Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
Arsenic trioxide
Accord Healthcare S.L.U.
L01XX27
arsenic trioxide
Antineoplastic agents
Leukemia, Promyelocytic, Acute
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Revision: 5
Authorised
2019-11-14
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER ARSENIC TRIOXIDE ACCORD 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION arsenic trioxide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor, pharmacist or nurse. - 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 Arsenic trioxide Accord is and what it is used for 2. What you need to know before you are given Arsenic trioxide Accord 3. How Arsenic trioxide Accord is given 4. Possible side effects 5. How to store Arsenic trioxide Accord 6. Contents of the pack and other information 1. WHAT ARSENIC TRIOXIDE ACCORD IS AND WHAT IT IS USED FOR Arsenic trioxide Accord is used in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease has not responded to other therapies. APL is a unique type of myeloid leukaemia, a disease in which abnormal white blood cells and abnormal bleeding and bruising occur. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ARSENIC TRIOXIDE ACCORD Arsenic trioxide Accord must be given under the supervision of a physician experienced in the treatment of acute leukaemias. YOU MUST NOT RECEIVE If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6). _ _ WARNINGS AND PRECAUTIONS You must talk to your doctor or nurse before you are given Arsenic trioxide Accord, if - you have impaired kidney function. - you have any liver problems. Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Accord. - You should have an electrical recording of the heart (electro Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of _ _ concentrate for solution for infusion contains 1 mg of arsenic trioxide _. _ One vial of 10 ml contains 10 mg of arsenic trioxide. For the full list of excipients, see section 6.1 _ _ 3. PHARMACEUTICAL FORM Concentrate for solution for infusion _ _ Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 – 8.3. _ _ _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: _ _ • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 10 3 /µl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. _ _ The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Arsenic trioxide must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed. Posology _ _ _ _ The same dose is recommended for adults and elderly. _Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) _ _ _ _Induction treatment schedule _ Arsenic trioxide _ _ must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved. If complete remission has not occurred by day 60, dosing must be discontinued. _Consolidation schedule_ Arsenic trioxide must be administered intravenously at a dose Perskaitykite visą dokumentą