| <DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>安斯泰来欧洲制药公司希望提醒医务人员，在使用他克莫司（<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">Protopic</SPAN>）软膏治疗中至重度过敏性皮炎时，需采取重要的风险最小化措施。</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>近期发表的流行病学研究提示，在接受外用钙调神经磷酸酶抑制剂（包括他克莫司软膏）治疗的患者中，皮肤<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">T</SPAN>细胞淋巴瘤的风险可能增高<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">1-3</SPAN>。在使用<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">Protopic</SPAN>的患者中，曾有恶性肿瘤，包括皮肤和其他类型淋巴瘤及皮肤癌的病例报告。<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">EMA</SPAN>已同意对这一风险做进一步研究，该研究正在筹备中。</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>建议医务人员采取以下措施：</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT face=Calibri><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px">●</SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"> </SPAN></SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"></SPAN></FONT></FONT></SPAN></SPAN></SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">当用于治疗活动性复发时（每日两次），不可给予长期的持续治疗。如在治疗<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">2</SPAN>周后，仍未见体征改善，应考虑改用其他治疗选择。</SPAN></FONT></FONT></FONT></SPAN></SPAN></FONT></FONT></DIV><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; WORD-SPACING: 0px; FONT: 12px/21px Simsun; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 0px; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px">
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; TEXT-INDENT: 28pt; LINE-HEIGHT: 18px; PADDING-TOP: 0px; TEXT-ALIGN: justify"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px">●</SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"> </SPAN></SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">维持使用期间（每周两次），应监测患者的治疗反应，并评估继续治疗的需要。经过<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">12</SPAN>个月的治疗后，应对患者的病情进行回顾，基于个体的效益<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">-</SPAN>风险评估，决定是否继续进行维持治疗。对于<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">2-16</SPAN>岁的儿童，在<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">12</SPAN>个月后应停止治疗，并评估是否需要继续这一治疗方案以及疾病的病程。</SPAN></FONT></FONT></SPAN></SPAN></FONT></FONT></DIV><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px">
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; TEXT-INDENT: 28pt; LINE-HEIGHT: 18px; PADDING-TOP: 0px; TEXT-ALIGN: justify"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px">●</SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 28px; PADDING-TOP: 0px"> </SPAN></SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">对于开始治疗时已存在的淋巴结病，应进行检查并定期评估。对于接受<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">Protopic</SPAN>治疗并发生淋巴结病的患者，应加强监测，确保淋巴结病缓解。在淋巴结病持续存在的情况下，需要检查淋巴结病的病因。在无明确淋巴结病病因或出现急性感染性单核细胞增多症的情况下，应考虑停用<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">Protopic</SPAN>。</SPAN></FONT></FONT></SPAN></SPAN></FONT></FONT></DIV><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">Protopic</SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">应禁用于先天性或获得性免疫缺陷患者或接受可导致免疫抑制的治疗的患者。应尽量减少皮肤在日光下的暴露，并避免使用紫外（<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">UV</SPAN>）光（日光浴、<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">UVB</SPAN>或<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">PUVA</SPAN>治疗）。应建议患者，在接受<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">Protopic</SPAN>治疗时，采取适当的防晒措施。</SPAN></FONT></FONT></FONT></FONT></FONT></FONT></FONT></FONT> |
