দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
GANCICLOVIR
HOFFMANN-LA ROCHE LIMITED
J05AB06
GANCICLOVIR
250MG
CAPSULE
GANCICLOVIR 250MG
ORAL
84
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0128037001; AHFS:
CANCELLED POST MARKET
2007-08-02
PRODUCT MONOGRAPH CYTOVENE ® ganciclovir capsules ganciclovir sodium for injection (sterile powder) Antiviral Agent Hoffmann-La Roche Limited Date of Preparation: 2455 Meadowpine Boulevard April 26, 1995 Mississauga, Ontario L5N 6L7 Date of Revision: July 18, 2003 Control # 082238 ® Registered Trademark © Copyright 1999 - 2003 CDS Version 1.2 (vials) and Version 1.2 (capsules) CYTOVENE® ganciclovir capsules ganciclovir sodium for injection (sterile powder) THERAPEUTIC CLASSIFICATION Antiviral Agent ACTIONS CYTOVENE (ganciclovir and ganciclovir sodium) is a synthetic nucleoside analogue of guanine which inhibits the replication of herpes viruses both_ in vitro_ and_ in vivo._ Intracellular ganciclovir is phosphorylated to ganciclovir monophosphate by a cellular deoxyguanosine kinase. Further phosphorylation occurs by several cellular kinases to produce ganciclovir triphosphate. It has been shown _in vitro_ that the levels of ganciclovir triphosphate are as much as 100-fold greater in CMV-infected cells than non-infected cells. Thus, there is a preferential phosphorylation of ganciclovir in virus-infected cells. In virus-infected cells, ganciclovir triphosphate is metabolized slowly, with 60 to 70% remaining intracellularly 18 hours after removal of ganciclovir from the extracellular fluid. The antiviral activity of ganciclovir is the result of inhibition of viral DNA synthesis by two modes: (1) ganciclovir triphosphate competitively inhibits dGTP incorporation into DNA by DNA polymerase and (2) incorporation of ganciclovir triphosphate into viral DNA causes subsequent termination or very limited viral DNA elongation. Ganciclovir inhibits mammalian cell proliferation_ _ _in _ _vitro_ at concentrations from 10 to 60 µg/mL, with bone marrow colony forming cells being most sensitive (IC 50 of 10 µg/mL). The pharmacokinetics of CYTOVENE (ganciclovir sodium for injection) have been evaluated in immunocompromised patients with serious CMV disease. In patients with normal renal - 2 - function, the plasma half-life w সম্পূর্ণ নথি পড়ুন