ADMELOG SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

INSULIN LISPRO

Dostopno od:

SANOFI-AVENTIS CANADA INC

Koda artikla:

A10AB04

INN (mednarodno ime):

INSULIN LISPRO

Odmerek:

100UNIT

Farmacevtska oblika:

SOLUTION

Sestava:

INSULIN LISPRO 100UNIT

Pot uporabe:

SUBCUTANEOUS

Enote v paketu:

3ML CARTRIDGE

Tip zastaranja:

Schedule D

Terapevtsko območje:

INSULINS

Povzetek izdelek:

Active ingredient group (AIG) number: 0131614001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2017-11-16

Lastnosti izdelka

_Product Monograph _
_ADMELOG® and ADMELOG® SoloSTAR® _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ADMELOG
®
AND ADMELOG
®
SOLOSTAR
®
(insulin lispro injection)
Solution for Injection, 100 units/mL, subcutaneous
Anti-Diabetic Agent
ATC code: A10AB04
Fast-acting insulin analogue
Sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Approval:
November 16, 2017
Date of Revision:
December 2, 2021
Submission Control No:
253748
_Product Monograph _
_ADMELOG_
_®_
_ and ADMELOG_
_®_
_ SoloSTAR_
_®_
_ _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
05/2021
7 WARNINGS 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
..............................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.........................................................................................................6
5.
OVERDOSAGE
............................................