2024年4月23日发(作者：)

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE 适应症和用途

Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate

β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being

evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.

本药作为正电子发射断层扫描(PET)成像的造影剂，用于对正接受阿尔茨海默病(AD)和其他

认知功能降低原因诊断的成人患者进行脑成像，以估算β-淀粉样蛋白神经炎性斑块密度。

A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a

neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces

the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan

indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown

this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in

patients with other types of neurologic conditions as well as older people with normal cognition.

Neuraceq is an adjunct to other diagnostic evaluations.

本药图像呈阴性表明神经斑稀少甚至于无，和在图像采集时与AD的神经病理学诊断不一致；

图像呈阴性降低了患者AD所致认知损害的可能性。本药图像呈阳性表明淀粉样神经斑较多

至密集；神经病理学测试显示AD患者可出现如此数量的淀粉样神经斑，但是其他类型的认

知损害患者(如认知正常的老人)同样可出现。本药为其他诊断性评价的辅助方法。

Limitations of Use 使用限制

•A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder.

本药图像呈阳性时不可确诊为AD或其他认知障碍。

•Safety and effectiveness of Neuraceq have not been established for:

用于以下情况的安全性和有效性尚不明确：

o Predicting development of dementia or other neurologic conditions;

预测痴呆或其他神经病的进展情况；

o Monitoring responses to therapies.

监测治疗反应。

2 DOSAGE AND ADMINISTRATION 用法用量

2.1 Radiation Safety -Drug Handling 放射安全-药物处理

Neuraceq is a radioactive drug and should be handled with appropriate safety measures to minimize

radiation exposure during administration [see Warnings and Precautions (5.2)]. Use waterproof

gloves and effective shielding, including lead-glass syringe shields when handling and

administering Neuraceq. Radiopharmaceuticals, including Neuraceq, should only be used by or

under the control of physicians who are qualified by specific training and experience in the safe use

and handling of radioactive materials, and whose experience and training have been approved by the

appropriate governmental agency authorized to license the use of radiopharmaceuticals.

本药为放射性药物，需要安全性处理以减少用药期间的放射暴露。当处理或给予本药时应佩

戴防水手套及安全性辐射屏蔽服(包括带针套的玻璃注射器)。使用放射性药物(包括本药)的

内科医生应在经过特殊训练且有安全使用或处理放射性物质的经验，其训练和经验经政府机

关批准，授权使用放射性药物。

2.2 Recommended Dosing and Administration Instructions 推荐剂量及给药程序

The recommended dose of Neuraceq is 300 MBq (8.1 mCi), maximum 30 mcg mass dose,

administered as a single slow intravenous bolus (6 sec/mL) in a total volume of up to 10 mL.

本药推荐剂量为300MBq(8.1mCi)，最大剂量为30μg。静脉弹丸式注射，注射速度为6秒/ml，

注射体积不超过10ml。

-Inspect the radiopharmaceutical dose solution prior to administration and do not use it if it contains

particulate matter 用药前须检查注射液，如有悬浮微粒不得使用。

-Use aseptic technique and radiation shielding to withdraw and administer Neuraceq solution. 取用

及给予本药注射液时应采取无菌措施及放射性屏蔽。

-Measure the activity of Neuraceq with a dose calibrator immediately prior to injection. 注射前立

即使用校准仪器，测量出需要的注射体积。

-Do not dilute Neuraceq 不得稀释本药。

-The injection must be intravenous in order to avoid irradiation as a result of local extravasation, as

well as imaging artifacts. Verify patency of the indwelling catheter by a saline test injection prior to

administration of Neuraceq. 为避免局部外渗导致放射以及成像伪影，本药必须静脉给药。用

药前注入生理盐水以确认留置导管是否通畅。

-An injection (6 sec/mL) into a large vein in the arm is recommended, followed by a saline flush of

approximately 10 mL. 推荐于手臂大血管注射（6秒/ml），随后以约10ml生理盐水冲洗。

-Dispose of unused product in a safe manner in compliance with applicable regulations. 依据适用

条理安全性处理未使用的药物。

2.3 Image Acquisition Guidelines 成像指导

Acquire PET images over 15 to 20 minutes starting 45 to 130 minutes after Neuraceq injection.

Keep the patient supine with the head positioned to center the brain, including the cerebellum, in the

PET scanner field of view. Reduce head movement with tape or other flexible head restraints if

necessary. Reconstruction should include attenuation correction with resulting transaxial pixel sizes

between 2 and 3 mm.

注射本药45-130分钟后开始15-20分钟的PET成像，患者处仰卧位，脑部(包括小脑)置于PET

扫描仪视野中。如需要可使用胶带或其他有弹性的头枕减少头部移动。重建应包括衰减校正，

使轴面像素大小在2-3mm之间。

2.4 Image Display and Interpretation 图像显示及判读

Neuraceq images should be interpreted only by readers who successfully complete Electronic

Media-or In-Person Training provided by the manufacturer [see Warnings and Precautions (5.1)].

The objective of Neuraceq image interpretation is to estimate β-amyloid neuritic plaque density in

brain gray matter, not to make a clinical diagnosis. Image interpretation is performed independently

of a patient’s clinical features and relies upon the recognition of image features in certain brain

regions.

本药图像仅可由成功完成制造商提供的电子培训程序的读者来判读。本药图像判读的目的时

为了提供一项对脑β-淀粉样神经斑密度的预估，并不是进行临床诊断。图像判读与患者临

床表现和依赖部分大脑区域的图像特征识别无关。

Image Display

图像显示

PET images should be displayed in the transaxial orientation using gray scale or inverse gray scale.