THYROGEN POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

THYROTROPIN ALFA

Dostupno od:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC koda:

V04CJ01

INN (International ime):

THYROTROPHIN

Doziranje:

0.9MG

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

THYROTROPIN ALFA 0.9MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

1.2 ML

Tip recepta:

Prescription

Područje terapije:

THYROID FUNCTION

Proizvod sažetak:

Active ingredient group (AIG) number: 0147561001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2002-05-31

Svojstava lijeka

_THYROGEN_
_®_
_ (thyrotropin alfa) Product Monograph _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
THYROGEN
®
Thyrotropin alfa for injection
Lyophilized Powder for Reconstitution and Intramuscular Injection
1.1 mg / vial
(0.9 mg / mL)
Human Thyroid Stimulating Hormone
ATC code: H01AB01
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
1755 Steeles Avenue West
Toronto, ON
M2R 3T4
Date of Initial Authorization:
May 31, 2002
Date of Revision:
May 17, 2023
Submission Control Number: 270255
_THYROGEN_
_®_
_ (thyrotropin alfa) Product Monograph _
_Page 2 of 48_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
...............................................................................................................
2
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
..................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 6
4
DOSAGE AND ADMINISTRATION
..................................................................................
6
4.1
Dosing Considerations
.............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
........................................................ 6
4.3
Reconstitution
.........................................................................................................
6
4.4
Administration
....................................................................................................