部份中文莫罗单抗-CD3处方资料（仅供参考）
【中文品名】莫罗单抗-CD3
【药效类别】T细胞抑制药
【通用药名】MUROMONAB-CD3
【别　　名】Anti-CD3 Mab, OKT-3 antibody, Orthoclone OKT-3
【C A 名称】Muromonab CD3
【开发单位】强生
【首次上市】1986年，美国

【用　　途】
一种单克隆抗T细胞抗体，用于肾、心脏和肝移植的排异和使供体骨髓的T细胞在移植前失活。
莫罗单抗-CD3产品说明: 
抗CD3（irot3）单抗与人体内的T细胞cd3抗原发生作用，cd3作用是免疫抑制剂。含量：抗cd3（IROT3）单抗每瓶5毫升，韩纯化单克隆抗体5毫克；缓冲液pH(7.0±0.5):磷酸二氢钠2.25毫克,磷酸氢二钠9.0毫克,氯化钠43毫克和聚山梨酯80(1.0毫克),注射用水.高效的质量保证系统保证生产过程和最终产品的质量。
药理学: 
抗CD3（irot3）单抗可逆转移植排斥反应，其机制是：通过阻断在急性肾排斥中期主要作用的所有Y细胞的功能，抗CD3（irot3）单抗通过与人类T细胞膜中20000道尔敦的分子反应，并阻断其作用。这些分子在体外与T细胞抗原识别结构相关，并起信号传到作用。在体内抗CD3（irot3）单抗同大多数外周血及组织中的T细胞反应，但尚未发现同其它造血成份或组织发生反应。使用抗CD3(iort3)单抗分钟后，所有的病人均可出现循环中CD3、CD4和CD8阳性细胞的急剧下降。有些病人在使用抗CD3(iort3)单抗治疗两周内，CD3阳性细胞数可回升。
药代动力学: 
对肾移植治疗有排斥危险的病人接受抗CD3(iort3)单抗后，对血浆浓度所作的药动力学分析证实，在治疗中平均irot3血浆浓度是2.5微克/毫升。在开始使用抗CD3(irot3)单抗进行治疗之后，T淋巴细胞和CD3的标志物在其表面开始减少。由此可见，抗CD3(iort3)单抗一系列浓度的变化是由于可变的单克隆消耗所致。抗CD3(iort3)单抗的半衰期是22小时。
药效学:
抗CD3(iort3)单抗是一种源于鼠科动物的单克隆抗体IgG 2a的同型，它识别95%的纯化人类淋巴细胞和0.1%的来自健康捐献者的单核pheripherc细胞。不识别多形核白细胞、单核细胞和红细胞。识别表现CD3抗原T细胞系，并且不识别B细胞系。在免疫组织化学研究中，识别淋巴结的pharacortical区域（也是别胎儿的
适应症状: 
本品为抗人T淋巴细胞T3（抗CD3）抗原的鼠源性单克隆抗体的无菌液体，其功能是免疫抑制剂。主要用于治疗及预防肾移植时患者出现的急性同种异体移植排斥反应。当本品与其他一些免疫抑制剂联合使用时，剂量降低至最低水平，以避免发生过度免疫抑制现象。
用量用法:
1.本品应在一分钟之内静脉推注完毕，不要以静脉点滴方式或与其他药物溶液混合给药。
2.当用本品治疗急性肾移植同种异体排斥反应时，推荐每天使用5毫升，连续使用10-14天。一经诊断出是急性排斥反应时就应开始治疗。至于预防性使用，每天静脉推注5毫升，连续15天，在手术去钳夹之前30分钟开始给药。
3.第一次推注本品后的48小时内应对患者进行密切监视。为了降低第一次推注本品后出现不良反应的发生率，应在给予本品之前给患者静脉注射一次1.0毫克/公斤体重的甲基泼尼龙琥珀酸钠，并在给予本品后30分钟静脉注射100毫克氢化可
不良反应及禁忌:
注意事项:
1.免疫抑制疗法能够使患者对感染的易感性增高。
2.在使用本品第一个剂量后0.5-6小时可能出现高热、寒站、呼吸困难和不适。因此，病人应该在能严密监护、配备有心肺复苏的设备和人员的设施中注射第一剂量。
3.潜在的致命性严重水肿是最严重的首剂注射本品的反应，但很少发生并且仅见于液体超负荷的患者。
4.如患者在使用本品之前体温超过37.8℃，应给予退热药以降低体温。由于存在有抗irot3的抗体，因而当考虑重复治疗时，就要慎重从事。
5.实验室检验：在使用本品治疗之前的24小时内所作的胸部X射线检查显示没有液体超负荷的象征。在使用本品治疗期间应该每隔一定时间监测一次白细胞总数和分类计数，还应在体外监测本品对患者循环血液中表达CD3抗原的T淋巴细胞所产生的效应。
古巴分子免疫学中心/ Cuba CIMAB ] - 鼠源CD3单克隆抗体 / muromonab-CD3
注：本品上市国家：法国、韩国、日本等，采购以咨询为准！
OKT3注射：5mg/5mL
生产厂家：杨森制药有限公司

Generic Name: muromonab-cd3  
Brand Name: Orthoclone OKT 3

Muromonab-CD3 may cause serious allergic reactions. These may occur at any time while you use muromonab-CD3. It may also cause other serious and sometimes fatal effects, including heart and nervous system problems. Tell your doctor right away if you experience shortness of breath; chest pain; numbness of an arm or leg; sudden severe dizziness, headache, nausea, or vomiting; fainting; severe stomach pain; trouble speaking; vision changes (eg, light sensitivity or blindness); one-sided weakness; seizures; or paralysis after you receive muromonab-CD3.

You should only receive muromonab-CD3 in a health care facility where you can receive proper treatment in case you have a severe allergic reaction or other severe side effects.

Your doctor may give you another medicine (methylprednisolone) to help lower the risk of certain severe side effects from muromonab-CD3.

Treating organ rejection after a kidney transplant. It is also used to treat organ rejection in patients with a heart or liver transplant if corticosteroids do not work well. It may also be used for other conditions as determined by your doctor.

Muromonab-CD3 is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

· you are allergic to any ingredient in muromonab-CD3 or to products made with mouse protein

· you have certain levels (greater than or equal to 1:1000) of antimouse antibody titers

· if you are pregnant, suspect that you may be pregnant, or are breast-feeding

· you have uncompensated heart failure, fluid overload, uncontrolled high blood pressure, or a history of seizures, or you are at risk for seizures

· you have a fever higher than 100 degrees F (37.8 degrees C), chickenpox, or shingles

Contact your doctor or health care provider immediately if any of these apply to you.

Some medical conditions may interact with muromonab-CD3. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

· if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

· if you have allergies to medicines, foods, or other substances

· if you have heart problems (eg, angina, heart failure), lung problems (eg, fluid buildup, chronic obstructive pulmonary disease), nervous system problems, or shock due to a severe infection (sepsis)

· if you have a fever or infection, swelling, high or low blood electrolyte levels (eg, potassium, sodium), or conditions that may increase or decrease the amount of fluid in the body (eg, dialysis, dehydration, blood loss)

· if you have history of seizures, blood clots or blood clotting problems, blood vessel problems, stroke, or recent heart attack or head injury

Some MEDICINES MAY INTERACT with muromonab-CD3. Tell your health care provider if you are taking any other medicines, especially any of the following:

· Diuretics (eg, furosemide, hydrochlorothiazide) because they may increase the risk of muromonab-CD3s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if muromonab-CD3 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Use muromonab-CD3 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

· Muromonab-CD3 will be given as an injection at your doctor's office, hospital, or clinic.

· If you miss a dose of muromonab-CD3, contact your doctor right away.

Ask your health care provider any questions you may have about the proper use of muromonab-CD3.

· Muromonab-CD3 may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use muromonab-CD3 with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

· Muromonab-CD3 may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

· Muromonab-CD3 may increase your risk of developing certain cancers (eg, lymphoma). Contact your doctor if you experience any unusual lumps or skin thickening, growths, or color changes. Discuss any questions or concerns with your doctor.

· Lab tests, including kidney and liver function, blood pressure, blood counts, blood electrolytes, weight checks, and chest x-rays, may be performed while you use muromonab-CD3. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

· Use muromonab-CD3 with caution in the ELDERLY; they may be more sensitive to its effects.

· Muromonab-CD3 should be used with extreme caution in CHILDREN; they may be more sensitive to its effects, including bleeding or swelling in the brain, seizures, meningitis, certain infections, blood clots, dehydration, and the development of certain cancers (eg, lymphoma).

· PREGNANCY and BREAST-FEEDING: It is not known if muromonab-CD3 can cause harm to the fetus. Do not use muromonab-CD3 if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while taking muromonab-CD3.

Every medicine can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite; diarrhea; dizziness; fatigue; flushing; headache; increased sweating; nausea; nervousness; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or tarry stools; calf pain/tenderness; chest pain; confusion; decreased hearing/deafness; decreased urination; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; hoarseness; mental or mood changes; muscle or joint aches or pain; neck soreness or stiffness; numbness of an arm or leg; one-sided weakness; paralysis; seizures; severe or persistent tiredness, weakness, nausea, vomiting, or diarrhea; shortness of breath; signs of infection (eg, chills, fever, sore throat); skin thickening, growths, or color change; speech changes; stomach pain; sudden severe dizziness or headache; swelling of the arms, legs, hands, or feet; tremor; trouble swallowing; uncontrolled muscle movements; unusual bruising or bleeding; unusual lumps; vision changes (eg, blindness, sensitivity to light); wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; diarrhea; fever; muscle pain; severe chills; shortness of breath; swelling; or vomiting.

Proper storage of muromonab-CD3:

Muromonab-CD3 is usually handled and stored by a health care provider. If you are using muromonab-CD3 at home, store muromonab-CD3 as directed by your pharmacist or health care provider. Keep muromonab-CD3 out of the reach of children and away from pets

· If you have any questions about muromonab-CD3, please talk with your doctor, pharmacist, or other health care provider.

· Muromonab-CD3 is to be used only by the patient for whom it is prescribed. Do not share it with other people.

· If your symptoms do not improve or if they become worse, check with your doctor.

· Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take muromonab-CD3 or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about muromonab-CD3. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to muromonab-CD3. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using muromonab-CD3.