TRIFLUOPERAZINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)

Διαθέσιμο από:

AA PHARMA INC

Φαρμακολογική κατηγορία (ATC):

N05AB06

INN (Διεθνής Όνομα):

TRIFLUOPERAZINE

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE) 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/1000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PHENOTHIAZINES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-05-26

Αρχείο Π.Χ.Π.

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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