Страна: Индонезия
Язык: индонезийский
Источник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL @ 40 MG + 1 AMPUL PELARUT @ 2 ML
2022-07-18
Generic Name: Parecoxib Trade Name: DYNASTAT CDS Effective Date: September 16, 2021 Supersedes: November 01, 2019 Approved by BPOM: 2021-0068271; 2021-0071563 Page 1 of 19 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Parecoxib Trade Name: DYNASTAT CDS Effective Date: September 16, 2021 Supersedes: November 01, 2019 CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Elderly patients and patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS). • DYNASTAT is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). ASTHMA AND SKIN REACTION DYNASTAT is contraindicated to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs (see WARNINGS and PRECAUTIONS). CONGESTIVE HEART FAILURE AND EDEMA DYNASTAT should be used with caution in patients with fluid retention or heart failure (see WARNINGS). HEPATIC EFFECTS Patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with DYNASTAT (see PRECAUTIONS). RENAL EFFECTS Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion (see WA Прочитать полный документ