PMS-DICLOFENAC-MISOPROSTOL TABLET (DELAYED-RELEASE)
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
01-06-2022
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Werkstoffen:
DICLOFENAC SODIUM; MISOPROSTOL
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
M01AB55
INN (Algemene Internationale Benaming):
DICLOFENAC, COMBINATIONS
Dosering:
50MG; 200MCG
farmaceutische vorm:
TABLET (DELAYED-RELEASE)
Samenstelling:
DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Therapeutisch gebied:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0222885003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2013-10-01
Productkenmerken
PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC-MISOPROSTOL
Diclofenac Sodium and Misoprostol
Enteric-Coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
75 mg diclofenac/200 mcg misoprostol
NSAID WITH A MUCOSAL PROTECTIVE AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 1, 2022
Submission
Control No: 263143
_ _
_pms-DICLOFENAC-MISOPROSTOL Product Monograph Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL
USE.........................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
...........................................................................................
17
DRUG
INTERACTIONS............................................................................................
22
DOSAGE AND
ADMINISTRATION.........................................................................
26
OVERDOSAGE
.........................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND
STABILITY....................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 31
PART II: SCIENTIFIC
INFORMATION...........................................................................
32
PHARMACEUTICAL
INFORMATION.....................................................................
32
CLINICAL TRIALS
...................................................................................................
34
DE
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