Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
MARCAN PHARMACEUTICALS INC
N05AH04
QUETIAPINE
25MG
TABLET (IMMEDIATE RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 25MG
ORAL
100/500
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858001; AHFS:
APPROVED
2013-01-16
Page1 of58 PRODUCT MONOGRAPH INCLUDING PATIENTMEDICATIONINFORMATION Pr MAR-QUETIAPINE QuetiapineTablets Immediate-ReleaseTablets,25, 100, 200 and300mg (asquetiapinefumarate), OralUse USP AntipsychoticAgent MarcanPharmaceuticals Inc. 2GurdwaraRoad,Suite#112 Ottawa,Ontario K2E1A2 Canada Date of InitialAuthorization: JAN 16,2013 Date ofRevision: NOV16,2022 SubmissionControl No.: 269102 Page2 of58 RECENT MAJORLABELCHANGES 7 WARNINGS ANDPRECAUTIONS- Musculoskeletal- Rhabdomyolysis 11/2022 7 WARNINGS ANDPRECAUTIONS – Psychiatric 11/2022 7 WARNINGS ANDPRECAUTIONS - Skin 11/2022 TABLE OF CONTENTS Sectionsorsubsectionsthatare notapplicableat the time of authorization are notlisted 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 ........................................................................................................................ 7 6. DOSA Prečítajte si celý dokument