VOLTAREN SUPPOSITORY
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
20-10-2021
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DICLOFENAC SODIUM
Fáanlegur frá:
NOVARTIS PHARMACEUTICALS CANADA INC
ATC númer:
M01AB05
INN (Alþjóðlegt nafn):
DICLOFENAC
Skammtar:
100MG
Lyfjaform:
SUPPOSITORY
Samsetning:
DICLOFENAC SODIUM 100MG
Stjórnsýsluleið:
RECTAL
Einingar í pakka:
30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0114417001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2021-11-08
Vara einkenni
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
.............
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