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IMPORTANT SAFETY INFORMATION for TASIGNA® (nilotinib) Capsules WARNING: QT PROLONGATION AND SUDDEN DEATHS TASIGNA prolongs the QT interval Tasigna 200 mg hard capsules One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate). This means taking your doses either an hour before a meal, or waiting until two hours afterwards. Hoeveel Tasigna innemen De aanbevolen dosering is 800 mg per dag. For the full list of excipients, see section 6. CML is een kanker van het bloed. Tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy. Tasigna® Capsules 200 mg Page 1 of 7 Approval Date: 14 December 07 10 0 MATERIAL SAFETY DATA SHEET NOVARTIS PHARMACEUTICALS CORPORATION One Health Plaza East Hanover, NJ 07936 24-Hour Emergency Telephone Number: 1-862-778-7000 Customer Interaction Center (MSDS requests): 1-888-669-6682. Excipient with known effect One hard capsule contains 156. Take the capsules when your stomach is empty of food. It is important that you keep the regular appointments with your doctor or hospital Doses of TASIGNA® (nilotinib) capsules should be taken approximately 12 hours apart. Deze dosis wordt bereikt door tweemaal daags twee harde capsules van 200 mg in te nemen. Dose Tasigna twice daily at approximately 12-hour intervals on an empty stomach. Waarvoor wordt dit middel gebruikt? Uw arts kan een lagere dosering voorschrijven afhankelijk van hoe u op de behandeling reageert. Het is verkrijgbaar in de vorm van capsules (150 en 200 mg). Wanneer Tasigna innemen Neem de harde capsules: tweemaal per dag in (ongeveer elke 12 uur);. Tasigna 150 mg hard capsules White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”. PHARMACEUTICAL FORM Hard capsule. IMPORTANT SAFETY INFORMATION for TASIGNA® (nilotinib) Capsules WARNING: QT PROLONGATION AND SUDDEN DEATHS TASIGNA prolongs the QT interval Hard capsule. Advise patients to swallow the capsules whole with water [see Boxed Warning, Clinical Pharmacology (12. 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. Adult patients should take 2 capsules in the morning and 2 capsules in the evening Capsules should be swallowed whole with water Patients must avoid food for 2 hours before and 1 hour after each dose. 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. Wat is Tasigna Tasigna is een geneesmiddel dat een werkzame stof bevat, nilotinib genoemd. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken. Tasigna is een geneesmiddel dat de werkzame stof nilotinib bevat. White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI” Nilotinib capsules are usually taken twice daily, morning and evening. You will need to have regular check-ups. 1) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+. Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna wordt gebruikt voor de behandeling van patiënten met chronische myeloïde leukemie (CML), een kanker van de witte bloedcellen Hoeveel Tasigna innemen De aanbevolen dosering is 800 mg per dag. Tasigna 200 mg hard capsules One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate). TASIGNA is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with CP and AP Ph+ CML with resistance or intolerance to prior tyrosine kinase inhibitor (TKI) therapy. Waarvoor wordt Tasigna gebruikt Tasigna wordt gebruikt om een type leukemie, genaamd Philadelphia-chromosoom positieve chronische myeloïde leukemie (Ph-positieve CML) te behandelen.