Kraj: Kanada
Język: angielski
Źródło: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
SIVEM PHARMACEUTICALS ULC
N05AH04
QUETIAPINE
100MG
TABLET
QUETIAPINE (QUETIAPINE FUMARATE) 100MG
ORAL
90/100/500
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858002; AHFS:
APPROVED
2009-07-02
_QUETIAPINE (Quetiapine Fumarate Immediate-Release Tablets) _ _Page 1 of 66 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR QUETIAPINE Quetiapine Tablets Immediate-Release Tablets, 25 mg, 100 mg, 200 mg & 300 mg quetiapine (as quetiapine fumarate), Oral Antipsychotic Agent Sivem Pharmaceuticals ULC 4705 Dobrin Street Saint-Laurent, Quebec, Canada H4R 2P7 www.sivem.ca Submission Control No: 263919 Date of Initial Authorization: June 02, 2016 Date of Revision: June 1, 2022 _QUETIAPINE (Quetiapine Fumarate Immediate-Release Tablets) _ _Page 2 of 66 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS - Musculoskeletal - Rhabdomyolysis 06/2022 7 WARNINGS AND PRECAUTIONS - Psychiatric 06/2022 7 WARNINGS AND PRECAUTIONS - Skin 06/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED 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 ....................................... Przeczytaj cały dokument