Land: Canada
Taal: Engels
Bron: Health Canada
PROPYLTHIOURACIL
PHEBRA CANADA INC
H03BA02
PROPYLTHIOURACIL
50MG
TABLET
PROPYLTHIOURACIL 50MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0103603001; AHFS:
APPROVED
2021-12-02
PROPYLTHIOURACIL TABLETS (propylthiouracil) Page 1 of 23 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr PROPYLTHIOURACIL TABLETS Propylthiouracil Tablets, 50 mg, Oral USP ATC Code: H03BA02 Thyroid therapy Phebra Canada Inc. 7171 Frederick-Banting, Suite 216 Montreal, QC Canada, H4S 1Z9 Website: www.phebra.com/cae Date of Initial Authorization: December 2, 2021 Submission Control Number: 251552 _ _ PROPYLTHIOURACIL TABLETS (propylthiouracil) Page 2 of 23 RECENT MAJOR LABEL CHANGES SECTION DATE _None at time of authorization_ 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 ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.1 Dosing Considerations ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.4 Administration................................................................................ Lees het volledige document