GRANISETRON HYDROCHLORIDE injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

AuroMedics Pharma LLC

INN (Rahvusvaheline Nimetus):

GRANISETRON HYDROCHLORIDE

Koostis:

GRANISETRON 1 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. Teratogenic Effects P regnancy Category B Reproduction studies have been performed in pregnant rat

Toote kokkuvõte:

Granisetron hydrochloride injection USP, 1 mg/mL (free base), is supplied in 1 mL Single-Dose Vials and 4 mg/4 mL Multiple-Dose Vials. 1 mg (base) per mL:    Single-Dose Vials in a carton of 1                                                    NDC 55150-175-01 4 mg per 4 mL (1 mg (base)/mL):    Multiple-Dose Vials in a carton of 1                                               NDC 55150-176-04 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion for the single-dose vials. Once the multiple-dose vial is penetrated, its contents should be used within 30 days. Do not freeze. Protect from light. Retain in carton until time of use. The vial stopper is not made with natural rubber latex.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

GRANISETRON HYDROCHLORIDE - GRANISETRON HYDROCHLORIDE INJECTION,
SOLUTION
AUROMEDICS PHARMA LLC
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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, USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
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/mL (free base). (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 patients with known hypersensitivity to other selective 5-HT
receptor