ASACOL 800 TABLET (DELAYED-RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MESALAZINE

Disponible desde:

ALLERGAN INC

Código ATC:

A07EC02

Designación común internacional (DCI):

MESALAZINE

Dosis:

800MG

formulario farmacéutico:

TABLET (DELAYED-RELEASE)

Composición:

MESALAZINE 800MG

Vía de administración:

ORAL

Unidades en paquete:

180

tipo de receta:

Prescription

Área terapéutica:

ANTI-INFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0116808010; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-01-27

Ficha técnica

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_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ASACOL
TM 800
Mesalamine Tablets (Delayed-Release) *
Tablets, 800 mg, Oral
Mfr. Std.
Lower Gastrointestinal Anti-inflammatory
Allergan Inc.
85 Enterprise Blvd., Suite 500
Markham, Ontario
L6G 0B5
www.allergan.ca
Date of Initial Approval:
April 26, 2005
Date of Revision:
March 18, 2021
Submission Control No: 245722
* also referred to as 5-aminosalicylic acid (5-ASA)
_ _
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_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS, Renal
04/2020
WARNINGS AND PRECAUTIONS, Acute Intolerance Syndrome
03/2021
WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
03/2021
TABLE OF CONTENTS
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
....................................................... 5
4.3
Administration
.............................................................