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

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DICLOFENAC SODIUM; MISOPROSTOL

Διαθέσιμο από:

GENMED A DIVISION OF PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

M01AB55

INN (Διεθνής Όνομα):

DICLOFENAC, COMBINATIONS

Δοσολογία:

75MG; 200MCG

Φαρμακοτεχνική μορφή:

TABLET (DELAYED-RELEASE)

Σύνθεση:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

250

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-01-26

Αρχείο Π.Χ.Π.

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