Страна: Канада
мова: англійська
Джерело: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
ACCORD HEALTHCARE INC
N05AH04
QUETIAPINE
300MG
TABLET (EXTENDED-RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 300MG
ORAL
60/100/1000
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858005; AHFS:
APPROVED
2016-03-29
_ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release Tablets) _ _Page 1 of 85 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACH-QUETIAPINE FUMARATE XR Quetiapine Fumarate Extended-Release Tablets Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as quetiapine fumarate), Oral Use House Standard Antipsychotic / Antidepressant Agent Accord Healthcare Inc. Date of Initial Authorization: 3535 boul. St. Charles, Suite 704 March 29, 2016 Kirkland, QC, H9H 5B9 Canada Date of Revision: February 9, 2022 Submission Control No: 255984 _ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release Tablets) _ _Page 2 of 85 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Musculoskeletal - Rhabdomyolysis 02/2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 02/2022 7 WARNINGS AND PRECAUTIONS, Skin 02/2022 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 ................................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION ............................................................ Прочитайте повний документ