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THYMOGLOBULIN(抗胸腺细胞球蛋白)注射剂

2012-09-24 14:17:08  作者:新特药房  来源:中国新特药网天津分站  浏览次数:378  文字大小:【】【】【
简介:通用名称THYMOGLOBULIN抗胸腺细胞球蛋白(兔)25mg/vial冻干静脉输液后重建的残疾人士,不含防腐剂,含有甘氨酸,甘露醇。 法律分类:接收类药物THYMOGLOBULIN免疫抑制剂(γ免疫球蛋白)。 制造商THYMOGLOBU ...

通用名称THYMOGLOBULIN
抗胸腺细胞球蛋白(兔)25mg/vial冻干静脉输液后重建的残疾人士,不含防腐剂,含有甘氨酸,甘露醇。

法律分类:
接收
类药物THYMOGLOBULIN
免疫抑制剂(γ免疫球蛋白)。

制造商THYMOGLOBULIN
Genzyme公司

【适应症】用于THYMOGLOBULIN
肾移植急性排斥反应与伴随免疫抑制治疗。

成人剂量为THYMOGLOBULIN
与糖皮质激素,对乙酰氨基酚,和/或抗组胺剂1小时输液之前事先投予。给第一高流量静脉输液进入静脉滴注超过6小时,4小时以上,在随后几天的治疗。胆碱1.5mg/kg为7-14天,每天一次。如果WBC 2000-3000 cells/mm3或血小板计数为50000-75000 cells/mm3:减少剂量的1/2。如果WBC <2000 cells/mm3或血小板<50000 cells/mm3:考虑停止治疗。

儿童剂量为THYMOGLOBULIN的
不推荐。

禁忌THYMOGLOBULIN
急性或慢性感染。

警告/ THYMOGLOBULIN的注意事项
应由经验丰富的医生在医院的环境管理和监督。有肾上腺素(1:1000)。避免快速输注。监测感染的治疗与抗感染的预防性治疗,若发生。增加的恶性肿瘤(如淋巴瘤,移植后淋巴组织增生疾病)的风险。监控CBC,白细胞,血小板,淋巴细胞计数。怀孕(Cat.C)。哺乳母亲:不推荐使用。

互作THYMOGLOBULIN
伴随活疫苗:不推荐。考虑降低维护免疫抑制治疗,抗体治疗期间避免overimmunosuppression。可能干扰与兔抗体免疫。

不良反应THYMOGLOBULIN
感染,重新感染,败血症,发热,发冷,疼痛,头痛,腹痛,腹泻,恶心,高血压,血管神经性水肿,呼吸困难,乏力,高血钾症,心动过速,全身不适,注射部位反应,过敏反应,严重的细胞因子释放综合征(5月是致命的),血小板减少和/或白细胞减少,淋巴细胞,中性粒细胞减少症,恶性肿瘤,抗体的产生。

THYMOGLOBULIN如何提供?
瓶(10毫升)-1


Generic Name for THYMOGLOBULIN
Anti-thymocyte globulin (rabbit) 25mg/vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains glycine, mannitol.

Legal Classification:
Rx
Pharmacological Class for THYMOGLOBULIN
Immunosuppressant (gamma immune globulin).

Manufacturer of THYMOGLOBULIN
Genzyme Corporation

Indications for THYMOGLOBULIN
Treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.

Adult dose for THYMOGLOBULIN
Premedicate with corticosteroids, acetaminophen, and/or antihistamines 1 hour prior to infusion. Give by IV infusion over 6 hours for 1st infusion into a high-flow vein, and over 4 hours on subsequent days of therapy. 1.5mg/kg once daily for 7–14 days. If WBC is 2000–3000 cells/mm3 or platelet count is 50000–75000 cells/mm3: reduce dose by 1/2. If WBC is <2000 cells/mm3 or platelets <50000 cells/mm3: consider discontinuing therapy.

Children's dosing for THYMOGLOBULIN
Not recommended.

Contraindications for THYMOGLOBULIN
Acute or chronic infections.

Warnings/Precautions for THYMOGLOBULIN
Should be administered and monitored by experienced physicians in a hospital setting. Have epinephrine (1:1000) available. Avoid rapid infusion. Monitor for infections; treat with anti-infective prophylactic therapy if occurs. Increase risk of malignancies (eg, lymphoma, post-transplant lymphoproliferation disease). Monitor CBC, WBC, platelet, lymphocyte counts. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions for THYMOGLOBULIN
Concomitant live vaccines: not recommended. Consider decreasing maintenance immunosuppression therapy during antibody therapy to avoid overimmunosuppression. May interfere with rabbit-based antibody immunoassays.

Adverse Reactions for THYMOGLOBULIN
Infections, reactivation of infection, sepsis, fever, chills, pain, headache, abdominal pain, diarrhea, nausea, hypertension, peripheral edema, dyspnea, asthenia, hyperkalemia, tachycardia, malaise, infusion site reactions; anaphylaxis, severe cytokine release syndrome (may be fatal), thrombocytopenia and/or leukopenia, lymphopenia, neutropenia, malignancies, antibody production.

How is THYMOGLOBULIN supplied?
Vial (10mL)—1

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