国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
DICLOFENAC SODIUM
臺灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)
M01AB05
注射劑
DICLOFENAC SODIUM (2808400410) 75.0MG
盒裝
製 劑
限由醫師使用
NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE CH-4332 STEIN, SWITZERLAND CH
diclofenac
無法口服情況下,短期使用於緩解發炎及因發炎反應引起之疼痛。
註銷日期: 2014/06/11; 註銷理由: 自請註銷; 有效日期: 2018/09/17; 英文品名: VOLTAREN, AMPOULES 75MG/3ML
已註銷
2013-04-10
VOLTAREN NSAIDs: non-steroid anti-inflammatory drug DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Solution for injection. ACTIVE SUBSTANCE The active substance is sodium-[o-[(2,6-dichlorophenyl)- amino]-phenyl]-acetate (= diclofenac sodium). One Voltaren ampoule of 3 mL contains 75 mg of diclofenac sodium. ACTIVE MOIETY Diclofenac EXCIPIENTS Mannitol; sodium metabisulphite (E223); benzyl alcohol; propylene glycol; water for injection; sodium hydroxide. Pharmaceutical formulations may vary between countries. INDICATIONS For relief of inflammation and painful conditions due to inflammatory if oral admission is not appropriate. DOSAGE AND ADMINISTRATION The dose is generally one 75 mg ampoule daily, given by deep intragluteal injection into the upper outer quadrant. CONTRAINDICATIONS Severe blood disorders. Severe hepatic disorders Severe renal disorders Known hypersensitivity to the diclofenac or any of the other excipients. Active gastric or intestinal ulcer, bleeding or perforation. Diclofenac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Last trimester of pregnancy WARNINGS AND PRECAUTIONS 1. CARDIOVASCULAR EFFECTS Treatment with NSAIDs including diclofenac, particularly at high dose and in long term, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke). Treatment with Voltaren is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or signifi 阅读完整的文件