Maa: Kanada
Kieli: englanti
Lähde: Health Canada
METHIMAZOLE
PALADIN LABS INC.
H03BB02
THIAMAZOLE
5MG
TABLET
METHIMAZOLE 5MG
ORAL
100
Prescription
ANTITHYROID AGENTS
Active ingredient group (AIG) number: 0104552001; AHFS:
APPROVED
2001-01-18
_ _ _TAPAZOLE_ _®_ _ (methimazole tablets) Product Monograph _ _Page 1 of 19_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TAPAZOLE® Methimazole Tablets, 5 mg and 10 mg, oral Manufacturer’s Standard Antithyroid Agent Paladin Labs Inc. 100 Alexis Nihon Blvd., Suite 600 Saint-Laurent, Quebec, Canada H4M 2P2 paladinlabs.com _ _ Date of Initial Authorization: DEC 31, 1951 Date of Revision: APR 13, 2023 Version 8.0 Submission Control Number: 270311 _ _ _TAPAZOLE_ _®_ _ (methimazole tablets) Product Monograph _ _Page 2 of 19_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2021 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 ................................................................................. 4 4.1 Dosing Considerations ............................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment .............................................. Lue koko asiakirja