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Hylenex-重组透明质酸酶人用注射剂
FDA批准重组人类透明质酸酶注射剂（Recombinant Human Hyaluronidase Injection，商品名Hylenex）作为其他注射药物的辅助药物（促进吸收和扩散），用于皮下注射以及皮下尿路造影术中促进不透射线物质的吸收.
日前宣布HYLENEX复合剂（透明质酸酶人体注射剂）在眼科市场上市。该药物用于促进其他注射药物的吸收和扩散。HYLENEX是第一个，也是唯一一个人体复合透明质酸酶医疗产品。百特公司提供的产品以一毫升单独包装，每支含有150个单位的透明质酸酶。
“作为一种复合蛋白质，HYLENEX代表着先进的和更加稳定的透明质酸酶供应，巧妙地解决了历史上与动物获取产品相伴随的质量和供应问题。”Halozyme医疗有限公司副总裁兼首席科学官GregoryFrost博士说，“此外，从复合来源取得的人体蛋白质帮助减轻了对种间病原传送的担忧，降低了动物获取产品产生免疫反应的潜在可能。”
由于HYLENEX被引入眼科市场，百特将继续发展它的INFUSE临床项目。在这个项目中，HYLENEX和其他溶液或药物将被皮下注射给患者。
INFUSE试验正在测试HYLENEX是否有可能为静脉注射有困难的患者提供一种替代性注射途径。
HYLENEX获得了美国食品药品管理局的许可，作为一种散布介质提高其他注射药物的吸收和扩散程度，以及用于皮下水合作用。HYLENEX的研发是与Halozyme医疗有限公司
HYLENEX重组（人类注射透明质酸）
初步U. S.批准：2005年
适应症
HYLENEX重组是一个组织的渗透性改性剂作为辅助显示在实现水化皮下输液增加其他注射毒品的分散和吸收在皮下尿路造影改善透X线的代理商的吸收
剂量和用法
皮下积液管理：
注入150 U
HYLENEX重组前皮下积液管理。这将有利于吸收1000毫升或更多的解决方案。皮下液体管理的剂量取决于病人的年龄，体重和临床状况以及实验室测定。皮下输液的速度和量不应超过静脉滴注就业者增加注射毒品的分散和吸收：
50-300 U（最典型的150 U）HYLENEX重组注射液。物理或化学的不兼容性的参考咨询建议
皮下尿路造影：
注入75 ü在每个肩胛骨HYLENEX重组皮下，注射造影剂在相同的网站
剂型和优势 150美国药典单位/ ml单剂量小瓶
禁忌
超敏反应
警告和注意事项
局部感染传播
眼损伤
静脉给药的酶失活
不良反应
最常见的不良反应有轻度局部注射部位反应；过敏性和过敏性反应的报道，很少；1-866-888-2472或FDA报告疑似不良反应，请联系百特医疗用品公司，在1- 800 - FDA - 1088或www.fda.gov / MedWatch通报。
药物相互作用
速尿，地西泮和苯妥英不与透明质酸。不应该用来提高多巴胺和/或α受体激动剂药物的分散和吸收透明质酸局部麻醉药：透明质酸赶忙发病和效果的持续时间缩短，增加全身反应的发生率。大剂量水杨酸，可的松，促肾上腺皮质激素，雌激素或抗组胺药可能需要分散效果相当于较大数额的透明质酸。
在特殊人群中使用
儿童用药：儿童的临床水化要求，可以通过管理HYLENEX重组促进皮下流体实现。皮下液体管理的剂量取决于病人的年龄，体重和临床状况以及实验室测定。对于早产儿或新生儿期间，每日剂量不应超过25毫升/公斤体重，和管理率不应大于2毫升每分钟。在皮下积液管理，必须特别注意在儿童患者中，控制率和输液总量，以避免过度水化。
Indication
Hylenex® recombinant (hyaluronidase human injection) is a tissue permeability modifier indicated as an adjuvant in subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs, and in subcutaneous urography for improving resorption of radiopaque agents.
Important Safety Information
Hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product.
Discontinue Hylenex recombinant if sensitization occurs.
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.
Hyaluronidase should not be used to reduce the swelling of bites or stings.
Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated.
Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
The most frequently reported adverse reactions have been local injection site reactions, such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products.
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of hyaluronidase.
Edema has been reported most frequently in association with subcutaneous fluid administration. The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of infusion. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur.
Hylenex recombinant contains albumin, which is a derivative of human blood that may carry a remote risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, CJD, or variant CJD (vCJD) have ever been identified for licensed albumin or albumin contained in other licensed products.
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产地国家: 美国
原产地英文商品名:
HYLENEX RECOMBINANT 150 UNITS/ML INJECTION 1ml/Vial 4 Vials
原产地英文药品名:
HYALURONIDASE RECOMBINANT HUMAN
原产地英文化合物名称:
HYLENEX RECOMBINANT 150药用單位/毫升/支 4支
中文参考商品译名:
重组透明质酸酶人用注射剂
生产厂家中文参考译名:
HALOZYME THERAP
生产厂家英文名:
HALOZYME THERAP
该药品相关信息网址1:
http://www.hylenex.com/
该药品相关信息网址2:
http://www.rxlist.com/hylenex-drug.htm
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