APO-ONDANSETRON TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

제공처:

APOTEX INC

ATC 코드:

A04AA01

INN (국제 이름):

ONDANSETRON

복용량:

8MG

약제 형태:

TABLET

구성:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

5-HT3 RECEPTOR ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0131120001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2006-11-15

제품 특성 요약

_APO-ONDANSETRON (Ondansetron hydrochloride dihydrate) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ONDANSETRON
Ondansetron Tablets
Tablets, 4 mg and 8 mg ondansetron (as ondansetron hydrochloride
dihydrate), oral
USP
Antiemetic
5-HT
3
receptor antagonist
ATC code A04AA01
APOTEX INC.
Date of Initial authorization:
150 Signet Drive
November 15, 2006
Toronto, Ontario
M9L 1T9
Date of Revision:
September 9, 2022
Submission Control Number: 261679
_APO-ONDANSETRON (Ondansetron hydrochloride dihydrate) _
_Page 2 of 38_
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
04/2021
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
......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
.........................................