Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Imatinib mesilate 119.5mg equivalent to imatinib base 100 mg;
Novartis New Zealand Ltd
Imatinib mesilate 119.5 mg (equivalent to imatinib base 100 mg)
100 mg
Film coated tablet
Active: Imatinib mesilate 119.5mg equivalent to imatinib base 100 mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Microcrystalline cellulose Opadry red 00F15613 Opadry yellow 00F12951 Purified water
Blister pack, PVC blisters, 20 tablets
Prescription
Prescription
Novartis Ringaskiddy Ltd
· Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML). · Treatment of adult and paediatic patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · Treatment of adult patients with new diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) integrated with chemotherapy. · Treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. · Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. · Treatment of adult patients with systemic mastocytosis (SM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. · Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). · Treatment of adult patients with Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). · Adjuvant treatment of adult patients following resection of Kit+GIST. · Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC (triplex) plastic - 20 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC blisters (PVC/aluminium blister) - 20 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture. Do not store above 30 centigrade - Blister pack, PVC/PE/PVDC (triplex) plastic - 60 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC blisters (PVC/aluminium blister) - 60 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture. Do not store above 30 centigrade
2003-01-31
CONSUMER MEDICINE INFORMATION Novartis New Zealand Limited Page 1 GLIVEC ® _imatinib _ _ _ _100mg tablets _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Glivec. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM www.medsafe.govt.nz . Those updates may contain important information about the medicine and its use of which you should be aware. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GLIVEC IS USED FOR • Glivec is used to treat adults and children who have chronic myeloid leukaemia (CML) and adults with acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL). CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. Glivec kills the abnormal cells while leaving normal cells alone. Glivec is also used to treat adults for: • MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. • SYSTEMIC MASTOCYTOSIS (SM). It is a cancer in which certain blood cells, called “mast” cells, grow out of control. • HYPEREOSINOPHILIC SYNDROME (HES) AND OR CHRONIC EOSINOPHILIC LEUKAEMIA (CEL). These are blood diseases in which some blood cells, named “eosinophils”, start growing out of control. • GASTRO-INTESTINAL STROMAL TUMOURS (GIST). This is a typ Soma hati kamili
NEW ZEALAND DATA SHEET 1 1 PRODUCT NAME GLIVEC 100 and 400* mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S) FILM-COATED TABLETS Each tablet contains 100 or 400* mg imatinib mesilate (beta crystals). 3. PHARMACEUTICAL FORM 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, NOT DIVISIBLE* Very dark yellow to brownish orange, ovaloid, biconvex with bevelled edges. Debossed with “NVR” on one side and “SL” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glivec ® is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML) (for paediatric use see section 4.2 Posology and method of administration). treatment of adult and paediatric patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section 4.2 Posology and method of administration). treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. 2 treatment of adult patients with systemic mastocytosis (SM) without the D816V c-KIT mutation or with c-Kit mutational status unknown. treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). treatment of adult patients with KIT+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). adjuvant treatment of adult patients following resection of KIT+GIST. trea Soma hati kamili