DICLOFENAC-SR TABLET (EXTENDED-RELEASE)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DICLOFENAC SODIUM

Saadav alates:

PRO DOC LIMITEE

ATC kood:

M01AB05

INN (Rahvusvaheline Nimetus):

DICLOFENAC

Annus:

100MG

Ravimvorm:

TABLET (EXTENDED-RELEASE)

Koostis:

DICLOFENAC SODIUM 100MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/250

Retsepti tüüp:

Prescription

Terapeutiline ala:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0114417001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2021-07-27

Toote omadused

_Diclofenac-SR _
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PRODUCT MONOGRAPH
PR
DICLOFENAC-SR
(Diclofenac Sodium Slow-Release Tablets)
75 and 100 mg
Acetic Acid Derivatives and Related Substances
PRO DOC LTÉE
Date of revision:
2925, boul. Industriel
February 5, 2021
Laval, Quebec
H7L 3W9
Control no. 246930
_Diclofenac-SR _
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_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
.........................................................................................................
15
DRUG INTERACTIONS
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
.................................................................................
26
CLINICAL TRIALS
..................................................................