GRANISETRON- granisetron hydrochloride injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Fresenius Kabi USA, LLC

SNN (starptautisko nepatentēto nosaukumu):

GRANISETRON HYDROCHLORIDE

Kompozīcija:

GRANISETRON 1 mg in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3 ) receptor antagonist indicated for: - The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low. 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

Produktu pārskats:

Granisetron Hydrochloride Injection, USP, 1 mg per mL (free base), is supplied in 1 mL single dose vials. CONTAINS NO PRESERVATIVE. Store single dose vials at 20° to 25°C (68° to 77°F)  [see USP Controlled Room Temperature]. Protect from light.  Do not freeze.  Retain in carton until time of use. Discard unused portions for the single-dose vials. The container closure is not made with natural rubber latex.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

GRANISETRON - GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRANISETRON
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
GRANISETRON HYDROCHLORIDE INJECTION.
GRANISETRON HYDROCHLORIDE INJECTION
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RX ONLY
INDICATIONS AND USAGE
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT )
receptor antagonist indicated for:
Prevention of nausea and/or vomiting associated with initial and
repeat courses of emetogenic cancer
therapy, including high-dose cisplatin. (1)
Prevention and treatment of postoperative nausea and vomiting in
adults. (1)
DOSAGE AND ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting (2.1):
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
Prevention of postoperative nausea and vomiting (2.2):
Recommended dosage is 1 mg, undiluted, administered intravenously over
30 seconds, before
anesthetic induction or immediately before reversal of anesthesia.
Treatment of postoperative nausea and vomiting (2.2):
Recommended dosage is 1 mg, undiluted, administered intravenously over
30 seconds.
DOSAGE FORMS AND STRENGTHS
Injection 1 mg per mL (free base). (3)
CONTRAINDICATIONS
Hypersensitivity to granisetron hydrochloride injection or to any of
its components. (4)
WARNINGS AND PRECAUTIONS
Granisetron hydrochloride 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 hydrochloride. 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
r