GRANISETRON- granisetron injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)

Commercializzato da:

Sandoz Inc.

INN (Nome Internazionale):

GRANISETRON HYDROCHLORIDE

Composizione:

GRANISETRON 1 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Granisetron hydrochloride injection, USP is a serotonin-3 (5-HT3 ) receptor antagonist indicated for: Granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. Pregnancy Category B Reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Benzyl alcohol may cross the placenta. Granisetron hydrochlori

Dettagli prodotto:

Granisetron hydrochloride injection USP, 1 mg/mL (free base), is supplied in 1 mL Single-Use Vials and 4 mL Multi-Use Vials. CONTAINS BENZYL ALCOHOL. NDC Number Volume 66758-035-01 Carton of 1 x 1 mL Single-Use Vial 66758-036-01 Carton of 1 x 4 mL Multi-Use Vial Store single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Once the multi-use vial is penetrated, its contents should be used within 30 days. Do not freeze. Protect from light. Retain in carton until time of use.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

GRANISETRON- GRANISETRON INJECTION
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRANISETRON HYDROCHLORIDE
INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR GRANISETRON
HYDROCHLORIDE INJECTION, USP.
GRANISETRON HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Granisetron hydrochloride injection, USP is a serotonin-3 (5-HT )
receptor antagonist indicated for:
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DOSAGE AND ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting (2.1):
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions:
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 ORWWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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Warnings and Precautions (5.4) 08/2014
3
Prevention of nausea and/or vomiting associated with initial and
repeat courses of emetogenic cancer therapy,
including high-dose cisplatin. (1)
Recommended dosage is 10 mcg/kg intravenously within 30 minutes before
initiation of chemotherapy.
Pediatric patients (2 to 16 years): Recommended dosage is 10 mcg/kg.
1 mg/mL (free base) single-use vial. (3)
4 mg/4mL (free base) multi-use vial. (3)
Hypersensitivity to granisetron or to any of its components. (4)
Granisetron does not stimulate gastric or intestinal peristalsis and
should not be used instead of nasogastric suction.
(5.1)
QT prolongation has been reported with granisetron. Use with caution
in patients with pre-existing arrhythmias or
cardiac conduction disorders. (5.2)
Hypersensitivity reactions, such as anaphylaxis, shortness of breath,
hypotension, and urticaria, may occur in patients
with known hypersensitivity to other selective 5-HT receptor
antagonists. (5.3)
3
Serotonin syndrome has been reported with other granisetron products,
alone but particularly with concomitant use
of seroto