药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201271520404435.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文ABLAVAR处方资料(仅供参考)
ABLAVAR (钆磷维塞三钠(gadofosveset trisodium)) – 以前称MS-325 批准日期:2008年12月22日
一般描述:钆磷维塞三钠化学式是三钠-{(2-(R)-[(4,4-diphenylcyclohexyl) phosphonooxymethyl]- diethylenetriaminepentaacetato)(aquo) gadolinium(III),相对分子量975.88 g/mol,和经验式C33H40GdN3Na3O15P。 适应证:ABLAVAR注射剂是一种基于钆对比剂适用于作为对比剂在磁共振血流成像(MRA)评价成人中主-髂动脉闭塞病(AIOD)有已知或怀疑周围血管病。
剂量和用法: 通过静脉推注给予ABLAVAR 注射剂,手工或通过功注射,剂量0.12 mL/kg体重(0.03 mmol/kg) 时间至30秒接着25-30 mL生理盐水冲洗。 成像在两个阶段,动力阶段在注射VASOVIST注射剂后立即;一般注射ABLAVAR注射剂后5至7分钟。
剂型和规格: 每mL ABLAVAR注射剂含244 mg钆磷维塞三钠(等同于0.25 mmol/mL)和在单次使用小瓶中。
禁忌证:既往对基于钆对比剂过敏反应史。
警告和注意事项: 某些患者给予基于钆对比剂可能导致肾源性系统纤维化。 来自ABLAVAR给药可能导致超敏反应,包括过敏样和或过敏反应。评估患者对基于钆对比剂过敏史和严密监查患者心脏呼吸急救所需的支持。 基于钆对比剂,包括ABLAVAR在肾功能不全患者中可能增加急性肾衰的风险。 在ABLAVAR 给药后曾报道QTc延长,评估患者有潜在情况史由于QTc延长可能叠加至心律失常
不良反应:最常见(>2%)不良反应是瘙痒、头痛、恶心、血管扩张和感觉异常。
黑框警告:肾源性系统纤维化(NSF) 基于钆的造影剂增加肾源性系统纤维化(NSF)风险。 在急性或慢性严重肾功能障碍患者中(肾小球过滤率 <30 mL/min/1.73m2), 或由于肝肾综合征或在肝移植围手术期任何严重程度的急性肾功能障碍, 在这些患者中,避免使用钆的造影剂除非诊断信息是必不可少的和用无对比剂增强磁共振成像(MRI)不能得到。NSF可能导致死亡或使衰弱的系统性纤维化影响皮肤、肌肉和内脏器官。筛选所有患者肾功能失调通过获得病史和/或实验室检验,当给予某种钆的造影剂,不要超过推荐剂量而且任何再给药前要有充分时间从体内消除药物。
INDICATIONS: ABLAVAR® is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
CONTRAINDICATIONS: History of a prior allergic reaction to a gadolinium-based contrast agent.
IMPORTANT SAFETY INFORMATION: WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended ABLAVAR dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.
ABLAVAR® Injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.
In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR® administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.
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