RISPERDAL ORAL SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

RISPERIDONE (RISPERIDONE TARTRATE)

から入手可能:

JANSSEN INC

ATCコード:

N05AX08

INN（国際名）:

RISPERIDONE

投薬量:

1MG

医薬品形態:

SOLUTION

構図:

RISPERIDONE (RISPERIDONE TARTRATE) 1MG

投与経路:

ORAL

パッケージ内のユニット:

30ML

処方タイプ:

Prescription

治療領域:

ATYPICAL ANTIPSYCHOTICS

製品概要:

Active ingredient group (AIG) number: 0124332003; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2023-09-29

製品の特徴

_Approved Product Monograph 1.doc _
_EDMS-RIM-104119 v8.0 _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISPERDAL
®
risperidone tartrate oral solution
risperidone 1 mg/mL
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
December 17, 2020
Submission Control No: 241861
All trademarks used under license.
© 2020 Janssen Inc.
_Approved Product Monograph 1.doc _
_EDMS-RIM-104119 v8.0 _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, SKIN
12/2020
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
5
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
...........................................................................................................
8
4.4
Missed Dose
.............................................................................................................
8
5
OVERDOSAGE
................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COM