Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BENDAMUSTIN HYDROCHLORIDE
SOHO INDUSTRI PHARMASI - Indonesia
BENDAMUSTIN HYDROCHLORIDE
100 MG
SERBUK
DUS, 1 VIAL @ 100 MG
SOHO INDUSTRI PHARMASI - Indonesia
2015-12-28
ribomustin_id_en_pi_ipi january 2021_clean_submitted.docx Page 1 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 Izlasiet visu dokumentu