BASAGLAR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

INSULIN GLARGINE

Tillgänglig från:

ELI LILLY 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 POST MARKET

Tillstånd datum:

2019-08-22

Produktens egenskaper

_ BASAGLAR™ Product Monograph _
_Page 1 of 52_
PRODUCT MONOGRAPH
BASAGLAR™
insulin glargine (rDNA origin)
Solution for Injection, 100 units/mL
THERAPEUTIC CLASSIFICATION
Anti-diabetic Agent
ATC code: A10AE04
Long-acting Recombinant Human Insulin Analogue
©ELI LILLY CANADA INC.
3650 Danforth Avenue
Scarborough, Ontario
M1N 2E8
Submission Control No: 200289
Date of Approval:
February 17, 2017
_ BASAGLAR™ Product Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
...................................................................................................
11
DRUG INTERACTIONS
....................................................................................................
22
DOSAGE AND
ADMINISTRATION................................................................................
23
OVERDOSAGE
..................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 27
STORAGE AND STABILITY
...........................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 31
PART II: SCIENTIFIC INFORMATION
...................................................................................
33
PHARMACEUTICAL