部份中文重组人干扰素β-1b处方资料（仅供参考）
英文名：Interferon Beta-1b（genetical recombination）
商标名：BETAFERON SC inj
中文名：重组人干扰素β-1b
生产商：拜耳药品
ベタフェロン皮下注用960万国際単位
药效分类
基因重组干扰素-β-1b制剂
批准日期：2000年11月
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
处理上的注意
1.记录的保存
本剂在特定生物由来产品相关的,因此使用本剂时,药品名(销售名称),其制造号码或制造符号(乐透号码),使用日期,使用了患者的姓名,地址等记录,至少保存20年。
2.指导孩子保管在孩子手够不到的地方。
药效药理
1.对多发性硬化症的作用
(1)将120万和1200万国际单位/kg注射为抗原(髓磷基性蛋白质)开始之日起1天内进行20天的皮下注射，以此来抑制了吗啡试验自我免疫性脑脊髓炎的病态延续。
(2)作用机制
1)抑制干扰素-γ的产生，减少来自抗原性抗原性细胞的抗原显示，从而抑制免疫响应的增强。
2)促进t细胞的阻尼器活性的上升及抗炎症性淀粉性的产生，抑制炎症性细胞的活性化。
3)抑制在very late antige -4中出现以及可溶性vascular -1的游离增加对细胞间的粘接抑制或者通过matrix metalloproteinase- 9的产能抑制对血液脑屏障的保护，抑制来自末梢血的炎症性细胞的中枢神经系统的浸润。
4)通过抑制具有少突神经胶质细胞害害性的肿瘤坏死因子等的产生，抑制脊髓。
如上所述，免疫调节及抗炎作用被解释为，影响自免疫疾病多发性硬化症症状的进行延迟和复发频率的减少。
2.其他药理作用
显示出抗病毒活性化、抑制细胞增殖作用以及自然杀伤细胞活性化作用。
适应症
预防和抑制多发性硬化症的复发
用法与用量
一般情况下，对成年人各有800万个国际单位隔天给皮下注射。
包装
注射剂
5瓶(溶液1.2毫升)和5瓶带注射针的双连接器(药液引进器)5个附加)
15瓶(溶液1.2毫升)和15瓶带注射针的双连接器(药液引进器)15个附加)
制造商(进口)
拜耳药品公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明附件：
1）：http://www.info.pmda.go.jp/go/pack/6399416D1033_1_13/
2）http://www.hosp.yamanashi.ac.jp/FileUpload/file/yakuzaibu/dibox0502.pdf 
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.