מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
OLANZAPINE
MINT PHARMACEUTICALS INC
N05AH03
OLANZAPINE
10MG
TABLET
OLANZAPINE 10MG
ORAL
15G/50G
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0128783002; AHFS:
APPROVED
2013-09-04
PRODUCT MONOGRAPH Pr MINT-OLANZAPINE Olanzapine Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg House Standard Antipsychotic Agent Mint Pharmaceuticals Inc. Date of Revision: 1093 Meyerside Drive, Unit 1 13 June 2017 Mississauga, Ontario L5T 1J6 SUBMISSION CONTROL NO: 206312 Page 2 of 63 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 .............................................................................................................. 30 DOSAGE AND ADMINISTRATION .......................................................................................... 31 OVERDOSAGE ............................................................................................................................ 33 ACTION AND CLINICAL PHARMACOLOGY ........................................................................ 34 STORAGE AND STABILITY ...................................................................................................... 36 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 36 PART II: SCIENTIFIC INFORMATION ................................................................................... 38 PHARMACEUTICAL INFORMATION ...................................................................................... 38 CLINICAL TRIALS ............................... קרא את המסמך השלם