DEFINITY®是一种心血管超声造影剂注射,由lipid-coated回波的微气泡充满octafluoropropane气体,提高临床医生对心脏左心室的看法在超声心动图来帮助诊断。
批准日期：公司：LANTHEUS MEDC
DEFINITY(全氟丙烷脂质微球[Perflutren Lipid Microsphere]) 可注射悬浮液，用于静脉注射
美国初步批准日期:2001年
警告:
严重的心肺反应见完整的盒式警告的处方信息
严重的心肺反应，包括死亡，发生在不常见的过程或后含全氟特微球给药。大多数严重反应发生在给药后30分钟内。评估所有患者是否存在任何妨碍明确给药的情况。随时准备复苏设备和训练有素的人员。
作用机制
全氟tren脂质微球的声阻抗低于血液，增强了血液的固有后向散射。这些物理声学性质的激活确定性提供了对比增强左心室和帮助描绘左心室心内膜边界在超声心动图。在动物模型中，激活定义的声学特性建立在机械指数0.7 (1.8 MHz频率)或以下。在临床试验中，大多数患者的影像学指标为或低于0.8。
适应症和用法
DEFINITY是一种超声造影剂，用于超声心动图不理想的患者，使左心室不透明，改善左心室心内膜边界的勾画。
剂量和管理
定义可以通过静脉注射(IV)丸或输注。最大剂量为两丸剂或单次静脉输注。激活度的推荐bolus剂量为10微升(microL)/kg的激活产品，在30-60秒内静脉注射bolus，然后用10mL盐水冲洗。如有必要，可在第一次注射后30分钟进行第二次10微升(microL)/kg剂量和第二次10毫升盐水冲洗，以延长造影剂增强效果。
激活确定性的推荐输注剂量是将1.3mL静脉输注到50mL无防腐剂的生理盐水中。注射速率应开始于4毫升/分钟，但为了达到最佳的图像增强，需要滴定，不超过10毫升/分钟。
剂型及强度
定义是作为一个单一使用2毫升透明玻璃小瓶包含透明液体包装四和十六一次性使用小瓶。
禁忌症
不要给已知或怀疑的病人下定义:
perflutren过敏症。
警告和预防措施
在微球给药过程中或给药后发生了严重的心肺反应，包括死亡。
在没有接触过含全氟酮微球产品的患者中发生过严重的急性过敏反应。
在确定给药前一定要准备好心肺复苏人员和设备，并监视所有患者的急性反应。
不良反应
最常见的不良反应(≥0.5%)头痛、肾/背痛,冲洗,恶心,胸部疼痛,注射部位反应,头晕。
包装提供/储存和处理
如何提供
定义是作为一个单独使用的2毫升透明玻璃小瓶，包含4(4)和16(16)个单独使用小瓶包装的透明液体。
一(1)2mL瓶- NDC (11994-011-01)
每个试剂盒4瓶(4)2mL瓶- NDC (11994-011-04)
16 (16) 2mL瓶/试剂盒- NDC (11994-011-16)
储存和处理
2 - 8°C之间的商店(36°-46°F)。
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ab9c79c-1b5c-4e86-899c-cc74686f070a
GENERIC NAME: PERFLUTREN LIPID MICROSPHERE SUSPENSION - INJECTABLE(pur-FLOOT-rin)
BRAND NAME(S): Definity
USES: This medication is used just before certain medical tests of the heart (e.g., echocardiograms) to help diagnose heart problems.
Perflutren improves the ability of doctors to eva luate heart problems and can help clarify results of earlier tests.
HOW TO USE: Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist. Inject this medication directly into a vein(IV bolus) or give over 5 to 15 minutes (IV infusion) in a saline solution usually just before the medical test; or use as directed by
the doctor.
After mixing the vial, if the product is not used within 5 minutes, gently turn the bottle upside down several times to make sure the suspension is mixed well before drawing into a syringe.
Draw up the product suspension into a syringe by pulling back on the plunger; do not inject air into the vial. Doing so may inactivate the drug. This product should appear as a milky, white suspension.
Before using, check this product visually for any unusual particles or discoloration. If either is present, do not use the liquid.
Learn how to store and discard needles and medical supplies safely.
Consult your pharmacist.
SIDE EFFECTS: Headache, nausea, or flushing may occur. If any of these effects persist or worsen, notify your doctor.
Tell your doctor immediately if any of these serious side effects occurs: back pain, redness/swelling/irritation at the injection site, chest pain.
Tell your doctor immediately if any of these unlikely but serious side effects occur: irregular heartbeat, fever, joint pain, tingling or numbness of the hands/feet, stomach pain, vomiting, vision or hearing problems, bruising. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs.
Symptoms of an allergic reaction include: rash, itching, dizziness, swelling, trouble breathing.
If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: other heart problems (e.g., childhood/congenital defects, pulmonary hypertension), previous heart procedures (e.g., cardiac shunt placement), lung problems (e.g., COPD or emphysema), any allergies(especially to fluorocarbons propellants).
Tell your doctor if you are pregnant before using this medication. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use. Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222.
Canadian residents should call their local poison control center directly.
NOTES: Laboratory and/or medical tests may be performed to monitor your progress.
MISSED DOSE: Not applicable.
STORAGE: Before mixing, store in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Once mixed, the suspension is good for 12 hours at room temperature and stored in the original vial.
Discard any unused portion of the vial. 
http://www.lantheus.com/products/overview/definity/