Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
INSULIN GLARGINE
SANOFI-AVENTIS CANADA INC
A10AE04
INSULIN GLARGINE
300UNIT
SOLUTION
INSULIN GLARGINE 300UNIT
SUBCUTANEOUS
3X1.5ML/ 5X1.5ML
Schedule D
INSULINS
Active ingredient group (AIG) number: 0147062002; AHFS:
APPROVED
2015-05-28
_Page 1 of 88 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION TOUJEO ® SOLOSTAR ® TOUJEO ® DOUBLESTAR ® Insulin glargine (rDNA origin) Solution for injection 300 U/mL Antidiabetic Agent Long-acting Recombinant Human Insulin Analogue sanofi-aventis Canada Inc. 2905 Place Louis R.-Renaud Laval, Quebec H7V 0A3 Date of Initial Approval: May 28, 2015 Submission Control No: 228382 Date of Revision: May 12, 2020 _Page 2 of 88 _ 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 ................................................................................................... 11 DRUG INTERACTIONS .................................................................................................... 19 DOSAGE AND ADMINISTRATION ................................................................................ 20 OVERDOSAGE .................................................................................................................. 24 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 24 STORAGE AND STABILITY............................................................................................ 27 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 29 PART II: SCIENTIFIC Přečtěte si celý dokument