Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
GANCICLOVIR (UNII: P9G3CKZ4P5) (GANCICLOVIR - UNII:P9G3CKZ4P5)
EXELA PHARMA SCIENCES, LLC
GANCICLOVIR
GANCICLOVIR 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
GANCICLOVIR INJECTION is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14)] . GANCICLOVIR INJECTION is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14 )] . GANCICLOVIR INJECTION is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir. Risk Summary Inanimal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data] . Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and on at least one case report in a pregnant woman, no adequate human data are a
GANCICLOVIR INJECTION is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 500 mg ganciclovir in 250 mL of solution (2 mg/mL) sealed with a Twist Off port from Technoflex, and oversealed in an aluminum pouch (NDC 51754-2500-1), in cases of 10 (NDC 51754-2500-3). Follow guidelines for handling and disposal for cytotoxic drugs.1 The premix flexible plastic container bag contains no preservative; any unused portion should be discarded [see Dosage and Administration (2.6)] . Gently shaking should redissolve any crystals that may have formed during transportation and/or storage at temperatures lower than recommended. The solution must be clear at the time of use. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
New Drug Application
GANCICLOVIR- GANCICLOVIR INJECTION, SOLUTION EXELA PHARMA SCIENCES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GANCICLOVIR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1989 _WARNING: HEMATALOGIC TOXICITY, IMPAIRMENT OF FERTILITY, TERATOGENICITY, AND_ _CARCINOGENICITY_ _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HEMATOLOGIC TOXICITY: GRANULOCYTOPENIA, ANEMIA, THROMBOCYTOPENIA, AND PANCYTOPENIA HAVE BEEN REPORTED IN PATIENTS TREATED WITH GANCICLOVIR. (5.1) IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA, GANCICLOVIR INJECTION MAY CAUSE TEMPORARY OR PERMANENT INHIBITION OF SPERMATOGENESIS IN MALES AND SUPPRESSION OF FERTILITY IN FEMALES. (5.2) FETAL TOXICITY: BASED ON ANIMAL DATA, GANCICLOVIR INJECTION HAS THE POTENTIAL TO CAUSE BIRTH DEFECTS IN HUMANS. (5.3) MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, GANCICLOVIR INJECTION HAS THE POTENTIAL TO CAUSE CANCER IN HUMANS. (5.4) INDICATIONS AND USAGE GANCICLOVIR INJECTION is a nucleoside analogue CMV DNA polymerase inhibitor indicated for the: Treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (1.1) Prevention of CMV disease in adult transplant recipients at risk for CMV disease. (1.2) DOSAGE AND ADMINISTRATION DOSAGE IN ADULT PATIENTS WITH NORMAL RENAL FUNCTION (2.3, 2.4) Treatment of CMV retinitis (2.3) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. Prevention of CMV disease in transplant recipients (2.4) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over Soma hati kamili