PMS-DICLOFENAC-SR TABLET (EXTENDED-RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DICLOFENAC SODIUM

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

M01AB05

INN (Internationale Bezeichnung):

DICLOFENAC

Dosierung:

75MG

Darreichungsform:

TABLET (EXTENDED-RELEASE)

Zusammensetzung:

DICLOFENAC SODIUM 75MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100/500

Verschreibungstyp:

Prescription

Therapiebereich:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0114417005; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2022-02-14

Fachinformation

PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC
PR
PMS-DICLOFENAC-SR
(diclofenac sodium)
50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 and 100 mg Suppositories
Acetic Acid Derivatives and Related Substances
PHARMASCIENCE INC. DATE OF REVISION:
6111 Royalmount Ave., Suite 100,
March 26, 2020
Montréal, Québec
H4P 2T4
www.pharmascience.com
CONTROL NO.: 237237
_pms-DICLOFENAC & pms-DICLOFENAC-SR Product Monograph_
_Page 2 of 40 _
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
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
..................................................