国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Idarubicin hydrochloride
Pfizer Healthcare Ireland
L01DB; L01DB06
Idarubicin hydrochloride
5 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Anthracyclines and related substances; idarubicin
Not marketed
1995-02-16
Page 1 of 6 2020-0061479, 2021-0071456, 2021-0071680 PACKAGE LEAFLET: INFORMATION FOR THE USER ZAVEDOS® 5MG AND 10MG HARD CAPSULES (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 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 Zavedos is and what it is used for 2. What you need to know before you take Zavedos 3. How to take Zavedos 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 Hard capsules 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 for the treatment of a type of leukaemia called acute non-lymphocytic leukaemia (ANLL) also referred to as acute myelogenous leukaemia (AML). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZAVEDOS DO NOT USE ZAVEDOS CAPSULES: - If you are allergic to Idarubicin hydrochloride or other similar anthracycline medicines or any of the other ingredients of this medicine (listed in Section 6). - 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 you have had a previous or current history of heart disease. - If you have had a previous or current history of abnormal heart rhythms. - If you have had a 阅读完整的文件
Health Products Regulatory Authority 28 January 2022 CRN009WXM Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zavedos 5 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Idarubicin hydrochloride 5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard Capsules Opaque, red cap and body, self-locking, hard gelatin capsule, size No. 4, containing an orange powder. Imprinted ‘IDARUBICIN 5’on the cap in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of acute myelogenous leukaemia (AML) intravenous chemotherapy is the first choice of remission induction. Zavedos capsules are indicated for remission induction as part of attenuated combination regimes in elderly, previously untreated AML patients only when intravenous administration cannot be employed (e.g. for medical reasons, such as difficult venous access or psychological reasons such as refusal of i.v. treatment). Zavedos capsules should not be used for palliative treatment of AML. Zavedos capsules are intended for use under the direction of physicians experienced in leukaemia chemo-therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage is usually calculated on the basis of body surface area. In adult AML the recommended dose schedule is 30 mg/m 2 orally given daily for 3 days as a single agent, or between 15 and 30 mg/m 2 orally daily for 3 days in combination with other antileukemic agents. These dosage schedules should, however, take into account the haematological status of the patient and the dosages of other cytotoxic drugs when used in combination. In patients with hepatic impairment a dose reduction of Zavedos should be considered (see section 4.4). The capsules should be swallowed whole with some water and should not be sucked, bitten or chewed. Zavedos capsules may also be taken with a light meal. 4.3 CONTRAINDICATIONS hypersensitivity to idarubicin or to any of the excipients listed in section 6.1, other anthracyclines or an 阅读完整的文件