Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NILOTINIB HYDROCHLORIDE MONOHYDRATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
NILOTINIB HYDROCHLORIDE MONOHYDRATE
120 Capsules
NOVARTIS PHARMA STEIN AG
_Consumer Medication Information Leaflet (RiMUP) _ TASIGNA ® NILOTINIB 50MG, 150MG AND 200MG HARD CAPSULES 1 WHAT IS IN THIS LEAFLET 1. WHAT TASIGNA IS USED FOR 2. HOW TASIGNA WORKS 3. BEFORE YOU USE TASIGNA 4. HOW TO USE TASIGNA 5. WHILE YOU ARE USING TASIGNA 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF TASIGNA 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 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. _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) in your body to see how Tasigna is tolerated. - pancreas and liver function in the body to see how Tasigna is tolerated. - the electrolytes in the body (potassium, magnesium). These are important in the functioning of the heart. - the level of sugar and fats in the blood. The heart rate will also be checked using a machine that measures electrical activity of the heart (a test called an “ECG”). Your doctor will regularly evaluate your treatment and decide whether you should continue to take Tasigna. If you are told to discontinue this medicine, your doctor will continue to monitor your CML and may tell you to r Lugege kogu dokumenti
Novartis Page 2 Malaysia Package Insert 18-May-2020 Tasigna 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 150mg 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”. Novartis Page 3 Malaysia Package Insert 18-May-2020 Tasigna 3 Tasigna 200 mg hard capsules White to 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 leukemia (Ph+ CML) in chronic phase (CP). Clinical effectiveness of TASIGNA in adults with newly diagnosed Ph+ CML-CP is based on major molecular response rate at 12 months and complete cytogenetic response rate by 12 months. • the treatment of pediatric patients 2 years of age and older with newly diagnosed Ph+ CML-CP. Clinical effectiveness of TASIGNA in pediatric patients with newly diagnosed Ph+ CML-CP is based on major molecular response b Lugege kogu dokumenti