RIBOMUSTIN

País: Indonésia

Língua: indonésio

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

Ingredientes ativos:

BENDAMUSTINE HYDROCHLORIDE

Disponível em:

SOHO INDUSTRI PHARMASI - Indonesia

DCI (Denominação Comum Internacional):

BENDAMUSTINE HYDROCHLORIDE

Dosagem:

100 MG

Forma farmacêutica:

SERBUK INJEKSI

Unidades em pacote:

DUS, 1 VIAL @ 100 MG

Fabricado por:

ONCOTEC PHARMA PRODUKTION GMBH - Federal Republic of Germany

Data de autorização:

2020-08-07

Características técnicas

ribomustin_id_en_pi_ipi january 2021_clean_submitted.docx
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NAME OF THE MEDICINAL PRODUCT
Ribomustin
TM
(Bendamustine hydrochloride)
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 25 mg bendamustine hydrochloride.
One vial contains 100 mg bendamustine hydrochloride.
1 mL of the concentrate contains 2.5 mg bendamustine hydrochloride
when reconstituted according to
Instructions for Use and Handling and Disposal.
For excipients, see List of Excipients.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White, microcrystalline powder.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
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
bendamustine hydrochloride has been demonstrated by several in-vitro
studies in different human
tumor cell lines (breast cancer, non-small cell and small cell lung
cancer, ovary carcinoma and different
leukemia) and in-vivo in different experimental tumor models with
tumors of mouse, rat and human
origin (melanoma, breast cancer, sarcoma, lymphoma, leukemia and small
cell lung cancer).
Bendamustine hydrochloride showed an activity profile in human tumor
cell lines different to that of
other alkylating agents. The active substance revealed no or very low
cross-resistance in human tumor
cell lines with different resistance mechanisms at least in part due
to a comparatively persistent DNA
interaction. Additionally, it was shown in clinical studies that there
is no complete cross-resistance of
bendamustine with anthracyclines, alkylating ag