SANDOZ-DICLOFENAC TABLET (DELAYED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DICLOFENAC SODIUM

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

M01AB05

INN (International Adı):

DICLOFENAC

Doz:

25MG

Farmasötik formu:

TABLET (DELAYED-RELEASE)

Kompozisyon:

DICLOFENAC SODIUM 25MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0114417003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-10-13

Ürün özellikleri

_Sandoz Diclofenac and Sandoz Diclofenac SR _
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_Page 1 of 38 _
PRODUCT MONOGRAPH
PR
SANDOZ DICLOFENAC
PR SANDOZ DICLOFENAC SR
(diclofenac sodium)
25 mg and 50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 and 100 mg Suppositories
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Sandoz Canada Inc.
Date of Revision: September 30, 2014
145 Jules Leger street
Boucherville, Quebec
J4B 7K8
Control no. 177772
_Sandoz Diclofenac and Sandoz Diclofenac SR _
_ _
_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
.........................................................................................................
16
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
...