IPG-RISPERIDONE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISPERIDONE

Διαθέσιμο από:

MARCAN PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

N05AX08

INN (Διεθνής Όνομα):

RISPERIDONE

Δοσολογία:

0.5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RISPERIDONE 0.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

60/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ATYPICAL ANTIPSYCHOTICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0124332007; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-01-19

Αρχείο Π.Χ.Π.

_IPG-RISPERIDONE Product Monograph _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IPG-RISPERIDONE
Risperidone
Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, Oral
House Standard
Antipsychotic Agent
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, Ontario,
Canada, K2E 1A2
Date of Initial Authorization:
NOV 02, 2010
Date of Revision:
MARCH 1, 2022
Submission Control No: 259920
_IPG-RISPERIDONE Product Monograph _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
7
WARNINGS AND PRECAUTIONS, Skin, 03/2022
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
..........................................................................................................
8
4.4
Missed Dose
............................................................................................................
8
5
OVERDOSAGE
................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS,