药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(2011101919323126.pdf,2011101919322637.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文贝米肝素钠处方资料(仅供参考)
更多欧洲国家批准bemiparin 西班牙Rovi公司的低分子量肝素(bemiparin,Hibor/Phivor)已经在欧盟6个国家获准用于预防血栓性疾病,这距离该药在西班牙上市已近4年。 延迟的原因一方面是公司要进行附加试验,另一方面是不得不在意大利、爱尔兰、澳大利亚、葡萄牙、希腊和英国指定获权者。因为西班牙是欧盟的参考会员国,所以该批准已经纳入欧盟相互承认程序。除在澳大利亚2003年上市以外,在其他新批准的市场bemiparin都在2002年上市。 手术前和手术后6个小时服用该药可以预防低危(腹部)和高危(整形)手术深静脉血栓形成,还可以在血透析时防止血液凝固。2002年春天分别在荷兰、法国和比利时进行申请。在美国和加拿大该药的IIIb 期临床试验即将开始,在2005年上市,公司正在这两个国家寻求市场营销伙伴。另外,该药还在东欧、土耳其和大多数拉丁美洲国家等待批准。但该药在德国遇到挫折,由于试验数据解释问题,批准令被撤销了。 西班牙的研究者报道称,贝米肝素钠(bemiparin sodium)(Ⅰ)与或不与口服抗凝血药(OAC)联用的治疗战略与传统的采用静脉输注不分馏肝素(UFH)加OAC相比,用于治疗深静脉血栓(DVT)的效价比好。
贝米肝素钠Bemiparin sodium 英文品名:bemiparin sodium 名称来源:p-INNList-75,1996;r-INNList-37,1997; 化学表述:Sodium salt of depolymerized heparin obtained by alkaline degradation of quaternary ammonium salt of heparin from pork intestinal mucosa; the majority of the components have a 2-O-sulfo-4-enepyranosuronic acid structure at the non-reducing end and a 2-N,6-O-disulfo-D-glucossamine structure at the reducing end of their chain; the average relative molecular mass is about 3600 (3000 to 4200); the degree of sulfatation is about 2 per disaccharidic unit. CA登记号:9041-08-1 品种类别:血液系统>抗凝血及溶栓药>肝素及类肝素类;
Drug Name: ZIBOR
Generic Ingredient(s): Bemiparin
Legal Class: POM
Drug Class: Antithrombotics
How Supplied: Bemiparin sodium
Indications: Prevention of thromboembolism in patients undergoing general or orthopaedic surgery. Prevention of clotting in extracorporeal circuit during haemodialysis. Treatment of established DVT, with or without pulmonary embolism.
Adults: General surgery: 2500iu by sc inj. 2hrs pre-op. or 6hrs post-op., then 2500iu once daily for min. 7—10 days. Orthopaedic surgery: 3500iu by sc inj. 2hrs pre-op. or 6hrs post-op., then 3500iu once daily for min. 7—10 days. Haemodialysis: bolus dose into arterial side of dialyser at the start of dialysis; under 60kg, bolus dose of 2500iu; over 60kg, bolus dose of 3500iu. DVT: 115iu/kg once daily by sc inj. for 5—9 days until oral anticoagulation can be established.
Children: Not recommended
Contraindications: Heparin-induced thrombocytopenia, haemorrhagic tendency, recent trauma or surgery to CNS, eyes or ears, severe liver or pancreatic impairment, active peptic ulcer, haemorrhagic stroke, cerebral aneurysm, cerebral neoplasms, bacterial endocarditis.
Precautions: Renal or hepatic impairment, uncontrolled severe hypertension, history of GI ulceration, thrombocytopenia, nephrolithiasis, urolithiasis, choroid or retinal vascular damage, other lesions or procedures with risk of bleeding. Risk of hypoaldosteronism leading to hyperkalaemia; monitor serum potassium particularly in patients treated for more than 7 days or those with diabetes, chronic renal failure, pre-existing acidosis, or if taking K+-sparing drugs. Monitor platelet counts before and during therapy; discontinue if thrombocytopenic. Pregnancy, lactation.
Interactions: Drugs affecting platelet function or coagulation.
Side Effects: Ecchymosis, haematoma and pain at inj. site. Bleeding complications, raised liver enzymes, allergic skin reactions.
Additional Notes: ▼ Report any adverse reaction to CHM.
Section:Cardiovascular System.
Sub Section:Thromboembolic disorders .
Drug Class:Antithrombotics.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(2011101919323126.pdf,2011101919322637.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |