VOLTAREN TABLET (DELAYED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DICLOFENAC SODIUM

Dostopno od:

NOVARTIS PHARMACEUTICALS CANADA INC

Koda artikla:

M01AB05

INN (mednarodno ime):

DICLOFENAC

Odmerek:

50MG

Farmacevtska oblika:

TABLET (DELAYED-RELEASE)

Sestava:

DICLOFENAC SODIUM 50MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0114417002; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2021-11-08

Lastnosti izdelka

Page 1 of 43
PRODUCT MONOGRAPH
PR
VOLTAREN
®
PR
VOLTAREN
® 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
Novartis Pharmaceuticals Canada Inc.
Date of Preparation:
385 Bouchard Blvd.,
July 5, 1989
Dorval, Quebec H9S 1A9
Date of Revision:
October 20, 2021
Control no. 253534
VOLTAREN and VOLTAREN SR are registered trademarks.
Page 2 of 43
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....................................................................................................20
DOSAGE AND
ADMINISTRATION.................................................................................23
OVERDOSAGE
.................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
................................................................26
STORAGE AND
STABILITY............................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................28
PART II: SCIENTIFIC INFORMATION
...........................................................................29
PHARMACEUTICAL
INFORMATION.............................................................................29
CLINICAL TRIALS
.............