PRODUCT DETAILS
- RLD: CYTOVENE-IV®
- Concentration: 500 mg per vial
- Fill Volume: Lyophilized Powder in a 10 mL vial
- Therapeutic Class: Antiviral
- Closure does not contain any natural rubber or latex
- Preservative free
PRODUCT DETAILS
| Concentration | NDC Number | Saleable Unit | Wholesaler Numbers |
|---|---|---|---|
| 500 mg per vial | 70436-089-55 | Box of 25 vials | Cardinal Health: 5520945 |
| McKesson: 3935939 | |||
| Amerisource: 10213365 |
Ganciclovir for Injection, USP is supplied in 10 mL sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze. Discard any unused portion of the reconstituted solution.
Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir.
Impairment of Fertility: Based on animal data and limited human data, ganciclovir for injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
Fetal Toxicity: Based on animal data, ganciclovir for injection has the potential to cause birth defects in humans.
Mutagenesis and Carcinogenesis: Based on animal data, ganciclovir for injection has the potential to cause cancer in humans.
Ganciclovir for injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation.
Ganciclovir for injection should be used with caution in patients with renal impairment because the half-life and plasma/serum concentration of ganciclovir will be increased due to reduced renal clearance. If renal function is impaired, dosage adjustments are recommended.
The most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, decreased appetite, dyspnea, abdominal pain, sepsis, hyperhidrosis, and blood creatinine increased.
Please see the package insert for Ganciclovir for Injection for full prescribing information.
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