GANCICLOVIR- ganciclovir sodium injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Pharmascience Inc.

INN (International Name):

GANCICLOVIR SODIUM

구성:

GANCICLOVIR 500 mg in 10 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 (14.1)]. Ganciclovir Injection is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)]. Ganciclovir Injection Ganciclovir 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. 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 pl

제품 요약:

How Supplied Ganciclovir Injection is supplied as follows: NDC Ganciclovir Injection (50 mg per mL) Package Factor 51817-171- 01 500 mg per 10 ml Single-Dose Vial 25 vials per carton 51817-589-02 500 mg per 10 ml Single-Dose Vial 1 vial per carton Ganciclovir Injection is a clear solution supplied in 10 mL sterile single-dose vials, each containing 543 mg ganciclovir sodium equivalent to 500 mg of ganciclovir.  The concentration of ganciclovir in the 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. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze. Discard unused portion.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

GANCICLOVIR- GANCICLOVIR SODIUM INJECTION, SOLUTION
PHARMASCIENCE INC.
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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: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL
TOXICITY,
MUTAGENESIS AND CARCINOGENESISWARNING: 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
INJECTION . (
5.1)
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
GANCICLOVIR
INJECTION 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 INJECTION HAS THE
POTENTIAL TO CAUSE
BIRTH DEFECTS IN HUMANS. ( 5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, GANCICLOVIR
INJECTION HAS
THE POTENTIAL TO CAUSE CANCER IN HUMANS. ( 5.5)
INDICATIONS AND USAGE
Ganciclovir Injection Ganciclovir Injection 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 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