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  药店国别: 英国药房
产地国家: 英国
所属类别: 妇科药物->子宫内膜异位
处方药:处方药
包装规格: 4%x5x1.5升
计价单位:
  点击放大  
生产厂家中文参考译名:
百特公司
生产厂家英文名:
Baxter
该药品相关信息网址1:
http://www.baxter.com.pr/healthcare_professionals/products/adept.html
原产地英文商品名:
ADEPT ADHESION REDUCTION SOLUTION 4% x 5 x 1.5L (Minimum order qty: 5)
原产地英文药品名:
ICODEXTRIN
中文参考商品译名:
ADEPT ADHESION REDUCTION SOLUTION 4%x5x1.5升 (最低购买量:5)
中文参考药品译名:
艾考糊精
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.
临床试验期:
完成
中文适应病症参考翻译1:
腹膜内使用作为良好手术技术的辅助手段,用于减少接受妇科腹腔镜粘连松解术的患者的术后粘连。
药品信息:

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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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 部分中文ADEPT ADHESION REDUCTION SOLUTION处方资料(仅供参考)


【英文名称】
ADEPT ADHESION REDUCTION SOLUTION

【设备描述和行动机制】

ADEPT®(4%Icodextrin)是一次性使用,无菌,透明,无色至淡黄色液体,用于腹膜内给药,含有浓度为4%w / v的艾考糊精在电解质溶液中。 Icodextrin是玉米淀粉衍生的水溶性支链葡萄糖聚合物,由α(1-4)和少于10%的α(1-6)糖苷键连接,重均分子量在13,000和19,000道尔顿之间,数量为 平均分子量为5,000至6,500道尔顿。

【使用指示】

ADEPT ADHESION REDUCTION SOLUTION适用于腹膜内使用作为良好手术技术的辅助手段,用于减少接受妇科腹腔镜粘连松解术的患者的术后粘连。

【禁忌】

ADEPT®禁忌:

•对已知或怀疑对基于玉米淀粉的聚合物过敏的患者,例如 艾考糊精,或麦芽糖或异麦芽糖不耐症,或糖原贮积病。

•在腹壁腔内存在明显感染(例如腹膜炎)。

•剖腹手术切口手术。 美国以外的临床经验报道了严重的术后伤口并发症,包括开裂和皮肤瘘形成,当ADEPT®用于剖腹手术切开的外科病例时。

•涉及肠切除或修复或阑尾切除术的手术。 根据美国以外的临床经验报道了包括肠切除术和滴注ADEPT®在内的手术后的吻合失败,肠梗阻和腹膜炎。

【警告】

•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。

【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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更新日期: 2019-1-28
附件:
201912719472227.pdf    

 
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