OCTASA TABLET (DELAYED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

MESALAZINE

Mevcut itibaren:

TILLOTTS PHARMA AG

ATC kodu:

A07EC02

INN (International Adı):

MESALAZINE

Doz:

1600MG

Farmasötik formu:

TABLET (DELAYED-RELEASE)

Kompozisyon:

MESALAZINE 1600MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Ürün özeti:

Active ingredient group (AIG) number: 0116808015; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-08-08

Ürün özellikleri

_OCTASA_
_®_
_ (Mesalamine Delayed-Release Tablets) _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
OCTASA®
Mesalamine* Delayed-Release Tablets
Tablets (delayed-release), 1600 mg, Oral use
Mfr. Std.
Intestinal Anti-inflammatory Agent
Tillotts Pharma AG
Baslerstrasse 15, CH-4310 Rheinfelden
Switzerland
Importer/Distributor:
C.R.I.
Burlington, ON, L7N 3G2
Date of Initial Authorization:
August 8, 2022
Date of Revision:
October 17, 2023
Submission Control Number: 275500
Octasa® is a trademark of Tillotts Pharma AG, Rheinfelden,
Switzerland.
*also known as 5-aminosalicylic acid (5-ASA) or Mesalazine
_OCTASA_
_®_
_ (Mesalamine Delayed-Release Tablets) _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
10/2023
7 WARNINGS AND PRECAUTIONS, Skin
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT 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
....