Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
OLANZAPINE
LABORATOIRE RIVA INC.
N05AH03
OLANZAPINE
10MG
TABLET (ORALLY DISINTEGRATING)
OLANZAPINE 10MG
ORAL
30
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0128783002; AHFS:
CANCELLED POST MARKET
2018-07-04
RIVA-OLANZAPINE ODT _ _ Page 1 of 59 PRODUCT MONOGRAPH PR RIVA-OLANZAPINE ODT (Olanzapine Orally Disintegrating Tablets) 5 mg, 10 mg, 15 mg, 20 mg Antipsychotic Agent Laboratoire Riva Inc. 660 Boul. Industriel Blainville, Québec J7C 3V4 Submission Control No: 172770 Date of Preparation: April 24, 2014 RIVA-OLANZAPINE ODT _ _ Page 2 of 59 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 ................................................................................................. 12 DRUG INTERACTIONS ................................................................................................. 26 DOSAGE AND ADMINISTRATION ............................................................................. 28 OVERDOSAGE ............................................................................................................... 29 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 30 STORAGE AND STABILITY ......................................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS ......................................................................................................... 35 DETAILED PHARMACOLOGY .............. Đọc toàn bộ tài liệu