Fludara oral 10mg film-coated Tablets

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

FLUDARABINE PHOSPHATE

Fáanlegur frá:

Genzyme Europe BV Paasheuvelweg 25, 1105 BP Amsterdam , Netherlands

ATC númer:

L01BB05

INN (Alþjóðlegt nafn):

FLUDARABINE PHOSPHATE 10 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

FLUDARABINE PHOSPHATE 10 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Leyfisstaða:

Authorised

Leyfisdagur:

2007-12-05

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUDARA ORAL 10 MG FILM-COATED TABLETS
Fludarabine phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fludara oral is and what it is used for
2.
What you need to know before you take Fludara oral
3.
How to take Fludara oral
4.
Possible side effects
5.
How to store Fludara oral
6.
Contents of the pack and other information
1.
WHAT FLUDARA ORAL IS AND WHAT IT IS USED FOR
Fludara oral contains the active substance fludarabine phosphate which
stops the growth of
new cancer cells. All cells of the body produce new cells like
themselves by dividing. Fludara
oral is taken up by the cancer cells and stops them dividing.
_ _
In cancers of the white blood cells (such as
_chronic lymphocytic leukaemia_
) , the body
produces 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 the normal disease
fighting functions and may push aside healthy blood cells. This can
result in infections, a
decrease in number of red blood cells
_(anaemia)_
, bruising, severe bleeding or even organ
failure.
Fludara is used in the treatment of B-cell chronic lymphocytic
leukaemia (B-CLL) in patients
with sufficient healthy blood cell production.
First treatment for chronic lymphocytic leukaemia with Fludara oral
should only be started in
patients with advanced disease having disease-related symptoms or
evidence of disease
progression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUDARA ORAL
D

Vara einkenni

1.
NAME OF THE MEDICINAL PRODUCT
Fludara oral 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg fludarabine phosphate.
Excipients: Lactose monohydrate 74.75 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Salmon-pink, capsule-shaped tablet marked with ‘LN’ in a regular
hexagon on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult
patients with sufficient bone
marrow reserves.
First line treatment with Fludara oral should only be initiated in
adult patients with advanced disease,
Rai stages III/IV (Binet stage C) or Rai stages I/II (Binet stage A/B)
where the patient has disease
related symptoms or evidence of progressive disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 40 mg fludarabine phosphate/m² body surface
given daily for 5 consecutive
days every 28 days by oral route. This dose corresponds to 1.6 times
the recommended intravenous
dose of fludarabine phosphate (25 mg/m
2
body surface per day).
The following table provides guidance for determining the number of
tablets of Fludara oral to be
administered:
BODY SURFACE AREA
(BSA)
[M²]
CALCULATED TOTAL DAILY DOSE BASED ON BSA
(ROUNDED UP OR DOWN TO WHOLE NUMBER)
[MG/DAY]
NUMBER OF TABLETS PER
DAY (TOTAL DAILY DOSE)
0.75 - 0.88
30 – 35
3 (30 mg)
0.89 - 1.13
36 – 45
4 (40 mg)
1.14 - 1.38
46 – 55
5 (50 mg)
1.39 - 1.63
56 – 65
6 (60 mg)
1.64 - 1.88
66 – 75
7 (70 mg)
1.89 - 2.13
76 – 85
8 (80 mg)
2.14 - 2.38
86 – 95
9 (90 mg)
2.39 - 2.50
96 – 100
10 (100 mg)
The duration of treatment depends on the success of treatment and the
tolerability of the drug.
Fludara oral should be administered until best response is achieved
(complete or partial remission,
usually 6 cycles) and then the drug should be discontinued.
Dose adjustments for the first treatment cycle (start of therapy with
Fludara) are not recommended
(except in patients with