국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
IMATINIB MESILATE EQUIV TO IMATINIB
ZYFAS PHARMA PTE LTD
L01XE01
CAPSULE
IMATINIB MESILATE EQUIV TO IMATINIB 400MG
ORAL
Prescription Only
DR. REDDY'S LABORATORIES LIMITED
ACTIVE
2021-11-15
MARCH 02, 2021 PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB 100 MG & 400 MG CAPSULES 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 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 or 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 is and what it is used for 2. What you need to know before you take imatinib 3. How to take imatinib 4. Possible side effects 5. How to store imatinib 6. Contents of the pack and other information 1. WHAT IMATINIB IS AND WHAT IT IS USED FOR Redistra 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 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. 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 leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib inhibits the growth of these cells. REDISTRA IS ALSO A TREATMENT FOR ADULTS FOR: Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of 전체 문서 읽기
For the use of a Physician or a Hospital only March 2, 2021 1 REDISTRA IMATINIB 100 MG & 400 MG CAPSULE DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS CAPSULE Each capsule contains 100 or 400 mg Imatinib (as Mesilate) IMATINIB CAPSULES 100 MG: Off-white to brownish yellow colour granular powder filled in Orange to grayish-orange opaque Size ‘1’ Hard Gelatin capsule imprinted with ‘RDY’ on cap and ‘100’ on body with red ink. IMATINIB CAPSULES 400 MG: Off-white to brownish yellow color granular powder filled in Very dark yellow to brownish-orange opaque Size '00' Hard Gelatin capsule imprinted with 'RDY' on cap and '400' on body with red ink. EXCIPIENTS IMATINIB 100 MG & 400 MG CAPSULE CONTAINS: Crospovidone, Sodium Stearyl Fumarate CAPSULE SHELL - IMATINIB 100 MG CAPSULE: Gelatin, Sodium laurilsulfate, Water, Titanium dioxide (E171), Iron Oxide red (E172), Iron Oxide yellow (E172), CAPSULE SHELL - IMATINIB 400 MG CAPSULE: Gelatin, Sodium laurilsulfate, Water, Titanium dioxide (E171), Iron Oxide black (E172), Iron oxide red (E172), Iron Oxide yellow (E172), CLINICAL INFORMATION INDICATIONS Imatinib is indicated for the • treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML). • treatment of adult and paediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. • treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. • treatment of adult patients with Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • adjuvant treatment of adult patients following complete gross resection of Kit+ GIST The effectiveness of Imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on 전체 문서 읽기