Land: Canada
Taal: Engels
Bron: Health Canada
DICLOFENAC SODIUM
APOTEX INC
M01AB05
DICLOFENAC
75MG
TABLET (EXTENDED-RELEASE)
DICLOFENAC SODIUM 75MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417005; AHFS:
DORMANT
2019-10-03
_APO-DICLO and APO-DICLO SR diclofenac sodium Page 1 of 52 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-DICLO Diclofenac Sodium Delayed-Release Tablets Delayed-Release Tablets, 25 mg and 50 mg, for oral use USP PR APO-DICLO SR Diclofenac Sodium Slow-Release Tablets Slow Release Tablets, 75 mg and 100 mg, for oral use Apotex Standard Non-Steroidal Anti-Inflammatory Drug (NSAID) APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: DEC 31, 1989 Date of Revision: SEP 22, 2022 Submission Control Number: 260911 _APO-DICLO and APO-DICLO SR diclofenac sodium Page 2 of 52 _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX- Risk in Pregnancy 09/2022 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, _Pregnancy_ 09/2022 7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_ 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 09/2022 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 .............................................................. 5 4 DOSAGE AND ADMINISTRATION...... Lees het volledige document