País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Nilotinib hydrochloride monohydrate 165.45mg equivalent to 150 mg nilotinib anhydrous free base; ;
Novartis New Zealand Ltd
Nilotinib hydrochloride monohydrate 165.45 mg (equivalent to 150 mg nilotinib anhydrous free base)
150 mg
Capsule
Active: Nilotinib hydrochloride monohydrate 165.45mg equivalent to 150 mg nilotinib anhydrous free base Excipient: Colloidal silicon dioxide Crospovidone Gelatin Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Opacode ink black S-1-277002 Poloxamer 188 Titanium dioxide
Blister pack, PVC/PVDC or PA/Al/PVDC, 28 capsules
Prescription
Prescription
Novartis Pharma Stein AG
TASIGNA is indicated for the: · treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, · treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant to at least one prior therapy including imatinib.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 28 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 40 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 112 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 120 capsules - 36 months from date of manufacture stored at or below 30°C
2010-05-19
TASIGNA ® 1 TASIGNA ® _nilotinib _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tasigna. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. 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.NOVARTIS.COM.AU IF YOU ARE IN AUSTRALIA AND MEDSAFE.GOVT.NZ IF YOU ARE IN NEW ZEALAND. Those updates may contain important information about the medicine and its use of which you should be aware. 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 TASIGNA IS USED FOR Tasigna is used to treat chronic myeloid leukaemia (CML). CML is a type of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. Tasigna kills the abnormal cells while leaving normal cells alone. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. Tasigna is only available with a doctor's prescription. It is not addictive. There is not enough information to recommend the use of this medicine in children and adolescents under 18 years of age. BEFORE YOU TAKE TASIGNA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TASIGNA IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO NILOTINIB (THE ACTIVE INGREDIENT) OR TO ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathi Leia o documento completo
Page 1 of 35 TASIGNA NEW ZEALAND DATA SHEET 1 PRODUCT NAME TASIGNA ® 150 mg and 200 mg Hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s) _150 mg hard capsules _ Each capsule contains 150 mg nilotinib base (as hydrochloride, monohydrate). _200 mg hard capsules _ Each capsule contains 200 mg nilotinib base (as hydrochloride, monohydrate). Excipients with known effects TASIGNA contains lactose and may not be suitable for patients that are intolerant to this ingredient (see section 4.4). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. _150 mg hard capsules _ White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”. _200 mg hard capsules _ White to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TASIGNA is indicated for the: • treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase, • treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant to at least one prior therapy including imatinib. 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the treatment of patients with CML. Dose Page 2 of 35 _Dosage in patients with newly diagnosed Ph+ CML-Chronic Phase (CP) _ The recommended dose of TASIGNA is 300 mg twice daily (see section 5.2). Treatment should be continued as long as the patient continues to benefit. _Dosage in newly diagnosed Ph+ CML-CP patients who have achieved a sustained deep _ _molecular response (MR 4.5) _ Discontinuation of treatment may be considered in eligible Ph+ CML-CP patients who have been treated with Tasigna at 300 mg twice daily for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately Leia o documento completo