国: カナダ
言語: 英語
ソース: Health Canada
ZUCLOPENTHIXOL ACETATE
LUNDBECK CANADA INC
N05AF05
ZUCLOPENTHIXOL
50MG
SOLUTION
ZUCLOPENTHIXOL ACETATE 50MG
INTRAMUSCULAR
5X1ML/5X2ML
Prescription
THIOXANTHENES
Active ingredient group (AIG) number: 0127601001; AHFS:
APPROVED
1997-01-30
_ _ _ _ _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 _ _ _ _ _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 ............................ 完全なドキュメントを読む