البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
DICLOFENAC SODIUM
TEVA CANADA LIMITED
M01AB05
DICLOFENAC
50MG
TABLET (ENTERIC-COATED)
DICLOFENAC SODIUM 50MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417002; AHFS:
APPROVED
2010-10-08
_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 ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION.................................................................... 4 1 INDICATIONS................................................................................................................. 4 1.1 Pediatrics ............................................................................................................ 4 1.2 Geriatrics ............................................................................................................. 4 2 CONTRAINDICATIONS.................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................... 6 4 DOSAGE AN اقرأ الوثيقة كاملة