PMS-DICLOFENAC TABLET (ENTERIC-COATED)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DICLOFENAC SODIUM

Dostupné s:

PHARMASCIENCE INC

ATC kód:

M01AB05

INN (Mezinárodní Name):

DICLOFENAC

Dávkování:

50MG

Léková forma:

TABLET (ENTERIC-COATED)

Složení:

DICLOFENAC SODIUM 50MG

Podání:

ORAL

Jednotky v balení:

100/500

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:

2022-02-14

Charakteristika produktu

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
..................................................