Onkotrone

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Mitoxantrone hydrochloride 2.328 mg/mL

Tilgjengelig fra:

Baxter Healthcare Ltd

INN (International Name):

Mitoxantrone hydrochloride 2.328 mg/mL

Dosering :

2 mg/mL

Legemiddelform:

Concentrate for injection

Sammensetning:

Active: Mitoxantrone hydrochloride 2.328 mg/mL Excipient: Glacial acetic acid Nitrogen Sodium acetate trihydrate Sodium chloride Water for injection

Enheter i pakken:

Vial, glass, Type I, 5 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Baxter Oncology GmbH

Indikasjoner:

Onkotrone is indicated for the treatment of: · Locally advanced or metastatic carcinoma of the breast · Non-Hodgkin's lymphoma · Adult acute non-lymphocytic leukaemia (ANLL) · Chronic myelogenous leukaemia in blast crisis

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, Type I - 5 mL - 3 years from date of manufacture stored at or below 25°C 7 days opened stored at or below 25°C 2 days reconstituted stored at or below 25°C - Vial, glass, Type I - 10 mL - 3 years from date of manufacture stored at or below 25°C 7 days opened stored at or below 25°C 2 days reconstituted stored at or below 25°C - Vial, glass, Type I - 12.5 mL - 3 years from date of manufacture stored at or below 25°C 7 days opened stored at or below 25°C 2 days reconstituted stored at or below 25°C - Vial, glass, Type I - 25 mL - 3 years from date of manufacture stored at or below 25°C 7 days opened stored at or below 25°C 2 days reconstituted stored at or below 25°C

Autorisasjon dato:

1999-08-10

Preparatomtale

NEW ZEALAND DATA SHEET
ONKOTRONE Data Sheet 22 October 2020
Page 1 of 12
Baxter Healthcare Ltd
1 ONKOTRONE (2mg/mL concentrate for injection)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mitoxantrone hydrochloride 2.328mg/mL (equivalent to mitoxantrone
2mg/mL) of solution for
injection.
3 PHARMACEUTICAL FORM
Concentrate for injection.
ONKOTRONE concentrated Injection is a clear, dark blue liquid with a
pH of 3.0 – 4.5.
Mitoxantrone hydrochloride is a hygroscopic dark blue solid.
For the full list of excipients, see Section 6.1.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ONKOTRONE is indicated for the treatment of:

Locally advanced or metastatic carcinoma of the breast

Non‐Hodgkin’s lymphoma

Adult acute non‐lymphocytic leukaemia (ANLL)

Chronic myelogenous leukaemia in blast crisis.
4.2
Dose and method of administration
The dose should be adjusted to each patient carefully. Doses greater
than 140mg/m
2
are not
recommended, particularly as a single bolus injection. Such
administrations have caused fatal
overdose as a result of severe leucopenia and infection.
_Use in Children _
Experience in paediatric patients is limited.
_Intrathecal use _
Safety for intrathecal use of mitoxantrone has not yet been
established.
_Breast cancer and Lymphoma _
_Single‐agent therapy _
The recommended initial dosage for use as a single agent is 14mg/m²
of body surface area, given as
a single intravenous dose, which may be repeated at 21 day intervals.
A lower initial dose (12mg/m
2
or less) is recommended in patients with inadequate marrow reserves
due to prior therapy or poor general condition.
Dosage modification and timing of subsequent dosing should be
determined by clinical judgement
depending on the degree and duration of myelosuppression. If 21 day
white blood cell and platelet
counts have returned
to adequate levels, prior doses can usually be repeated. The following
table
indicates a guide to dosing based on myelosuppression for the
treatment of breast cancer and non‐
Hodgkin’s lymphoma.
NE