Țară: Canada
Limbă: engleză
Sursă: Health Canada
RISPERIDONE
SANDOZ CANADA INCORPORATED
N05AX08
RISPERIDONE
4MG
TABLET
RISPERIDONE 4MG
ORAL
60
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0124332005; AHFS:
APPROVED
2006-07-05
_ _ _Sandoz Risperidone _ _ _ _Page 1 of 65 _ PRODUCT MONOGRAPH PR SANDOZ RISPERIDONE Risperidone Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Manufacturer Standard Antipsychotic Agent Sandoz Canada Inc. Date of Revision: August 27, 2020 110 Rue de Lauzon Boucherville, QC J4B 1E6 Submission control no: 238208 _ _ _Sandoz Risperidone _ _ _ _Page 2 of 65 _ 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 ................................................................................................. 15 DRUG INTERACTIONS.................................................................................................. 26 DOSAGE AND ADMINISTRATION .............................................................................. 31 OVERDOSAGE ................................................................................................................ 34 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 35 STORAGE AND STABILITY ......................................................................................... 37 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 37 PART II: SCIENTIFIC INFORMATION ........................................................................... 39 PHARMACEUTICAL INFORMATION ......................................................................... 39 CLINICAL TRIALS .......................................................................................................... 40 DETAILED PHARMA Citiți documentul complet