Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BENDAMUSTINE HYDROCHLORIDE
FRESENIUS KABI MALAYSIA SDN. BHD
BENDAMUSTINE HYDROCHLORIDE
1 Vials
Fresenius Kabi Oncology Limited
Not Applicable Perskaitykite visą dokumentą
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 Perskaitykite visą dokumentą