特点：量大、价低、副作用少 倍泰龙包括下列成份：                               　 活性物质：1毫升注射用药中含有0.25毫克干扰素β-1b(800万单位)每瓶中含有无菌粉末状干扰素β-1b共0.3毫克(960万单位)中含有，超出公认单次剂量20%。 无活性成份：人白蛋白，葡萄糖 倍泰龙包装规格 每包倍泰龙含5或15个干扰素β-1b粉剂瓶,另有5或15个0.54%氯化钠注射液。 倍泰龙生产商和市场销售许可商的名称;ScheringAGD-13342柏林德国 倍泰龙的适应症 倍泰龙用于复发-缓解型多发性硬化患者（在2年内出现至少2次神经功能缺损的症状和体征，缓解完全或不完全），且保持有步行能力的患者。在这些患者中应用倍泰龙，可减少临床复发的次数，减轻发作时的严重程度，减少住院率，延长缓解期。 对继发－进展型多发性硬化的患者，倍泰龙能减慢疾病的进展，减少发作频率，患者发展至残疾、必须坐轮椅的时间也被推迟。 倍泰龙的使用方法 (剂量和给药方法) 在给药前，先用干扰素专用注射水1.2毫升将干扰素β-1b粉剂完全溶解，然后抽取1毫升配好的液体皮下注射，隔日1次。该剂量相当于0.25毫克（800万单位）。　　　　　　　　　　　　　　　　　　 治疗可由医生或护士进行，若你已完全掌握也可自己注射。在附页中有皮下注射的说明供参考，同时对注射液的配制也有详细说明。 漏掉一次治疗后如何处理？ 若不小心漏掉一次治疗，应尽可能早的补给治疗。并在48小时后给与下一次治疗。 倍泰龙有哪些副作用？ 注射局部可出现发红、肿胀、感染、疼痛、过度敏感、皮肤松解、组织坏死等，通常无特异性的反应　发生（见倍泰龙用药注意事项）。随着时间的延长，这些反应发生的机会通常会降低。　流感样症状（发热，寒战、肌肉疼痛、全身不适、大汗）也较常见。随着时间的延长发生率降低。　　 如果副作用严重，或出现其他副作用，请及时和你的医生联系。 倍泰龙如何保存？ 倍泰龙必须冷藏（2~8°C）。使用前应置于冰箱内冷藏（但不能放在冷冻室）。 若配制好的药液并不立即注射，可以在冰箱内冷藏3小时（忌冷冻）。 也可将未配制的Betaferon置于室温下，可保存3小时，但不能超过25°C。 据独立比较试验显示，ScheringAG公司的beta-1b干扰素产品Betas(f)eron治疗复发性多发性硬化症（RRMS）比Biogen公司的Avonex(beta-1a)效果更好 倍泰龙（干扰素β-1b、Betaferon）使用方法指导： BETAFERON Betaferon Information Betaferon is part of the medication class called interferons. This type of medication is similar to certain proteins produced by the human organism, proteins that assist the organism in fighting attacks, such as viral infections, against the immune system of the patient. Betaferon Indications Betaferon is typically prescribed in patients that present first-time symptoms indicating a possible onset of multiple sclerosis or for the treatment of patients suffering from relapsing-remitting multiple sclerosis or from secondary progressive multiple sclerosis. In patients susceptible to developing multiple sclerosis, the examining health care professional will rule out any other possible causes of the patient’s symptoms prior to prescribing a treatment with this medication. Betaferon may also be prescribed for the treatment of other clinical conditions as well. If you would like to obtain further information regarding the reason you have been prescribed a treatment with this drug, it is best that you consult the prescribing physician. Betaferon Warnings Betaferon should not be employed in the treatment of patients that are hypersensitive to this drug or to any of its ingredients. Also, this medical product should not be used to treat patients affected by severe liver disease or patients suffering from severe depression and those with suicidal tendencies. Patients that are pregnant should also not receive a treatment with Betaferon. Other medical conditions may also affect the health care provider’s decision to prescribe a treatment with this drug. It is best that you make sure that the prescribing health care professional is familiar with your medical history and general health condition before starting a treatment with this drug. Betaferon Intake Guidelines In most cases, the Betaferon injection will be administered by an authorized health care professional in hospital settings. However, you may obtain permission to administer the medication in the comfort of your own home. In such situations you will receive detailed instructions on how to properly administer the injection. You should closely follow the administration instructions, and prior to administering the injection you will need to prepare it by mixing the powder from a vial of Betaferon with 1.2 ml of solvent from the pre-filled syringe. You should note that the injection site needs to be changed regularly in order to reduce the risk of infection and to allow the area to recover. Betaferon Dosage Typically, the Betaferon dosage is of 1.0 ml of the prepared solution administered through subcutaneous injection once every two days. The treatment course will start with low doses (of 0.25 ml); the dose will be increased for every four injections by an additional 0.25 ml until the full dose of 1.0 ml is reached. The dosage and the administration schedule may vary from one case to another, depending on the affection being treated, the organism’s tolerance to the medication and on several other factors. It is advised to discuss with your personal health care provider regarding the exact Betaferon dosage best suited to your current situation. Betaferon Overdose It is strongly advised that you only use the prescribed dosage of Betaferon with each injection, and do not exceed the recommended number of administrations. While an overdose with this drug may not result in life-threatening situations, it may cause complications and severe consequences. At this time, the exact symptoms of an overdose with this drug are not known. If you believe that you have injected too much of this medical product or that you have exceeded the prescribed number of injections, you should consult with a specialized health care professional or contact the nearest emergency room. Betaferon Missed Dose In the event that you miss a Betaferon injection it is advised to administer it as soon as you remember and administer the following injection on time. If the moment when you remember is too close to another Betaferon injection, you should completely skip the missed dose and consult your personal physician regarding the matter. You should never administer a higher dose of this drug in order to make up for a lost one unless your prescribing health care professional specifically instructs you to do so. Betaferon Side Effects It is common at the beginning of the Betaferon treatment to experience mild side effects, such as reactions at the site of the injection or flu like symptoms. These will typically go away in time as your organism becomes adjusted to the medication. In order to reduce the incidence of such side effects, the initial dose needs to be low enough and then gradually increased until it reaches the normal dosage. Apart from these symptoms, Betaferon may cause a number of other side effects. Most of them are mild and do not require discontinuation of the treatment; however a few of them may pose a serious threat to the patient’s health condition, such as allergic reactions, a clear decline in the patient’s mood or a worsening of the depression, the appearance or accentuation of suicidal tendencies, unusual bleeding or bruising, susceptibility to infections, arrhythmia, jaundice, loss of appetite, nausea and vomiting, swelling of the legs or ankles or pain radiating from the belly towards the back side. Other side effects not listed here may appear. It is best that you consult with your personal physician whenever you experience any unexpected signs and symptoms associated with Betaferon treatment. Betaferon Drug Reactions Betaferon may interact with other drugs and medication, and as such it is recommended that you let your personal physician know of any other medication you are currently taking before starting a therapy course with this drug. Usage of Betaferon simultaneously with drugs that affect the immune system response, drugs that affect the blood cell production or drugs that require a certain system of liver enzymes in order to be removed from the organism may not be recommended. For further information regarding Betaferon drug interactions, it is advised to consult a pharmacist, a doctor or a nurse. 倍泰龙®（Betaferon®）已获欧盟国批准，成为治疗早期多发性硬化的一线治疗药物 德国先灵公司宣布倍泰龙®（干扰素β-1b，Betaferon®）已经获得欧盟委员会许可，在原治疗指征上扩大适应症，用于治疗第一次发作拟诊多发性硬化，许可国家包括25个欧盟国、以及冰岛和挪威。 随着这项许可的颁布，倍泰龙®成为目前唯一获得批准的、大剂量、高频率的治疗早期多发性硬化的药物。随着倍泰龙®治疗指征的扩大，早期多发性硬化有了新的治疗选择。倍泰龙®早期治疗能降低从疾病早期发展至临床确诊多发性硬化（CDMS）的风险，延缓疾病的进展。倍泰龙®新的治疗指征的通过，使多数有一次临床发作可能发展至多发性硬化的患者能及早开始治疗。 多发性硬化研讨会大会主席，英国泰恩河纽卡尔斯大学 (University of Newcastle upon Tyne)临床神经病学教授David Bates称：“在多发性硬化早期就出现不可逆的神经损伤和脑萎缩，所以早期开始有效的治疗非常重要。我们现在有能力在早期对患者开始治疗，早期治疗有着长达16年出色的安全资料。” 此次倍泰龙®扩大临床适应症，是建立在BENEFIT a临床试验的研究基础上，该研究表明对于早期拟诊MS的患者，给予倍泰龙®250μg后发展至CDMS的患者较对照组减少50%1,b。此外，根据McDonald诊断标准2，应用倍泰龙®早期治疗能更好地保护患者，治疗组患者发展为进展型多发性硬化的机率较对照组减少2倍。在安慰剂组， 85%患者在第一次临床发病后2年内发展为临床确诊的多发性硬化。 先灵公司特殊疾病治疗全球运营部总监Darlene Jody博士说，“BENEFIT临床试验的研究结果表明，倍泰龙®能有效延缓早期患者的疾病进程，特别在疾病早期开始治疗。” Berlex（先灵公司美国子公司）已于2006年2月向美国食品药品监督管理局提交了生物制剂补件申请(sBLA)，申请扩大倍泰龙®临床适应症，目前正在受理中。 倍泰龙®扩展后的适应症为：有单次脱髓鞘发作，处于炎性活动期的患者，伴有其它指征如患者病情严重需要使用皮质激素；排除了其它可能的诊断；很有可能发展至临床确诊的多发性硬化。BENEFIT临床试验为甄别适宜倍泰龙®治疗的早期多发性硬化患者建立了标准。这个标准同时反映了在首次发作的拟似多发性硬化患者中，单个病灶d和多个病灶d会有不同的转归。 倍泰龙®还用于治疗 复发-缓解型多发性硬化，至少在2年内有2次及2次以上的发作 继发进展型多发性硬化，疾病活动期，有复发的证据 Notes： a　倍泰龙®（Betaferon®/Betaseron®）在新发多发性硬化的最初治疗 b　经过标准基线共变校正，50%风险减低。 c　在试验结束的2年的时候 d　单一病灶发病指临床异常能用中枢神经系统的单一病灶解释。多个病灶发病指临床异常需要用至少两个基础病灶来解释。 参考文献 1.　L Kappos. Betaferon® in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT): clinical results. Presented at ECTRIMS/ACTRIMS 2005. 2.　McDonald et al. Recommended Diagnostic Criteria for MS. Ann Neurol 2001; 50:121-127.