英文药名：BETAFERON SC inj（Interferon Beta-1b[genetical recombination]） 中文药名：重组干扰素β-1b注射剂 生产厂家：拜耳药品 ベタフェロン皮下注用960万国際単位 治疗类别名称 重组干扰素-β-1b的配方 商標名 BETAFERON SC inj. 960 構造式 165個のアミノ酸からなる蛋白質 一般名 インターフェロンベータ-1b（遺伝子組換え） Interferon Beta-1b（genetical recombination） 略名：IFN-β-1b 分子式 C903H1397N245O252S5 分子量 19,877.57 操作注意事项 1.维修记录 由于这种药物是对应于特定生物制品，如果用这个药，药名（品牌名），序列号和生产代码（批号），使用日期，谁使用的名称的患者，记录地址等等，可以存储在至少20年。 2.被指示，让他们在儿童接触不到的地方。 药效药理 1. 针对多发性硬化症作用 (1) 在120和1200万国际单位/千克由一个20天皮下施用抑制豚鼠实验性自身免疫性脑脊髓炎的病症的进展一天内，从所述抗原（髓鞘碱性蛋白）给药开始日期 (2) 作用机序 1) 通过减少抗原从生产抑制和干扰素-γ的抗原呈递细胞呈递抑制免疫应答的增强。 2) 提高产量增加和抗炎性T细胞抑制基因活性的细胞因子和抑制炎症细胞的活化。 3) 抗原-4的表达抑制和可溶性血管细胞黏附的通过由于通过粘接抑制或抑制产生的细胞 - 细胞的基质金属蛋白酶-9的血脑屏障保护炎性细胞从外周血自由增加分子-1的中枢神经系统抑制渗透。 4) 通过抑制生产具有少突胶质细胞毒性髓鞘生成细胞，例如肿瘤坏死因子抑制脱髓鞘。 2. 其他药理作用 抗病毒活性，显示出细胞生长抑制作用和自然杀伤细胞的活化作用。 适应症 复发预防和抑制多发性硬化的进展 用法与用量 成人隔日施用至800万国际单位皮下给药。 包装规格 注射液 5瓶 ：[液1.2毫升（注射器）附： 5个注射用药瓶连接器] 15瓶：[液1.2毫升（注射器）附：15个和注射针与瓶连接器] 制造商（进口） 拜耳药品社有限公司 原处方资料附件：http://www.info.pmda.go.jp/go/pack/6399416D1033_1_13/ BETAFERON SC inj.（Interferon Beta-1b (genetical recombination)） BETAFERON SC inj.（ベタフェロン皮下注用960万国際単位）  Brand name : BETAFERON SC inj. 　Active ingredient: Interferon Beta-1b (genetical recombination) 　Dosage form: white Lyophilized powder (reconstitution with the diluent supplied before injection), injection 　Print on wrapping:  Effects of this medicine This medicine suppresses enhancement of immune response by acting on immune cells and prevents activation of inflammatory cells and/or invasion of these cells into the central nervous system. It is usually used to prevent relapse and delay progression of multiple sclerosis. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have a past history of depression or suicidal ideation. If you have hepatic/renal disease. If you have autoimmune hepatitis. If you have convulsive diseases such as epilepsy, psychoneurotic disorder, heart disease or have a past history of these conditions. If you have hypertension. If you have diabetes mellitus (including past history and family history). If you have autoimmune disease or predisposition to autoimmune diseases excluding multiple sclerosis. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is ((to be written by a healthcare professional)) •In general, for adults, the usual dosage is 1 mL (800 x 10^4 IU) of an injection solution containing the preparation dissolved in the solution provided, administered subcutaneously every other day. Strictly follow the instructions. •Do not inject into to an area which has rash or erosion. Do not inject into an area of skin that is redness, discoloration, swelling, hardness or pain. •Change the site of injection every time. Be cautious not to inject this medicine to the same spot repeatedly. Read the Self-Injection Manual or Betaferon Diary to check injection sites. •For details on how to use this medicine, read the Self-Injection Manual or Instructions for Patients. Listen and ask your doctor carefully, and ask your doctor if you have any questions because you will inject the medicine by yourself or have a member of your family inject for you. Do not leave anything unclear. •If you miss a dose, inject the prescribed dose as soon as possible. Your next dose should be injected 2 days after that dose. •If you accidentally used more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop using this medicine unless your doctor instructs you to do so. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include fever, headache, injection site redness, pain or induration, malaise, nausea, and joint pain. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •being depressed, shallow sleep, excitement, feeling irritated [depression, suicide attempt, manic state, aggressive behavior] •shortness of breath/breathing difficulty when going up stairs or over working, dry cough, fever [interstitial pneumonia] •injection site pain, redness or hardening [injection site necrosis] •general malaise, decreased appetite, yellow discoloration of the skin or the white of the eyes [serious liver disorder] •fitful shortness of breath, respiratory distress, hives [serious hypersensitive reaction] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Store it at a temperature of lower than 30 degrees Celsius. Do not place in direct sunlight or in potentially high-temperature places such as inside a car. When storing in the refrigerator, for example in intensely hot times of the summer, do not freeze this medicine. When taking this medicine out from the refrigerator to use it, make sure to let the medicine recover to room temperature before use. •Keep the medicine out of the reach of children. For other storage methods, see the Self-Injection Manual or Instructions for Patients. •Discard the remainder. Do not store them. For other disposal methods, read the Self-Injection Manual or Instructions for Patients. •[To family members] If you notice any unusual behavior or symptoms (no changes in facial expression, speaking less words, looks depressed, etc.) while observing the daily life of the patient, consult a doctor immediately, as these may represent side effects of the medicine. Multiple sclerosis (MS) is a specific disease and refractory. Various burdens are immeasurable from a healthy person, such as going to the hospital or what actually happens to the patient. Betaferon does not cure MS but rather prevents recurrence and inhibits progress, but it is a little useful medicine. It seems there is a worsening of sudden symptoms from the middle, so it is important to start and continue early drugs. I would like to make efforts to give guidance and advice on proper use as well as reducing mental burden so that it can be used more effectively and safely. Bayer Yakuhin, Ltd.Self-injection Revised: 9/2013 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.