AURO-ONDANSETRON INJECTION SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

MAH:

AURO PHARMA INC

ATC_code:

A04AA01

INN:

ONDANSETRON

dosage:

2MG

pharmaceutical_form:

SOLUTION

composition:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2MG

administration_route:

INTRAVENOUS

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

5-HT3 RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0131120004; AHFS:

authorization_status:

APPROVED

authorization_date:

2019-08-14

SPC

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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
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4
1.2 Geriatrics (≥65 years of age)
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4
2 CONTRAINDICATIONS
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5
4 DOSAGE AND ADMINISTRATION
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