SOLIQUA SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

INSULIN GLARGINE; LIXISENATIDE

제공처:

SANOFI-AVENTIS CANADA INC

ATC 코드:

A10AE54

INN (국제 이름):

INSULIN GLARGINE AND LIXISENATIDE

복용량:

100UNIT; 33MCG

약제 형태:

SOLUTION

구성:

INSULIN GLARGINE 100UNIT; LIXISENATIDE 33MCG

관리 경로:

SUBCUTANEOUS

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

INSULINS

제품 요약:

Active ingredient group (AIG) number: 0260350001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-07-06

제품 특성 요약

_Product Monograph Master Template _
_Template Date: _
_SOLIQUA_
_Insulin glargine and Lixisenatide injection _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SOLIQUA®
Insulin glargine and Lixisenatide injection
100 units/mL + 33 mcg/mL
Solution for injection in a prefilled pen for subcutaneous injection
Antidiabetic Agent
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
www.sanofi.ca
Date of Initial Authorization:
JUL 06, 2018
Date of Revision:
JUN 28, 2023
Submission Control Number: 271298
_Product Monograph Master Template _
_Template Date: _
_SOLIQUA Insulin glargine and Lixisenatide injection _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
06/2023
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
4.2
Recommended Dose and Dosage
Adjustment.......................................................6
4.4
Administration
.....................................................................................................9
4.5
Missed Dose
............