Bendamustine Hydrochloride Kabi 100mg Powder for Concentrate for Solution for Infusion

Country: Malaysia

Language: English

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

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Name):

BENDAMUSTINE HYDROCHLORIDE

Units in package:

1 Vials

Manufactured by:

Fresenius Kabi Oncology Limited

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1
PROPOSED PACKAGE INSERT
NAME OF THE PRODUCT
Bendamustine Hydrochloride Kabi 25mg Powder for Concentrate for
Solution for
Infusion
Bendamustine Hydrochloride Kabi 100mg Powder for Concentrate for
Solution for
Infusion
NAME AND STRENGTH OF ACTIVE INGREDIENT
Bendamustine Hydrochloride Kabi 25mg Powder for Concentrate for
Solution for
Infusion contain Bendamustine hydrochloride 25mg
Bendamustine Hydrochloride Kabi 100mg Powder for Concentrate for
Solution for
Infusion contain Bendamustine hydrochloride 100mg
2
For use only of a Registered Medical Practitioner or a Hospital or a
Laboratory
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION
DESCRIPTION:
Bendamustine Hydrochloride Kabi 25 mg or 100 mg Powder:
White to off white lyophilized powder or cake contained in an amber
glass vial.
After reconstitution with water for injection and further dilution
with 0.9% w/v NaCl
solution: Clear colorless to a pale yellow solution.
COMPOSITION:
25 MG/VIAL
Each vial contains:
Bendamustine Hydrochloride
25 mg
Mannitol Ph.Eur
30 mg
100 MG/VIAL
Each vial contains:
Bendamustine Hydrochloride
100 mg
Mannitol Ph.Eur
120 mg
CHEMICAL STRUCTURE:
The
chemical name
of bendamustine
hydrochloride
is
5-
[Bis
(2-chloroethyl)amino]-1-
methyl-2-benzimidazolebutyric
acid
hydrochloride
or
4-[5-[Bis
(2-chloroethyl)amino]-1-
methyl benzimidazol-2-yl] butanoic acid hydrochloride. Its empirical
molecular formula
is
C
16
H
21
Cl
2
N
3
O
2
∙ HCl, and the molecular weight is 394.72.
PHARMACOLOGY:
Pharmacotherapeutic
group:
Antineoplastic
agents,
alkylating
agents,
ATC
code:
L01AA09. Bendamustine is an alkylating antitumor agent with unique
activity containing
a purine-like benzimidazole ring. The antineoplastic and cytocidal
effect of bendamustine is
based essentially on a cross-linking of DNA single and double strands
by alkylation. As
a result, DNA matrix functions and DNA synthesis and repair are
impaired. Bendamustine
is active against both quiescent and dividing cells.
The exact mechanism of action of bendamustine remains unknown. The
antitumor effect of