国: マルタ
言語: 英語
ソース: Medicines Authority
IMATINIB
Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands
L01XE01
IMATINIB 100 mg
FILM-COATED TABLET
IMATINIB 100 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-10-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB TEVA PHARMA 100 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 WHAT IS IN THIS LEAFLET: 1. What Imatinib Teva Pharma is and what it is used for 2. What you need to know before you take Imatinib Teva Pharma 3. How to take Imatinib Teva Pharma 4. Possible side effects 5. How to store Imatinib Teva Pharma 6. Contents of the pack and other information 1. WHAT IMATINIB TEVA PHARMA IS AND WHAT IT IS USED FOR Imatinib Teva Pharma is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in 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 Teva Pharma is used to treat a late stage of Chronic Myeloid Leukaemia called “blast crisis.” In children however it may be used to treat all stages of the illness. In the rest of this leaflet, we will use the abbreviation, CML, when talking about this disease. If you have any questions about how Imatinib Teva Pharma works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMATINIB TEVA PHARMA 完全なドキュメントを読む
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Teva Pharma 100 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Imatinib Teva Pharma 100 mg Film-coated Tablets are orange-brown, round, film-coated tablets debossed with 7629 on one side and a score line on the other side. The tablet is debossed with 9 and 3 at each side of the score line. The film-coated tablets have a diameter of 9 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib Teva Pharma is indicated for the treatment of: Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase._ _ Adult and paediatric patients with Ph+ CML in blast crisis._ _ The effect of imatinib on the outcome of bone marrow transplantation has not been determined._ _ In adult and paediatric patients, the effectiveness of imatinb is based on overall haematological and cytogenetic response rates and progression-free survival in CML. There are no controlled trials demonstrating a clinical benefit or increased survival for this disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies. For doses of 400 mg and above (see dosage recommendation below) a 400 mg tablet is available. 1 完全なドキュメントを読む