Fludarabine Kabi 50mg Lyophilized Powder for Solution for Injection or Infusion

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

FLUDARABINE PHOSPHATE

Disponibil de la:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (nume internaţional):

FLUDARABINE PHOSPHATE

Unități în pachet:

1vial Vials

Produs de:

Fresenius Kabi Oncology Limited (XI Route)

Caracteristicilor produsului

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For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
FLUDARABINE KABI 50MG LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
DESCRIPTION:
Fludarabine Kabi 50mg Lyophilized Powder for Solution for Injection or
Infusion, is a sterile
lyophilized white or almost white powder or cake. The reconstituted
solution is clear and
colourless.
COMPOSITION:
Each Vial contains:
Fludarabine Phosphate
50 mg
Mannitol
50mg
Sodium Hydroxide
q.s. to adjust pH
CHEMICAL STRUCTURE:
The
chemical
name
for
Fludarabine
phosphate
is
9
_H_
-Purin-6-amine,
2-fluoro-9-(5-
_O_
-
phosphono-β-D-arabinofuranosyl)(2-fluoro-ara-AMP). The molecular
formula of Fludarabine
phosphate is C
10
H
13
FN
5
O
7
P (molecular weight- 365.2) and the structure is:
PHARMACOLOGY:
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites,
purine analogues
ATC code: L01B B05
Fludarabine is a water-soluble fluorinated nucleotide analogue of the
antiviral agent vidarabine,
9 ß D arabinofuranosyladenine (ara A) that is relatively resistant to
deamination by adenosine
deaminase.
Fludarabine is rapidly dephosphorylated to 2F-ara-A which is taken up
by cells and then
phosphorylated intracellularly by deoxycytidine kinase to the active
triphosphate, 2F ara ATP.
This metabolite has been shown to inhibit ribonucleotide reductase,
DNA (deoxyribonucleotide)
polymerase α/δ and ε, DNA primase and DNA ligase thereby inhibiting
DNA synthesis.
Furthermore, partial inhibition of RNA polymerase II and consequent
reduction in protein
synthesis occur.
While some aspects of the mechanism of action of 2F ara ATP are as yet
unclear, it is assumed
that effects on DNA, RNA (ribonucleic acid) 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 CLL lymphocytes to 2F ara A
triggers extensive DNA
fragmentation and cell death characteristic of apoptosis.
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PHARMACOKINETICS
•
PLASMA AND URINARY PH