| <P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">美国</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">与</SPAN> <SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">7</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">23</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">天批准</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Tudorza Pressair</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">aclidinium bromide</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，</SPAN><SPAN><SPAN lang=ZH style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-fareast-language: ZH" XML:LANG="ZH">阿地溴铵</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）用于与慢性阻塞性肺病（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">），包括慢性支气管炎和肺气肿相关的支气管痉挛（呼吸道狭窄）长期维持治疗。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是一种严重的肺部疾病，使呼吸困难。吸烟是</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的主要原因。根据美国国家心脏、肺和血液研究所数据，慢性</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是美国第四大死亡原因，其症状包括胸闷、长期咳嗽、痰多。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial" XML:LANG="EN-US">T</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">udorza Pressair</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是一种长效抗胆碱剂，能帮助肺部气道松弛，改善呼吸畅通。为干粉吸入剂型，每天使用两次。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">“</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是一种严重的疾病，随着时间的推移会日趋严重，”</SPAN> <SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt"><SPAN lang=EN-US XML:LANG="EN-US"><FONT face=Arial>FDA</FONT></SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的药物评价和研究中心药品评价</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">II</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">办公室主任</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Curtis Rosebraugh</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">博士指出。“这种</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">长期维持治疗药物可为数百万</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">患有这种糟糕疾病</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; mso-font-kerning: 0pt" XML:LANG="EN-US"><FONT face="Times New Roman">??</FONT></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">者增加了治疗选择。”</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Tudorza Pressair</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的安全性和疗效在三项随机</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">-</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">安慰剂对照验证性临床试验中得到证实。有</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">1276</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">名</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">40</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">岁及以上临床诊断为</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">者参与，他们有</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">10</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年以上吸烟史，至少每天一包。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Tudorza Pressair</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">可能会导致严重的副作用，包括“</SPAN><SPAN><SPAN lang=ZH style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-fareast-language: ZH" XML:LANG="ZH">矛盾性支气管痉挛</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">“、</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">新发生或加重的眼压升高（急性窄角型青光眼），或新或加重性尿潴留。</SPAN> <SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt"><SPAN lang=EN-US XML:LANG="EN-US"><FONT face=Arial>Tudorza Pressair</FONT></SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">不可由于突发呼吸问题（急性支气管痉挛）抢救治疗，不推荐用于年龄小于</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">18</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">岁人群。使用</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Tudorza Pressair</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">患者报告的最常见的副作用包括头痛、鼻腔炎症（鼻咽炎）、咳嗽。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Tudorza Pressair</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">由</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Forest</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">制药公司销售。</SPAN></P> |
