Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
ETRAVIRINE
JANSSEN INC
J05AG04
ETRAVIRINE
200MG
TABLET
ETRAVIRINE 200MG
ORAL
60
Prescription
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0152450002; AHFS:
APPROVED
2011-11-14
_Approved Product Monograph 1.docx _ _EDMS-RIM-1139595 v6.0 _ _Page 1 of 52 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr INTELENCE ® etravirine tablets tablets, 100 mg, 200 mg, oral Human Immunodeficiency Virus (HIV) non-nucleoside reverse transcriptase inhibitor Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.com/canada Date of Initial Authorization: March 27, 2008 Date of Revision: MAR 28, 2024 M Control Number: 280475 All trademarks used under license. © 2024 Janssen Inc. _Approved Product Monograph 1.docx _ _EDMS-RIM-1139595 v6.0 _ _Page 2 of 52 _ RECENT MAJOR LABEL CHANGES 1 Indications 03/2024 1 Indications, 1.1 Pediatrics 03/2024 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 03/2024 4 Dosage and Administration, 4.4 Administration 10/2022 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 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ...................................................................................... 5 4.2 Recommended Dose a Διαβάστε το πλήρες έγγραφο