
NOVARTIS PHARMA PRODUKTIONS GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ VATIVIO ® TABLET Imatinib Mesylate (100mg, 400mg) WHAT IS IN THIS LEAFLET 1. What Vativio is used for 2. How Vativio works 3. Before you use Vativio 4. How to use Vativio 5. While you are using Vativio 6. Side effects 7. Storage and Disposal of Vativio 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT VATIVIO IS USED FOR Vativio is a medicine to treat cancer. Vativio 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. Vativio 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 / myeloproliferative 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 VATIVIO WORKS Vativio works by slowing the growth of abnormal cells. Vativio kills the abnormal cells while leaving normal cells alone in the diseases listed above. If you have any questions about how Vativio works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE VATIVIO Your Vativio 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 _ Lue koko asiakirja
Novartis Page 2 Malaysian Package Insert 04-Oct-2021 Vativio VATIVIO Protein-tyrosine kinase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS FILM-COATED TABLETS 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 • Vativio 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 04-Oct-2021 Vativio • 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 Ph+ ALL as monotherapy. • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrange Lue koko asiakirja