TRIFLUOPERAZINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)

Disponible desde:

AA PHARMA INC

Código ATC:

N05AB06

Designación común internacional (DCI):

TRIFLUOPERAZINE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE) 10MG

Vía de administración:

ORAL

Unidades en paquete:

100/1000

tipo de receta:

Prescription

Área terapéutica:

PHENOTHIAZINES

Resumen del producto:

Active ingredient group (AIG) number: 0131362004; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-05-26

Ficha técnica

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_TRIFLUOPERAZINE _
_Page 1 of 22 _
PRESCRIBING INFORMATION
TRIFLUOPERAZINE
Trifluoperazine Hydrochloride Tablets BP
1, 2, 5, 10 and 20 mg
ANTIANXIETY-ANTIEMETIC-ANTIPSYCHOTIC
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
DATE OF REVISION:
OCTOBER 9, 2014
SUBMISSION CONTROL NO: 173661
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_TRIFLUOPERAZINE _
_Page 2 of 22_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION………………………………….....3
SUMMARY PRODUCT
INFORMATION……………………………………………....3
INDICATIONS AND CLINICAL
USE………………………………………………….3
CONTRAINDICATIONS………………………………………………………………...4
WARNINGS AND
PRECATIONS………………………………………………………4
DRUG
INTERACTIONS………………………………………………………………..12
DOSAGE AND
ADMINISTRATION…………………………………………………..14
OVERDOSAGE…………………………………………………………………………15
ACTION AND CLINCAL
PHARMACOLOGY……………………………………….16
STORAGE AND
STABILITY…………………………………………………………..16
DOSAGE FORMS, COMPOSITION AND
PACKAGING…………………………….17
PART II: SCIENTIFIC
INFORMATION…………………………………………………...18
PHARMCEUTICAL
INFORMATION……….………………….…………………......18
PART III: CONSUMER
INFORMATION……………………………………………..……19
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_TRIFLUOPERAZINE _
_Page 3 of 22 _
TRIFLUOPERAZINE
(Trifluoperazine Hydrochloride)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
oral
Tablets:1 mg, 2 mg, 5
mg, 10 mg and 20 mg
carnauba wax, cornstarch, FD&C Blue #2
aluminum lake, hydroxypropyl methyl-
cellulose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
polye