CLOPIXOL DEPOT 200MG/ML SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ZUCLOPENTHIXOL DECANOATE

Disponibil de la:

LUNDBECK CANADA INC

Codul ATC:

N05AF05

INN (nume internaţional):

ZUCLOPENTHIXOL

Dozare:

200MG

Forma farmaceutică:

SOLUTION

Compoziție:

ZUCLOPENTHIXOL DECANOATE 200MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

10X1ML/10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THIOXANTHENES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1997-01-30

Caracteristicilor produsului

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