AURO-ONDANSETRON INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

제공처:

AURO PHARMA INC

ATC 코드:

A04AA01

INN (International Name):

ONDANSETRON

복용량:

2MG

약제 형태:

SOLUTION

구성:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2MG

관리 경로:

INTRAVENOUS

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

5-HT3 RECEPTOR ANTAGONISTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2019-08-14

제품 특성 요약

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