Land: Canada
Språk: engelsk
Kilde: Health Canada
OLANZAPINE
ABBOTT LABORATORIES, LIMITED
N05AH03
OLANZAPINE
10MG
TABLET (ORALLY DISINTEGRATING)
OLANZAPINE 10MG
ORAL
100
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0128783002; AHFS:
CANCELLED POST MARKET
2015-12-31
_ _ _Abbott-Olanzapine ODT Product Monograph _ _Page 1 of 62 _ PRODUCT MONOGRAPH PR ABBOTT-OLANZAPINE ODT Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg, 20 mg Antipsychotic Agent BGP Pharma Inc. 8401 Trans-Canada Highway Saint-Laurent, Quebec H4S 1Z1 Date of Preparation: January 6, 2015 Submission Control No.: 180719 _ _ _Abbott-Olanzapine ODT Product Monograph _ _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 ............................................................31 STORAGE AND STABILITY ..........................................................................................34 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................34 PART II: SCIENTIFIC INFORMATION ...............................................................................35 PHARMACEUTICAL INFORMATION ..........................................................................35 CLINICAL TRIALS ............................................................................................ read_full_document