TIROCAP CAPSULE

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

LEVOTHYROXINE SODIUM

Доступна с:

IBSA INSTITUT BIOCHIMIQUE SA

код АТС:

H03AA01

ИНН (Международная Имя):

LEVOTHYROXINE SODIUM

дозировка:

88MCG

Фармацевтическая форма:

CAPSULE

состав:

LEVOTHYROXINE SODIUM 88MCG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

THYROID AGENTS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2021-06-21

Характеристики продукта

_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