CAMBIA POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC POTASSIUM

Available from:

ARALEZ PHARMACEUTICALS CANADA INC

ATC code:

M01AB05

INN (International Name):

DICLOFENAC

Dosage:

50MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

DICLOFENAC POTASSIUM 50MG

Administration route:

ORAL

Units in package:

3/9

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0122516001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-03-14

Summary of Product characteristics

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