Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
ANGITA PHARMA INC.
N05AH04
QUETIAPINE
300MG
TABLET (IMMEDIATE RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 300MG
ORAL
15G/50G
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858005; AHFS:
APPROVED
2021-06-14
Page 1 of 59 PRODUCT MONOGRAPH PR AG-QUETIAPINE FUMARATE Quetiapine Tablets USP 25 mg, 100 mg, 200 mg and 300 mg quetiapine (as quetiapine fumarate) Antipsychotic Agent _ANGITA PHARMA INC. _ _DATE OF REVISION:_ 1310 rue Nobel June 11, 2021 Boucherville, Québec J4B 5H3 Submission Control No.: 252148 Page 2 of 59 TABLE OF CONTENTS PRODUCT MONOGRAPH .................................................................................................... 1 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ...................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS ............................................................................... 4 ADVERSE REACTIONS ............................................................................................... 15 DRUG INTERACTIONS ............................................................................................... 31 DOSAGE AND ADMINISTRATION ........................................................................... 33 OVERDOSAGE ............................................................................................................. 35 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 36 STORAGE AND STABILITY ....................................................................................... 38 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 38 PART II: SCIENTIFIC INFORMATION ............................................................................. 39 PHARMACEUTICAL INFORMATION ....................................................................... 39 CLINICAL TRIALS .......................................................................... Perskaitykite visą dokumentą