FLUDARA

国: インドネシア

言語: インドネシア語

ソース: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

有効成分:

FLUDARABINE PHOSPHATE

から入手可能:

AVENTIS PHARMA - Indonesia

INN（国際名）:

FLUDARABINE PHOSPHATE

投薬量:

50.000 MG

医薬品形態:

SERBUK INJEKSI

パッケージ内のユニット:

DUS, 5 VIAL @ 50 MG

製:

BAXTER ONCOLOGY GMBH - German Democratic Republic

承認日:

2021-10-25

製品の特徴

1
FLUDARA
®
FLUDARABINE PHOSPHATE
Important information, please read carefully! COMPOSITION
Each vial contains 50 mg fludarabine phosphate. 1 ml of reconstituted
solution for injection/infusion contains 25 mg
fludarabine phosphate.
Each vial also contains 50 mg of mannitol and sodium hydroxide which
is present to maintain the desired pH. PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antineoplastic agents, purine analogues
ATC code: L01B B05
Fludara contains fludarabine phosphate, a fluorinated nucleotide
analogue of the antiviral agent vidarabine, 9-ß-D-
arabinofuranosyladenine (ara-A) that is relatively resistant to
deamination by adenosine deaminase.
Fludarabine phosphate 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 polymerase

,

and

, 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
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.
For the indication Lg-NHL a randomised phase III trial in pre-treated
Lg-NHL patients compared Fludara with a commonly
used combination chemo-therapy cyclophosphamide, vincristine and
prednisone (CVP). The overall response rates did not
differ statistically significantly, although it was slightly higher in
the Fludara- (55%) than in the CVP treatment arm (50%).
PHARMACOKINETIC PROPERTIES
PLASMA AND URINARY PHARMACOKINETICS OF FLUDARABINE (2F-ARA-A)
The pharmacokinetics o