RISPERDAL ORAL SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISPERIDONE (RISPERIDONE TARTRATE)

Διαθέσιμο από:

JANSSEN INC

Φαρμακολογική κατηγορία (ATC):

N05AX08

INN (Διεθνής Όνομα):

RISPERIDONE

Δοσολογία:

1MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

RISPERIDONE (RISPERIDONE TARTRATE) 1MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ATYPICAL ANTIPSYCHOTICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2023-09-29

Αρχείο Π.Χ.Π.

_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