Fludara oral

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Fludarabine phosphate 10mg

Disponible depuis:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

DCI (Dénomination commune internationale):

Fludarabine phosphate 10 mg

Dosage:

10 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Fludarabine phosphate 10mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified talc Titanium dioxide

Unités en paquet:

Blister pack, 15 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Bayer AG

indications thérapeutiques:

The treatment of B-cell chronic lympocytic leukaemia.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, - 15 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 20 tablets - 24 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

2001-08-10

Notice patient

FLUDARA ORAL®
1
FLUDARA ORAL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FLUDARA ORAL?
FLUDARA ORAL contains the active ingredient Fludarabine phosphate.
FLUDARA ORAL is used 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. For more
information, see Section 1. Why am I using FLUDARA ORAL?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLUDARA ORAL?
Do not use if you have ever had an allergic reaction to Fludarabine
phosphate or any of the ingredients listed at the end of the
CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use FLUDARA ORAL?
in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FLUDARA ORAL and affect how it
works. A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE FLUDARA ORAL?
•
Swallow the tablets whole with a full glass of water. Do not chew or
break the tablets.
•
The exact number of tablets you should take is calculated by your
doctor. The usual dose is between 3 to 10 tablets a day.
More instructions can be found in Section 4. How do I use FLUDARA
ORAL? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLUDARA ORAL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
FLUDARA ORAL
•
Call your doctor straight away if you notice anything new or unusual
on your skin, suggestive of
skin cancer
THINGS YOU
SHOULD NOT DO
•
Do not take FLUDARA ORAL to treat any other complaints unless your
doctor tells you to
•
Do not stop taking your medicine or change the dosage without checking
with your doctor
DRIVING OR USING
MACHINES
�

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