Onkotrone 25mg/12.5ml solution for infusion vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Mitoxantrone hydrochloride

Commercializzato da:

Baxter Healthcare Ltd

Codice ATC:

L01DB07

INN (Nome Internazionale):

Mitoxantrone hydrochloride

Dosaggio:

2mg/1ml

Forma farmaceutica:

Solution for infusion

Via di somministrazione:

Intravenous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 08010200; GTIN: 05413760208848

Scheda tecnica

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