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Privigen(Immune Globulin Intravenous)静脉用免疫球蛋白

2015-12-02 10:27:15  作者:新特药房  来源:互联网  浏览次数:0  文字大小:【】【】【
简介: 静脉注射免疫球蛋白Privigen(Immune Globulin Intravenous)获美国及欧盟批准用于慢性炎症脱髓鞘性多发性神经病(CIDP)治疗。作为一种静脉注射的人免疫球蛋白,本品的浓度为10%,适用于CIDP患者,静脉 ...

静脉注射免疫球蛋白Privigen(Immune Globulin Intravenous)获美国及欧盟批准用于慢性炎症脱髓鞘性多发性神经病(CIDP)治疗。作为一种静脉注射的人免疫球蛋白,本品的浓度为10%,适用于CIDP患者,静脉给药。
批准日期:2013年4月5日   公司:CSL Behring AG
Privigen,免疫球蛋白静脉注射(人),10%的液体,供皮下注射使用
美国首次批准:2007
警告:
急性肾功能障碍/衰竭
请参阅完整的黑框警告完整的处方信息。
使用免疫球蛋白静脉注射(人类)(IGIV)的产品,特别是含有蔗糖,已报道与肾功能不全,急性肾功能衰竭,渗透肾病和死亡易感人群有关。 Privigen不含蔗糖。
对于患者的肾功能不全或肾功能衰竭的风险,管理Privigen在最低输液速度可行的。
目前的主要变化
警告和注意事项,高蛋白血症 06/2009
作用机制
原发性体液免疫缺陷的治疗
Privigen为初级体液免疫缺陷的替代疗法,并且提供调理性和中和IgG抗体对抗细菌,病毒,寄生虫和支原体剂及其毒素的广谱。动作的有价证券的机制尚未完全阐明。
慢性免疫性血小板减少性紫癜的治疗
高剂量的慢性ITP的治疗中免疫球蛋白的作用机制尚未完全阐发
适应症和用法
Privigen是一种免疫球蛋白静脉注射(人),10%的液体指示用于治疗:
原发性体液免疫缺陷(PI)
慢性免疫血小板减少性紫癜(ITP)
用法用量
静脉使用仅
指示剂量初始输注率维持输注速度(如能耐受)
PI 200-800毫克/公斤
每3-4周为0.5mg/kg/min的
(0.005毫升/千克/分钟)增加至8毫克/公斤/分钟
(0.08毫升/千克/分钟)
ITP为1g /公斤,连续2天0.5毫克/公斤/分钟
(0.005毫升/千克/分钟)增加至4mg/kg/min的
(0.04毫升/千克/分钟)
保证患者预先存在肾功能不全是不卷耗尽,并停止Privigen如果肾功能恶化。
对于患者的肾功能不全或血栓事件的风险,管理Privigen在最低输注速度可行的。
剂型和规格
Privigen是含有10%的IgG(0.1克/毫升)的液体溶液。
禁忌
过敏性或严重的全身反应人免疫球蛋白的历史
血症(Privigen包含稳定剂的L-脯氨酸)
IgA缺乏的患者抗体IgA和过敏史
警告和注意事项
IgA缺乏患者的抗体IgA的是,在发展中重度过敏和过敏性反应的风险更大。
监测肾功能,包括血液尿素氮和血清肌酸酐和尿输出的患者处于发展急性肾功能衰竭的风险。
血症,增加的血清的粘度,低钠血症,可能会发生在接收IGIV疗法的患者。
可发生血栓事件。监测患者的已知风险因素血栓事件;考虑血粘度为那些在高粘血症的风险评估基准。
无菌性脑膜炎,可能会出现症状,尤其是大剂量或快速输注。
溶血能发展到由于增强红细胞封存Privigen处理后续。监测患者,溶血和溶血性贫血。
监测患者肺部不良反应(输血相关的急性肺损伤[TRALI])。
避免使用高剂量方案的(慢性ITP)患者的膨胀液量或者液体体积的关注的。
Privigen是由人血浆和可能含有感染剂,例如,病毒和,理论上,在Creutzfeldt-Jakob病剂。
抗体的被动转移可能会混淆血清学试验。
不良反应
PI - 最常见的不良反应有头痛,疼痛,恶心,乏力,畏寒和。
慢性ITP - 最常见的不良反应有头痛,发热/热疗,和贫血。
药物相互作用
抗体的被动转移可瞬时干扰免疫应答活病毒疫苗。
特殊人群中使用
怀孕:没有人或动物的数据。只有在明确需要使用。
患者65岁以上,或任何病人在发展中肾功能不全的风险,不要超过推荐剂量,并注入Privigen在最小速率可行的。
包装规格/储存与处理
Privigen在单次使用的供给,含有功能活性IgG的标示量防撕小瓶。在包装Privigen中使用的元件无乳胶。
Privigen的以下介绍可供选择:
NDC多项填补尺寸(毫升)克
44206-436-0550   5
44206-437-10100 10
44206-438-20200 20
每个小瓶具有一体悬挂带并用两个剥离带示出的产品名称,批号,和到期日期的标签。
当在室温下储存(高达25℃[77℉]),Privigen稳定长达24个月的,由印在外包装和小瓶标签失效日期所指示的。


PRIVIGEN - human immunoglobulin g liquid 
CSL Behring AG


Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is indicated as replacement therapy for patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Privigen is also indicated to raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
•Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
•Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of human immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
•For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA, who have had hypersensitivity reactions. Patients with IgA deficiency and antibodies to IgA are at greater risk of severe hypersensitivity and anaphylactic reactions.
In patients at risk for developing acute renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine; discontinue if renal function deteriorates. Ensure that patients with preexisting renal insufficiency or otherwise predisposed are not volume-depleted and administer Privigen at the minimum rate of infusion practicable.
Thrombosis might occur with Privigen, even in the absence of known risk factors. Patients could also experience hyperproteinemia, increased serum viscosity, or hyponatremia; infrequently, aseptic meningitis syndrome (AMS) may occur—more frequently with high doses (2 g/kg) and/or rapid infusion.
Hemolysis, either intravascular or due to enhanced red blood cell sequestration, can develop subsequent to treatment. Risk factors include non-O blood group, underlying inflammation, and high doses. Closely monitor patients for hemolysis and hemolytic anemia. Consider the relative risks and benefits before prescribing high-dose regimen for chronic ITP in patients at increased risk of thrombosis, hemolysis, acute kidney injury or volume overload. Monitor patients for pulmonary adverse reactions and signs of transfusion-related acute lung injury (TRALI).
Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical studies of patients being treated with Privigen for PI, the most common adverse reactions observed in >5% of subjects were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature.
In clinical studies of patients being treated with Privigen for chronic ITP, the most common adverse reactions seen in >5% of subjects were headache, elevated body temperature, positive DAT, anemia, nausea, epistaxis, vomiting, increases in conjugated and unconjugated bilirubin, decreased hematocrit, and increased blood lactate dehydrogenase. A serious adverse reaction was aseptic meningitis syndrome (AMS).
Treatment with Privigen might interfere with a patient’s response to live virus vaccines and could lead to misinterpretation of serologic testing. Use in pregnant women only if clearly needed. In patients over 65 or in any patient at risk of developing renal insufficiency, do not exceed recommended dose and infuse Privigen at the minimum rate practicable.
For more information about Privigen, please see full prescribing information.
http://www.privigen.com/
http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=10743

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