Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CELECOXIB
PFIZER INDONESIA - Indonesia
CELECOXIB
100.00 MG
KAPSUL
DUS, 10 BLISTER @ 10 KAPSUL
PFIZER PHARMACEUTICALS LLC - United States of America
2020-02-24
Generic Name: Celecoxib Trade Name: Celebrex CDS Effective Date: November 01, 2019 Supersedes: August 16, 2018 Approved by BPOM: 2019-0053572 Page 1 of 30 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Celecoxib Trade Name: Celebrex CDS Effective Date: November 01, 2019 Supersedes: August 16, 2018 CARDIOVASCULAR RISK • NSAID S may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with dose and duration of use. Patients with CV disease or CV risk factors may be at greater risk (see WARNINGS and CLINICAL STUDIES). • CELEBREX 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 CELEBREX 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 CELEBREX 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 abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with CELEBREX (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 WARNINGS). DESCRIPTION CELEBREX (celecoxi Izlasiet visu dokumentu