CLOPIXOL-ACUPHASE 50MG/ML SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ZUCLOPENTHIXOL ACETATE

Saadav alates:

LUNDBECK CANADA INC

ATC kood:

N05AF05

INN (Rahvusvaheline Nimetus):

ZUCLOPENTHIXOL

Annus:

50MG

Ravimvorm:

SOLUTION

Koostis:

ZUCLOPENTHIXOL ACETATE 50MG

Manustamisviis:

INTRAMUSCULAR

Ühikuid pakis:

5X1ML/5X2ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

THIOXANTHENES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0127601001; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

1997-01-30

Toote omadused

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_Page 1 of 34_
PRODUCT MONOGRAPH
Pr
CLOPIXOL
®
Zuclopenthixol Tablets Lundbeck Std.
(10 mg and 25 mg zuclopenthixol as zuclopenthixol hydrochloride)
Lundbeck standard
Pr
CLOPIXOL-ACUPHASE
®
50 mg/mL Zuclopenthixol Intramuscular Injection
(45.25 mg/mL zuclopenthixol as zuclopenthixol acetate)
Lundbeck standard
Pr
CLOPIXOL
® DEPOT
200 mg/mL Zuclopenthixol Intramuscular Injection
(144.4 mg/mL zuclopenthixol as zuclopenthixol decanoate)
Lundbeck standard
ANTIPSYCHOTIC AGENT
Lundbeck Canada Inc.
1000 De la Gauchetière Street West
Suite 500
Montréal, QC
H3B 4W5
Date of Revision:
08 April 2014
Submission Control No : 171198
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_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
............................