英文药名：Epoetin SYRINGE injection（Epoetin Kappa[Genetical Recombination]）

中文药名：基因重组阿法依伯汀注射器

生产厂家：KISSEI药品

エポエチンアルファBS注750シリンジ「JCR」／エポエチンアルファBS注1500シリンジ「JCR」／エポエチンアルファBS注3000シリンジ「JCR」／

治疗类别名称
重组人促红细胞生成素
一般名
エポエチン　カッパ（遺伝子組換え）
［エポエチンアルファ後続１］
Epoetin Kappa（Genetical Recombination）
［Epoetin Alfa Biosimilar 1］
本質
促红细胞生成素卡帕是重组人红细胞生成素，在中国仓鼠卵巢细胞中产生。促红细胞生成素的Kappa，由165个氨基酸残基糖蛋白（分子量：约28000）是。
操作注意事项
<注射器>
1.请活塞杆的不讲理的操作。此外逆止器，则不会被删除，直到给药结束后。
2.不要从枕头收拾尽可能在使用之前取下注射器。
3.注射器尖端的胶片前端帽时，或当异常被发现，如注射器破裂不能使用。
适应病症
1. 透析肾性贫血
2. 早产儿贫血
用法用量
1. 透析肾性贫血
法依泊汀（基因重组）以后，通常情况下，一个成年人，一旦3000国际单位，每周静脉给药尽可能三次放缓。
当不能获得的贫血改善效果，作为维持量，通常情况下，一个成年人，一次每周二至三次1500国际单位，每周给药，或者一旦3000国际单位的两倍。
的贫血改善效果（30％血细胞比容）为10g/dL的血红蛋白浓度和前后目标值。
应当指出的是，在任何情况下贫血症状的程度，将根据年龄等，在维持剂量最高剂量进行调整，并且一旦3000国际单位，每周三次施用。
2. 早产儿贫血
通常情况下，阿法依伯汀（基因重组）为公斤，每周两次，一次200个国际单位皮下给药。
然而，出了早产儿早期贫血期间，（在血细胞比容值30％）为10克血红蛋白浓度/升，如果临床症状被认为是稳定的之前和之后，要停止给药。
所述剂量可根据贫血症状的程度进行调节。
药效药理
1. 关于促红细胞生成素受体的作用
1）在受体与氟化钡/ EPOR细胞结合研究是人类红细胞生成素受体表达细胞，这种药物对人类红细胞生成素受体具有高亲和力。
2）在的BaF/EPOR细胞显示人促红细胞生成素依赖性增殖的能力，显示出浓度依赖性的细胞增殖的作用。另外，在人骨髓红系祖细胞，它增加了晚期红细胞祖细胞（CFU-E）和以浓度依赖的方式上年度红系祖细胞（BFU-E）的菌落数。
2. 对正常及病理模型动物的影响
1）网织红细胞计数剂量依赖性增加了单次静脉和单皮下注射到正常大鼠。此外，持续3周静脉内增加血红蛋白水平，每周三次。
2）在通过5/6肾切除制备肾性贫血大鼠模型3周静脉内每周三次连续增加血红蛋白水平。
制造厂商
JCR制药有限公司[联盟]KISSEI药品

完整处方资料附件：http://www.info.pmda.go.jp/go/pack/3999427A1026_1_06/3999427A1026_1_06?view=body#18
IMPORTANT SAFETY INFORMATION ABOUT EPOGEN®
EPOGEN® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
EPOGEN® should not be used in place of emergency treatment for anemia (red blood cell transfusions).
EPOGEN® has not been proven to improve quality of life, fatigue, or well-being.
Important Safety Information
EPOGEN® may cause serious side effects that can lead to death, including:
For people with cancer:
In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take EPOGEN®.
Your healthcare provider has received special training in order to prescribe EPOGEN® and will talk with you in detail about these risks.
For all people who take EPOGEN®, including people with cancer or chronic kidney disease:
Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with EPOGEN® to increase red blood cells (RBCs) to near the same level found in healthy people.
Blood clots. Blood clots may happen at any time while taking EPOGEN®. If you are receiving EPOGEN® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take a blood thinner to lessen the chance of blood clots during or following surgery.
Call your healthcare provider or get medical help right away if you have any of these symptoms:
Chest pain
Trouble breathing or shortness of breath
Pain or swelling in your legs
A cool or pale arm or leg
Sudden confusion, trouble speaking, or trouble understanding others’ speech
Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
Sudden trouble seeing
Sudden trouble walking, dizziness, loss of balance or coordination
Loss of consciousness (fainting)
Hemodialysis vascular access stops working
If you decide to take EPOGEN®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.
If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take EPOGEN®, even if you do not have an increase in your hemoglobin level.
Do not take EPOGEN® if you:
Have cancer and have not been counseled by your healthcare provider about treatment with EPOGEN®.
Have high blood pressure that is not controlled (uncontrolled hypertension).
Have been told by your healthcare provider that you have, or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with EPOGEN® or other erythropoietin medicines.
Have had a serious allergic reaction to EPOGEN®.
Pregnant women, breastfeeding women, and babies should not receive EPOGEN® from multidose vials.
Before taking EPOGEN®, tell your doctor if you: have heart disease; have high blood pressure; have had a seizure or stroke; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
EPOGEN® may cause other serious side effects:
High blood pressure. High blood pressure is a common side effect of EPOGEN® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medication while taking EPOGEN®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
Seizures. If you have seizures while taking EPOGEN®, get medical help right away and tell your healthcare provider.
Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking EPOGEN®.
Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness and fainting due to a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using EPOGEN® and call your healthcare provider or get medical help right away.
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产地国家： 日本 
原产地英文商品名:
Epoetin（エポエチンアルファBS注750シリンジ）750IU/SYRINGE
原产地英文药品名:
Epoetin Kappa（Genetical Recombination）
中文参考商品译名:
Epoetin注射剂（エポエチンアルファBS注750シリンジ）750单位/注射器
中文参考药品译名:
基因重组阿法依伯汀
生产厂家中文参考译名:
KISSEI药品
生产厂家英文名:
Kissei Pharmaceutical Co

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产地国家： 日本 
原产地英文商品名:
Epoetin（エポエチンアルファBS注1500シリンジ）1500IU/SYRINGE
原产地英文药品名:
Epoetin Kappa（Genetical Recombination）
中文参考商品译名:
Epoetin注射剂（エポエチンアルファBS注1500シリンジ）1500单位/注射器
中文参考药品译名:
重组阿法依伯汀
生产厂家中文参考译名:
KISSEI药品
生产厂家英文名:
Kissei Pharmaceutical Co

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产地国家： 日本 
原产地英文商品名:
Epoetin（エポエチンアルファBS注3000シリンジ）3000IU/SYRINGE
原产地英文药品名:
Epoetin Kappa（Genetical Recombination）
中文参考商品译名:
Epoetin注射剂（エポエチンアルファBS注3000シリンジ）3000单位/注射器
中文参考药品译名:
重组阿法依伯汀
生产厂家中文参考译名:
KISSEI药品
生产厂家英文名:
Kissei Pharmaceutical Co