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.

Manufactured by:

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

LabelLabel
GRANISETRON HYDROCHLORIDE granisetron hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-841
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRANISETRON HYDROCHLORIDE (GRANISETRON) GRANISETRON 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
HYDROCHLORIC ACID
METHYLPARABEN
PROPYLPARABEN
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-841-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 4 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (64679-841-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078565 06/30/2008
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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