APIDRA SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

INSULIN GLULISINE (RECOMBINANT DNA ORIGIN)

Dostopno od:

SANOFI-AVENTIS CANADA INC

Koda artikla:

A10AB06

INN (mednarodno ime):

INSULIN GLULISINE

Odmerek:

100UNIT

Farmacevtska oblika:

SOLUTION

Sestava:

INSULIN GLULISINE (RECOMBINANT DNA ORIGIN) 100UNIT

Pot uporabe:

SUBCUTANEOUS

Enote v paketu:

10ML

Tip zastaranja:

Schedule D

Terapevtsko območje:

INSULINS

Povzetek izdelek:

Active ingredient group (AIG) number: 0151630001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2006-04-12

Lastnosti izdelka

_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
.......