ONKOTRONE mitozantrone 10mg/5mL (as hydrochloride) concentrated injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

mitozantrone hydrochloride, Quantity: 2.328 mg/mL (Equivalent: mitozantrone, Qty 2 mg/mL)

Dostupno od:

Baxter Healthcare Pty Ltd

Farmaceutski oblik:

Injection, concentrated

Sastav:

Excipient Ingredients: sodium chloride; glacial acetic acid; sodium acetate; water for injections

Administracija rute:

Intravenous

Jedinice u paketu:

1 vial

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

Visual Identification: Dark blue solution, free from visible particles; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2001-01-24

Uputa o lijeku

ONKOTRONE (mitozantrone)
Consumer Medicine Information
ONKOTRONE CMI 030505
Page 1 of 5
Baxter
ONKOTRONE
_Mitozantrone _
CONSUMER MEDICINE INFORMATION_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ONKOTRONE.
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
ONKOTRONE against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ONKOTRONE IS USED
FOR
ONKOTRONE is used to treat
various types of cancer. These
include breast cancer, non-
Hodgkin’s lymphoma (a cancer
of the lymph glands), and
leukaemia.
ONKOTRONE belongs to a
group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
ONKOTRONE works by
stopping cancer cells from
growing and multiplying.
Your doctor may have
prescribed ONKOTRONE for
another reason. Ask your doctor
if you have any questions about
why ONKOTRONE has been
prescribed for you.
ONKOTRONE may be used in
combination with other
medicines to treat cancer.
ONKOTRONE is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
ONKOTRONE
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT HAVE ONKOTRONE IF
YOU HAVE AN ALLERGY TO
ONKOTRONE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic
reaction to ONKOTRONE may
include:

shortness of breath,
wheezing, difficulty
breathing or a tight feeling in
your chest

swelling of the face, lips,
tongue or other parts of the
body

rash, itching, hives or
flushed, red skin

dizziness or light-headedness
DO NOT HAVE ONKOTRONE IF
YOU HAVE, OR HAVE HAD, ANY OF
THE FOLLOWING MEDICAL
CONDITIONS, UNLESS YOU HAVE
FIRST DISCUSSED THIS WITH YOUR
DOCTOR:

severe liver problems_ _

heart pro

Svojstava lijeka

Onkotrone (Mitozantrone hydrochloride) Concentrated Injection
Version 1.1
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AUSTRALIAN PRODUCT INFORMATION –
ONKOTRONE (MITOZANTRONE HYDROCHLORIDE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Mitozantrone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mitozantrone hydrochloride is a hygroscopic dark blue solid.
Onkotrone concentrated Injection liquid has a pH of 3.0 - 4.5. One mL
of the solution for injection
contains 2.328 mg mitozantrone hydrochloride (equivalent to 2 mg
mitozantrone).
Excipients: sodium chloride, sodium acetate, glacial acetic acid and
water for injections.
3
PHARMACEUTICAL FORM
Onkotrone is a clear, dark blue concentrated Injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
The dose should be adjusted to each patient carefully. Doses greater
than 140 mg/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 days intervals. A
lower initial dose (12 mg/m
2
or less) is recommended in patients with inadequate bone 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
Onkotrone (Mitozantrone hydrochloride) Concentrated Injection
Version 1.1
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counts