TEVA-ONDANSETRON TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-01-2016
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Active ingredient:
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)
Available from:
TEVA CANADA LIMITED
ATC code:
A04AA01
INN (International Name):
ONDANSETRON
Dosage:
4MG
Pharmaceutical form:
TABLET
Composition:
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4MG
Administration route:
ORAL
Units in package:
30/100 & 10/30UD
Prescription type:
Prescription
Therapeutic area:
5-HT3 RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0131120003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-19
Summary of Product characteristics
_TEVA-ONDANSETRON and ONDANSETRON INJECTION Product Monograph _
_Page 1 of 37 _
PRODUCT MONOGRAPH
PR
TEVA-ONDANSETRON
Ondansetron Tablets, USP
4 mg and 8 mg ondansetron (as ondansetron hydrochloride dihydrate)
PR
ONDANSETRON INJECTION
Ondansetron Injection, USP
2 mg/mL ondansetron (as ondansetron hydrochloride dihydrate)
Antiemetic
(5-HT
3
receptor antagonist)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
JANUARY 25, 2016
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No.: 190801
_TEVA-ONDANSETRON and ONDANSETRON INJECTION Product Monograph _
_Page 2 of 37 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
SUMMARY PRODUCT INFORMATION
.......................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................................
3
CONTRAINDICATIONS
..................................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................................
4
ADVERSE
REACTIONS...................................................................................................................
6
DRUG INTERACTIONS
...................................................................................................................
8
DOSAGE AND ADMINISTRATION
.............................................................................................
10
OVERDOSAGE................................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
15
STORAGE AND STABILITY
.........................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.
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