Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ALLOPURINOL
MARCAN PHARMACEUTICALS INC
M04AA01
ALLOPURINOL
300MG
TABLET
ALLOPURINOL 300MG
ORAL
30/1000
Prescription
ANTIGOUT AGENTS
Active ingredient group (AIG) number: 0103654003; AHFS:
APPROVED
2016-03-29
_ _ _IPG-Allopurinol PM _ _ _ _Page 1 of 26 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR IPG-ALLOPURINOL Allopurinol Tablets Tablets, 100, 200 and 300 mg, oral USP Xanthine Oxidase Inhibitor Marcan Pharmaceuticals Inc. 2 Gurdwara Road, Suite #112 Ottawa, Ontario K2E 1A2 Date of Initial Authorization: OCT 22, 2012 Date of Revision: MAY 13, 2022 Submission Control Number: 258941 _ _ _IPG-Allopurinol PM _ _ _ _Page 2 of 26 _ RECENT MAJOR LABEL CHANGES 3 Serious Warnings and Precautions Box 05/2022 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 05/2022 7 Warnings and Precautions 05/2022 7 Warnings and Precautions, 7.1.4 Geriatrics 05/2022 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 Recommended Dose and Dosage Adjustment....................................................... 5 4.5 Missed Dose .......................................... Přečtěte si celý dokument