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  药店国别: 日本药房
产地国家: 日本
所属类别: 糖尿病->糖尿病
处方药:处方药
包装规格: 200毫克/毫升 3毫升 5支
计价单位:
   
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
NOVO Nodisk
原产地英文商品名:
Tresiba injection 200mg/ml 3ml 5 units (cold-storage)
原产地英文药品名:
Insulin degludec
中文参考商品译名:
Tresiba 注射剂 200毫克/毫升 3毫升 5支(冷藏)
中文参考药品译名:
胰岛素
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Diabetes
临床试验期:
完成
中文适应病症参考翻译1:
糖尿病
药品信息:
2012年9月29日 电 /生物谷BIOON/-- 诺和诺德今天宣布日本卫生、劳动和福利部门已经批准Tresiba上市,用于糖尿病的治疗。 Tresiba是新一代每日服用的胰岛素制剂,由诺和诺德进行研发。在日本Tresiba进行了26小时药效监测的实验,在全球范围内则进行了42小时。 全球范围内的临床实验共招募了10000名1型和2型糖尿病患者进行参与。在To-target实验中,相比甘精胰岛素,Tresiba更明显的降低了糖化血红蛋白的比率,也减少了夜间低血糖的风险。 Tresiba将会适用于FlexTouch,这是由诺和诺德开发的胰岛素注射笔,其具有方便的自动注射功能,适合患者使用。 诺和诺德执行副总裁Mads Krogsgaard Thomsen表示,非常高兴日本能够批准Tresiba上市,这一药物将会帮助患者更好的控制血糖,并显著降低夜间低血糖的风险。 In March 2013, Novo Nordisk launched Tresiba (insulin degludec), its new once-daily basal insulin for type 1 and type 2 diabetes, in the UK and Denmark. Tresiba will be priced roughly 70% higher than the other leading basal insulins, Lantus (insulin glargine) and Levemir (insulin detemir), in the UK and about 49% higher than Lantus in Denmark. However, because the UK’s National Health Service has been able to negotiate the price of Lantus and Levemir down, Tresiba will still be only $3.63 per day there ($109 per month; for someone taking 50 units/day). In phase 3 trials, Tresiba demonstrated a similar A1c reduction versus Lantus (insulin glargine), but with a 26% lower risk of nocturnal hypoglycemia. The insulin will come in two devices – a pre-filled FlexTouch pen or the refillable Penfill – and in two concentrations (U-100 and U-200), allowing users to take a maximum of 80 or 160 units in a single injection. The latter dose is the highest possible in an injection on the market, and is useful for people with significant insulin resistance and high insulin needs who currently must split their basal insulin injections. Another advantage of Tresiba is an option for more flexible daily dosing than is possible with current basal insulins. While Novo Nordisk is officially recommending that Tresiba be taken at the same time each day to get the best results from the drug, patients have the possibility of delaying or taking the injection earlier as needed (as long as there is a minimum of eight hours and a maximum of 40 hours between the injections). For instance, if your last Tresiba dose was on Monday at 9 am, your Tuesday dose could be taken at 5 pm, and your Wednesday dose could be taken at 9 am again.
更新日期: 2013-10-22
附件:
20142623094335.pdf    

 
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