APO-MYCOPHENOLATE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

MYCOPHENOLATE MOFETIL

Доступна з:

APOTEX INC

Код атс:

L04AA06

ІПН (Міжнародна Ім'я):

MYCOPHENOLIC ACID

Дозування:

500MG

Фармацевтична форма:

TABLET

Склад:

MYCOPHENOLATE MOFETIL 500MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

50/100

Тип рецепту:

Prescription

Терапевтична области:

IMMUNOSUPPRESSIVE AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0128158002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-12-19

Характеристики продукта

_APO-MYCOPHENOLATE, mycophenolate mofetil tablets _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 1 of 71_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MYCOPHENOLATE
mycophenolate mofetil tablets
Film-Coated Tablets, 500 mg, Oral
USP
Immunosuppressive Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
November 30, 2011
Date of Revision:
January 18, 2023
Submission Control Number: 266782
_APO-MYCOPHENOLATE, mycophenolate mofetil tablets _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 71_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
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................................................... 5
4.4
Administration
.................................................................................................
6
5.
OVERDOSAGE..................................................