Rx Item-Ganciclovir 500Mg Iv Bag 10X250Ml By Exela Pharma

CYTOVENE IV- ganciclovir sodium injection, powder, lyophilized, for solution
Genentech, Inc.

FOR INTRAVENOUS INFUSION ONLY

WARNING

THE CLINICAL TOXICITY OF CYTOVENE-IV INCLUDES GRANULOCYTOPENIA, ANEMIA AND THROMBOCYTOPENIA. IN ANIMAL STUDIES GANCICLOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED ASPERMATOGENESIS.

CYTOVENE-IV IS INDICATED FOR USE ONLY IN THE TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS IN IMMUNOCOMPROMISED PATIENTS AND FOR THE PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE (see INDICATIONS AND USAGE).

DESCRIPTION



Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.

CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intravenous administration only. Each vial of CYTOVENE-IV contains the equivalent of 500 mg ganciclovir as the sodium salt (43 mg sodium). Reconstitution with 10 mL of Sterile Water for Injection, USP, yields a solution with pH 11 and a ganciclovir concentration of approximately 50 mg/mL. Further dilution in an appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION).

Ganciclovir is a white to off-white crystalline powder with a molecular formula of C9 H13 N5 04 and a molecular weight of 255.23. The chemical name for ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25�C and an n-octanol/water partition coefficient of 0.022. The pKa s for ganciclovir are 2.2 and 9.4.

Ganciclovir, when formulated as monosodium salt in the IV dosage form, is a white to off-white lyophilized powder with the molecular formula of C9 H12 N5 Na04 , and a molecular weight of 277.22. The chemical name for ganciclovir sodium is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25�C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37�C.

The chemical structures of ganciclovir sodium and ganciclovir are:

Chemical Structure
(click image for full-size original)
ganciclovir sodium ganciclovir
All doses in this insert are specified in terms of ganciclovir.

VIROLOGY

Mechanism of Action
Ganciclovir is an acyclic nucleoside analogue of 2?-deoxyguanosine that inhibits replication of herpes viruses. Ganciclovir has been shown to be active against cytomegalovirus (CMV) and herpes simplex virus (HSV) in human clinical studies.

To achieve anti-CMV activity, ganciclovir is phosphorylated first to the monophosphate form by a CMV-encoded (UL97 gene) protein kinase homologue, then to the di- and triphosphate forms by cellular kinases. Ganciclovir triphosphate concentrations may be 100-fold greater in CMV-infected than in uninfected cells, indicating preferential phosphorylation in infected cells. Ganciclovir triphosphate, once formed, persists for days in the CMV-infected cell. Ganciclovir triphosphate is believed to inhibit viral DNA synthesis by (1) competitive inhibition of viral DNA polymerases; and (2) incorporation into viral DNA, resulting in eventual termination of viral DNA elongation.

Antiviral Activity
The median concentration of ganciclovir that inhibits CMV replication (IC50 ) in vitro (laboratory strains or clinical isolates) has ranged from 0.02 to 3.48 �g/mL. Ganciclovir inhibits mammalian cell proliferation (CIC50 ) in vitro at higher concentrations ranging from 30 to 725 �g/mL. Bone marrow-derived colony-forming cells are more sensitive (CIC50 0.028 to 0.7 �g/mL). The relationship of in vitro sensitivity of CMV to ganciclovir and clinical response has not been established.

RX ITEM-Ganciclovir 500Mg Iv Bag 10X250M
NDC 63323-0315-10 UPC/GTIN No.3-63323-31510-8 Mfg.Part No.315110

Ganciclovir 500Mg Iv Bag 10X250Ml By Exe
BRAND: GANCICLOVIR NDC: 63323-0315-10,63323031510 UPC: 3-63323-31510-8,363323315108 Fresenius Kabi USA Llc

GANCICLOVIR SODIUM INTRAV
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