TEVA-DICLOFENAC EC TABLET (ENTERIC-COATED)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DICLOFENAC SODIUM

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

M01AB05

INN (Nama Internasional):

DICLOFENAC

Dosis:

50MG

Bentuk farmasi:

TABLET (ENTERIC-COATED)

Komposisi:

DICLOFENAC SODIUM 50MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2010-10-08

Karakteristik produk

_TEVA-DICLOFENAC EC and TEVA-DICLOFENAC SR Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-DICLOFENAC EC
Pr
TEVA-DICLOFENAC SR
Diclofenac Sodium Enteric Coated Tablets
Diclofenac Sodium Slow-Release Tablets
Enteric Coated Tablets, 25 mg, 50 mg, Oral
Slow-release Tablets, 75 mg and 100 mg, Oral
Teva Standard
Non-Steroidal Anti-Inflammatory Drug
(NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
October 08, 2010
Date of Revision:
December 20, 2022
Submission Control Number: 266861
_TEVA-DICLOFENAC EC and TEVA-DICLOFENAC SR Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX- Risk in Pregnancy
12/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests,
_Pregnancy_
12/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions _
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...............................................................................................
2
TABLE OF CONTENTS
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2
PART I:
HEALTH PROFESSIONAL
INFORMATION....................................................................
4
1
INDICATIONS.................................................................................................................
4
1.1
Pediatrics
............................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 6
4
DOSAGE AN