Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
MESALAZINE
ALLERGAN INC
A07EC02
MESALAZINE
400MG
TABLET (ENTERIC-COATED)
MESALAZINE 400MG
ORAL
180
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0116808001; AHFS:
CANCELLED POST MARKET
2020-07-17
_ _ _Page 1 of 25_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ASACOL TM 5-aminosalicylic Acid Enteric Coated Tablets Tablets, 400 mg, Oral Mfr. Std. Lower Gastrointestinal Anti-inflammatory Allergan Inc. 85 Enterprise Blvd., Suite 500 Markham, Ontario L6G 0B5 www.allergan.ca Date of Preparation: June 11, 1985 Date of Revision: March 18, 2021 Submission Control No: 245536 _ _ _ _ _Page 2 of 25_ 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 Recommended Dose and Dosage Adjustment ....................................................... 5 4.2 Administration ........................................................................................................ 5 4.3 Missed Dose .......................................................................................................... 6 5 OVE Đọc toàn bộ tài liệu