Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ALLOPURINOL
JAMP PHARMA CORPORATION
M04AA01
ALLOPURINOL
100MG
TABLET
ALLOPURINOL 100MG
ORAL
100/1000
Prescription
ANTIGOUT AGENTS
Active ingredient group (AIG) number: 0103654001; AHFS:
APPROVED
2014-03-06
_ _ _JAMP-Allopurinol PM_ _ _ _ _ _Page 1 of 26_ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP-ALLOPURINOL Allopurinol Tablets, USP Tablets, 100, 200 and 300 mg, oral USP Xanthine Oxidase Inhibitor JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Submission Control Number: 266368 Date of Initial Authorization: March 6, 2014 Date of Revision: August 24, 2022 _ _ _JAMP-Allopurinol PM_ _ _ _ _ _Page 2 of 26_ _ _ RECENT MAJOR LABEL CHANGES 3 Serious Warnings and Precautions Box 08/2022 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 08/2022 7 Warnings and Precautions 08/2022 7 Warnings and Precautions, 7.1.4 Geriatrics 08/2022 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 ......... Prečítajte si celý dokument