Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
nilotinib
Novartis Europharm Limited
L01EA03
nilotinib
Antineoplastic agents
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.Tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available,paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Revision: 45
Authorised
2007-11-19
61 B. PACKAGE LEAFLET 62 PACKAGE LEAFLET: INFORMATION FOR THE USER TASIGNA 50 MG, 150 MG AND 200 MG HARD CAPSULES nilotinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tasigna is and what it is used for 2. What you need to know before you take Tasigna 3. How to take Tasigna 4. Possible side effects 5. How to store Tasigna 6. Contents of the pack and other information 1. WHAT TASIGNA IS AND WHAT IT IS USED FOR WHAT TASIGNA IS Tasigna is a medicine containing an active substance called nilotinib. WHAT TASIGNA IS USED FOR Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML). CML is a cancer of the blood which makes the body produce too many abnormal white blood cells. Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from previous treatment including imatinib. It is also used in adult and paediatric patients who experienced serious side effects with previous treatment and are not able to continue taking it. HOW TASIGNA WORKS In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body to produce abnormal white blood cells. Tasigna blocks this signal, and thus stops the production of these cells. 63 MONITORING DURING TASIGNA TREATMENT Regular tests, including blood tests, will be performed during treatment. These tests will monitor: - the amount of blood cells (white blood cells, red blood cells and platelets) i Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tasigna 50 mg hard capsules Tasigna 150 mg hard capsules Tasigna 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tasigna 50 mg hard capsules One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate). _Excipient with known effect _ One hard capsule contains 39.03 mg lactose monohydrate. Tasigna 150 mg hard capsules One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate). _Excipient with known effect _ One hard capsule contains 117.08 mg lactose monohydrate. Tasigna 200 mg hard capsules One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate). _Excipient with known effect _ One hard capsule contains 156.11 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Tasigna 50 mg hard capsules White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint “NVR/ABL” on cap. Tasigna 150 mg hard capsules White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”. Tasigna 200 mg hard capsules White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI”. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician exper Pročitajte cijeli dokument