FLUDARABINE EBEWE fludarabine phosphate 50 mg/2 mL concentrated injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

fludarabine phosphate, Quantity: 50 mg

Prieinama:

Sandoz Pty Ltd

INN (Tarptautinis Pavadinimas):

Fludarabine phosphate

Vaisto forma:

Injection, concentrated

Sudėtis:

Excipient Ingredients: dibasic sodium phosphate dihydrate; sodium hydroxide; water for injections; nitrogen

Vartojimo būdas:

Intravenous

Vienetai pakuotėje:

2mL (in 5mL vial) x 10 vials per carton, 2mL (in 5mL vial) x 5 vials per carton, 2mL (in 5mL vial) x 1 vial per carton

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Fludarabine Ebewe is indicated for the treatment of B-cell chronic lymphocytic leukaemia.

Produkto santrauka:

Visual Identification: Clear, colourless to almost colourless solution, in a clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2008-01-17

Pakuotės lapelis

FLUDARABINE EBEWE
_Fludarabine Phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet provides a summary of
some of the important things you
need to know about this medicine. It
does not contain all 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 receiving Fludarabine
Ebewe against the benefits they
expect it will 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
RECEIVING FLUDARABINE EBEWE, ASK
YOUR DOCTOR.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
It is important to remember that
Fludarabine Ebewe is a
PRESCRIPTION ONLY
MEDICINE.
Fludarabine Ebewe will only be
given to you by specially trained
personnel in a hospital environment.
WHAT FLUDARABINE
EBEWE IS USED FOR
Fludarabine Ebewe 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 Ebewe
works by hindering the production of
new DNA. Therefore, when
Fludarabine Ebewe is taken up by the
cancer cells it stops the growth of
new cancer cells. It has been
discovered that Fludarabine Ebewe
works especially well against some
cancers of the white blood cells.
Fludarabine Ebewe may have been
prescribed for another reason. Ask
your doctor if you have any questions
about why Fludarabine Ebewe has
been prescribed for you.
BEFORE YOU ARE GIVEN
FLUDARABINE 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.
•
YOUR KIDNEY FUNCTION IS
SEVERELY REDUCED
•
THE NUMBER OF RED B

Prekės savybės

190626-Fludarabine Ebewe-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
FLUDARABINE EBEWE 50 MG/2 ML INJECTION (FLUDARABINE
PHOSPHATE)
1.
NAME OF THE MEDICINE
Fludarabine phosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fludarabine phosphate is a white or almost white, hygroscopic
crystalline powder, slightly
soluble in water, freely soluble in dimethylformamide, and very
slightly soluble in anhydrous
ethanol.
Fludarabine Ebewe is a sterile, clear, colourless solution containing
50 mg fludarabine
phosphate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Fludarabine Ebewe 50 mg/2 mL injection
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Fludarabine Ebewe is indicated for the treatment of B-cell chronic
lymphocytic leukaemia.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS_
The recommended dose is 25 mg/m
2
body surface given daily for 5 consecutive days every 28
days by the intravenous route. Each vial contains 25 mg fludarabine
phosphate per mL (50 mg
in 2 mL).
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
into 10 mL of physiological
saline. Alternatively, the required dose drawn up in a syringe may be
diluted into 100 mL
physiological saline and infused over approximately 30 minutes.
The duration of treatment depends on the treatment success and the
tolerability of the drug.
Fludarabine Ebewe should be administered up to achievement of best
response (complete or
partial remission, usually 6 cycles) and then the drug should be
discontinued.
_TOXICITY_
Dosage
may
be
decreased
or
delayed
based
on
evidence
of
haematological
and
non-
haematological toxicity. Physicians should consider delaying or
discontinuing the drug if
toxicity occurs.
_RETREATMENT OPTIONS AFTER INITIAL FLUDARABINE EBEWE TREATMENT_
Patients who primarily respond to Fludarabine Ebewe have a good chance
of responding
again to Fludarabine Ebewe monotherapy. A crossover