GRANISETRON HYDROCHLORIDE (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Granisetron hydrochloride injection USP, 1 mg/mL (free base), is supplied in 4 mL Multi-Use Vials. Contains preservative.
NDC 64679-841-01 (package of 1 Multi-Use Vial)
Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]
Once the multi-use vial is penetrated, its contents should be used within 30 days.
Do not freeze. Protect from light.
17 PATIENT COUNSELING INFORMATION
Patients should be informed that the most common adverse reactions for the indication of chemotherapy induced nausea and vomiting are headache and constipation (see Table 1).
Patients should be advised of the risk of allergic reactions if they have a prior allergic reaction to a class of antiemetics known as 5-HT3 receptor antagonists.
Electrocardiogram changes (QT prolongation) have been reported with the use of granisetron hydrochloride injection. Patients should be cautioned about the use of this drug if they have heart problems or take medications for heart problems.
Patients should be informed that granisetron hydrochloride injection, USP 0.1 mg/mL contains no preservative.
Advise patients of the possibility of serotonin syndrome with concomitant use of granisetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.
Wockhardt Limited
Mumbai, India.
Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.
Rev.250914
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Granisetron Hydrochloride
GENERIC: Granisetron Hydrochloride
DOSAGE: Injection
ADMINSTRATION: Intravenous
NDC: 64679-841-01
STRENGTH: 1 mg/mL
QTY: 4 mL Multi-Use Vial
LabelGRANISETRON HYDROCHLORIDE granisetron hydrochloride injection | ||||||||||||||||||
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Labeler — Wockhardt USA LLC. (170508365) |
Registrant — Wockhardt USA LLC. (170508365) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Wockhardt Limited | 676257570 | ANALYSIS (64679-841), LABEL (64679-841), MANUFACTURE (64679-841), PACK (64679-841) |
Revised: 12/2019 Wockhardt USA LLC.
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