GANCICLOVIR- ganciclovir sodium injection, powder, lyophilized, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

GANCICLOVIR SODIUM (UNII: 02L083W284) (GANCICLOVIR - UNII:P9G3CKZ4P5)

から入手可能:

Hikma Pharmaceuticals USA Inc.

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)] . Ganciclovir for Injection, USP is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)]. 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. Risk Summary In animal 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 in at least one case report in a

製品概要:

How Supplied Ganciclovir for Injection, USP is supplied in 10 mL sterile single-dose vials, each containing 543 mg ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder. The concentration of ganciclovir in the reconstituted solution is 50 mg/mL. Because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. Ganciclovir for Injection, USP is supplied in cartons of 10 single-dose vials (NDC 0143-9299-10). Storage Store at 20° to 25°C (68° to 77°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. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

GANCICLOVIR- GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GANCICLOVIR FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GANCICLOVIR FOR
INJECTION.
GANCICLOVIR FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1989
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL
TOXICITY,
MUTAGENESIS AND CARCINOGENESIS
_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 AND LIMITED HUMAN DATA,
GANCICLOVIR
MAY CAUSE TEMPORARY OR PERMANENT INHIBITION OF SPERMATOGENESIS IN
MALES AND
SUPPRESSION OF FERTILITY IN FEMALES. (5.3)
FETAL TOXICITY: BASED ON ANIMAL DATA, GANCICLOVIR HAS THE POTENTIAL TO
CAUSE BIRTH
DEFECTS IN HUMANS. (5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, GANCICLOVIR HAS
THE
POTENTIAL TO CAUSE CANCER IN HUMANS. (5.5)
INDICATIONS AND USAGE
Ganciclovir for Injection, USP is a deoxynucleoside analogue
cytomegalovirus (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
Ganciclovir for injection is administered only intravenously. (2.1)
DOSAGE IN ADULT PATIENTS WITH NORMAL RENAL FUNCTION
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 intrave