ONKOTRONE Solution for Injection 2.328mg/1 Millilitre

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

MITOXANTRONE HYDROCHLORIDE

Verfügbar ab:

Asta Medica Ltd

Dosierung:

2.328mg/1 Millilitre

Darreichungsform:

Solution for Injection

Berechtigungsdatum:

2001-06-29

Fachinformation

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