מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
RISPERIDONE
PHARMEL INC
N05AX08
RISPERIDONE
1MG
TABLET (ORALLY DISINTEGRATING)
RISPERIDONE 1MG
ORAL
100
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0124332003; AHFS:
CANCELLED PRE MARKET
2017-09-13
PRODUCT MONOGRAPH PR PHL-RISPERIDONE Risperidone tablets 0.25, 0.5, 1, 2, 3 and 4 mg Risperidone tartrate oral solution risperidone 1 mg/mL PR PHL-RISPERIDONE ODT Risperidone orally disintegrating tablets 0.5, 1 and 2 mg ANTIPSYCHOTIC AGENT PHARMEL INC. DATE OF PREPARATION: 6111 Royalmount Ave., Suite 100 July 26, 2006 Montreal, Quebec H4P 2T4 DATE OF REVISION : April 29, 2008 Control No. 121494 Page 2 of 60 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 4 CONTRAINDICATIONS .................................................................................................. 5 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 13 DRUG INTERACTIONS ................................................................................................. 23 DOSAGE AND ADMINISTRATION ............................................................................. 25 OVERDOSAGE ............................................................................................................... 28 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 29 STORAGE AND STABILITY ......................................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 31 PART II: SCIENTIFIC INFORMATION ................................................................................ 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS ..................................................................... קרא את המסמך השלם