Kraj: Kanada
Język: angielski
Źródło: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
JAMP PHARMA CORPORATION
N05AH04
QUETIAPINE
25MG
TABLET (IMMEDIATE RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 25MG
ORAL
100/500
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858001; AHFS:
APPROVED
2017-07-21
JAMP-Quetiapine Page 1 of 58 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP-QUETIAPINE Quetiapine Tablets Immediate-Release Tablets, 25, 100, 200 and 300 mg (as quetiapine fumarate), Oral Use USP Antipsychotic Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: July 21, 2017 Date of Revision: JAN 4, 2023 Submission Control No.: 270220 JAMP-Quetiapine Page 2 of 58 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS- Musculoskeletal- Rhabdomyolysis 01/2023 7 WARNINGS AND PRECAUTIONS – Psychiatric 01/2023 7 WARNINGS AND PRECAUTIONS - Skin 11/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED 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 ..................................................................................... 5 4.1 Dosing Considerations ................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment .......................................................... 5 4.4 Administration ........................................................................................................ 7 4.5 Missed Dose................................................................................................................... 7 5. OVERDOSAGE ............................................................ Przeczytaj cały dokument