Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
INSULIN GLULISINE (RECOMBINANT DNA ORIGIN)
SANOFI-AVENTIS CANADA INC
A10AB06
INSULIN GLULISINE
100UNIT
SOLUTION
INSULIN GLULISINE (RECOMBINANT DNA ORIGIN) 100UNIT
SUBCUTANEOUS
5X3ML
Schedule D
INSULINS
Active ingredient group (AIG) number: 0151630001; AHFS:
APPROVED
2006-04-12
_APIDRA, insulin glulisine injection (rDNA origin) _ _Page 1 of 74 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION APIDRA insulin glulisine injection (rDNA origin) Solution for injection 100 U/mL ATC code: A10AB _ _ Antidiabetic Agent Short-acting Recombinant Human Insulin Analogue sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud_ _ Laval, Quebec H7V 0A3 Date of Initial Authorization: April 12, 2006 Date of Revision: December 1, 2021 Submission Control Number: 254035 _APIDRA, insulin glulisine injection (rDNA origin) _ _ _ _Page 2 of 74 _ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION 4.4 Administration 05/2021 7 WARNING AND PRECAUTIONS 05/2021 TABLE OF CONTENTS _Sections or subsections that are not applicable at the time of authorization are not listed. _ PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................4 1 INDICATIONS ................................................................................................................4 1.1 Pediatrics ............................................................................................................4 1.2 Geriatrics.............................................................................................................4 2 CONTRAINDICATIONS ...................................................................................................4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..............................................................5 4 DOSAGE AND ADMINISTRATION...................................................................................5 4.1 Dosing Considerations .........................................................................................5 4.4 Administration.....................................................................................................6 5 OVERDOSAGE ...............................................................................................................7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....... Izlasiet visu dokumentu