通用中文 | L-精氨酸盐酸盐和L-赖氨酸盐酸盐 | 通用外文 | arginine / lysine |
品牌中文 | 品牌外文 | LysaKare | |
其他名称 | |||
公司 | PTC Therapeutics(PTC Therapeutics) | 产地 | 瑞士(Switzerland) |
含量 | 25g/ 25g | 包装 | 1片/盒 |
剂型给药 | 注射剂 | 储存 | 室温 |
适用范围 | 治疗 |
通用中文 | L-精氨酸盐酸盐和L-赖氨酸盐酸盐 |
通用外文 | arginine / lysine |
品牌中文 | |
品牌外文 | LysaKare |
其他名称 | |
公司 | PTC Therapeutics(PTC Therapeutics) |
产地 | 瑞士(Switzerland) |
含量 | 25g/ 25g |
包装 | 1片/盒 |
剂型给药 | 注射剂 |
储存 | 室温 |
适用范围 | 治疗 |
2019年5月29日,人用药品委员会(CHMP)采纳了积极意见,建议批准药品LysaKare的上市许可,旨在用l(177Lu)氧代脱氮素放射治疗期间保护肾脏免受辐射。 。该药品的申请人是Advanced Accelerator Applications。
LysaKare将以25克/ 25克溶液的形式提供输液。 LysaKare的活性物质是L-精氨酸盐酸盐和L-赖氨酸盐酸盐(ATC代码:V03AF11)的氨基酸,其减少肾小管中l(177Lu)氧代脱氢核苷的重吸收和保留。
LysaKare的好处是能够减少肾脏暴露于l(177Lu)氧代奥曲肽的辐射。最常见的副作用是恶心和呕吐。
完整的适应症是:“在成人中使用l(177Lu)氧代奥替肽治疗肽受体放射性核素治疗(PRRT)期间肾脏辐射暴露减少。”建议LysaKare由放射性治疗经验丰富的医生管理。
On 29 May 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product LysaKare, intended for protecting the kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide. The applicant for this medicinal product is Advanced Accelerator Applications.
LysaKare will be available as 25 g / 25 g solution for infusion. The active substances of LysaKare are the amino acids L-Arginine Hydrochloride and L-Lysine Hydrochloride (ATC code: V03AF11) that decrease reabsorption and retention of lutetium (177Lu) oxodotreotide in the kidney tubules.
The benefits with LysaKare are its ability to reduce exposure of the kidneys to radiation from lutetium (177Lu) oxodotreotide. The most common side effects are nausea and vomiting.
The full indication is: “Reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.” It is proposed that LysaKare be administered by physicians experienced in radioactive therapy.