CCP-ONDANSETRON TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
22-06-2017
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Aktiv ingrediens:
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)
Tilgjengelig fra:
CELLCHEM PHARMACEUTICALS INC.
ATC-kode:
A04AA01
INN (International Name):
ONDANSETRON
Dosering :
8MG
Legemiddelform:
TABLET
Sammensetning:
ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8MG
Administreringsrute:
ORAL
Enheter i pakken:
10/30/100
Resept typen:
Prescription
Terapeutisk område:
5-HT3 RECEPTOR ANTAGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0131120001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2023-08-03
Preparatomtale
_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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