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

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DICLOFENAC SODIUM; MISOPROSTOL

Pieejams no:

GENMED A DIVISION OF PFIZER CANADA ULC

ATĶ kods:

M01AB55

SNN (starptautisko nepatentēto nosaukumu):

DICLOFENAC, COMBINATIONS

Deva:

50MG; 200MCG

Zāļu forma:

TABLET (DELAYED-RELEASE)

Kompozīcija:

DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG

Ievadīšanas:

ORAL

Vienības iepakojumā:

250

Receptes veids:

Prescription

Ārstniecības joma:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-01-26

Produkta apraksts

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