Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
IDARUBICIN HYDROCHLORIDE
Accord Healthcare Limited
L01DB06
IDARUBICIN HYDROCHLORIDE
SOLUTION FOR INJECTION
IDARUBICIN HYDROCHLORIDE 5 mg/m3
POM
ANTINEOPLASTIC AGENTS
Authorised
PATIENT INFORMATION LEAFLET IDARUBICIN 5 MG/5 ML SOLUTION FOR INJECTION IDARUBICIN 10 MG/10 ML SOLUTION FOR INJECTION IDARUBICIN 20 MG/20 ML SOLUTION FOR INJECTION IDARUBICIN (HYDROCHLORIDE) 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 any further questions, ask your doctor or pharmacist. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Idarubicin Injection is and what it is used for 2. What you need to know before you are given Idarubicin Injection 3. How to use Idarubicin Injection 4. Possible side effects 5. How to store Idarubicin Injection 6. Contents of the pack and other information 1. WHAT IDARUBICIN INJECTION IS AND WHAT IT IS USED FOR Idarubicin Injection belongs to a group of medicines called as citotoxics and antimitotics agents, which intercalate with DNA and interact with topoisomerase II, having an inhibitory effect on the synthesis of nucleic acid. Idarubicin Injection is a medicine used for the treatment : Adults -Acute non-lymphocytic leukaemia, for remission induction in untreated patients or for remission induction in relapsed or refractory patients. -Acute lymphocytic leukaemia as second line treatment. Children -Acute non-lymphocytic leukaemia, in combination with cytarabine, for remission induction in untreated patients. -Acute lymphocytic leukaemia as second line treatment. Idarubicin Injection may also be used in combination with other anticancer agents. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IDARUBICIN INJECTION DO NOT TAKE IDARUBICIN INJECTION: - if you are allergic to idarubicin or to any of the other ingredients in this medicine (listed in section 6); - if you Belgenin tamamını okuyun
1. NAME OF THE MEDICINAL PRODUCT Idarubicin 5 mg/5 ml solution for injection Idarubicin 10 mg/10 ml solution for injection Idarubicin 20 mg/20 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml contains 5 mg of idarubicin hydrochloride. Each vial of 10 ml contains 10 mg of idarubicin hydrochloride. Each vial of 20 ml contains 20 mg of idarubicin hydrochloride. Each ml of solution contains 1 mg idarubicin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, orange red solution, free of visible suspended particles. pH: 3 - 4.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cytotoxic and antimitotic agent. Adults - For the treatment of acute myeloid leukaemia (AML), 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). Children - For first line treatment of acute myeloid leukaemia (AML), in combination with cytarabine, for remission induction. - For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Idarubicin Accord 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 usually calculated on the basis of body surface area (mg/m 2 ). For intravenous use. ACUTE NON-LYMPHOCYTIC LEUKAEMIA (AML) Adults: In acute non-lymphocytic leukaemia the recommended dose is 12 mg/m 2 IV daily for 3 days in combination with cytarabine. Other dose schedule which could be used in acute non-lymphocytic leukaemia, as a single agent or in combination, is 8 mg/m 2 IV daily for 5 days. Children: the recommended dose range is 10-12 mg/m 2 i.v. daily for 3 days in combination with cytarabine._ _ ACUTE LYMPHOCYTIC LEUKAEMIA (ALL) Adults: As single agent the suggested dose is 12 mg/m 2 i.v. daily for 3 days. Children: As single agent the suggested dose is 10 mg/m 2 i.v. daily for 3 da Belgenin tamamını okuyun