HYPURIN NPH INSULIN ISOPHANE PORK SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-06-2017
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Active ingredient:
INSULIN ISOPHANE INJECTION PORK
Available from:
WOCKHARDT UK LIMITED
ATC code:
A10AC03
INN (International Name):
INSULIN (PORK)
Dosage:
100UNIT
Pharmaceutical form:
SUSPENSION
Composition:
INSULIN ISOPHANE INJECTION PORK 100UNIT
Administration route:
INTRAMUSCULAR
Units in package:
10
Prescription type:
Schedule D
Therapeutic area:
INSULINS
Product summary:
Active ingredient group (AIG) number: 0151573001; AHFS:
Authorization status:
MARKETED
Authorization date:
2006-04-01
Summary of Product characteristics
PRODUCT MONOGRAPH
HYPURIN® NPH INSULIN, PORK
INSULIN INJECTION, ISOPHANE (PORCINE) PH EUR
SUSPENSION FOR INJECTION 100 IU/ML
ANTI-DIABETIC AGENT
SPONSOR: WOCKHARDT UK LTD 2000 ELLESMERE ROAD, UNIT 16 SCARBOROUGH, ONTARIO M1H 2W4
MANUFACTURER: WOCKHARDT UK LTD
ASH ROAD NORTH
WREXHAM, LL13 9UF
UNITED KINGDOM
CONTROL #:
204997
DATE OF
APPROVAL
:
JUNE 15
,
201
7
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................1
SUMMARY PRODUCT
INFORMATION........................................................................1
INDICATIONS AND CLINICAL
USE..............................................................................1
CONTRAINDICATIONS
....................................................................................................1
WARNINGS AND PRECAUTIONS
..................................................................................1
ADVSERSE REACTIONS
..................................................................................................5
DRUG
INTERACTIONS.....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
....................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
.............................................................8
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING
INSTRUCTIONS.........................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................10
PART II: SCIENTIFIC INFORMATION
..........................................................................11
PHARMACEUTICAL
INFORMATION.........................................................................11
CLINICAL
TRIALS................................
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