FDA Says Gilead Issues Voluntary Nationwide Recall Of One Lot Of Veklury For Injection 100 Mg/Vial Due To The Presence Of A Glass Particle
FDA Says Gilead Issues Voluntary Nationwide Recall Of One Lot Of Veklury For Injection 100 Mg/Vial Due To The Presence Of A Glass Particle
Veklury (remdesivir) for Injection 100 mg/vial may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.Gilead Sciences, Inc. (NASDAQ:GILD) today announced it is issuing a voluntary recall of one lot of Veklury (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation.
吉利德科學公司（納斯達克：GILD）今天宣佈，正在自願召回一批製劑（瑞德西韋）用於注射的100毫克/瓶的Veklury，以消費者層面。 吉利德收到了客戶投訴，並在公司調查期間確認瓶中存在玻璃顆粒。
Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. The glass particulate can potentially travel, through the blood vessels, to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead has not received any reports of adverse events related to this recall.
風險聲明：使用含玻璃顆粒的注射劑可能導致局部刺激或腫脹，作爲對外來物質的反應。 玻璃顆粒可能通過血管傳播到各種器官，並阻塞心臟、肺部或腦部的血管，可能導致中風，甚至導致死亡。 到目前爲止，吉利德尚未收到與此次召回相關的任何不良事件報告。
Veklury (remdesivir) for Injection 100 mg/vial is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are:
Veklury（瑞德西韋）注射劑100毫克/瓶適用於治療成人和兒童COVID-19患者（出生至18週歲，體重至少1.5公斤）：
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death
- 住院，或
- 未住院患有輕至中度COVID-19並且有高風險進展爲重症COVID-19，包括住院或死亡的患者
Veklury (remdesivir) for Injection 100 mg/vial may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
Veklury（瑞德西韋）注射劑100毫克/瓶只能在醫務人員立即獲得用於治療嚴重輸注或過敏反應（如過敏性休克）並有必要啓動急救系統（EMS）的藥物的設置中進行給藥。
譯文內容由第三人軟體翻譯。