Busulfan Kabi Injection 6mgml Concentrate for Solution for Infusion

Land: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

BUSULFAN

Fáanlegur frá:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Alþjóðlegt nafn):

BUSULFAN

Einingar í pakka:

10 ml; 8x10 ml

Framleitt af:

Fresenius Kabi Oncology Limited

Upplýsingar fylgiseðill

Not Applicable

Vara einkenni

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
BUSULFAN KABI INJECTION 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
DESCRIPTION:
Busulfan
Kabi
Injection
6mg/ml
Concentrate
for
Solution
for
Infusion
is
intended
for
intravenous administration. It is supplied as a clear, colorless,
viscous solution free from visible
particles.
COMPOSITION:
Each ml Contains:
Busulfan USP
6 mg
N, N Dimethylacetamide Ph.Eur.
0.33ml
Polyethylene glycol USNF
0.67ml
CHEMICAL STRUCTURE:
The chemical name for Busulfan, USP is 1,4-butanediol,
dimethanesulfonate. The molecular
formula of Busulfan, USP is C
6
H
14
O
6
S
2
(molecular weight- 246.30) and the structure is:
PHARMACOLOGY:
PHARMACODYNAMICS:
Busulfan is a bifunctional alkylating agent in which two labile
methanesulfonate groups are
attached to opposite ends of a four-carbon alkyl chain. In aqueous
media, Busulfan hydrolyzes
to release the methanesulfonate groups. This produces reactive
carbonium ions that can alkylate
DNA. DNA damage is thought to be responsible for much of the
cytotoxicity of Busulfan.
PHARMACOKINETICS:
PHARMACOKINETICS IN ADULTS
ABSORPTION
The pharmacokinetics of intravenous Busulfan was studied in 124
evaluable patients following a
2-hour intravenous infusion for a total of 16 doses over four days.
Immediate and complete
availability of the dose is obtained after intravenous infusion of
Busulfan. Similar blood
exposure was observed when comparing plasma concentrations in adult
patients receiving oral
WARNING MYELOSUPPRESSION
Busulfan Injection causes severe and prolonged myelosuppression at the
recommended dosage.
Hematopoietic progenitor cell transplantation is required to prevent
potentially fatal complications of
the prolonged myelosuppression.
_ _
1
and intravenous Busulfan at 1 mg/kg and 0.8 mg/kg respectively. Low
inter (CV=21%) and intra
(CV=12%) patient variability on Busulfan exposure was demonstrated
through a population
pharmacokinetic analysis, performed on 102 patients.
DISTRIBUTION
Terminal volume of distribution