Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Arsenic trioxide
Mylan Ireland Limited
L01XX27
arsenic trioxide
Antineoplastic agents
Leukemia, Promyelocytic, Acute
Arsenic trioxide Mylan 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 beenexamined.
Revision: 4
Authorised
2020-04-01
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARSENIC TRIOXIDE MYLAN 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 or your 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 Mylan is and what it is used for 2. What you need to know before you are given Arsenic trioxide Mylan 3. How to use Arsenic trioxide Mylan 4. Possible side effects 5. How to store Arsenic trioxide Mylan 6. Contents of the pack and other information 1. WHAT ARSENIC TRIOXIDE MYLAN IS AND WHAT IT IS USED FOR Arsenic trioxide Mylan 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 MYLAN _ _ Arsenic trioxide Mylan must be given under the supervision of a physician experienced in the treatment of acute leukaemias. YOU MUST NOT RECEIVE ARSENIC TRIOXIDE MYLAN 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 Mylan, 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 Mylan. - You should have an electrical recording o Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Arsenic trioxide Mylan 1 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate contains 1 mg of arsenic trioxide. Each 10 ml vial 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 concentrate) Sterile, clear, colourless, aqueous solution with a pH of 7.5 to 8.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arsenic trioxide Mylan 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 Mylan 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 Mylan 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 Mylan must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week. Treatment should be continued f Přečtěte si celý dokument