VASOTEC IV SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-09-2013
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Active ingredient:
ENALAPRILAT
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
C09AA02
INN (International Name):
ENALAPRIL
Dosage:
1.25MG
Pharmaceutical form:
SOLUTION
Composition:
ENALAPRILAT 1.25MG
Administration route:
INTRAVENOUS
Units in package:
2ML
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0118001001; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-04-03
Summary of Product characteristics
_ _
VASOTEC
®
IV
Page 1 of 30
PRODUCT MONOGRAPH
Pr
VASOTEC
® IV
ENALAPRILAT INJECTION
1.25 MG/ML IN 2 ML VIALS
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
Sandoz Canada Inc.
Date of Revision: September 20, 2013
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
SUBMISSION CONTROL NO: 167061
_ _
VASOTEC
®
IV
Page 2 of 30
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
.........................................................................................................................................
3
WARNINGS
AND
PRECAUTIONS
........................................................................................................................
4
ADVERSE
REACTIONS
.........................................................................................................................................
7
DRUG
INTERACTIONS
........................................................................................................................................
13
DOSAGE
AND
ADMINISTRATION
....................................................................................................................
14
OVERDOSAGE
......................................................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................................................
15
STORAGE
AND
STABILITY
................................................................................................................................
17
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
...........................
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