Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)
Mylan Institutional LLC
GRANISETRON HYDROCHLORIDE
GRANISETRON 0.1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- 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: • • DOSAGE AND ADMINISTRATION Prevention of chemotherapy-induced nausea and vomiting (2.1): • • Prevention of postoperative nausea and vomiting (2.2): • Treatment of postoperative nausea and vomiting (2.2): • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Most common adverse reactions: • • 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 Lestu allt skjalið