ELTROXIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LEVOTHYROXINE SODIUM

Disponibil de la:

ASPEN PHARMACARE CANADA INC.

Codul ATC:

H03AA01

INN (nume internaţional):

LEVOTHYROXINE SODIUM

Dozare:

150MCG

Forma farmaceutică:

TABLET

Compoziție:

LEVOTHYROXINE SODIUM 150MCG

Calea de administrare:

ORAL

Unități în pachet:

500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THYROID AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0107794004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2001-08-03

Caracteristicilor produsului

_ELTROXIN_
_®_
_ levothyroxine sodium _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ELTROXIN
®
Levothyroxine sodium
Tablets, 50 mcg, 100 mcg, 150 mcg and 200 mcg, Oral ,
BP
Thyroid hormone
ATC Code: H03AA01
Aspen Pharmacare Canada Inc.
Unit 8-1155 North Service Road West,
Oakville, Ontario, L6M 3E3
Date of Initial Authorization:
Dec. 30, 1951
Date of Revision:
July 28, 2023
Submission Control Number: 273170
_ELTROXIN_
_®_
_ levothyroxine sodium _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
1 Indication
10/2021
1 Indications, 1.1 Pediatrics
10/2021
4 Dosage and Administration, 4.1 Dosing Considerations
10/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
10/2021
4 Dosage and Administration, 4.4 Administration
10/2021
7 Warnings and Precautions
07/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed
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
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1 Dosing Considerations
.................................................................................................
5
4.2 Recommended Dose