Nazione: Canada
Lingua: inglese
Fonte: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
ANGITA PHARMA INC.
N05AH04
QUETIAPINE
200MG
TABLET (EXTENDED-RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 200MG
ORAL
15G/50G
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858003; AHFS:
APPROVED
2021-09-21
PRODUCT MONOGRAPH PR AG-QUETIAPINE XR Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as quetiapine fumarate) House Standard Antipsychotic / Antidepressant Agent Angita Pharma Inc. Date of Preparation: 1310 rue Nobel September 20, 2021 Boucherville, Québec J4B 5H3, Canada Submission Control No: 255711 Product Monograph of AG-Quetiapine XR Page 2 of 79 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 17 DRUG INTERACTIONS ......................................................................................................... 37 DOSAGE AND ADMINISTRATION ..................................................................................... 39 OVERDOSAGE ........................................................................................................................ 43 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 44 STORAGE AND STABILITY ................................................................................................. 47 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 47 PART II: SCIENTIFIC INFORMATION ...............................................................................48 PHARMACEUTICAL INFORMATION ................................................................................. Leggi il documento completo