GANCICLOVIR injection, powder, lyophilized, for solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Par Pharmaceutical, Inc.

INN (Alþjóðlegt nafn):

GANCICLOVIR SODIUM

Samsetning:

GANCICLOVIR 500 mg in 10 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Ganciclovir 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 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. 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 pregnant woman, no adequate human

Vörulýsing:

How Supplied Ganciclovir for Injection, USP (ganciclovir sodium) is supplied in 10 mL sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white lyophilized cake or powder. Ganciclovir for Injection is supplied in cartons of 25 single-dose vials (NDC 42023-173-25). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

GANCICLOVIR- GANCICLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
PAR PHARMACEUTICAL, INC.
----------
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 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
one hour) every 12 hours for 14 to 21 days.
Maintenance: 5 mg/kg (given intravenously at a constant rate
over one 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 ov