APO-LEVOTHYROXINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LEVOTHYROXINE SODIUM

Disponible desde:

APOTEX INC

Código ATC:

H03AA01

Designación común internacional (DCI):

LEVOTHYROXINE SODIUM

Dosis:

100MCG

formulario farmacéutico:

TABLET

Composición:

LEVOTHYROXINE SODIUM 100MCG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0107794005; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2023-02-06

Ficha técnica

_APO-LEVOTHYROXINE (levothyroxine sodium tablets) _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEVOTHYROXINE
Levothyroxine Sodium Tablets
Tablets, 100 mcg and 300 mcg, Oral
House Standard
Thyroid Hormone
ATC Code: H03AA01
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 23, 2023
Submission Control Number: 254426
_APO-LEVOTHYROXINE (levothyroxine sodium tablets) _
_Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE N OT 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......................................................... 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing
Considerations.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 6
4.4
Administration
...................................................................................................
10
4.5
Missed Dose
....................