TRIFLUOPERAZINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)

Mevcut itibaren:

AA PHARMA INC

ATC kodu:

N05AB06

INN (International Adı):

TRIFLUOPERAZINE

Doz:

20MG

Farmasötik formu:

TABLET

Kompozisyon:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE) 20MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

PHENOTHIAZINES

Ürün özeti:

Active ingredient group (AIG) number: 0131362005; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2010-05-26

Ürün özellikleri

_ _
_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