部份中文巨細胞病毒免疫球蛋白处方资料（仅供参考）
英文名：human cytomegalovirus immunoglobulin
商品名：Cytotect CP Biotest Inf
中文名：巨細胞病毒免疫球蛋白静脉注射剂
生产商：Biotest(Schweiz)AG
药品简介
Cytotect CP Biotest(human cytomegalovirus immunoglobulin)是一种针对巨细胞病毒的高抗体滴度的巨细胞病毒特异性高免疫球蛋白制剂。该产品被批准用于预防接受免疫抑制治疗的患者，特别是移植受者的CMV感染的临床表现。应考虑同时使用足够的抗病毒药物预防CMV。
结果表明；Cytect CP Biotest除了具有中和病毒等抗病毒作用外，还可以刺激CMV特异性免疫。
作用机制
Cytect CP Biotest是一种CMV特异性多克隆免疫球蛋白制剂，其与CMV表面抗原结合，从而中和CMV进入宿主细胞的潜力，并呈递CMV颗粒进行吞噬。Cytotect CP Biotest抗体还调节免疫细胞（树突状细胞、单核细胞、B-和T-细胞）并与之相互作用，除了对CMV复制的病毒抑制外，还发挥积极的免疫平衡。
适应症
预防接受免疫抑制治疗的患者，特别是移植受者巨细胞病毒感染的临床表现。
应考虑同时使用足够的抗病毒药物预防CMV。
用法与用量
剂量
单次剂量为每公斤体重1ml。
应在移植当天开始给药。在骨髓移植的情况下，也可以设想在移植前10天开始预防，特别是在CMV血清阳性患者中。应每隔2至3周给予至少6次单次剂量。
儿科人群
儿童和青少年（0-18岁）的posology与成人没有什么不同，因为每个适应症的posology都是根据体重给出的，并根据上述情况的临床结果进行调整。
肝损伤
没有证据表明需要调整剂量。
肾功能损害
除非临床证明，否则不得调整剂量。
老年人
除非临床证明，否则不得调整剂量。
给药方法
静脉注射
Cytect CP Biotest应以0.08ml/kg BW/hr的初始速率静脉输注10分钟。如果出现不良反应，必须降低给药率或停止输液。如果耐受性良好，则在剩余的输注中，给药速率可逐渐增加至最大0.8ml/kg BW/hr。
禁忌症
•对活性物质（人巨细胞病毒免疫球蛋白）或列出的任何赋形剂过敏。
•选择性IgA缺乏症患者产生IgA抗体，因为服用含有IgA的产品可能导致过敏反应。
保质期
3年。
该药品应在首次打开后立即使用。
储存的特殊注意事项
储存在冰箱中（2°C-8°C）。将小瓶放在外纸箱中以避光。不要冻结。
容器的性质和内容
10毫升或50毫升用于静脉输注的即用溶液，装在带有塞子（溴丁基）和盖子（铝）的小瓶（II型玻璃）中。
一个盒子包含：
1个装有10ml（1000U）溶液的小瓶，用于输液或
1个装有50ml（5000U）输液溶液的小瓶
处置和其他处置的特殊预防措施
使用之前，应将药品恢复到室温或体温。
使用前应目视检查产品是否有特殊物质和变色。溶液应为透明或淡乳白色，无色或浅黄色。请勿使用浑浊或有沉淀的溶液。
请参阅随附的Cytect CP Biotest完整处方信息：
https://www.medicines.org.uk/emc/product/11030/smpc
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Cytotect Biotest
Human immunoglobulin anti- cytomegalovirus (50I.U./ml/10I.U./ml)
Composition: 1ml solution contains:
protein 100 mg, of which human immunoglobulin makes up at least 95% Antibody content against cytomegalovirus 50 I.U. Further
constituents : Sodium chloride, water for injections.
Indications: Prophylaxis of clinical manifestations of
cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.
Contra-Indications: Megalotect® is contra-indicated in patients who are intolerant to human immunoglobulin especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA.
Pregnancy and lactation : The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Long lasting clinical experience with immunoglobulins does indicate that no harmful effects on the course of pregnancy, on the foetus and the neonate are to be expected.
Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Special precautions for use: Certain severe adverse drug reactions may be related to the rate of infusion.
The recommended infusion rate given under "Method of administration" must be closely followed and patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Patients should be observed for at least 20 minutes after administration. Effects on ability to drive and use machines: There are no indications that Megalotect® may impair the ability to drive and use machines.
Dosage instructions and duration of application: As a rule doses containing 50 units (PEI) Per Kg Body Weight, Which Corresponds To 1 ml, should be administered. Administration should be initiated on the day of transplantation or the day prior to this (bone marrow transplantation). A total of at least 6 doses at 2 to 3 weeks' intervals should be given.
Interactions with other medicinal products: Live attenuated virus vaccines: immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella. After injection of immunoglobulins the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Method of administration: Megalotect® is intended for intravenous use. During the infusion, the rate of 20 drops per minute(corresponding to 1 ml per minute) must not be exceeded.
Megalotect should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions which are cloudy or which have deposits. Megalotect should be brought to room or body temperature before administration.
Special precautions for storage: Megalotect® has to be stored at + 2ºC TO +8 ºC Protected From Light. Do not freeze. Megalotect should not be used after the expiry date indicated on the label. Any unused solution must be discarded because of bacterial contamination risk.
Presentations: Ampoules with 5 ml, 10 ml and 20 ml, infusion bottle with 50 ml. For additional information see package insert.