SANDOZ-DICLOFENAC SUPPOSITORY

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DICLOFENAC SODIUM

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

M01AB05

INN (Nama Internasional):

DICLOFENAC

Dosis:

100MG

Bentuk farmasi:

SUPPOSITORY

Komposisi:

DICLOFENAC SODIUM 100MG

Rute administrasi :

RECTAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0114417001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2021-01-25

Karakteristik produk

_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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_Page 1 of 40 _
PRODUCT MONOGRAPH
PR
SANDOZ-DICLOFENAC
PR
SANDOZ-DICLOFENAC 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
Sandoz Canada Inc.
Date of revision:
110 Rue de Lauzon,
January 6, 2020
Boucherville, Quebec
J4B 1E6
Control no. 233855
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
_ _
_Page 2 of 40 _
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
.........................................................................................................
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
.................