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详细处方信息以本药内容附件PDF文件（201951623244323.pdf）的“原文Priscribing Information”为准
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部分中文Ultibro Breezhaler处方资料（仅供参考）

【英文名称】Ultibro Breezhaler

【适用证】

Ultibro Breezhaler被指定为维持性支气管扩张剂治疗，以缓解成人慢性阻塞性肺病（COPD）患者的症状。

【用法用量】

剂量学：

推荐剂量是每天一次使用Ultibro Breezhaler吸入器吸入一粒胶囊。

建议Ultibro Breezhaler在每天的同一时间服用。 如果错过剂量，应在同一天尽快服用。 应指导患者一天内不要服用超过一剂。

【禁忌】

对活性物质或6.1节中列出的任何赋形剂过敏

【特殊警告和使用注意事项】

Ultibro Breezhaler不应与含有其他长效β-肾上腺素能激动剂或长效毒蕈碱拮抗剂（Ultibro Breezhaler成分所属的药物治疗组）的药物同时使用（见4.5节）。

哮喘： 由于缺乏此适应症的数据，Ultibro Breezhaler不应用于治疗哮喘。

当用于治疗哮喘时，长效β2-肾上腺素能激动剂可能会增加哮喘相关严重不良事件（包括哮喘相关死亡）的风险。

不适合急性使用：

Ultibro Breezhaler不适用于治疗支气管痉挛的急性发作。

过敏症：

据报道，在给予Ultibro Breezhaler的活性物质茚达特罗或格隆铵后，立即出现过敏反应。如果出现过敏反应的迹象，特别是血管性水肿（呼吸困难或吞咽困难，舌头，嘴唇和面部肿胀）荨麻疹或皮疹，应立即停止治疗，并采取替代疗法。

【INDICATIONS AND USAGE】

Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

【Special warnings and precautions for use】

Ultibro Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ultibro Breezhaler belong (see section 4.5).

Asthma:

Ultibro Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.

Not for acute use:

Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.

Hypersensitivity:

Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler. If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face) urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.

【Contraindications】

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

【Posology and method of administration】

Posology:

The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler.

Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day.

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详细处方信息以本药内容附件PDF文件（201951623244323.pdf）的“原文Priscribing Information”为准
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