TRIFLUOPERAZINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)

Dostupno od:

AA PHARMA INC

ATC koda:

N05AB06

INN (International ime):

TRIFLUOPERAZINE

Doziranje:

5MG

Farmaceutski oblik:

TABLET

Sastav:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE) 5MG

Administracija rute:

ORAL

Jedinice u paketu:

100/1000

Tip recepta:

Prescription

Područje terapije:

PHENOTHIAZINES

Proizvod sažetak:

Active ingredient group (AIG) number: 0131362002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2010-05-26

Svojstava lijeka

_ _
_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
_ _
_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
_ _
_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