GANCICLOVIR injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

GANCICLOVIR (UNII: P9G3CKZ4P5) (GANCICLOVIR - UNII:P9G3CKZ4P5)

Dostopno od:

EXELA PHARMA SCIENCES, LLC

INN (mednarodno ime):

GANCICLOVIR

Sestava:

GANCICLOVIR 2 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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].

Status dovoljenje:

New Drug Application

Lastnosti izdelka

GANCICLOVIR- GANCICLOVIR INJECTION, SOLUTION
EXELA PHARMA SCIENCES, LLC
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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: 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