Maa: Kanada
Kieli: englanti
Lähde: Health Canada
AMITRIPTYLINE HYDROCHLORIDE
APOTEX INC
N06AA09
AMITRIPTYLINE
75MG
TABLET
AMITRIPTYLINE HYDROCHLORIDE 75MG
ORAL
100
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0101524004; AHFS:
APPROVED
2013-03-19
_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _ _Page 1 of 47_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr APO-AMITRIPTYLINE Amitriptyline hydrochloride tablets Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral USP Antidepressant APOTEX INC. 150 Signet Drive Toronto, Ontario Canada, M9L 1T9 Date of Initial Authorization: March 13, 2013 Date of Revision: October 31, 2023 Submission Control Number: 276872 _APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _ _Page 2 of 47_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 10/2023 7 WARNINGS AND PRECAUTIONS 10/2023 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 10/2023 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 6 4.1 Dosing Considerations ................................................................................................ 6 4.2 Recommended Dose and Lue koko asiakirja