Fludarabine Phosphate 50mg Powder for Solution for Injection or Infusion

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Fludarabine phosphate

Fáanlegur frá:

Fresenius Kabi Oncology Plc

ATC númer:

L01BB; L01BB05

INN (Alþjóðlegt nafn):

Fludarabine phosphate

Skammtar:

50 milligram(s)

Lyfjaform:

Powder for solution for injection/infusion

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Purine analogues; fludarabine

Leyfisstaða:

Not marketed

Leyfisdagur:

2013-05-03

Upplýsingar fylgiseðill

FLUDARABINE PHOSPHATE 50 MG - PACK INSERT - IRELAND+UK+MALTA
(Travesh Sharma) D:\Europe\Fludarabine\Ireland+UK+Malta\Fludarabine
phosphate 50 mg - Pack Insert - Ireland+UK+Malta.indd
SIZE:
339 X 300 MM
5 APRIL 2013 9:18 AM
VER. 04
TIMES NEW ROMAN 8.5 PTS.
Black
xxxxxx
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V001/BO
The following
information is
intended for healthcare
professionals only:
Fludarabine as other
potiential cytotoxic
medicines must
be prepared by
qualified personnel
in a designated area.
Consideration must
be given to handling
and disposal according
to guidelines used for
cytotoxic drugs.
FOR INTRAVENOUS USE
ONLY.
INCOMPATIBILITIES
Must not be mixed with
other drugs.
INSTRUCTIONS FOR USE
AND HANDLING
RECONSTITUTION
Fludarabine must be
prepared for use by
aseptically adding sterile
water for injections.
When reconstituted
with 2 ml of sterile
water for injections,
the powder must fully
dissolve in less than
60 seconds. Each ml of
the resulting solution
will contain 25 mg of
fludarabine phosphate.
The solution should be
inspected visually. The
reconstituted/ diluted
solution must be clear,
colorless and without
particles.
DILUTION
The reconstituted
solution draws up into a
syringe. For intravenous
bolus injection this
dose is further diluted
into 10 ml 0.9%
sodium chloride. For
intravenous infusion
the solution is diluted
into 100 ml 0.9%
sodium chloride or 5%
dextrose injection and
infused over 30 minutes.
In clinical studies,
the product has been
diluted in 100 ml or
125 ml of 5% dextrose
(for injection) or 0.9
% sodium chloride
solution.
The dilution
compatibility study
has been carried out in
polyolefin infusion bags.
After first opening, the
product should be used
immediately.
AFTER RECONSTITUTION:
The physicochemical
stability of the
drug product after
reconstitution in water
for injections has been
demonstrated for 24
hours at 25°C ± 2°C/
60% ± 5%RH and for 7
days at 5°C ± 3°C.
From a microbiological
point of view, the
product should be used
immediately. If not
used immediately, in-
use storage times and
PACKAGE LEAFLE

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fludarabine Phosphate 50mg Powder for Solution for Injection or
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of fludarabine phosphate.
1 ml of reconstituted solutions contains 25 mg of fludarabine
phosphate.
Excipient with known effect:
Each vial of fludarabine phosphate 50 mg powder for solution for
injection /infusion contains less than 1 mmol sodium
(23 mg), i.e. essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/ infusion.
Sterile lyophilized white or almost white powder or cake.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of B cell chronic lymphocytic leukaemia (CLL) in patients
with sufficient bone marrow reserves.
First line treatment with fludarabine should only be initiated in
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
Fludarabine should be administered under the supervision of a
qualified physician experienced in the use of
antineoplastic therapy.
Intravenous administration
Fludarabine must be administered only intravenously.
No cases have been reported in which paravenously administered
fludarabine led to severe local adverse reactions.
However, unintentional paravenous administration must be avoided.
Adults
The recommended dose of fludarabine is 25 mg/m2 body surface area
given daily for 5 consecutive days every 28 days
by the intravenous route.
Each vial is to be made up in 2 ml water for injections. Each ml of
the resulting solution for
injection /infusion contains 25 mg fludarabine phosphate (see section
6.6).
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 sodium
chloride 9 mg/ml (0.9%). Altern