Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DICLOFENAC SODIUM
NOVARTIS INDONESIA - Indonesia
DICLOFENAC SODIUM
25 MG/ML
CAIRAN INJEKSI
DUS, 5 AMPUL @ 3 ML
LEK PHARMACEUTICALS D.D.
2015-08-25
PAGE 1 OF 14 VOLTAREN ® ANTIRHEUMATIC, ANTI-INFLAMMATORY CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This may increase with dose and duration of use. Voltaren is contraindicated in established congestive heart failure (New York Heart Association [NYHA] classification II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. Patients with congestive heart failure (NYHA-I) or risk factors for cardiovascular disease may be at greater risk (See WARNINGS). Voltaren 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). DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Solution for injection. ACTIVE SUBSTANCE(S) The active substance is diclofenac sodium. One Voltaren ampoule of 3 mL contains 75 mg of diclofenac sodium. For excipients, see section List of excipients. ACTIVE MOIETY Diclofenac LIST OF EXCIPIENTS Mannitol; sodium metabisulphite (E223); benzyl alcohol; propylene glycol; sodium hydroxide; water for injection. CLINICAL PHARMACOLOGY PHARMACOTHERAPEUTIC GROUP, ATC Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances (ATC code: M01A B05). MECHANISM OF ACTION (MOA) Voltaren contains diclofenac sodium, a non-steroidal compound with pronounced antirheumatic, anti-inflammatory, analgesic, and antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated in experiments, is considered to be fundamental to its mechanism of action. Prostaglandins p Izlasiet visu dokumentu