药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201941621012627.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文EXTRANEAL处方资料(仅供参考)
【英文名称】EXTRANEAL
【适用证】
EXTRANEAL(艾考糊精)在连续阴性腹膜透析(CAPD)或腹膜透析(APD)用于治疗晚期 - 肾上腺疾病期间,在长期(8至16小时)停留期间进行单次交换。 与使用腹膜平衡试验(PET)定义的具有高平均或更高转运特性的患者相比,EXTRANEAL还表明改善(与4.25%葡萄糖相比)长期停留超滤和胰酶和尿素氮的清除[见临床药理学(12),ClinicalStudies(14))]。
【用法用量】
EXTRANEAL仅用于腹膜内给药。 不适用于静脉注射。 管理人员单独进行每日交换以进行长时间连续的腹膜透析或腹膜透析。 建议停留时间为8到16小时。 管理10-20分钟的时间,这对患者来说是舒适的。
治疗方式,治疗频率,交换量,停留时间和透析时间应由治疗腹膜透析治疗晚期肾病的处方医师开始和监督。 建议接受腹膜透析的患者应在受医生监督的程序中接受适当的培训。
【禁忌】
对Cornstarch或Icodextrin过敏
EXTRANEAL适用于已知对玉米淀粉或艾考糊精过敏的患者。
代谢疾病
EXTRANEAL用于患有麦芽糖或异麦芽糖耐受的患者和糖原贮积病患者。
严重的乳酸性酸中毒
EXTRANEAL适用于严重乳酸中毒患者。 如果转化为碳酸氢盐受损,EXTRANEAL含有乳酸可能导致酸中毒恶化,并可能与过度换气,嗜睡,低血压或心律不齐有关。
【INDICATIONS AND USAGE】
EXTRANEAL (icodextrin) is indicated forasingle daily exchangefor thelong (8- to 16- hour) dwell during continuousambulatory peritoneal dialysis (CAPD) orautomated peritoneal dialysis (APD) for the management ofend-stagerenal disease. EXTRANEAL isalso indicated to improve (compared to 4.25%dextrose) long-dwell ultrafiltration and clearance ofcreatinineand urea nitrogen in patients with high average or greater transportcharacteristics,as defined using the peritonealequilibration test (PET) [see ClinicalPharmacology (12), ClinicalStudies (14)].
【DOSAGEAND ADMINISTRATION】
EXTRANEAL is intended for intraperitonealadministration only. Not for intravenous injection. Administerasasingle daily exchangefor thelong dwellin continuousambulatory peritoneal dialysis orautomated peritoneal dialysis. Therecommended dwelltimeis 8- to 16- hours. Administer over a period of 10-20 minutesataratethat iscomfortablefor the patient.
The mode oftherapy, frequency oftreatment,exchange volume, duration of dwell,and length of dialysis should beinitiated and supervised by the prescribing physician experienced in thetreatment ofend-stagerenal disease with peritoneal dialysis. It is recommended that patients being placed on peritoneal dialysis should beappropriately trained in a programthat is under supervision ofa physician.
【CONTRAINDICATIONS】
Allergy to Cornstarch orIcodextrin
EXTRANEAL iscontraindicated in patients with a known allergy to cornstarch or icodextrin.
Metabolic Diseases
EXTRANEAL iscontraindicated in patients withmaltose or isomaltoseintoleranceand in patients with glycogen storage disease.
Severe Lactic Acidosis
EXTRANEAL iscontraindicated in patients with severelacticacidosis. EXTRANEAL contains lactate whichmay contributeto worsening acidosis ifconversion to bicarbonateis impaired and may beassociated with hyperventilation, lethargy, hypotension or irregular heart rhythms.
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