ACT DICLO-MISO TABLET (ENTERIC-COATED)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DICLOFENAC SODIUM; MISOPROSTOL

Beschikbaar vanaf:

ACTAVIS PHARMA COMPANY

ATC-code:

M01AB55

INN (Algemene Internationale Benaming):

DICLOFENAC, COMBINATIONS

Dosering:

75MG; 200MCG

farmaceutische vorm:

TABLET (ENTERIC-COATED)

Samenstelling:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

Toedieningsweg:

ORAL

Eenheden in pakket:

100/250/500

Prescription-type:

Prescription

Therapeutisch gebied:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2019-08-08

Productkenmerken

_ _
_ _
_Page 1 of 54_
PRODUCT MONOGRAPH
PR
ACT_ _DICLO-MISO
Diclofenac sodium and Misoprostol Enteric-coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
and
75 mg diclofenac/200 mcg misoprostol
NSAID with a
Mucosal Protective Agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date of Revision:
December 09, 2015
Submission Control No: 190014
_ _
_ _
_Page 2 of 54_
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
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
........................................................................