GD-DICLOFENAC/MISOPROSTOL 50 TABLET (DELAYED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DICLOFENAC SODIUM; MISOPROSTOL

Disponible des:

GENMED A DIVISION OF PFIZER CANADA ULC

Codi ATC:

M01AB55

Designació comuna internacional (DCI):

DICLOFENAC, COMBINATIONS

Dosis:

50MG; 200MCG

formulario farmacéutico:

TABLET (DELAYED-RELEASE)

Composición:

DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG

Vía de administración:

ORAL

Unidades en paquete:

250

tipo de receta:

Prescription

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0222885003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2010-01-26

Fitxa tècnica

_ _
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
.................