SANDOZ RISPERIDONE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RISPERIDONE

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

N05AX08

INN (nume internaţional):

RISPERIDONE

Dozare:

1MG

Forma farmaceutică:

TABLET

Compoziție:

RISPERIDONE 1MG

Calea de administrare:

ORAL

Unități în pachet:

60/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ATYPICAL ANTIPSYCHOTICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2006-07-05

Caracteristicilor produsului

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PRODUCT MONOGRAPH
PR SANDOZ RISPERIDONE
Risperidone Tablets
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
Manufacturer Standard
Antipsychotic Agent
Sandoz Canada Inc.
Date of Revision: August 27, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission control no: 238208
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
15
DRUG
INTERACTIONS..................................................................................................
26
DOSAGE AND ADMINISTRATION
..............................................................................
31
OVERDOSAGE
................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 35
STORAGE AND STABILITY
.........................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 37
PART II: SCIENTIFIC INFORMATION
...........................................................................
39
PHARMACEUTICAL INFORMATION
.........................................................................
39
CLINICAL TRIALS
..........................................................................................................
40
DETAILED
PHARMA