Mitozantrone Ebewe

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Mitoxantrone hydrochloride 2.3284 mg/mL Equivalent to mitoxantrone 2 mg/mL. Australian approved name is Mitozantrone hydrochloride.

Fáanlegur frá:

Sandoz New Zealand Limited

INN (Alþjóðlegt nafn):

Mitoxantrone hydrochloride 2.3284 mg/mL (Equivalent to mitoxantrone 2 mg/mL. Australian approved name is Mitozantrone hydrochlor

Skammtar:

2 mg/mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Mitoxantrone hydrochloride 2.3284 mg/mL Equivalent to mitoxantrone 2 mg/mL. Australian approved name is Mitozantrone hydrochloride. Excipient: Glacial acetic acid Hydrochloric acid Nitrogen Sodium acetate Sodium chloride Sodium sulfate Water for injection

Einingar í pakka:

Vial, glass, single dose, Type I, colourless with fluoropolymer coated halobutyl rubber stopper and Al crimp cap 10 mg/5 mL, 5 m

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Synthesia a.s.

Ábendingar:

Mitozantrone Ebewe is indicated for the treatment of: · metastatic carcinoma of the breast · non-Hodgkin's lymphoma · adult acute non-lymphocytic leukaemia (ANLL) · chronic myelogenous leukaemia in blast crisis

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I, colourless with fluoropolymer coated halobutyl rubber stopper and Al crimp cap 10 mg/5 mL - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type I, colourless with fluoropolymer coated halobutyl rubber stopper and Al crimp cap 20 mg/10 mL - 10 mL - 24 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2007-06-01

Upplýsingar fylgiseðill

Mitozantrone Ebewe
Mitozantrone Ebewe_CMI_v2_Dec 2014
Page 1 of 3
MITOZANTRONE EBEWE
_Mitozantrone (My-toe-ZAN-trone). _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Mitozantrone Ebewe.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you taking
mitozantrone against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
It is important to remember
that Mitozantrone Ebewe is a
PRESCRIPTION ONLY
MEDICINE.
Mitozantrone Ebewe will only
be given to you by specially
trained personnel in a hospital
environment.
WHAT MITOZANTRONE EBEWE IS
USED FOR
Mitozantrone (My-toe-ZAN-
trone) belongs to the group of
medicines called
antineoplastics. It is typically
used to treat cancer of the
breast, but may also be used for
the treatment of non-Hodgkin's
Lymphoma and leukaemia.
Mitozantrone may also be used
to treat other conditions as
determined by your doctor.
Ask your doctor if you have
any questions about why
Mitozantrone Ebewe has been
prescribed for you.
BEFORE YOU ARE GIVEN
MITOZANTRONE EBEWE
_THIS MEDICINE SHOULD NOT BE _
_GIVEN TO YOU IF: _
YOU ARE PREGNANT OR INTEND
TO BECOME PREGNANT.
This medicine is not
recommended during
pregnancy.
YOU ARE BREAST-FEEDING OR
PLAN TO BREAST FEED.
This medicine is not
recommended while you are
breast-feeding.
YOU HAVE AN ALLERGIC OR
UNUSUAL REACTION PREVIOUSLY
TO MITOZANTRONE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic
reaction may include rashes,
itching and redness of the skin
and swelling of the tongue or
face.
IF YOU ARE NOT SURE WHETHER
ANY OF THESE APPLY TO YOU,
CHECK WITH YOUR DOCTOR OR
PHARMACIST.
BEFORE YOU ARE GIVEN
MITOZANTRONE, TELL YOUR
DOCTOR IF:
YOU HAVE OR HAVE HAD ANY
OTHER MEDICAL CONDITIONS,
ES

Vara einkenni

NEW ZEALAND DATA SHEET
Page 1 of 14
1 PRODUCT NAME
MITOZANTRONE EBEWE
®
2 mg/mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10mg in 5mL or 20mg in 10mL mitoxantrone (as
hydrochloride) [Australian
approved name is mitozantrone hydrochloride].
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Mitozantrone Ebewe is a sterile, clear, blue, aqueous, isotonic
solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mitozantrone Ebewe is indicated for the treatment of:
•
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
Dosage
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 mitozantrone has not yet been
established.
BREAST CANCER AND LYMPHOMA
SINGLE-AGENT THERAPY
The recommended initial dosage for use as single agent is 14 mg/m
2
of body surface area, given
as a single intravenous dose, which may be repeated at 21 day
intervals. A lower initial dose
(12 mg/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.
NEW ZEALAND DATA SHEET
Page 2 of 14
TABLE 1: DOSAGE GUIDE BASED ON MYELOSUPPRESSION
WBC AND PLATELET NADIR
TIME TO RECOVERY
SUBSEQUENT DOSING
If WBC nadir > 1.5 x 10