TRULICITY SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DULAGLUTIDE

Disponível em:

ELI LILLY CANADA INC

Código ATC:

A10BJ05

DCI (Denominação Comum Internacional):

DULAGLUTIDE

Dosagem:

1.5MG

Forma farmacêutica:

SOLUTION

Composição:

DULAGLUTIDE 1.5MG

Via de administração:

SUBCUTANEOUS

Unidades em pacote:

0.5ML

Tipo de prescrição:

Prescription

Área terapêutica:

INCRETIN MIMETICS

Resumo do produto:

Active ingredient group (AIG) number: 0157570002; AHFS:

Status de autorização:

CANCELLED PRE MARKET

Data de autorização:

2021-07-22

Características técnicas

_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