FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

fludarabine phosphate, Quantity: 50 mg

Beszerezhető a:

Juno Pharmaceuticals Pty Ltd

INN (nemzetközi neve):

Fludarabine phosphate

Gyógyszerészeti forma:

Injection, powder for

Összetétel:

Excipient Ingredients: mannitol; sodium hydroxide

Az alkalmazás módja:

Intravenous

db csomag:

1 x 5 mL vial

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Treatment of B-cell chronic lymphocytic leukaemia

Termék összefoglaló:

Visual Identification: white or almost white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2009-05-13

Betegtájékoztató

Fludarabine JUNO CMI
FLUDARABINE JUNO
_fludarabine phosphate 50 mg powder for injection vial _
CONSUMER MEDICINE INFORMATION
WHAT
IS
IN
THIS
LEAFLET?
This
leaflet
answers
some common questions
about Fludarabine JUNO.
It does not contain all of
the available information.
It does not take the place
of talking to your doctor.
All medicines have risks
and
benefits.
Your
doctor
has
weighed
the
risks of using Fludarabine
JUNO
against
the
benefits it is expected to
have for you. Only your
doctor is able to weigh up
all the relevant facts and
you
should
consult
him/her about all aspects
of
this
medication
as
it
relates to you.
If you have any concerns
about using Fludarabine
JUNO, ask your doctor.
KEEP THIS LEAFLET.
You may want to read it
again.
WHAT
FLUDARABINE
JUNO
IS
USED
FOR
AND HOW IT WORKS
Fludarabine
JUNO
is
used to treat a form of
leukaemia
known
as
chronic
lymphocytic
leukaemia, or CLL.
All
cells
in
the
body
produce
new
cells
like
themselves
by
dividing.
For
this
purpose,
the
cells'
genetic
material
(DNA)
must
be
copied
and
reproduced.
Fludarabine JUNO works
by
hindering
the
production of new DNA.
Therefore,
when
Fludarabine
JUNO
is
taken up by the cancer
cells it stops the growth
of
new
cancer
cells.
It
has been discovered that
Fludarabine JUNO works
especially
well
against
some
cancers
of
the
white blood cells.
BEFORE
YOU
ARE
GIVEN
FLUDARABINE
JUNO
_WHEN YOU MUST NOT USE _
_IT _
_ _
You
must
not
be
given
Fludarabine JUNO if any
of the following apply to
you:
•
Pregnancy or breast-
feeding
•
Allergy
(hypersensitivity)
to
any
of the ingredients of this
medicine
•
Your kidney function
is severely reduced
•
The
number
of
red
blood
cells
is
reduced
due to a breaking down
of these cells (hemolytic
anemia)
The
effects
of
Fludarabine JUNO have
not
been
studied
in
children. It should not be
used
together
with
the
leukaemia
drug
pentostatin.
_BEFORE YOU USE IT _
If
it
is
found
that
your
kidneys
do
not
work
properly
you
may
be
given this medicine at a
reduced dose.
If your liver does not work
properly, you have

Termékjellemzők

Australian Product Information
Fludarabine JUNO Product Information v4.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
FLUDARABINE JUNO _(FLUDARABINE PHOSPHATE) _
_ _
1 NAME OF THE MEDICINE
Fludarabine phosphate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50mg of fludarabine phosphate.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
White or almost white powder for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of B-cell chronic lymphocytic leukaemia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Formulation for intravenous use
Fludarabine JUNO should be administered under the supervision of a
qualified doctor
experienced in the use of antineoplastic therapy.
It
is
strongly
recommended
that
Fludarabine
JUNO
should
only
be
administered
intravenously. Paravenous administration must be avoided.
Adults
The recommended dose is 25 mg/m
2
body surface, given daily for five consecutive days
every 28 days by the intravenous route. Each vial is to be made up
with water for injections
2 mL. Each mL of the resulting solution will contain fludarabine
phosphate 25 mg.
The required dose (calculated on the basis of the patient's body
surface) is drawn up into a
syringe. For intravenous bolus injection, this dose is further diluted
in physiological saline 10
mL. Alternatively, the required dose drawn up in a syringe may be
diluted in physiological
saline 100 mL and infused over approximately 30 minutes.
The duration of treatment depends on the treatment success and the
tolerability of the drug.
Fludarabine JUNO should be administered up to achievement of best
response (complete or
Australian Product Information
Fludarabine JUNO Product Information v4.0
Page | 2
partial remission, usually six cycles) and then the drug should be
discontinued.
Toxicity
Dosage may be decreased or delayed based on evidence of haematological
and non-
haematological toxicity. Doctors should consider delaying or
discontinuing the drug if toxicity
occurs.
Impaired state of health
A n