GRANISETRON HYDROCHLORIDE injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Yung Shin Pharmaceutical Inc. Co., Ltd.

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 is recommended even where the incidence of postoperative nausea and/or vomiting is low. Granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in pregnant rats at intravenous

Produkto santrauka:

Granisetron Hydrochloride Injection USP, 0.1 mg(base)/mL (free base), is supplied in 1 mL Single-Use Vial. CONTAINS NO PRESERVATIVE. NDC Number                  Contents                    Package size NDC 63126-331-15        0.1 mg(base)/mL        5 Single-Use Vials Store single-use vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Discard unused portion for the single-use vials. Do not freeze. Protect from light. Retain in carton until time of use.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION,
SOLUTION
YUNG SHIN PHARMACEUTICAL INC. CO., LTD.
----------
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 USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 08/2014
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 0.1 mg(base)/mL. (3)
CONTRAINDICATIONS
Hypersensitivity to granisetron 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 pa