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

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Slate Run Pharmaceuticals, LLC

Начин на приложение:

INTRAVENTRICULAR

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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, USP 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 placental transfer of ganciclovir has been shown to occur based on ex vivo experiments wit

Каталог на резюме:

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 25 vials (NDC 70436-089-55). Storage 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

GANCICLOVIR- GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SLATE RUN PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GANCICLOVIR FOR
INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR GANCICLOVIR FOR
INJECTION, USP.
GANCICLOVIR FOR INJECTION, USP 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 for Injection,
USP 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 for Injection, USP
has the potential to cause birth
defects in humans. (5.4)
Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for
Injection, USP 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, USP 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