Country: Канада
Језик: Енглески
Извор: Health Canada
DICLOFENAC POTASSIUM
ARALEZ PHARMACEUTICALS CANADA INC
M01AB05
DICLOFENAC
50MG
POWDER FOR SOLUTION
DICLOFENAC POTASSIUM 50MG
ORAL
3/9
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0122516001; AHFS:
APPROVED
2012-03-14
_ _ _CAMBIA_ _®_ _ (diclofenac potassium) Product Monograph _ _Page 1 of 33_ PRODUCT MONOGRAPH PR CAMBIA ® Diclofenac potassium powder for oral solution 50 mg Nonsteroidal Anti-Inflammatory Drug (NSAID) Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga Road, Suite 800 Mississauga, Ontario L5N 6J5 www.miravohealthcare.com Date of Revision: December 6, 2021 Submission Control No: 253454 *Doing business as (d/b/a) Miravo Healthcare _ _ _CAMBIA_ _® _ _(diclofenac potassium) Product Monograph _ _Page 2 of 33_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................15 DRUG INTERACTIONS ..................................................................................................18 DOSAGE AND ADMINISTRATION ..............................................................................22 OVERDOSAGE ................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ............................................................23 STORAGE AND STABILITY ..........................................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ................................................................................26 PHARMACEUTICAL INFORMATION ............................................................... Прочитајте комплетан документ