TRESIBA SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

INSULIN DEGLUDEC

제공처:

NOVO NORDISK CANADA INC

ATC 코드:

A10AE06

INN (국제 이름):

INSULIN DEGLUDEC

복용량:

200UNIT

약제 형태:

SOLUTION

구성:

INSULIN DEGLUDEC 200UNIT

관리 경로:

SUBCUTANEOUS

패키지 단위:

3ML/ 3X3ML

처방전 유형:

Schedule D

치료 영역:

LONG-ACTING INSULINS

제품 요약:

Active ingredient group (AIG) number: 0159410002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-08-25

제품 특성 요약

_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_TRESIBA_
_® _
_(insulin degludec injection _
_Page 1 of 68_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TRESIBA
®
insulin degludec injection
TRESIBA
®
Penfill
®
100 U/mL, Solution for injection in a cartridge
TRESIBA
®
FlexTouch
®
100 U/mL, Solution for injection in a pre-filled pen
TRESIBA
®
FlexTouch
®
200 U/mL, Solution for injection in a pre-filled pen
Subcutaneous
Antidiabetic Agent
Long-Acting Basal Insulin Analogue
ATC Code: A10AE06
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
Canada L5N 6M1
Date of Initial Authorization:
AUG 25, 2017
Date of Revision:
OCT 27, 2022
Submission Control Number: 258642
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_TRESIBA_
_® _
_(insulin degludec injection _
_Page 2 of 68_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
03/2021
7 Warnings and Precautions, 7.11 Pregnant Women
11/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
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 ADMINIS