Land: Canada
Språk: engelsk
Kilde: Health Canada
MESALAZINE
ALLERGAN INC
A07EC02
MESALAZINE
800MG
TABLET (DELAYED-RELEASE)
MESALAZINE 800MG
ORAL
180
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0116808010; AHFS:
CANCELLED POST MARKET
2021-01-27
_ _ _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) _ _ _ _ _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 ............................................................. Les hele dokumentet