TRESIBA SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

INSULIN DEGLUDEC

Tersedia dari:

NOVO NORDISK CANADA INC

Kode ATC:

A10AE06

INN (Nama Internasional):

INSULIN DEGLUDEC

Dosis:

100UNIT

Bentuk farmasi:

SOLUTION

Komposisi:

INSULIN DEGLUDEC 100UNIT

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

5X3ML

Jenis Resep:

Schedule D

Area terapi:

LONG-ACTING INSULINS

Ringkasan produk:

Active ingredient group (AIG) number: 0159410001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-08-25

Karakteristik produk

_ _
_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