Țară: Canada
Limbă: engleză
Sursă: Health Canada
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)
AURO PHARMA INC
A04AA01
ONDANSETRON
2MG
SOLUTION
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2MG
INTRAVENOUS
15G/50G
Prescription
5-HT3 RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131120004; AHFS:
APPROVED
2019-08-14
ONDANSETRON INJECTION BP/AURO-ONDANSETRON INJECTION PRODUCT MONOGRAPH PAGE 1 OF 46 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ONDANSETRON INJECTION BP Sterile Solution, 2 mg / mL ondansetron (as ondansetron hydrochloride dihydrate), Intravenous BP PR AURO-ONDANSETRON INJECTION Ondansetron Injection Sterile Solution, 2 mg / mL ondansetron (as ondansetron hydrochloride dihydrate), Intravenous BP Antiemetic (5-HT3 receptor antagonist) ATC code A04AA01 Auro Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8 CANADA Date of Initial Authorization: February 7, 2017 Date of Revision: March 9, 2023 Submission Control Number: 268107 ONDANSETRON INJECTION BP/AURO-ONDANSETRON INJECTION PRODUCT MONOGRAPH PAGE 2 OF 46 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial Ischemia and Coronary Artery Spasm 03/2023 7 WARNINGS AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant Women 02/2021 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 ................................................................................................................ 4 1.2 Geriatrics (≥65 years of age) ....................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ....................................................................... Citiți documentul complet