GD-DICLOFENAC/MISOPROSTOL 50 TABLET (DELAYED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
02-09-2022
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Aktiva substanser:
DICLOFENAC SODIUM; MISOPROSTOL
Tillgänglig från:
GENMED A DIVISION OF PFIZER CANADA ULC
ATC-kod:
M01AB55
INN (International namn):
DICLOFENAC, COMBINATIONS
Dos:
50MG; 200MCG
Läkemedelsform:
TABLET (DELAYED-RELEASE)
Sammansättning:
DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG
Administreringssätt:
ORAL
Enheter i paketet:
250
Receptbelagda typ:
Prescription
Terapiområde:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0222885003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2010-01-26
Produktens egenskaper
_ _
PRODUCT MONOGRAPH
PR
GD
®
-DICLOFENAC/MISOPROSTOL 50
diclofenac sodium and misoprostol enteric-coated tablets
50 mg diclofenac/200 mcg misoprostol
PR
GD
®
-DICLOFENAC/MISOPROSTOL 75
diclofenac sodium and misoprostol enteric-coated tablets
75 mg diclofenac/200 mcg misoprostol
NSAID with a
Mucosal Protective Agent
GenMed, a division of Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
www.pfizer.ca
DATE OF PREPARATION:
January 21, 2010
DATE OF REVISION:
September 2, 2022
Submission Control No: 261769
®
GD is a trademark of Pfizer Canada ULC
GenMed, a division of Pfizer Canada ULC, Licensee
Pfizer Canada ULC 2022
_GD-diclofenac/misoprostol (diclofenac sodium plus misoprostol) -
Product Monograph _
_Page 2 of 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................18
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................28
STORAGE AND STABILITY
..........................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................
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