SANDOZ-DICLOFENAC TABLET (DELAYED-RELEASE)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DICLOFENAC SODIUM

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

M01AB05

INN (Mezinárodní Name):

DICLOFENAC

Dávkování:

25MG

Léková forma:

TABLET (DELAYED-RELEASE)

Složení:

DICLOFENAC SODIUM 25MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0114417003; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2016-10-13

Charakteristika produktu

_Sandoz Diclofenac and Sandoz Diclofenac SR _
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PRODUCT MONOGRAPH
PR
SANDOZ DICLOFENAC
PR SANDOZ DICLOFENAC SR
(diclofenac sodium)
25 mg and 50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 and 100 mg Suppositories
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Sandoz Canada Inc.
Date of Revision: September 30, 2014
145 Jules Leger street
Boucherville, Quebec
J4B 7K8
Control no. 177772
_Sandoz Diclofenac and Sandoz 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
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
16
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
...