TRULICITY SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DULAGLUTIDE

Tilgjengelig fra:

ELI LILLY CANADA INC

ATC-kode:

A10BJ05

INN (International Name):

DULAGLUTIDE

Dosering :

1.5MG

Legemiddelform:

SOLUTION

Sammensetning:

DULAGLUTIDE 1.5MG

Administreringsrute:

SUBCUTANEOUS

Enheter i pakken:

0.5ML

Resept typen:

Prescription

Terapeutisk område:

INCRETIN MIMETICS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2021-07-22

Preparatomtale

_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