CARMUSTINE-JUNO carmustine 100 mg powder for injection vial with diluent vial

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

carmustine, Quantity: 100 mg

Доступна з:

Dr Reddys Laboratories Australia Pty Ltd

Фармацевтична форма:

Injection, diluent for

Склад:

Excipient Ingredients: ethanol absolute

Адміністрація маршрут:

Intravenous Infusion

Одиниць в упаковці:

1 powder for injection vial and 1 diluent vial

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

CARMUSTINE-JUNO is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. Malignant Glioma 2. Multiple Myeloma - in combination with prednisone. 3. Hodgkin?s Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4. Non-Hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

Огляд продуктів:

Visual Identification: Clear, colourless, mobile, volatile liquid; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Registered

Дата Авторизація:

2020-08-12

інформаційний буклет

CARMUSTINE JUNO
_Carmustine (kar-MUS-teen)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CARMUSTINE
JUNO
®
. 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
CARMUSTINE JUNO
against the
benefits that are expected.
This
leaflet does not contain
everything
about CARMUSTINE JUNO. Your
doctor has been provided with full
information and can answer any
questions you may have. Follow
your doctor's advice even if it differs
from what is in this leaflet.
Please read this leaflet carefully and
keep it in a safe place so you may
refer to it later.
WHAT CARMUSTINE
JUNO IS USED FOR
CARMUSTINE JUNO is used to
treat malignant
glioma, a type of
brain cancer, and
multiple myeloma,
a cancer of the
blood. It may also be
used to treat
other types of cancers
called
Hodgkin's Disease and Non-
Hodgkin's lymphomas.
CARMUSTINE JUNO belongs
to a group of
medicines called
cytotoxic
medicines. You may
also hear of
these being called
chemotherapy
medicines.
CARMUSTINE JUNO may be
used in
combination with other
medicines to
treat your cancer.
Your doctor may have prescribed
CARMUSTINE JUNO for another
use. Ask your
doctor if you have any
questions
about why
CARMUSTINE JUNO was
prescribed for you.
This medicine is available
only with
a doctor's prescription.
HOW CARMUSTINE
JUNO WORKS
CARMUSTINE JUNO works by
killing cancer cells.
The use of CARMUSTINE
JUNO to treat your
condition can
lead to side-effects,
which are
discussed below.
BEFORE YOU ARE GIVEN
CARMUSTINE JUNO
_WHEN YOU MUST NOT BE GIVEN _
_IT_
You must not have CARMUSTINE
JUNO if you
have a history of severe
allergic
reactions to CARMUSTINE
JUNO or to any of the
ingredients
listed at the end of this
leaflet.
Do not have CARMUSTINE JUNO
if you have, or
have had, any of the
following
medical conditions, unless
you have
discussed it with your
doctor:
•
kidney problems
•
lung disease
•
blood disorder with a reduced
n

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION – CARMUSTINE JUNO
(CARMUSTINE) POWDER FOR INJECTION PLUS DILUENT
1
NAME OF THE MEDICINE
Carmustine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each carton includes a vial containing 100 mg carmustine and a vial
containing 3 mL ethanol
absolute sterile diluent.
3
PHARMACEUTICAL FORM
Carmustine 100 mg/vial is lyophilized pale yellow flakes or congealed
mass or powder in an
amber glass vial. Sterile ethanol absolute is a clear, colourless
liquid in a clear glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CARMUSTINE JUNO is indicated as palliative therapy as a single agent
or in established
combination
therapy with other approved chemotherapeutic agents in the following:
1.
Malignant Glioma
2.
Multiple Myeloma - in combination with prednisone.
3.
Hodgkin’s Disease - as secondary therapy in combination with other
approved
drugs
in
patients
who
relapse
while
being
treated
with
primary
therapy,
or
who fail to
respond to primary therapy.
4.
Non-Hodgkin’s
lymphomas
-
as
secondary therapy in
combination
with
other
approved drugs for patients who relapse while being treated with
primary therapy
or
who fail to respond to primary therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
CARMUSTINE JUNO
is
administered
by
slow
intravenous
infusion.
CARMUSTINE JUNO
SHOULD NOT BE
GIVEN BY RAPID INTRAVENOUS INJECTION
The recommended dose of CARMUSTINE JUNO as a single agent in
previously untreated
patients
is
200 mg/m
2
intravenously every 6 weeks. This may be given as a single dose or
divided into
daily injections such as 100 mg/m
2
on successive days. When CARMUSTINE JUNO
is used in combination
with other myelosuppressive drugs or in patients in whom bone
marrow reserve is
depleted, the doses should be adjusted accordingly.
A repeat course of CARMUSTINE JUNO should not be given until
circulating blood elements
1
have
returned
to
acceptable
levels
(platelets
above
100,000/mm
3
;
leucocytes
above
4,000/mm
3
);
this
usually
occurs
within
6
weeks.
Blood
counts
should
be
monitored
frequently