LANTUS SOLUTION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
12-10-2016
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Aktiva substanser:
INSULIN GLARGINE
Tillgänglig från:
SANOFI-AVENTIS CANADA INC
ATC-kod:
A10AE04
INN (International namn):
INSULIN GLARGINE
Dos:
100UNIT
Läkemedelsform:
SOLUTION
Sammansättning:
INSULIN GLARGINE 100UNIT
Administreringssätt:
SUBCUTANEOUS
Enheter i paketet:
100
Receptbelagda typ:
Schedule D
Terapiområde:
INSULINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0147062001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2016-04-07
Produktens egenskaper
_Page 1 of 78 _
PRODUCT MONOGRAPH
LANTUS
®
Insulin glargine (rDNA origin)
Solution for injection 100 U/mL
ATC code: A10AE04
Antidiabetic Agent
_ _
Long-acting Recombinant Human Insulin Analogue
_ _
sanofi-aventis Canada Inc.
2905 Place Louis R.Renaud
Laval, Quebec H7V 0A3
Date of Approval:
July 10, 2015
Submission Control No: 176776
_Page 2 of 78 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
DESCRIPTION
.........................................................................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
4
WARNINGS AND
PRECAUTIONS........................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
10
DRUG INTERACTIONS
........................................................................................................
16
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 20
STORAGE AND
STABILITY................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 25
PART II: SCIENTIFIC INFORMATION
..............
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