Страна: Канада
Язык: английский
Источник: Health Canada
DIFLUNISAL
AA PHARMA INC
N02BA11
DIFLUNISAL
500MG
TABLET
DIFLUNISAL 500MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0113161002; AHFS:
APPROVED
2014-04-11
_DIFLUNISAL (diflunisal tablets) _ _Page 1 of 47_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DIFLUNISAL Diflunisal Tablets Tablet, 250 mg and 500 mg, Oral USP Non-Steroidal Anti-inflammatory Drug (NSAID) AA PHARMA INC. 1165 Creditstone Road, Unit #1 Vaughan, Ontario L4K 4N7 Date of Initial Authorization: April 10, 2014 Date of Revision: September 23, 2022 Submission Control Number: 262252 _ _ _DIFLUNISAL (diflunisal tablets) _ _Page 2 of 47_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS 09/2022 2 CONTRAINDICATIONS 09/2022 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of Cardiovascular (CV) Adverse Events 09/2022 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of Gastrointestinal (GI) Adverse Events 09/2022 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk in Pregnancy 09/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 09/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 09/2022 7 WARNINGS AND PRECAUTIONS, General 09/2022 7 WARNINGS AND PRECAUTIONS, Cardiovascular 09/2022 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery 09/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 09/2022 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 09/2022 7 WARNINGS AND PRECAUTIONS, Genitourinary 09/2022 7 WARNINGS AND PRECAUTIONS, Hematologic 09/2022 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 09/2022 7 WARNINGS AND PRECAUTIONS, Immune 09/2022 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 09/2022 7 WARNINGS AND PRECAUTIONS, Neurologic 09/2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 09/2022 7 WARNINGS AND PRECAUTIONS, Renal 09/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential, Fertility 09/2022 7 WARNINGS AND PRECAUTIONS, Respiratory 09/2022 7 WARNINGS AND PRECAUTIONS, Skin 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women 09/2022 _ _ _DIFLUNISAL (diflunisal tablets) _ _Page 3 of 47_ 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 09/2022 TABLE OF CONTENTS SECTI Прочитать полный документ