英文药名：REPLAGAL FOR INTRAVENOUS DRIP INFUSION（Agalsidase Alfa(Genetical Recombination)）
中文药名：阿尔法半乳糖苷酶基因重组注射剂
生产厂家：住友制药
リプレガル点滴静注用3.5mg
治疗类别名称
α-半乳糖苷酶制剂
商標名
REPLAGAL
一般名
アガルシダーゼ アルファ（遺伝子組換え）
Agalsidase Alfa (Genetical Recombination)
化学名（本質）
α-半乳糖苷酶
α-半乳糖苷酶A的基因人纤维肉瘤细胞中的表达增加了应变的扩增（HT-1080），其通过从（C2029H3080N544O587S27衍生的细胞系产生的398个氨基酸残基;分子量：45,351.21，1件或两个C包括那些末端氨基酸残基被缺失）亚基由两个以上的糖构成的蛋白质（分子量：约102000）
审批条件
由于案件审理在日本是非常有限的，上市后，直到一定数量的情况下，数据集成，通过开展各种情况下的使用效果调查，药物以及了解用于收集在早期就安全和这种药物的疗效数据的患者的背景信息采取必要的措施以确保正确使用这种药物。
药效药理
半乳糖苷酶的α（重组）是一个人溶酶体水解酶，其具有用于切断半乳糖残基是在CTH的末端α-糖苷键的酶活性。半乳糖苷酶的α是一个糖蛋白（基因重组）是6，其被取入细胞通过糖链的甘露糖-6-磷酸残基结合甘露糖-6-磷酸受体在细胞表面上）。
当给予阿尔法半乳糖苷酶（重组）对α-半乳糖苷酶基因敲除小鼠，肝脏，分布于心脏和肾脏等，CTH在这些器官的积累量减少。
适应病症
法布里病
用法用量
每机身重1kg每隔一周为0.2mg，静脉滴注。
包装规格
3.5mg：1瓶
制造厂商
住友制药有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/3959410A1025_1_07/
REPLAGAL FOR INTRAVENOUS DRIP INFUSION 3.5mg（リプレガル点滴静注用3.5mg）
Brand name : REPLAGAL FOR INTRAVENOUS DRIP INFUSION 3.5mg
Active ingredient: Agalsidase alfa (genetical recombination)
Dosage form: Injection
Print on wrapping:
Effects of this medicine
This medicine replaces the human enzyme alfa-galactosidase.
It is usually used for treatment of Fabry Disease.
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 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, this medicine is administered by intravenous drip infusion every two weeks.
•The treatment period with this medicine depends on your symptoms.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, chills, fatigability, pain of the extremities, feeling hot and breathing difficulty. 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.
•breathing difficulty, hives, systemic redness with itch [anaphylactoid symptoms]
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
•If you become unwell during an infusion, you should tell your doctor immediately.
Sumitomo Dainippon Pharma Co.,Ltd.Injection
Revised: 11/2012
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.