देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nilotinib hydrochloride monohydrate
Novartis Pharmaceuticals UK Ltd
L01XE08
Nilotinib hydrochloride monohydrate
150mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5010678920079
PACKAGE LEAFLET: INFORMATION FOR THE USER TASIGNA ® 150 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. It is also used in paediatric patients with CML who are no longer benefiting from previous treatment including imatinib or 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 the body to see how Tasigna is tolerated. - pancreas and liver पूरा दस्तावेज़ पढ़ें
OBJECT 1 TASIGNA 150MG HARD CAPSULES Summary of Product Characteristics Updated 20-May-2018 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Tasigna ® 150 mg hard capsules 2. Qualitative and quantitative composition One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect One hard capsule contains 117.08 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule. White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”. 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, - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML. Posology Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs. If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose. _Posology for Philadelphia chromosome positive CML adult patients_ The recommended dose is 300 mg twice daily. For a dose of 400 mg once daily (see dose adjustments below), 200 mg hard capsules are available. _Posology for Philadelphia chromosome positive CML paediatric patients_ Dosing in paediatric patients is individualised and is based on body surface area (mg/m 2 ). The recommended dose of nilotinib is 230 mg/m 2 twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1). Different strengths of Tasigna hard capsules can be combined to attain the desired dose. There is no experience with treatment of paediatric patients below 2 years of पूरा दस्तावेज़ पढ़ें