País: Canadá
Idioma: inglés
Fuente: Health Canada
RISPERIDONE
ANGITA PHARMA INC.
N05AX08
RISPERIDONE
1MG
TABLET
RISPERIDONE 1MG
ORAL
250ML
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0124332003; AHFS:
APPROVED
2011-06-07
_AG-Risperidone Product Monograph _Page 1 of 61 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr AG-RISPERIDONE Risperidone Tablets Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, Oral House Standard Antipsychotic Agent Angita Pharma Inc. 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Submission Control No.: 263793 Date of Initial Authorization: August 22, 2011 Date of Revision: June 2, 2022 _AG-Risperidone Product Monograph _Page 2 of 61 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin ,06/2022 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION...................................................................4 1 INDICATIONS ....................................................................................................................... 4 1.1 Pediatrics ...................................................................................................................... 4 1.2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.............................................................. 5 4 DOSAGE AND ADMINISTRATION....................................................................................... 5 4.1 Dosing Considerations .................................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment .............................................................. 5 4.3 Administration ............................................................................................................... 7 4.4 Missed Dose ................................................................................................................. 7 5 OVERDOSAGE..................................................................................................................... 8 Leer el documento completo