【警告】 strong>
•使用艾考糊精后,罕见的无菌性腹膜炎报告。滴注ADEPT®后腹腔 - 盆腔疼痛的鉴别诊断应包括腹膜腔感染,穿孔肠或其他粘性,腹腔内出血,以及除无菌性腹膜炎外的其他危及生命的术后并发症。
•术后通过腹腔镜端口部位泄漏ADEPT®液体与伤口并发症有关,如皮下积液,皮肤分离和感染。筋膜的精细闭合可能有助于减少妇科腹腔镜手术后与液体外渗相关的伤口并发症。
•用ADEPT®治疗的患者罕见有超敏反应的报道。一些患者报告了过敏反应。
•在美国以外的ADEPT®临床经验中,罕见有肺水肿,肺积液和心律失常的报告。这些病例倾向于发生在老年人或其他虚弱的患者(例如癌症患者)中。 ADEPT®预防粘连的潜在益处应与严重合并症患者严重并发症的风险进行仔细权衡。
•与任何植入材料一样,ADEPT®可能会发生异物反应。
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【DEVICE DESCRIPTION AND MECHANISM OF ACTION】
ADEPT® (4% Icodextrin) Adhesion Reduction Solution is a single use, sterile, clear, colorless-to-pale yellow fluid for intraperitoneal administration containing icodextrin at a concentration of 4% w/v in an electrolyte solution. Icodextrin is a
cornstarch-derived, water-soluble branched glucose polymer
linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number-average molecular weight between 5,000 and 6,500 Daltons.
【INDICATION FOR USE】
ADEPT® Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.
【CONTRAINDICATIONS】
ADEPT® is contraindicated:
• In patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with maltose or isomaltose intolerance, or with glycogen storage disease.
• In the presence of frank infection (e.g. peritonitis) in the abdominopelvic cavity.
• In procedures with laparotomy incision. Serious post operative wound complications including dehiscence and cutaneous fistula formation have been reported from clinical experience outside the US when ADEPT® was used in surgical cases with laparotomy incision.
• In procedures involving bowel resection or repair, or appendectomy. Anastomotic failure, ileus and peritonitis following procedures involving bowel resection and instillation of ADEPT® have been reported from clinical experience outside of the US.
【WARNINGS】
• There have been rare reports of sterile peritonitis following the use of icodextrin. The differential diagnosis of abdomino-pelvic pain following instillation of ADEPT® should include peritoneal cavity infection, perforated bowel or other viscous, intraperitoneal bleeding, and other life threatening post-operative complications in addition to sterile peritonitis.
• Leaking ADEPT® fluid through laparoscopic port sites post-operatively is associated with wound complications such as subcutaneous fluid collection, skin separation and infection. Meticulous closure of fascia may help reduce wound complications related to fluid extravasation following gynecologic laparoscopy surgery.
• There have been rare reports of hypersensitivity reactions in patients treated with ADEPT®. Anaphylaxis has been reported in a few patients.
• There are rare reports of pulmonary edema, pulmonary effusion and arrhythmia from clinical experience with ADEPT® outside of the US. These cases tended to occur in elderly or otherwise debilitated patients (e.g. cancer patients). The potential benefit of ADEPT® for adhesion prevention should be carefully weighed against the risk of serious complications in patients with serious co-morbidities.
• Foreign body reactions may occur with ADEPT®, as with any implanted material.
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详细处方信息以本药内容附件PDF文件(201912719472227.pdf)的“原文Priscribing Information”为准
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