GD-DICLOFENAC/MISOPROSTOL 75 TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DICLOFENAC SODIUM; MISOPROSTOL

Boleh didapati daripada:

GENMED A DIVISION OF PFIZER CANADA ULC

Kod ATC:

M01AB55

INN (Nama Antarabangsa):

DICLOFENAC, COMBINATIONS

Dos:

75MG; 200MCG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

250

Jenis preskripsi:

Prescription

Kawasan terapeutik:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0222885004; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2010-01-26

Ciri produk

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