Country: Канада
Језик: Енглески
Извор: Health Canada
URSODIOL
ANGITA PHARMA INC.
A05AA02
URSODEOXYCHOLIC ACID
500MG
TABLET
URSODIOL 500MG
ORAL
100/1000
Prescription
CHOLELITHOLYTIC AGENTS
Active ingredient group (AIG) number: 0122789002; AHFS:
APPROVED
2020-09-23
AG-Ursodiol (Ursodiol Tablets) _ _ Page 1 of 32 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AG-URSODIOL Ursodiol Tablets Tablets, 250 mg & 500 mg, Oral USP Bile Acid Preparation Angita Pharma Inc. 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: September 23, 2020 Date of Revision: September 26, 2023 Submission Control Number: 278847 AG-Ursodiol (Ursodiol Tablets) _ _ Page 2 of 32 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 09/2023 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 4 DOSAGE AND ADMINISTRATION ............................................................................... 4 4.1 Dosing Considerations ........................................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment ................................................................... 5 4.3 Administration .................................................................................................................... 5 4.4 Missed Dose ..................... Прочитајте комплетан документ