DICLOFENAC EC TABLET (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DICLOFENAC SODIUM

Mevcut itibaren:

SANIS HEALTH INC

ATC kodu:

M01AB05

INN (International Adı):

DICLOFENAC

Doz:

50MG

Farmasötik formu:

TABLET (ENTERIC-COATED)

Kompozisyon:

DICLOFENAC SODIUM 50MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2022-12-15

Ürün özellikleri

Page 1 of 38
PRODUCT MONOGRAPH
PR
DICLOFENAC EC
Diclofenac Sodium Enteric Coated Tablets, USP
50 mg Tablets
Acetic Acid Derivatives and Related Substances
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com
Date of Revision:
January 25, 2021
Submission Control No.: 247252
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
.....................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................
20
OVERDOSAGE
...................................................................................................................
22
ACTION AND CLINICAL
PHARMACOLOGY................................................................
22
STORAGE AND STABILITY
.............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
...................................................................................
25
PHARMACEUTICAL INFORMATION
.............................................................................
25
CLINICAL TRIALS
.............................................................................................................