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详细处方信息以本药内容附件PDF文件（201953023593114.pdf）的“原文Priscribing Information”为准
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部分中文贝坦利处方资料（仅供参考）

2013年1月14日讯 /生物谷BIOON/ --安斯泰来（Astellas）宣布，Betmiga（mirabegron）获欧盟委员会（EC）批准，用于膀胱过度活动症（OAB）的治疗。

mirabegron可选择性地与膀胱肌肉的β-3肾上腺素受体结合并将其激活，这有助于促进膀胱充盈和储尿，这是膀胱控制药物的一种新机制。

目前的标准治疗是一类名为抗毒蕈碱类的药物，但该药会引起致严重的口干、便秘等副作用，从而导致许多患者停止用药。

【英文名称】Betmiga

【适用证】 Betmiga含有活性物质mirabegron。 它是膀胱肌肉松弛剂（一种所谓的β3-肾上腺素能受体激动剂），可降低膀胱过度活动症的活动并治疗相关症状。

Betmiga用于治疗成人膀胱过度活动症的症状，例如：

- 突然需要清空膀胱（称为尿急）

- 不得不比平时更多地排空膀胱（称为尿频增加）

- 无法控制何时排空膀胱（称为尿急性尿失禁）

【用法用量】

请务必按照医生的说法服用此药。 如果您不确定，请咨询您的医生或药剂师。

推荐剂量是每天一次口服50毫克片剂。 如果您有肾脏或肝脏问题，您的医生可能需要每天一次口服减量至25毫克片剂。 你应该服用含有液体的药物并吞服整个药片。 不要压碎或咀嚼平板电脑。 Betmiga可以带或不带食物。

【使用注意】

在服用Betmiga之前，请咨询您的医生或药剂师：

- 如果您排空膀胱有困难，或者尿液流量不足，或者您服用其他药物治疗膀胱过度活动症，如抗胆碱能药物。

- 如果您有肾脏或肝脏问题。您的医生可能需要减少您的剂量或者可能告诉您不要服用Betmiga，特别是如果您正在服用其他药物，如伊曲康唑，酮康唑（真菌感染），利托那韦（HIV / AIDS）或克拉霉素（细菌感染）。

告诉您的医生您服用的药物。

- 如果您有心电图（心脏追踪）异常，称为QT间期延长，或者您正在服用任何已知导致

这种情况的药物，例如：

用于心律异常的药物，如奎尼丁，索他洛尔，普鲁卡因胺，伊布利特，氟卡尼，多非利特和胺碘酮;

用于过敏性鼻炎的药物;

o抗精神病药物（精神疾病药物），如甲硫哒嗪，美索达嗪，氟哌啶醇和氯丙嗪;

o抗感染药，如喷他脒，莫西沙星，红霉素和克拉霉素。 如果您有高血压病史，Mirabegron可能会导致您的血压升高或使您的血压恶化。建议您的医生在服用Mirabegron时检查您的血压

【INDICATIONS AND USAGE】

Betmiga contains the active substance mirabegron. It is a bladder muscle relaxant (a so called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms.

Betmiga is used to treat the symptoms of an overactive bladder in adults such as:

- suddenly needing to empty your bladder (called urgency)

- having to empty your bladder more than usual (called increased urinary frequency)

- not being able to control when to empty your bladder (called urgency incontinence)

【WARNINGS AND PRECAUTIONS】

Talk to your doctor or pharmacist before taking Betmiga:

- if you have trouble emptying your bladder or you have a weak urine stream or if you take other medicines for the treatment of overactive bladder such as anticholinergic medicines.

- if you have kidney or liver problems. Your doctor may need to reduce your dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections).

Tell your doctor about the medicines that you take.

- if you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause this such as

o medicines used for abnormal heart rhythm such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;

o medicines used for allergic rhinitis;

o antipsychotic medicines (medicines for mental illness) such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;

o anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking Mirabegron

【DOSAGE AND ADMINISTRATION】

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 50 mg tablet by mouth once daily. If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 mg tablet by mouth once daily. You should take this medicine with liquids and swallow the tablet whole. Do not crush or chew the tablet. Betmiga can be taken with or without food.

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详细处方信息以本药内容附件PDF文件（201953023593114.pdf）的“原文Priscribing Information”为准
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