TRULICITY SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DULAGLUTIDE

제공처:

ELI LILLY CANADA INC

ATC 코드:

A10BJ05

INN (국제 이름):

DULAGLUTIDE

복용량:

0.75MG

약제 형태:

SOLUTION

구성:

DULAGLUTIDE 0.75MG

관리 경로:

SUBCUTANEOUS

패키지 단위:

0.5ML

처방전 유형:

Prescription

치료 영역:

INCRETIN MIMETICS

제품 요약:

Active ingredient group (AIG) number: 0157570001; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2021-07-22

제품 특성 요약

_TRULICITY_
_®_
_ Product Monograph_
Page 1 of 58
PRODUCT MONOGRAPH
Pr
TRULICITY
®
dulaglutide injection
0.75 mg/0.5 mL and 1.5 mg/0.5 mL
Solution for injection in a single-use prefilled syringe or single-use
prefilled pen
Antihyperglycemic Agent
Human Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario M1N 2E8
1-888-545-5972
www.lilly.ca
DATE OF INITIAL APPROVAL:
November 10, 2015
DATE OF REVISION:
September 11, 2020
SUBMISSION CONTROL NO: 232128
TRULICITY is a registered trademark owned by or licensed to Eli Lilly
and Company, its subsidiaries or affiliates.
_TRULICITY_
_®_
_ Product Monograph_
Page 2 of 58
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
24
DO