DICLOFENAC MISOPROSTOL TABLET (ENTERIC-COATED)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DICLOFENAC SODIUM; MISOPROSTOL

Dostupné z:

ABRI PHARMACEUTICALS INC

ATC kód:

M01AB55

INN (Medzinárodný Name):

DICLOFENAC, COMBINATIONS

Dávkovanie:

50MG; 200MCG

Forma lieku:

TABLET (ENTERIC-COATED)

Zloženie:

DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG

Spôsob podávania:

ORAL

Počet v balení:

100/250/500

Typ predpisu:

Prescription

Terapeutické oblasti:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0222885003; AHFS:

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2017-09-12

Súhrn charakteristických

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_Page 1 of 48_
PRODUCT MONOGRAPH
_PR_
DICLOFENAC MISOPROSTOL
Diclofenac sodium and Misoprostol Enteric-coated Tablets
50 mg diclofenac/200 µg misoprostol
and
75 mg diclofenac/ 200 µg misoprostol
NSAID with a
Mucosal Protective Agent
Abri Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, ON
Canada, L5N 2B8
Date of Preparation:
April 18, 2013
Submission Control No: 163906
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_Page 2 of 48_
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
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
...............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 24
STORAGE AND STABILITY
.........................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 26
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
PHARMACEUTICAL INFORMATION
.........................................................................
28
CLINICAL TRIALS
................................................................................