Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Idarubicin hydrochloride
Pfizer Healthcare Ireland
L01DB; L01DB06
Idarubicin hydrochloride
1 milligram(s)/millilitre
Solution for injection
Anthracyclines and related substances; idarubicin
Marketed
2019-09-06
Page 1 of 7 2020-0061479, 2021-0071456, 2021-0071680 PACKAGE LEAFLET: INFORMATION FOR THE USER ZAVEDOS® 5 MG AND 10 MG POWDER FOR SOLUTION FOR INJECTION idarubicin hydrochloride 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 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 Zavedos is and what it is used for 2. What you need to know before you take Zavedos 3. How Zavedos will be given to you 4. Possible side effects 5. How to store Zavedos 6. Contents of the pack and other information 1. WHAT ZAVEDOS IS AND WHAT IT IS USED FOR Zavedos contains an active ingredient called idarubicin hydrochloride, which belongs to a group of medicines called anthracyclines. Zavedos interferes with ways in which the cells of your body grow and increase in number and is used in the treatment of cancers (chemotherapy). Zavedos is used in adults and children for the treatment of acute non lymphoblastic leukaemia (ANLL), also referred to as acute myeloid leukaemia (AML). Zavedos is also used in adults and children as a second line treatment of relapsed acute lymphoblastic leukaemia (ALL). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZAVEDOS DO NOT TAKE ZAVEDOS: - If you have ever had an allergic (hypersensitivity) reaction to - idarubicin or any of the other ingredients of this medicine (listed in section 6). - other anthracyclines or anthracenediones. - If you have an infection which is not under control. - If your liver or kidneys are not working properly. - If you have had previous or current history of bone marrow depression caused by previous therapy. - If Прочитайте повний документ
Health Products Regulatory Authority 23 February 2024 CRN00F0J5 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zavedos 1mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 1 mg of idarubicin hydrochloride. Each vial of 5 mL of solution contains 5 mg of idarubicin hydrochloride. Each vial of 10 mL of solution contains 10 mg of idarubicin hydrochloride. Each vial of 20 mL of solution contains 20 mg of idarubicin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection Orange-red, clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults For the treatment of acute non-lymphoblastic leukaemia (ANLL), for remission induction in untreated patients or for remission induction in relapsed or refractory patients. For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Paediatric population For first line treatment of acute non-lymphoblastic leukaemia (ANLL), in combination with cytarabine, for remission induction. For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage is calculated on the basis of body surface area. Acute non-lymphoblastic leukaemia (ANLL) _Adults_ 12 mg/m 2 /day i.v. daily for 3 days in combination with cytarabine. or 8 mg/m 2 /day i.v. daily for 5 days with/without combination. _ _ _Paediatric population_ 10-12 mg/m 2 /day i.v. daily for 3 days in combination with cytarabine. Acute lymphoblastic leukaemia (ALL) _Adults_ As single agent in ALL the suggested dose in adults is 12 mg/m 2 /day i.v. daily for 3 days. _ _ Health Products Regulatory Authority 23 February 2024 CRN00F0J5 Page 2 of 11 _Paediatric population_ 10 mg/m 2 /day i.v. daily for 3 days, as a single agent. NOTE: These are general guidelines. Refer to individual protocols for exact dosage. A Прочитайте повний документ