DICLOFENAC SR TABLET (EXTENDED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DICLOFENAC SODIUM

Mevcut itibaren:

SANIS HEALTH INC

ATC kodu:

M01AB05

INN (International Adı):

DICLOFENAC

Doz:

75MG

Farmasötik formu:

TABLET (EXTENDED-RELEASE)

Kompozisyon:

DICLOFENAC SODIUM 75MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0114417005; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-03-02

Ürün özellikleri

Page 1 of 42
PRODUCT MONOGRAPH
Pr
DICLOFENAC EC
Pr
DICLOFENAC SR
(Diclofenac Sodium)
50 mg Enteric Coated Tablets
75 mg Slow Release Tablets
Mfr. Standard
Nonsteroidal Anti-Inflammatory Drug (NSAID)
SANIS HEALTH INC.
333 Champlain Street, Suite 102
Dieppe, New Brunswick
E1A 1P2
www.sanis.com
DATE OF REVISION:
June 3, 2015
SUBMISSION CONTROL NO: 184359
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
4
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................................
6
ADVERSE REACTIONS
.............................................................................................................
15
DRUG INTERACTIONS
.............................................................................................................
17
DOSAGE AND ADMINISTRATION
.........................................................................................
21
OVERDOSAGE
...........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
23
STORAGE AND STABILITY
.....................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 25
PART II: SCIENTIFIC INFORMATION
..........................................................................................
27
PHARMACEUTICAL INFORMATION
............................................................