部份中文卡介苗免疫治疗剂处方资料（仅供参考）
效率分类名称
其他生物制品
抗肿瘤药物
批准日期：2003年10月
商標名
IMMUCYST
一般名
BCG・コンノート株
Bacillus of Calmette and Guerin（BCG)・Connaught strain
性　状
它是一种减毒的牛结核杆菌结核分枝杆菌活菌，它是一种酸性杆菌，显示出代码形成。
审批条件
为了进一步阐明该药在国内的有效性和安全性，在日本进行适当的上市后临床试验
药效药理
1. 抗肿瘤作用
(1) 通过将小鼠膀胱移行细胞癌细胞系MB49或MBT-2与该药物混合并皮下移植来抑制肿瘤生长和植入。
(2) 在通过用盐酸处理小鼠的膀胱内壁制备的小鼠膀胱癌模型中观察到存活的显着延长，并且在癌细胞植入膀胱后2天将MB49细胞注射入膀胱。
2. 作用机序
尽管作用的明确机制尚未阐明，但是该药物通过细胞外基质蛋白纤连蛋白的粘附1）被肿瘤细胞，巨噬细胞等吸收并激活免疫活性细胞如巨噬细胞和T淋巴细胞 要做。 这些活化的免疫活性细胞直接损伤癌细胞并分泌抗肿瘤细胞因子（肿瘤坏死因子，干扰素-γ等）并破坏癌细胞。
由于该药物不直接对人膀胱癌细胞显示细胞杀伤作用，推测如上所述诱导免疫反应显示对膀胱癌细胞的抗肿瘤作用。
适应病症
浅表性膀胱癌，膀胱上皮内癌
用法与用量
加入3毫升裂解溶液附加到1瓶（81毫克）的产品，制成均匀的悬浮液，进一步用40毫升日本药典盐水稀释，制备一个统一的卡介苗稀释液。
浅表性膀胱癌，膀胱上皮内癌
将尿道导管在无菌条件下插入膀胱，在排出残余尿液后缓慢注入BCG稀释剂，并尽可能将其保持在膀胱中2小时。 通常每周重复一次，持续8周。
浅表性膀胱癌
将尿道导管在无菌条件下插入膀胱，在排出残余尿液后缓慢注入BCG稀释剂，并尽可能将其保持在膀胱中2小时。 在经尿道膀胱肿瘤切除术后至少连续14天，每周一次，连续6周，以及连续3周，6,12和18个月，从开始给药开始第3,6,12和18个月，每周一次，连续3周。 根据病人的情况，酌情给药。
存储方法·到期日期等
保存方法
储存在2〜8°C避光
有效期限
自认证之日起两年（小瓶和外箱上的最后生效日期）
包装规格
81毫克：1瓶（附：解液）
制造商
赛诺菲有限公司
注：以上中文资料不够完整，使用者以原处方资料为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/6391701X1030_3_02/
Adjustment and addition of dosage of adjuvant therapy after TURBT for superficial bladder cancer of imcyst® for bladder cancer
About additional indication of anti-malignant agent 'imsist® for bladder 81 mg'
On August 20, 2010, sanofi-aventis Co., Ltd. (Headquarters: Shinjuku-ku, Tokyo, President: Patrick Shoka, hereinafter "sanofi-aventis") and Nippon Kayaku Co., Ltd. (Headquarters: President and Chief Executive Officer, Chiyoda- : Nippon Kayaku, hereinafter referred to as "Nippon Kayaku") is an anti-cancer agent sold by sanofi-aventis "imsist® 81 mg for bladder" (generic name: dry BCG for intravesical (Connaught stock), manufacturing approval: Nippon Kayaku) announced today that we have received additional approval of dosage and dose at adjunctive therapy after transurethral bladder tumor resection (TURBT) in superficial bladder cancer.
Imsist®is an antineoplastic agent containing as active ingredient BCG·Connaught stock developed by the Connaught Institute of Canada (currently sanofi pasteur tool: vaccine business department of sanofi·aventis group). In Japan, in October 2002 Nippon Kayaku obtained manufacturing and marketing approval for the efficacy and efficacy of superficial bladder cancer and carcinoma in the bladder epithelium. After that, we conducted a clinical trial to add dosage and dose at adjuvant therapy after transurethral resection in superficial bladder cancer, and applied in April 2009. With this additional approval, ImSyst ® enables maintenance injection therapy in addition to BCG induction therapy for bladder cancer patients with high risk of recurrence.
ImSyst ® has been used for treatment of patients with superficial bladder cancer and bladder intraepithelial carcinoma since its release in 2003 in Japan. In addition, adjuvant therapy by imsist after TURBT has been approved in 52 countries around the world as an effective treatment for preventing the recurrence and development of bladder cancer.