Fludara

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Fludarabine phosphate 25 mg/mL;  

Disponible depuis:

sanofi-aventis new zealand limited

DCI (Dénomination commune internationale):

Fludarabine phosphate 25 mg/mL

Dosage:

50 mg/2mL

forme pharmaceutique:

Powder for injection

Composition:

Active: Fludarabine phosphate 25 mg/mL   Excipient: Mannitol Sodium hydroxide

Unités en paquet:

Vial, glass, 5 dose units

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Bayer AG

Descriptif du produit:

Package - Contents - Shelf Life: Vial, glass, - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 4°C, refrigerate, do not freeze

Date de l'autorisation:

1991-08-28

Notice patient

Page 1 of 5
FLUDARA ORAL
®
(FLU-DA-RA)
_Fludarabine phosphate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLUDARA ORAL.
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 FLUDARA
ORAL against the benefits they
expect it will have for you.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FLUDARA ORAL
IS USED FOR
This medicine is an anti-cancer
drug approved to treat a form of
leukaemia known as B-cell chronic
lymphocytic leukaemia (B-CLL).
This is a cancer of a type of white
blood cells called lymphocytes.
Patients with B-CLL have too many
abnormal white blood cells
(lymphocytes) and lymph nodes
start to grow in various parts of the
body. The abnormal white blood
cells cannot carry out their normal
disease fighting functions, and may
push aside healthy blood cells. This
can result in infections, a
decreased number of red blood
cells (anaemia), bruising and/or
bleeding.
FLUDARA is a medication that
stops the growth of new cancer
cells. All cells of the body produce
new cells like themselves by
dividing. To do this, the cells’
genetic material (DNA) must be
copied and reproduced. FLUDARA
is taken up by the cancer cells and
hinders the production of new DNA.
ASK YOU DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
There is not enough information to
recommend the use of this
medicine for children.
BEFORE YOU TAKE
FLUDARA ORAL
_ _
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT HAVE ANY FLUDARA IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
fludarabine
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
ras

Résumé des caractéristiques du produit

flu-ccdsv27-dsv7-14feb23
Page 1
NEW ZEALAND DATA SHEET
1
FLUDARA
® ORAL 10 MG FILM COATED TABLET
FLUDARA ORAL 10 mg film coated tablet.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fludarabine phosphate.
FLUDARA ORAL film coated tablets contain 10 mg of fludarabine
phosphate.
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Film coated tablet.
FLUDARA ORAL film coated tablets are salmon coloured oval shaped
tablets with "LN"
indented in a regular hexagon on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLUDARA ORAL is indicated for the treatment of B-cell chronic
lymphocytic leukaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSE _
_TABLETS FOR ORAL USE _
_Adults _
FLUDARA ORAL tablets should be prescribed by a qualified physician
experienced in the
use of antineoplastic therapy.
The recommended dose is 40 mg fludarabine phosphate/m
2
body surface given daily for 5
consecutive days every 28 days by the oral route. FLUDARA ORAL tablets
can be taken
either on an empty stomach or together with food. The tablets are to
be swallowed whole
with water, and must not be chewed or broken.
flu-ccdsv27-dsv7-14feb23
Page 2
The duration of treatment depends on the treatment success and the
tolerability of the drug.
FLUDARA ORAL 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.
_IMPAIRED STATE OF HEALTH _
A number of clinical settings may predispose to increased toxicity
from FLUDARA ORAL.
These include advanced age, renal insufficiency and bone marrow
impairment- see Section
4.4, Use in Specialised groups, Impaired state of health. Such
patients should be monitored
closely for excessive toxicity and the dose modified accordingly.
_Impaired renal function _
Dosage reduction is required in renally impa