OCTASA TABLET (DELAYED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MESALAZINE

Dostępny od:

TILLOTTS PHARMA AG

Kod ATC:

A07EC02

INN (International Nazwa):

MESALAZINE

Dawkowanie:

1600MG

Forma farmaceutyczna:

TABLET (DELAYED-RELEASE)

Skład:

MESALAZINE 1600MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-08-08

Charakterystyka produktu

_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
....