Страна: Канада
Язык: английский
Источник: Health Canada
OLANZAPINE
TORRENT PHARMACEUTICALS LIMITED
N05AH03
OLANZAPINE
20MG
TABLET (ORALLY DISINTEGRATING)
OLANZAPINE 20MG
ORAL
100
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0128783006; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2021-12-20
_ _ _ _ _Page 1 of 62_ PRODUCT MONOGRAPH PR TORRENT-OLANZAPINE ODT Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg, 20 mg Antipsychotic Agent Torrent Pharmaceuticals Ltd. Ahmedabad-Mehsana Highway Taluka - Kadi, Dist. Mehsana Indrad-382 721, Gujarat, India Distributed by: Torrent Pharma Canada Inc. Woodbridge, ON, L4H 1Y6 Date of Revision : February 07, 2014 Submission Control No: 166045 _ _ _ _ _Page 2 of 62_ 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 ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................27 DOSAGE AND ADMINISTRATION ..............................................................................29 OVERDOSAGE ................................................................................................................31 ACTION AND CLINICAL PHARMACOLOGY ............................................................32 STORAGE AND STABILITY ..........................................................................................34 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................34 PART II: SCIENTIFIC INFORMATION ...............................................................................36 PHARMACEUTICAL INFORMATION ..........................................................................36 CLINICAL TRIALS .............................................................. Прочитать полный документ