TEVA-CHLORPROMAZINE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
13-12-2012
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ingredients actius:
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE)
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
N05AA01
Designació comuna internacional (DCI):
CHLORPROMAZINE
Dosis:
100MG
formulario farmacéutico:
TABLET
Composición:
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) 100MG
Vía de administración:
ORAL
Unidades en paquete:
100/500/1000
tipo de receta:
Prescription
Área terapéutica:
PHENOTHIAZINES
Resumen del producto:
Active ingredient group (AIG) number: 0106167002; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2011-03-08
Fitxa tècnica
_TEVA-CHLORPROMAZINE _
_ _
_Product Monograph _
_Page 1 of 18_
PRODUCT MONOGRAPH
PR
TEVA-CHLORPROMAZINE
Chlorpromazine Hydrochloride Tablets
25 mg, 50 mg and 100 mg
Teva Standard
Antipsychotic–Antiemetic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date of Preparation:
December 11, 2012
SUBMISSION CONTROL NO: 154593
_TEVA-CHLORPROMAZINE _
_ _
_Product Monograph _
_Page 2 of 18_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
REFERENCES
..............................................................
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