Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
MITOXANTRONE HYDROCHLORIDE
Asta Medica Ltd
2.328mg/1 Millilitre
Solution for Injection
2001-06-29
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ONKOTRONE Concentrate 2 mg/ml concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mitoxantrone hydrochloride. Each 1 ml of solution contains 2 mg mitoxantrone (as mitoxantrone hydrochloride). 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Sterile dark blue aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onkotrone Concentrate is indicated for the treatment of: - Advanced breast cancer - Non-Hodgkin's Lymphoma - Adult acute non-lymphocytic leukaemia - Non-resectable primary hepatocellular carcinoma 4.2 POSOLOGY AND METHOD OF ADMINSTRATION _Intravenous application:_ 1. ADVANCED BREAST CANCER, NON-HODGKIN'S LYMPHOMA, HEPATOCELLULAR CARCINOMA During monotherapy, a dose of mitoxantrone 14 mg/m is recommended as the initial dose for the first cycle. This dose can be repeated after 21 days. In patients with diminished bone marrow reserves as a result of previous radiation and/or chemotherapy or those in a general poor state of health, the initial dose should be reduced to mitoxantrone 12 mg/m or as appropriate for the haematological status. For each repeated application of Onkotrone Concentrate, the dose should be adjusted in each case in accordance with the individual patient's progress and the extent and duration of myelosuppression. If leucocyte and platelet counts have returned to normal after 21 days then the original dose can be repeated. _The following general recommendations can be given for dose adjustment in the treatment of advanced breast cancer, _ _non-Hodgkin's lymphoma and hepatocellular carcinoma:_ 2 2 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 06/12/2005_ _CRN 2017573_ _page number: 1_ Combined use Lire le document complet