瑞士制药巨头罗氏(Roche)近日宣布,美国食品和药物管理局(FDA)已批准Herceptin Hylecta(trastuzumab and hyaluronidase-oysk,曲妥珠单抗和透明质酸酶)皮下注射液,用于:(1)联合化疗用于治疗HER2阳性早期乳腺癌(淋巴结阳性,或淋巴结阳性且ER/PR阴性,或具有一个高危特征)患者;(2)单独或联合紫杉醇用于既往已接受一种或多...
申请类型 BLA 申请号 761106 药品名称 HERCEPTIN HYLECTA 活性成分 TRASTUZUMAB AND HYALURONIDASE-OYSK 执行时间 2024-06-20 持有公司 GENENTECH INC 说明书 下载 扩展信息 VIP试用医疗器械查询APP下载客服中心常见问题数据可视化数据分析挖掘系统网站地图业务介绍友情链接 400-678-0778 投诉热线:...
In the HannaH Trial, a total of 596 patients with HER2-positive operable or locally advanced BC, including inflammatory BC, were randomized to receive 8 cycles of either Herceptin Hylecta or intravenous trastuzumab concurrently with chemotherapy, followed by surgery and continued therapy with either He...
Home Herceptin Hylecta FDA PI Print Save Herceptin Hylecta: Package Insert / Prescribing InfoPlay pronunciation Package insert / product label Generic name: trastuzumab and hyaluronidase-oysk Dosage form: injection, solution Drug class: HER2 inhibitors J Code (medical billing code): J9356 (10 mg, ...
After the solution of HERCEPTIN HYLECTA is withdrawn from the vial and into the syringe, replace the transfer needle with a syringe closing cap. Label the syringe with the peel-off sticker. Administration The injection site should be alternated between the left and right thigh. New injections ...
HannaH was a randomized, open-label study to compare the pharmacokinetics, efficacy, and safety of HERCEPTIN HYLECTA compared to intravenous trastuzumab in women with HER2-positive breast cancer. Patients randomized to the HERCEPTIN HYLECTA arm received a dose of 600 mg HERCEPTIN HYLECTA every 3 week...