PMS-DICLOFENAC-SR TABLET (EXTENDED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

M01AB05

INN (Nama Antarabangsa):

DICLOFENAC

Dos:

75MG

Borang farmaseutikal:

TABLET (EXTENDED-RELEASE)

Komposisi:

DICLOFENAC SODIUM 75MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2022-02-14

Ciri produk

PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC
PR
PMS-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
PHARMASCIENCE INC. DATE OF REVISION:
6111 Royalmount Ave., Suite 100,
March 26, 2020
Montréal, Québec
H4P 2T4
www.pharmascience.com
CONTROL NO.: 237237
_pms-DICLOFENAC & pms-DICLOFENAC-SR Product Monograph_
_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
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
..................................................