Country: Canada
Language: English
Source: Health Canada
ONDANSETRON (ONDANSETRON HYDROCHLORIDE)
ANGITA PHARMA INC.
A04AA01
ONDANSETRON
4MG
TABLET
ONDANSETRON (ONDANSETRON HYDROCHLORIDE) 4MG
ORAL
10/100
Prescription
5-HT3 RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131120003; AHFS:
APPROVED
2011-08-22
_ _ _AG-Ondansetron Product Monograph _ _Page 1 of 35 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AG-ONDANSETRON Ondansetron Tablets Tablets, 4 mg and 8 mg ondansetron (as ondansetron hydrochloride), oral USP Antiemetic 5-HT3 receptor antagonist ATC code A04AA01 Angita Pharma Inc. 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: August 22, 2011 Date of Revision: NOV 16, 2022 Submission Control Number: 268929 _ _ _ _ _AG-Ondansetron Product Monograph _ _Page 2 of 35 _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS 11/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 11/2022 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial Ischemia and Coronary Artery Spasm 11/2022 7 WARNINGS AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant Women 10/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics (<18 years of age) .................................................................................... 4 1.2 Geriatrics (≥65 years of age) .................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Read the complete document