英文药名: Euflexxa(Sodium Hyaluronic Acid Injection Kit)
中文药名: 注射用透明质酸钠
【中文品名】透明质酸 【药效类别】抗关节炎药,眼科用药 【通用药名】HYALURONIC ACID 【别 名】HA, Healon, Hyalartil, ARTZ 【用 途】本品作为一种关节内注射药用于治疗骨关节炎;还用于白内障手术和矫形外科手术。
药品简介
美国批准透明质酸钠治疗膝关节炎疼痛 Savient 制药公司日前宣布,FDA 已批准其 1%透明质酸钠(sodium hyaluronate, Nuflexxa)的上市申请.本品用于治疗对保守的非药物疗法和简单的止痛剂[如:对乙酰氨基酚(acetaminophen)]应答不充分的膝关节炎患者,以缓解疼痛. 本品是首个在美国获准的源自非鸟类动物的透明质酸(HA).本品在欧盟也已获准,将以Euflexxa 之名在欧洲上市. 本品由以色列 Bio-Technology General Ltd 公司拥有,而Savient 制药公司是其全资子公司. 美国疾病预防和控制中心(CDC)及关节炎基金会报告,2002 年美国关节炎或慢性关节疾病患者达 7000 万(约占成人数的1/3),是1985 年的 2 倍.按千年研究公司(Millennium Research Group)近来公布的研究显示,2004 年美国用于关节炎治疗的HA 市场约达 3.5 亿美元,较2003 年增长11%.
EUFLEXXA (1% sodium hyaluronate) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics (e.g., acetaminophen).
Important Safety Information EUFLEXXA is contraindicated in patients who have a known hypersensitivity to hyaluronate preparations or who have knee joint infections, infections, or skin disease in the area of the injection site.
EUFLEXXA should not be administered through a needle previously used with medical solutions containing benzalkonium chloride. Do not use skin disinfectants for skin preparation that contain quaternary ammonium salts.
Do not inject intravascularly due to potential for systemic adverse events.
The safety and effectiveness of injection in conjunction with other intra-articular injectables, or into joints other than the knee have not been studied. Remove any joint effusion prior to injecting. Transient pain or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA.
The most common adverse events related to EUFLEXXA injections reported in 12- and 26-week clinical studies were arthralgia, back pain, pain in extremity, musculoskeletal pain, and joint swelling. In an open-label extension of the 26-week clinical study with repeat series of injections, the most common adverse events related to EUFLEXXA at Week 52 were arthralgia and joint swelling.
规格: 10mg/ml 3 x 2ml 10mg/ml 6 x 2ml
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