CANBUSUL- Busulfan Injection 6 mgml Concentrate for Solution for Infusion

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

BUSULFAN

Dostupné s:

UNIMED SDN BHD

INN (Mezinárodní Name):

BUSULFAN

Jednotky v balení:

1 Vials

Výrobce:

Shilpa Medicare Limited

Charakteristika produktu

Note: Pharma code position may vary
as per folding machine suitability.
30 mm
30 mm
50 mm
FRONT PAGE
45xxxxx
BUSULFAN INJECTION
xxx
BUSULFAN INJECTION
6 MG/ML CONCENTRATE
FOR SOLUTION FOR INFUSION
(60 MG/10 ML)
PRODUCT NAME
Busulfan Injection 6 mg/mL Concentrate for Solution for Infusion
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Busulfan Injection 60 mg/10 mL.
Each mL contains: Busulfan ......... 6 mg.
PRODUCT DESCRIPTION
CANBUSUL- Busulfan Injection 6 mg/mL concentrate for solution for
infusion is A clear colorless
solution filled in flint vial with rubber stopper and aluminium
flip-off seal.
Each ml contains: Busulfan ......... 6 mg
PHARMACODYNAMICS
Pharmacotherapeutic group: Alkyl Sulfonates, ATC code: L01AB01.
MECHANISM OF ACTION
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
The pharmacokinetics of Busulfan Injection has been investigated. The
information presented on
biotransformation and elimination is based on oral busulfan.
The pharmacokinetics of Busulfan Injection were studied in 59 patients
participating in a prospective
trial of a Busulfan Injection-cyclophosphamide preparatory regimen
prior to allogeneic hematopoietic
progenitor stem cell transplantation. Patients received 0.8 mg/kg
Busulfan Injection every six hours,
for a total of 16 doses over four days. Fifty-five of fifty-nine
patients (93%) administered Busulfan
Injection maintained AUC values below the target value (<1500
μM•min).
TABLE: Steady State Pharmacokinetic Parameters Following Busulfan
Injection Infusion (0.8 mg
per kg; N=59)
Mean
CV (%)
Range
Cmax (ng/mL)
1222
18
496 – 1684
AUC (µM.min)
1167
20
556 – 1673
CL (mL/min/kg)1
2.52
25
1.49 – 4.31
1
Clearance normalized to actual body weight for a