Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
DICLOFENAC SODIUM; MISOPROSTOL
GENMED A DIVISION OF PFIZER CANADA ULC
M01AB55
DICLOFENAC, COMBINATIONS
50MG; 200MCG
TABLET (DELAYED-RELEASE)
DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG
ORAL
250
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0222885003; AHFS:
APPROVED
2010-01-26
_ _ 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 ................. Διαβάστε το πλήρες έγγραφο