DICLOFENAC EC TABLET (ENTERIC-COATED)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
28-01-2021
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Aktivní složka:
DICLOFENAC SODIUM
Dostupné s:
SANIS HEALTH INC
ATC kód:
M01AB05
INN (Mezinárodní Name):
DICLOFENAC
Dávkování:
50MG
Léková forma:
TABLET (ENTERIC-COATED)
Složení:
DICLOFENAC SODIUM 50MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
Prescription
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0114417002; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2022-12-15
Charakteristika produktu
Page 1 of 38
PRODUCT MONOGRAPH
PR
DICLOFENAC EC
Diclofenac Sodium Enteric Coated Tablets, USP
50 mg Tablets
Acetic Acid Derivatives and Related Substances
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com
Date of Revision:
January 25, 2021
Submission Control No.: 247252
Page 2 of 38
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
....................................................................................................
14
DRUG INTERACTIONS
.....................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................
20
OVERDOSAGE
...................................................................................................................
22
ACTION AND CLINICAL
PHARMACOLOGY................................................................
22
STORAGE AND STABILITY
.............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
...................................................................................
25
PHARMACEUTICAL INFORMATION
.............................................................................
25
CLINICAL TRIALS
.............................................................................................................
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