País: Malta
Idioma: anglès
Font: Medicines Authority
IMATINIB
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
L01XE01
IMATINIB 400 mg
FILM-COATED TABLET
IMATINIB 400 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2016-01-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB ACTAVIS GROUP 400 MG FILM-COATED TABLETS imatinib 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Imatinib Actavis Group is and what it is used for 2. What you need to know before you take Imatinib Actavis Group 3. How to take Imatinib Actavis Group 4. Possible side effects 5. How to store Imatinib Actavis Group 6. Contents of the pack and other information 1. WHAT IMATINIB ACTAVIS GROUP IS AND WHAT IT IS USED FOR Imatinib Actavis Group is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer. IMATINIB ACTAVIS GROUP IS A TREATMENT FOR ADULTS AND CHILDREN FOR: - CHRONIC MYELOID LEUKAEMIA (CML). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control. In adult patients, Imatinib Actavis Group is intended for use in the most advanced phase of the disease (blast crisis). In children and adolescents, Imatinib Actavis Group can be used in different phases of the disease (chronic, accelerated phase and blast crisis). - PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA (PH-POSITIVE ALL) . Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic l Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Imatinib Actavis Group 100 mg film-coated tablets Imatinib Actavis Group 200 mg film-coated tablets Imatinib Actavis Group 300 mg film-coated tablets Imatinib Actavis Group 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 119.5 mg imatinib mesilate corresponding to 100 mg of imatinib. Excipient with known effect: Each film-coated tablet contains 76 mg lactose monohydrate (see section 4.4). Each film-coated tablet contains 239 mg imatinib mesilate corresponding to 200 mg of imatinib. Excipient with known effect: Each film-coated tablet contains 152 mg lactose monohydrate (see section 4.4). Each film-coated tablet contains 358.5 mg imatinib mesilate corresponding to 300 mg of imatinib. Excipient with known effect: Each film-coated tablet contains 228 mg lactose monohydrate (see section 4.4). Each film-coated tablet contains 478 mg imatinib mesilate corresponding to 400 mg of imatinib. Excipient with known effect: Each film-coated tablet contains 304 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Imatinib Actavis Group 100 mg film-coated tablets: brownish-orange, round, 10.5 mm in diameter, biconvex, film-coated tablets with no scoring or markings. Imatinib Actavis Group 200 mg film-coated tablets: brownish-orange, ovaloid, 17 mm in length and 8 mm in width, biconvex, film-coated tablets with a score line on one side and “200” marked on the other side. The score line is not intended for breaking the tablet. Imatinib Actavis Group 300 mg film-coated tablets: brownish-orange, ovaloid, 19 mm in length and 9 mm in width, biconvex, film-coated tablets with a score line on one side and “300” marked on the other side. The score line is not intended for breaking the tablet. Imatinib Actavis Group 400 mg film-coated tablets: brownish-orange, capsule-shape, 22 mm in length and 10 mm in width, biconv Llegiu el document complet