VOLTAREN SUPPOSITORY
Страна: Канада
Език: английски
Източник: Health Canada
Данни за продукта
(SPC)
20-10-2021
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Активна съставка:
DICLOFENAC SODIUM
Предлага се от:
NOVARTIS PHARMACEUTICALS CANADA INC
АТС код:
M01AB05
INN (Международно Name):
DICLOFENAC
дозиране:
100MG
Лекарствена форма:
SUPPOSITORY
Композиция:
DICLOFENAC SODIUM 100MG
Начин на приложение:
RECTAL
Броя в опаковка:
30
Вид предписание :
Prescription
Терапевтична област:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Каталог на резюме:
Active ingredient group (AIG) number: 0114417001; AHFS:
Статус Оторизация:
CANCELLED POST MARKET
Дата Оторизация:
2021-11-08
Данни за продукта
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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