SANDOZ-DICLOFENAC TABLET (DELAYED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DICLOFENAC SODIUM

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

M01AB05

INN (mednarodno ime):

DICLOFENAC

Odmerek:

25MG

Farmacevtska oblika:

TABLET (DELAYED-RELEASE)

Sestava:

DICLOFENAC SODIUM 25MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-10-13

Lastnosti izdelka

_Sandoz Diclofenac and Sandoz Diclofenac SR _
_ _
_Page 1 of 38 _
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 _
_ _
_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
...