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【治疗用卡介苗(必赛吉)60mg说明书】治疗用卡介苗的使用说明-宝芝林药品库
当前位置: 网上药店  >  药品库  >  抗肿瘤  > 

治疗用卡介苗(必赛吉)

治疗用卡介苗(必赛吉)
治疗用卡介苗(必赛吉)使用说明书

【药品名称】治疗用卡介苗(必赛吉)

【通用名称】治疗用卡介苗

【生产企业】成都生物制品研究所有限责任公司

【功效主治】60mg(6.0×107CFU)/瓶

【用法用量】取治疗用卡介苗 2瓶(120mg),溶于40~50ml生理盐水并充分摇匀,按外科导尿手术,将导尿管插入膀胱腔,将稀释好的药液,经导尿管注入。注入后,病人不断变换体位,如左侧、右侧、仰卧和俯卧,各约30分钟,经2小时后自行排除药液,对高龄患者或体弱者卡介苗用量可减半(60mg/次)。卡介苗灌注一般在手术后1~2周侍受损组织恢复后进行。给药周期为:开始每周1次,共6次;继之每2周1次,共3次;以后每月1次,直至1年,总计19次。每半年一次检查膀胱癌有无复发。必要时每月1次再持续1~2年以巩固疗效。

【化学成分】治疗用卡介苗系用卡介菌经培养收集菌体,制备高浓度卡介菌悬液,加入适宜稳定剂(成分为明胶、蔗糖、氯化钾、谷氨酸钠)冻干制成的免疫治疗剂。

【性  状】

【适用疾病】膀胱癌

【药理作用】

【相互作用】

【不良反应】1. 治疗用卡介苗在使用后可能发生“卡介苗全身性反应”,由于难以从感染的器官分离卡介菌,如果没有检查到引起该症状的其他病因,则该症状可认定为“卡介苗全身性反应”,临床症状包括:发烧39.5℃或39.5℃以上,持续12小时或12小时以上;发烧38.5℃或38.5℃以上,持续48小时或48小时以上;肺炎、肝炎、外泌尿生殖器机能异常,有活体组织检查的肉芽肿性炎症,或败血症的传统症状,包括循环不良,急性呼吸困难和散在的血管内凝结。2. 治疗卡介苗在使用后可能引起局部反应。灌注后,膀胱受药液刺激可出现尿频、尿急、血尿、排尿困难等症状3. 治疗用卡介苗在使用可能出现低热。常在用药2~3个小时出现,持续数天不等。不需停药,也不需治疗,能自愈。发生率高,常有半数以上的病人可发生这类症状。4. 有少数患者使用治疗用卡介苗后可自觉不适乏力,关节疼痛,体温达38℃以上。还有个别患者由于卡介苗菌侵入局部组织,细菌生长繁殖,引起尿道炎、前列腺炎、睾丸炎或附睾炎。5. 极个别患者,因卡介苗经血液引起卡介苗性肺炎或肝炎。凡出现全身性反应的病人,均应立即停止用药,并用抗痨药,对症药等进行治疗。就国内和国外的资料,临床用药后所见的局部和全身反应的发生率见下表:各类表现 美国Ticc苗资料(143人)* 国内资料(351人)** Lamm资料(1288人)** 出现人数 % 出现人数 % 出现人数 %尿痛/排尿困难 401 59.5 223 63.5 1163 91尿频 272 40.4 146 41.6 1150 90血尿 175 26 112 31.9 550 43发热 134 19.9 152 45 411 31.9不适/乏力 50 7.4 63 17.9 307 24前列腺结节 —— —— 12 3.4 22 1.7关节痛 18 2.7 4 1.1 6 0.5其他 362 53.7 92 25.6 166 130注:*治疗同时服用抗痨药 **治疗时未服药6.导致死亡报道:国外曾已报告两例使用卡介苗死亡的病例,都与全身性卡介苗反应有关。一例与前期肝脏酒精中毒有关,未注意导尿管创伤而腔内用药有关。第二例,可能与没有意识到全身性卡介苗反应有关。

【禁 忌 症】由于治疗用卡介苗为生物免疫增强剂,由卡介菌活菌制成,需特别注意。1. 有免疫缺陷或损害者(如艾滋病病人)有可能引起卡介苗全身性疾病的危险。2. 正使用免疫抑制药物或放射治疗者。亦有上述同样的危险性。3. 对卡介苗过敏者,有可能引起强烈过敏反应。4. 发热及急性传染病患者,包括活动性结核病人。侍疾病治愈后再行治疗。5. 严重的慢性疾病(如心、脑、血管疾病、慢性肾病)禁用。查看完整

治疗用卡介苗用药指南

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