CCP-ONDANSETRON TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-06-2017
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Active ingredient:
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)
Available from:
CELLCHEM PHARMACEUTICALS INC.
ATC code:
A04AA01
INN (International Name):
ONDANSETRON
Dosage:
8MG
Pharmaceutical form:
TABLET
Composition:
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8MG
Administration route:
ORAL
Units in package:
10/30/100
Prescription type:
Prescription
Therapeutic area:
5-HT3 RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0131120001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2023-08-03
Summary of Product characteristics
_CCP-Ondansetron _
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PRODUCT MONOGRAPH
PR
CCP-ONDANSETRON
Ondansetron Tablets
House Standard
4 mg and 8 mg ondansetron (as ondansetron hydrochloride dihydrate)
Antiemetic
(5-HT
3
receptor antagonist)
Date of Revision: June 19, 2017
CellChem Pharmaceuticals Inc.
30 Concourse Gate, Unit 1
Ottawa, Ontario
K2E 7V7
Submission Control No: 205268
_CCP-Ondansetron _
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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
.........................................................................................................
5
DRUG INTERACTIONS
..........................................................................................................
8
DOSAGE AND ADMINISTRATION
......................................................................................
9
OVERDOSAGE
......................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 12
STORAGE AND STABILITY
...............................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
16
PHARMACEUTICAL INFORMATION
...............................................................................
16
CLINICAL TRIALS
.................
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