البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mitoxantrone hydrochloride
Baxter Healthcare Ltd
L01DB07
Mitoxantrone hydrochloride
2mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010200; GTIN: 05413760208848
OBJECT 1 ONKOTRONE INJECTION 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 01-Apr-2015 | Baxter Healthcare Ltd 1. Name of the medicinal product Onkotrone Injection 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 Injection 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 administration _Intravenous application:_ 1. Advanced Breast Cancer, Non-Hodgkin's Lymphoma, Hepatocellular Carcinoma. During monotherapy, a dose of mitoxantrone 14 mg/m 2 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 2 or as appropriate for the haematological status. For each repeated application of Onkotrone Injection, 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:_ LOWEST VALUE (NADIR) OF LEUCOCYTES AND PLATELETS (AS A RULE, 6-15 DAYS AFTER APPLICATION) RETURN TO NORMAL RECOMMENDED DOSAGE More than 1.5 x 10 9 /l leucocytes and more than 50 x 10 9 /l platelets 21 days or less As previous dose or increase by 2 mg/m 2 if myel اقرأ الوثيقة كاملة