| 简介：
部分中文阿巴西普重组处方资料（仅供参考）
英文名：ORENCIA
商标名：Abatacept（Genetical Recombination）
中文名：阿巴西普重组注射剂
生产商：百时美施贵宝
药品简介
Orencia（abatacept，阿巴西普）静脉输液（IV）和皮下注射剂（SC），联合氨甲喋呤（MTX），用于既往未接受MTX治疗（MTX初治）的类风湿性关节炎（RA）成人患者高度活动性和进展性疾病的治疗。
オレンシア点滴静注用250mg
薬效分类名
T细胞选択的共刺激调节剤
欧文商標名
ORENCIA FOR I.V. INFUSION
一般名：
アバタセプト（遺伝子組換え）
Abatacept（Genetical Recombination）
本質：
abadcept 是一种转基因融合蛋白, 1至第125个人细胞毒性 t 淋巴细胞抗原-4, 126至358只由来自人类igg1, 131137 的变异fc区域组成, 140和第149个氨基酸残基被 ser 取代。 阿巴克普是由中国仓鼠卵巢细胞生产的。 ab承担是一种糖蛋白, 由一个亚基2分子组成, 由358个氨基酸残基 (分子量: 约 92000) 组成。
批准条件
制定药品风险管理计划并加以实施。
类风湿性关节炎
1. 在进行大规模的生产和销售调查后, 我们将对该制剂的安全性进行深入的检查, 并考虑长期管理的安全性和传染病的表达等。
2. 为确认该制剂的有效性 (包括预防联合销毁的评估) 和安全性, 我们将在制造和销售后与适当的控制组进行双盲比较临床试验。
药用药理学
1. 作用机制
abiccept 通过与抗原呈现细胞表面的cd80/cd86 结合, 抑制通过cd28的共刺激信号。 因此, 基质金属蛋白酶通过激活类风湿关节炎发病过程中的 t 细胞和抑制细胞因子的产生, 激活其他免疫细胞或激活关节中的结缔组织细胞, 它被认为是抑制炎症介质的生产。
2. 药理作用
取代了抗原特异性的小t细胞的增殖, 而记忆t细胞在体外的增殖, il-2被抑制了tnf-α和ifn-γ等炎症细胞因子的产生。此外, 在胶原蛋白诱导的关节炎大鼠中, 抑制了病理进展、抗胶原蛋白抗体的产生和关节破坏。
适应病症
以下疾病在现有治疗中无效
类风湿性关节炎
青少年特发性关节炎合并多关节活动
用法与用量
类风湿性关节炎
通常情况下, 成人是静脉输液以下剂量作为一个剂量作为 abakcept (重组)。 第一次服用后, 在两周和四周内给予, 并在4周后每隔四周给药一次。
患者体重: 小于60公斤
用量: 500毫克
瓶号: 2瓶
患者体重:60 公斤或以上, 100公斤或以下
用量: 750毫克
瓶号: 3瓶
患者体重: 100公斤以上
剂量: 1克
瓶号: 4瓶
青少年特发性关节炎合并多关节活动
通常, 一个 10 mgg/kg (体重) 是静脉输液作为 abakcept (重组)。 第一次服用后, 在两周和四周内给予, 并在4周后每隔四周给药一次。
但是, 如果重量小于75公斤或超过100公斤, 静脉输液应提供一次750毫克, 重量超过100公斤。
包装规格
注射
250毫克: 1小瓶(仅准备注射器: 1pc)
制造商（进口）
百时美施贵宝有限公司
销售
大野药业有限公司
ORENCIA FOR I.V. INFUJION（オレンシア点滴静注用250mg）
Brand name : ORENCIA FOR I.V. INFUJION
Active ingredient: Abatacept(Genetical Recombination)
Dosage form: injection
Print on wrapping:
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Effects of this medicine
This medicine blocks co-stimulatory signal between antigen presenting cells and T cells, resulting in blocking T-cell activation and cytokine production related to rheumatoid arthritis. It is usually used to treat rheumatoid arthritis which conventional treatments showed insufficient results.
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 serious infectious disease.
•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, administer intravenously at an interval of 2 weeks for the first 3 doses and then every 4 weeks.
Intravenous infusion takes about 30 minutes.
Precautions while taking this medicine
•If you feel something is wrong such as breathlessness or itch during or after administration, consult with your doctor or nurse immediately.
•Chest X-ray or other examination should be done periodically in order to prevent severe adverse drug reaction during or after administration. However, if you have prolonged cough or fever, contact with your doctor before the next consultation day and see your doctor as soon as possible.
•Wash hands and gargle and regulate your daily life to prevent infectious disease. If you notice any unusual signs with your physical condition such as sputum, sore throat, nasal discharge, congested nose, lassitude, rash, itching of skin, shortness of breath or breathlessness, consult with your doctor, nurse or pharmacist.
•If you notice any unusual signs other than those above or notice any changes in your physical conditions, consult with your doctor, nurse or pharmacist.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, blood pressure elevation, decreased blood pressure, hypertension, upper respiratory infection (including nasopharyngitis), upper respiratory tract inflammation, nausea, stomatitis, rash (including eczema, prurigo, erythema) and sore throat. 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.
•sputum, sore throat, nasal discharge, congested nose, lassitude [serious infection desease (sepsis, pneumonia, bronchitis, cellulitis, urinary-tract infection)]
•lassitude, rash, itching of skin, shortness of breath, breathlessness [serious hypersensitivity (shock, anaphylactoid symptoms)]
•fever, dry cough, breathlessness, shortness of breath [interstitial pneumonia]
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.
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