GRANISETRON HYDROCHLORIDE injection, solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Mylan Institutional LLC

INN (Isem Internazzjonali):

GRANISETRON HYDROCHLORIDE

Kompożizzjoni:

GRANISETRON 0.1 mg in 1 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Granisetron hydrochloride injection is a serotonin-3 (5-HT3 ) receptor antagonist indicated for: 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 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. It is not known whether granisetron is excreted

Sommarju tal-prodott:

Granisetron Hydrochloride Injection, USP is supplied as follows: NDC Granisetron Hydrochloride Injection, USP Package Factor 67457-861-01 0.1 mg per mL Single-Dose Vial 5 vials per carton 67457-863-01 1 mg per mL Single-Dose Vial 1 vial per carton Single-dose vials contain no preservative. NDC Granisetron Hydrochloride Injection, USP Package Factor 67457-864-04 4 mg per 4 mL (1 mg per mL) Multiple-Dose Vial 1 vial per carton Multiple-dose vials contain methylparaben and propylparaben as preservatives. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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.Discard Unused Portion 30 days after vial penetration Do not freeze. Protect from light. Retain vial in carton until time of use. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION,
SOLUTION
MYLAN INSTITUTIONAL 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
INDICATIONS AND USAGE
Granisetron hydrochloride injection is a serotonin-3 (5-HT3) receptor
antagonist indicated for:
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DOSAGE AND ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting (2.1):
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Prevention of postoperative nausea and vomiting (2.2):
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Treatment of postoperative nausea and vomiting (2.2):
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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 MYLAN PHARMACEUTICALS
INC.AT 1-877-446-3679 (1-877-
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)
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
Recommended dosage is 1 mg, undiluted, administered intravenously over
30 seconds, before anesthetic induction
or immediately before reversal of anesthesia.
Recommended dosage is 1 mg, undiluted, administered intravenously over
30 seconds
Injection 1 mg per mL (free base). (3)
Injection 0.1 mg per mL (free base). (3)
Hypersensitivity to granisetron or to any of its components. (4)
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