Onkotrone 20mg/10ml solution for infusion vials

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Mitoxantrone hydrochloride

Διαθέσιμο από:

Baxter Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

L01DB07

INN (Διεθνής Όνομα):

Mitoxantrone hydrochloride

Δοσολογία:

2mg/1ml

Φαρμακοτεχνική μορφή:

Solution for infusion

Οδός χορήγησης:

Intravenous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08010200; GTIN: 05413760208824

Αρχείο Π.Χ.Π.

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