SANDOZ-DICLOFENAC TABLET (DELAYED-RELEASE)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DICLOFENAC SODIUM

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

M01AB05

INN (Међународно име):

DICLOFENAC

Дозирање:

50MG

Фармацеутски облик:

TABLET (DELAYED-RELEASE)

Састав:

DICLOFENAC SODIUM 50MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2021-02-04

Карактеристике производа

_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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_Page 1 of 42 _
PRODUCT MONOGRAPH
PR
SANDOZ-DICLOFENAC
PR
SANDOZ-DICLOFENAC SR
(diclofenac sodium)
50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 mg Suppositories
Acetic Acid Derivatives and Related Substances
Sandoz Canada Inc.
Date of revision:
110 Rue de Lauzon
June 6, 2022
Boucherville,
Quebec
J4B 1E6
Control no. 259798
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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_Page 2 of 42 _
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....................................................................................................19
DOSAGE AND
ADMINISTRATION.................................................................................22
OVERDOSAGE
.................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
................................................................25
STORAGE AND
STABILITY............................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................27
PART II: SCIENTIFIC INFORMATION
...........................................................................28
PHARMACEUTICAL
INFORMATION.............................................................................28
CLINICAL TRIALS
.......