TRURAPI SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

INSULIN ASPART

Dostopno od:

SANOFI-AVENTIS CANADA INC

Koda artikla:

A10AB05

INN (mednarodno ime):

INSULIN ASPART

Odmerek:

100UNIT

Farmacevtska oblika:

SOLUTION

Sestava:

INSULIN ASPART 100UNIT

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Schedule D

Povzetek izdelek:

Active ingredient group (AIG) number: 0144802001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-07-20

Lastnosti izdelka

_Product Monograph _
_ _
_TRURAPI Insulin aspart injection _
_Page 1 of 74_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TRURAPI®
insulin aspart injection
Solution for Injection, 100 Units/mL, subcutaneous
Manufacturer Standard
Anti-diabetic Agent
ATC Code: A10AB05
Fast-acting insulin analogue
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval (Québec) Canada - H7V 0A3
Date of Initial Authorization:
October 15, 2020
Date of Revision:
July 20, 2022
Submission Control Number: 254352
_Product Monograph _
_ _
_TRURAPI Insulin aspart injection _
_Page 2 of 74_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
04/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
04/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, 4.4
Administration
04/2022
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
04/2022
7 WARNING AND PRECAUTIONS
05/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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 ADMINISTRATION
.......................................................................................4
4.1
Dosing Considerations
............................................................................................5
4.2
Recommended Dose and Dosage Adjustment
............................................................5