药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201932017443321.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文PROVAYBLUE处方资料(仅供参考)
【英文名称】PROVAYBLUE
【适用证】
PROVAYBLUE(亚甲基蓝)是一种氧化还原剂,用于治疗患有获得性高铁血红蛋白血症的儿科和成人患者。 该指示在加速批准下获得批准。 该指征的持续批准可能取决于后续试验中的临床益处的验证。 (1,14)
【用法用量】
在5-30分钟内静脉注射1 mg / kg。 (2.1)
如果高铁血红蛋白水平保持在30%以上或临床症状持续存在,则在第一次给药后一小时给予重复剂量高达1 mg / kg。 (2.1)
【禁忌】
PROVAYBLUE在以下条件下禁忌(4):
对亚甲蓝的严重超敏反应
因溶血性贫血风险而患有葡萄糖-6-磷酸脱氢酶缺乏症(G6PD)的患者
【注意事项】
过敏反应:如果发生严重或危及生命的过敏反应,停止使用PROVAYBLUE,治疗过敏反应,并监测直至症状和症状消退(5.2)
缺乏有效性:如果在2次剂量后没有解决高铁血红蛋白血症,请考虑替代治疗(2.1,5.3)
溶血性贫血:停止使用PROVAYBLUE和输血(5.4)
干扰体内监测设备:使用脉搏血氧仪以外的方法评估氧饱和度(5.5)
对驱动和操作机器的能力的影响:建议患者在神经系统和视觉症状消退之前避免这些活动(5.6)
【INDICATIONS AND USAGE】
PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. ( 1, 14)
【DOSAGE AND ADMINISTRATION】
Administer 1 mg/kg intravenously over 5-30 minutes. ( 2.1)
If methemoglobin level remains above 30% or if clinicalsymptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose. ( 2.1)
【CONTRAINDICATIONS】
PROVAYBLUE is contraindicated in the following conditions ( 4):
Severe hypersensitivity to methylene blue
Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
【WARNINGS AND PRECAUTIONS】
Hypersensitivity: If severe or life threatening allergic reaction occurs, discontinue PROVAYBLUE , treat the allergic reaction, and monitor untilsigns and symptoms resolve ( 5.2)
Lack of Effectiveness: Consider alternative treatments if there is no resolution of methemoglobinemia after 2 doses ( 2.1, 5.3)
Hemolytic Anemia: Discontinue PROVAYBLUE and transfuse ( 5.4)
Interference with In-Vivo Monitoring Devices: Use methods other than pulse oximetry to assess oxygen satruation (5.5)
Effects on Ability to Drive and Operate Machinery: Advise patients to refrain from these activities until neurologic and visualsymptoms have resolved ( 5.6)
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201932017443321.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |