Страна: Канада
Язык: английский
Источник: Health Canada
LETROZOLE
PRO DOC LIMITEE
L02BG04
LETROZOLE
2.5MG
TABLET
LETROZOLE 2.5MG
ORAL
30
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0132937001; AHFS:
APPROVED
2013-02-14
PR _ Letrozole_ _®_ _ (letrozole) Tablets _ _Page 1 of 68_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR LETROZOLE ® Letrozole tablets Tablets, 2.5 mg, for oral use Aromatase inhibitor Pro Doc Ltée. 2925 Boulevard Industriel Laval, Québec, H7L 3W9 Date of Initial Authorization: FEB 14, 2013 Date of Revision: JUN 16, 2023 Submission Control Number: 275917 _ _ _ _ _ _ PR _ Letrozole_ _®_ _ (letrozole) Tablets _ _Page 2 of 68 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 06 / 2023 RECENT MAJOR LABEL CHANGES ............................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics .................................................................................................................... 4 1.2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ................................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ........................................................... 5 4.4 Administration ............................................................................................................ 6 4.5 Missed Dose ............................................................................................................... 6 5 OVERDOSAGE ................................................. Прочитать полный документ