GENEPHARM MITOZATRONE HYDROCHLORIDE mitozantrone hydrochloride 25mg/12.5mL concentrate for injection vial

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

mitozantrone hydrochloride

Доступна з:

Novotech Australia Pty Ltd

ІПН (Міжнародна Ім'я):

Mitozantrone hydrochloride

Статус Авторизація:

Registered

інформаційний буклет

CONSUMER MEDICINE INFORMATON
MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Mitozantrone
Hydrochloride
Injection Concentrate.
It does not contain all the available information. It does not take
the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Mitozantrone Hydrochloride Injection Concentrate against the benefits
this medicine is
expected to have for you.
This medicine is likely to be used while you are in hospital.
IF POSSIBLE,
PLEASE READ THIS
LEAFLET CAREFULLY
BEFORE THIS MEDICINE IS GIVEN TO YOU.
If you have any concerns about taking this medicine, ask your doctor
or nurse.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE IS USED FOR
Mitozantrone belongs to a group of medicines called antineoplastic or
cytotoxic
medicines. You may also hear of these being called chemotherapy
medicines.
It is used to treat some types of cancer, such as:
•
breast cancer, including breast cancer which has spread to other parts
of the body
•
some types of leukaemia
•
non-Hodgkin’s lymphoma, a cancer of the lymph glands.
Mitozantrone is thought to work by interfering with the growth of
cancer cells, which
slows their growth and destroys them. The growth of normal cells in
other parts of your
body may also be affected.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MITOZANTRONE
HYDROCHLORIDE
INJECTION CONCENTRATE HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor’s prescription.
Mitozantrone Hydrochloride Injection Concentrate will be given to you
only by specially
trained personnel in a hospital environment.
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CMI v2 15/6/2010
Mitozantrone Hydrochloride Injection Concentrate is not recommended
for use in
children as there is not enough information on its effects in
children.
BEFORE YOU ARE GIVEN MITOZANTRONE HYDR

Характеристики продукта

PRODUCT INFORMATION
NAME OF THE MEDICINE
MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE
Mitozantrone hydrochloride
DESCRIPTION
Mitozantrone hydrochloride is a hygroscopic dark blue solid, sparingly
soluble in water,
slightly soluble in methanol, practically insoluble in acetone,
acetonitrile or chloroform.
Mitozantrone hydrochloride is a potent cytotoxic synthetic
anthracenedione.
Molecular formula: C
22
H
28
N
4
O
6
.2HCl
Molecular weight: 517.4.
CAS Number: 70476-82-3.
PHARMACOLOGY
Although its mechanism of action has not been fully determined,
mitozantrone
hydrochloride is a DNA-reactive agent. It has a cytocidal effect on
proliferating and non-
proliferating cultured human cells.
_In vitro_
studies suggest that mitozantrone is not cell-
cycle phase specific.
In animals, the principal toxic effects of mitozantrone hydrochloride
at doses within the
human therapeutic range are reversible myelosuppression (manifested
predominantly as
leucopenia; erythropenia and thrombocytopenia are normally less
severe) and
lymphocytic depletion of the lymphoid organs. Gastrointestinal
haemorrhage and
congestion were noted in continuous daily dosing studies but not in
the intermittent
schedules to be used clinically.
In dog and monkey studies with mitozantrone hydrochloride, doxorubicin
was studied
simultaneously at equileucopenic doses as a positive control for
anthracycline-induced
cardiomyopathy. Dogs given mitozantrone hydrochloride and untreated
control dogs
showed slight dilation of the sarcoplasmic reticulum which regressed
over time. In
monkeys, clinical signs of congestive heart failure were observed in
animals given
doxorubicin, but not mitozantrone hydrochloride. Myocyte alterations
in doxorubicin-
treated monkeys were characteristic of degeneration, whereas myocyte
alterations in
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monkeys treated with mitozantrone hydrochloride were suggestive of
cellular
regeneration and repair. In rats, there was no evidence of the
progressive cardiomyopathy
characteristic of anthracyclines.
An analysis of cardio