Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)
APOTEX INC
A04AA01
ONDANSETRON
4MG
SOLUTION
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4MG
ORAL
15G/50G
Prescription
5-HT3 RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131120002; AHFS:
APPROVED
2020-07-08
_APO-ONDANSETRON (ondansetron hydrochloride dihydrate) _ _Page 1 of 37 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-ONDANSETRON Ondansetron Oral Solution Oral Solution, 4 mg /5 mL ondansetron (as ondansetron hydrochloride dihydrate), Oral USP Antiemetic 5-HT 3 receptor antagonist ATC Code A04AA01 Apotex Inc 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: February 16, 2007 Date of Revision: September 9, 2022 Submission Control Number: 261676 _APO-ONDANSETRON (ondansetron hydrochloride dihydrate) _ _Page 2 of 37 _ _ _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, Adults 09/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 09/2022 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial Ischemia and Coronary Artery Spasm 09/2022 7 WARNINGS AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant Women 07/2021 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 ........ Soma hati kamili