Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Imatinib mesilate 119.5mg Equivalent to 100 mg imatinib base
Novartis New Zealand Ltd
Imatinib mesilate 119.5 mg (Equivalent to 100 mg imatinib base)
100 mg
Capsule
Active: Imatinib mesilate 119.5mg Equivalent to 100 mg imatinib base Excipient: Colloidal silicon dioxide Crospovidone Gelatin Iron oxide red Iron oxide yellow Magnesium stearate Microcrystalline cellulose Tekprint red SW-1102 Titanium dioxide
Blister pack, PVC or PVC/PE/PVDC (not marketed), 24 capsules
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 or PVC/PE/PVDC - 24 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC or PVC/PE/PVDC - 48 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC or PVC/PE/PVDC - 96 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC or PVC/PE/PVDC - 120 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC or PVC/PE/PVDC - 180 capsules - 24 months from date of manufacture stored at or below 30°C
2001-03-12
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 Läs hela dokumentet
NEW ZEALAND DATA SHEET 1 1 PRODUCT NAME GLIVEC 100 and 400* mg film-coated tablets GLIVEC 50 and 100 mg hard capsules* 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S) FILM-COATED TABLETS Each tablet contains 100 or 400* mg imatinib mesilate (beta crystals). HARD CAPSULES* Each capsule contains 50 or 100 mg imatinib mesilate (beta crystals). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Hard capsules* 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. 50 MG CAPSULES* White to yellow powder in a light yellow to orange-yellow opaque capsule, marked “NVR SH”. 100 MG CAPSULES* White to yellow powder in an orange to greyish-orange opaque capsule, marked “NVR SI”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glivec ® is indicated for the 2 • 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. • treatment of adult patients with systemic mastocytosis ( Läs hela dokumentet