TIROCAP CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LEVOTHYROXINE SODIUM

Disponible desde:

IBSA INSTITUT BIOCHIMIQUE SA

Código ATC:

H03AA01

Designación común internacional (DCI):

LEVOTHYROXINE SODIUM

Dosis:

88MCG

formulario farmacéutico:

CAPSULE

Composición:

LEVOTHYROXINE SODIUM 88MCG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

THYROID AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0107794006; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-06-21

Ficha técnica

_TIROCAP™ (levothyroxine sodium capsules) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TIROCAP™
Levothyroxine Sodium capsule
Capsules,13 mcg, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125
mcg,
137 mcg, 150 mcg, 175 mcg and 200 mcg, oral
Thyroid Hormone
ATC Code: H03AA01
Institut Biochimique SA (IBSA)
Via del Piano 266
CH-6915 Pambio-Noranco,
Switzerland
Imported by:
Progress Therapeutics Inc.
14-320 Harry Walker Parkway North
Newmarket ON
Canada, L3Y 7B4
Date of Initial Authorization:
November 25, 2020
Date of Revision:
June 17, 2021
Submission Control No: 248553
_ _
_TIROCAP™ (levothyroxine sodium capsules) _
_Page 2 of 32_
TABLE OF CONTENTS
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
4.3
Administration...................................................................................................
9
4.4
Missed
Dose.....................................................................................................
9
5
OVER