CLOPIXOL DEPOT 200MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZUCLOPENTHIXOL DECANOATE

Available from:

LUNDBECK CANADA INC

ATC code:

N05AF05

INN (International Name):

ZUCLOPENTHIXOL

Dosage:

200MG

Pharmaceutical form:

SOLUTION

Composition:

ZUCLOPENTHIXOL DECANOATE 200MG

Administration route:

INTRAMUSCULAR

Units in package:

10X1ML/10ML

Prescription type:

Prescription

Therapeutic area:

THIOXANTHENES

Product summary:

Active ingredient group (AIG) number: 0127602001; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-01-30

Summary of Product characteristics

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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
............................