英文药名：MIRCERA Injection Syringe（Epoetin beta pegol[genetical recombination]）

中文药名：基因重组红细胞生成素β单抗注射器

生产厂家：中外制药

ミルセラ注シリンジ25μg／ミルセラ注シリンジ50μg／ミルセラ注シリンジ75μg／ミルセラ注シリンジ100μg／ミルセラ注シリンジ150μg／ミルセラ注シリンジ200μg／ミルセラ注シリンジ250μg

治疗类别名称
长效红细胞生成刺激剂
批准日期：2011年7月
商標名
MIRCERA
一般名
エポエチン　ベータ　ペゴル（遺伝子組換え）
(Epoetin Beta Pegol（Genetical Recombination））（JAN)
本質
红细胞生成素β单抗是中国仓鼠卵巢细胞PEG糖蛋白的生产＃（分子量：约60000），红细胞生成素β（重组）是线性甲氧基聚乙二醇（分子量：约30,000）1分子红细胞生成素β的（主装订位置：了Ala1，Lys45或Lys52）1个氨基酸残基有一个酰胺键。
＃：165的氨基酸残基（分子式和分子量：C809H1301N229O240S5;18,235.70）由糖蛋白（分子量：约30000）
药效药理
1. 红血细胞增加作用
(1) 该药物给药的单一正常小鼠，网织比率，红血细胞的数目，观察到血红蛋白浓度和血球比容的值的剂量依赖性增加。
(2) 在每三周一次的频率并在一周分别在正常小鼠和正常大鼠反复给药，观察到血红细胞的可持续数任何增加。
(3) 这种药物在5/6肾切除术的大鼠是肾性贫血的模型动物一次观察到红细胞计数每周剂量依赖性增加的频率被反复给药。
2. 作用机序
(1) 本剂被认为是通过结合红细胞生成素受体作用于骨髓中的红系祖细胞，它促进增殖和分化成红细胞。
(2) 当一个人的骨髓和脐带血的CD34阳性细胞在该药物存在为液体培养物（体外），红系细胞以剂量依赖的方式增加。
适应病症
○肾性贫血
用法用量
○该患者的血液透析
(1) 初始剂量
成年人，在两周内静脉给药为50μg。
(2) 制剂切换的初始剂量
成人，静脉内使用一次，一次100μG或150μG至4周。
(3) 維持用量
成人，一次静脉内给药至四周，一次25-250μg。此外，贫血症状，将根据年龄等，最高剂量进行调整，并一次250μg。
○患者腹膜透析患者透析前和慢性肾脏病
(1) 初始用量
成人，两周给药一次皮下或静脉，一次25μg
(2) 制剂切换的初始剂量
成人，皮下或静脉内至四周一次100μG或150μG。
(3) 维持剂量
成人，给药一次皮下或静脉内至四周一次25-250μg。此外，程度也无论如何贫血症状，将根据年龄等，最高剂量进行调整，并一次250μg。
包装规格
注射器
25微克：0.3毫升×1注射器、10注射器
50微克：0.3毫升×1注射器、10注射器
75微克：0.3毫升×1注射器、10注射器
100微克：0.3毫升×1注射器、10注射器
150微克：0.3毫升×1注射器、10注射器
200微克：0.3毫升×1注射器
250微克：0.3毫升×1注射器

制造厂商
中外制药有限公司
MIRCERA Injection Syringe 25 mcg（ミルセラ注シリンジ25μg） 
Brand name : MIRCERA Injection Syringe 25 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping: 
MIRCERA Injection Syringe 50 mcg（ミルセラ注シリンジ50μg） 
Brand name : MIRCERA Injection Syringe 50 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping:
MIRCERA Injection Syringe 75 mcg（ミルセラ注シリンジ75μg） 
Brand name : MIRCERA Injection Syringe 75 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping:
MIRCERA Injection Syringe 100 mcg（ミルセラ注シリンジ100μg） 
Brand name : MIRCERA Injection Syringe 100 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping:
MIRCERA Injection Syringe 150 mcg（ミルセラ注シリンジ150μg）
Brand name : MIRCERA Injection Syringe 150 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping:
MIRCERA Injection Syringe 200 mcg（ミルセラ注シリンジ200μg）
Brand name : MIRCERA Injection Syringe 200 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping:
MIRCERA Injection Syringe 250 mcg（ミルセラ注シリンジ250μg） 
Brand name : MIRCERA Injection Syringe 250 mcg
　Active ingredient: Epoetin beta pegol (genetical recombination)
　Dosage form: injection
　Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney 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 have or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral infarction, etc).
If you have: hypertenstion or allergic predisposition.
•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>>
•For patients on dialysis: In general, inject intravenously once every two weeks or every four weeks after the completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four weeks. When anemia improves, inject at an interval of once every four weeks.
•Depending on your response to the treatment, you may be administered this medicine over a long time.
•Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
•Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
•Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as instructed by your doctor.
•While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
•headache, grogginess, convulsion  [cerebral hemorrhage, hypertensive encephalopathy]
•chest pain, feeling of tight chest [myocardial infarction]
•chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch, edema, falling in blood pressure [shock, anaphylactoid symptoms]
•lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or walking up a slope [pure red-cell aplasia.]
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.
Chugai Pharmaceutical Co., Ltd.Injection
Revised: 8/2012
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.
http://www.info.pmda.go.jp/go/pack/3999432G1020_1_02/