ACT DICLO-MISO TABLET (ENTERIC-COATED)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DICLOFENAC SODIUM; MISOPROSTOL

Dostupné s:

ACTAVIS PHARMA COMPANY

ATC kód:

M01AB55

INN (Mezinárodní Name):

DICLOFENAC, COMBINATIONS

Dávkování:

75MG; 200MCG

Léková forma:

TABLET (ENTERIC-COATED)

Složení:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

Podání:

ORAL

Jednotky v balení:

100/250/500

Druh předpisu:

Prescription

Terapeutické oblasti:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2019-08-08

Charakteristika produktu

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