Land: Kanada
Språk: engelska
Källa: Health Canada
ALLOPURINOL
APOTEX INC
M04AA01
ALLOPURINOL
100MG
TABLET
ALLOPURINOL 100MG
ORAL
100/1000
Prescription
ANTIGOUT AGENTS
Active ingredient group (AIG) number: 0103654001; AHFS:
APPROVED
2013-03-18
_APO-ALLOPURINOL (Allopurinol) Tablets – Product Monograph_ _ _ _Page 1 of 26 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-ALLOPURINOL Allopurinol Tablets Tablets, 100, 200 and 300 mg, oral USP ATC Code: M04AA01 Xanthine Oxidase Inhibitor APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of initial authorization March 18, 2013 Date of Revision: July 7, 2022 Submission Control Number: 264690 _APO-ALLOPURINOL (Allopurinol) Tablets – Product Monograph_ _ _ _Page 2 of 26 _ _ _ RECENT MAJOR LABEL CHANGES 3 Serious Warnings and Precautions Box 07/2022 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 07/2022 7 Warnings and Precautions 07/2022 7 Warnings and Precautions, 7.1.4 Geriatrics 07/2022 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 .......................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................... 5 4 DOSAGE AND ADMINISTRATION .......................................................................................... 5 4.2 Recom Läs hela dokumentet