מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
DARUNAVIR
MARCAN PHARMACEUTICALS INC
J05AE10
DARUNAVIR
600MG
TABLET
DARUNAVIR 600MG
ORAL
100
Prescription
HIV PROTEASE INHIBITORS
Active ingredient group (AIG) number: 0151656003; AHFS:
APPROVED
2020-09-01
_ _ ___________________________________________________________________________________________________ _ _ _ _ _MAR-DARUNAVIR _ _Page 1 of 105 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MAR-DARUNAVIR Darunavir tablets Tablets, 400 mg, 600 mg and 800 mg, Oral Human Immunodeficiency Virus (HIV) Protease Inhibitor Marcan Pharmaceuticals Inc. 2 Gurdwara Rd, Suite #112 Ottawa, Ontario K2E 1A2 Date of Initial Authorization: September 1, 2020 Date of Revision: January 5, 2023 Submission Control Number: 270480 _ _ ___________________________________________________________________________________________________ _ _ _ _ _MAR-DARUNAVIR _ _Page 2 of 105 _ RECENT MAJOR LABEL CHANGES NOT APPLICABLE 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 ................................................................................ 5 4.1 Dosing Considerations...................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment................................................... 5 4.5 Missed Dose .......................... קרא את המסמך השלם