Fludarabine Actavis

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

Fludarabine phosphate

متاح من:

Actavis Australia Pty Ltd

الفئة:

Medicine Registered

نشرة المعلومات

 
Actavis Australia Pty Ltd 
FLUDARABINE ACTAVIS 50  
fludarabine phosphate 50 mg powder for injection vial 

CONSUMER MEDICINE INFORMATION                        
                                MAY 2009 

WHAT IS IN THIS LEAFLET? 

This leaflet answers some 
common questions about 
Fludarabine Actavis 50.   
It does not contain all of 
the available information.  
It does not take the place 
of talking to your doctor. 

All medicines have risks 
and benefits.  Your 
doctor has weighed the 
risks of using 
Fludarabine Actavis 50 
against the benefits it is 
expected to 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 using Fludarabine 
Actavis 50, ask your 
doctor. 

Keep this leaflet. You 
may want to read it again. 

WHAT FLUDARABINE 
ACTAVIS 50 IS USED FOR 
AND HOW IT WORKS 

Fludarabine Actavis 50 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 Actavis 50 
works by hindering the 
production of new DNA. 
Therefore, when 
Fludarabine Actavis 50 is 
taken up by the cancer 
cells it stops the growth 
of new cancer cells. It has 
been discovered that 
Fludarabine Actavis 50 
works especially well 
against some cancers of 
the white blood cells. 

BEFORE YOU ARE GIVEN 
FLUDARABINE ACTAVIS 50 

_WHEN YOU MUST NOT USE _
_IT _
You must not be given 
Fludarabine Actavis 50 if 
any of the following 
apply to you:  
•  Pregnancy or breast-
feeding  
•  Allergy 
(hypersensitivity) to 
any of the ingredients�

خصائص المنتج

Fludarabine Actavis 

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

FLUDARABINE ACTAVIS 50 fludarabine phosphate 50mg powder for
injection vial 

FLUDARABINE PHOSPHATE 

DESCRIPTION 

Chemical name: 9-β-D-arabinofuranosyl
-2-fluoroadenine 5'-(dihydrogen phosphate). 
Molecular formula: C
10
H
13
FN
5
O
7
P. MW: 365.2. CAS: 75607-67-9 

Fludarabine phosphate is a fluorinated nucleotide analogue of
the antiviral agent vidarabine (9-
beta-d-arabinofuranosyladenine) that is relatively resistant to
deamination by adenosine 
deaminase. When reconstituted as instructed, the pH range of
the final solution is 7.2 to 8.2 
(target 7.7). 

Fludarabine phosphate is a white or almost white, hygroscopic,
crystalline powder. It is slightly 
soluble in water; very slightly soluble in dehydrated
alcohol; freely soluble in dimethylformamide. 

PHARMACOLOGY 

Fludarabine phosphate is rapidly dephosphorylated to fludarabine
(2F-ara-A), which is taken up by 
cells and then phosphorylated intracellularly by deoxycytidine
kinase to the active triphosphate, 
fludarabine triphosphate (2F-ara-ATP). This metabolite has been shown
to inhibit ribonucleotide 
reductase, DNA polymerase alpha, delta and epsilon, DNA
primase and DNA ligase, thereby 
inhibiting DNA synthesis. Furthermore, partial inhibition of RNA
polymerase II and consequent 
reduction in protein synthesis occurs. 

While some aspects of the mechanism of action of fludarabine
triphosphate are as yet unclear, it 
is assumed that effects on DNA, RNA and protein synthesis all
contribute to inhibition of cell 
growth with inhibition of DNA synthesis being the dominant factor.
In addition, in vitro studies 
have  shown  that  exposure  of  chronic lymphocytic
leukaemia (CLL) lymphocytes to fludarabine 
(2F-ara-A) triggers extensive DNA fragmentation and cell death
characteristic of apoptosis. 
FLUDARABINE ACTAVIS – Product information 
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Fludarabi