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详细处方信息以本药内容附件PDF文件（201951516072320.pdf）的“原文Priscribing Information”为准
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部分中文Metalyse处方资料（仅供参考）

【英文名称】Metalyse

【适用证】

METALYSE®适用于心肌梗塞急性期（AMI）的溶栓治疗。 症状出现后应尽快开始治疗。 可在症状出现后12小时内开始治疗。

【用法用量】

METALYSE®应根据体重给药，最大剂量为50 mg（10,000 IU）。施用正确剂量所需的体积可以从以下方案计算：

患者体重类别（kg）METALYSE®（IU）METALYSE®（mg）  相应体积的重构溶液（mL）

<60 6,000 30 6

≥60至<70 7,000 35 7

≥70至<80 8,000 40 8

≥80至<90 9,000 45 9

≥9010,000 50 10

所需剂量应在约10秒内作为单次静脉推注给药。

预先存在的静脉注射线仅用于给予0.9％氯化钠溶液，可用于METALYSE®的给药，静脉注射线应在注射METALYSE®后冲洗，以便正确分娩。 METALYSE®与葡萄糖溶液不相容。

METALYSE®不应与其他药物混合使用，不应在同一注射瓶中，也不应与同一静脉注射液（甚至不使用肝素）混合使用。在稀释或给药之前，只要溶液和容器允许，在给药前应目视检查肠胃外药物产品的颗粒物和变色。

重组溶液仅供单个患者使用。应丢弃任何多余的溶液。

【禁忌】

METALYSE®在以下情况下禁用，因为溶栓治疗与较高的出血风险相关（另请参阅预防措施 - 出血）：

•目前或过去6个月内出现明显的出血性疾病

•目前同时口服抗凝治疗的患者（INR> 1.3）

•任何中枢神经系统损害史（即肿瘤，动脉瘤，颅内或脊柱手术）

•已知的出血性素质

•严重的不受控制的高血压，即收缩压> 180 mm Hg和/或舒张压> 110 mm Hg

•在过去2个月内进行大手术，实质器官活检或显着创伤（包括与当前AMI相关的任何创伤）

•最近对头部或头盖骨的创伤

•在过去2周内长时间或创伤性心肺复苏（> 2分钟）

•严重肝功能不全，包括肝功能衰竭，肝硬化，门静脉高压症（食管静脉曲张）和活动性肝炎

【使用注意】

使用METALYSE®治疗急性心肌梗死患者的决定应在有使用溶栓治疗经验的医生和监测其使用的设施的咨询下进行。 与其他血栓溶解剂一样，建议在使用METALYSE®时，可以在任何情况下使用标准的复苏设备和药物。

【INDICATIONS AND USAGE】

METALYSE® is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of symptoms. Treatment can be initiated within 12 hours of symptom onset.

【CONTRAINDICATIONS】

METALYSE® is contraindicated in the following situations because thrombolytic therapy is associated with a higher risk of bleeding (see also PRECAUTIONS - Bleeding):

•Significant bleeding disorder either at present or within the past 6 months

•Patients with current concomitant oral anticoagulant therapy (INR > 1.3)

•Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)

•Known haemorrhagic diathesis

• Severe uncontrolled hypertension i.e. systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg

• Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)

• Recent trauma to the head or cranium

• Prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks

•Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis

【WARNINGS AND PRECAUTIONS】

The decision to treat a patient with acute myocardial infarction with METALYSE® should be taken under the consultation of a physician experienced in the use of thrombolytic treatment and with the facilities to monitor its use. As with other thrombolytics, it is recommended that when METALYSE® is administered standard resuscitation equipment and medication be available in all circumstances.

【DOSAGE AND ADMINISTRATION】

METALYSE® should be administered on the basis of body weight, with a maximum dose of 50 mg (10,000 IU). The volume required to administer the correct dose can be calculated from the following scheme:

Patient’s body weight category (kg) METALYSE®(IU) METALYSE®(mg) Corresponding volume of reconstituted solution (mL)

< 60 6,000 30 6

≥ 60 to < 70 7,000 35 7

≥ 70 to < 80 8,000 40 8

≥ 80 to < 90 9,000 45 9

≥ 90 10,000 50 10

The required dose should be administered as a single intravenous bolus over approximately 10 seconds.

A pre-existing intravenous line, which has been used for administration of 0.9% Sodium Chloride solution only, may be used for administration of METALYSE® and the intravenous line should be flushed after METALYSE® injection for proper delivery. METALYSE® is incompatible with glucose solution.

METALYSE® should not be mixed with other medication, neither in the same injection-vial nor the same intravenous line (not even with heparin). Before dilution or administration, parenteral drug products should be visually inspected for particulate matter and discolouration prior to administration whenever solution and container permit.

The reconstituted solution is for single use, in a single patient. Any excess solution should be discarded.

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详细处方信息以本药内容附件PDF文件（201951516072320.pdf）的“原文Priscribing Information”为准
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