卡介苗和卡介苗(BCG)的杆菌灌注英文版说明书IMMUCYST lntravesical 81mg

药店国别： 产地国家：日本 处方药：是 所属类别： 81毫克/瓶+(3mLdiluent) 包装规格： 81毫克/瓶+(3mLdiluent) 计价单位：盒 生产厂家中文参考译名： 　生产厂家英文名：Sanofi 原产地英文商品名：IMMUCYST(イムシスト膀注用)81mg/vial+3mL diluent 原产地英文药品名：BCG Immunotherapeutic Immucyst 　中文参考商品译名：巴斯德(イムシスト膀注用)81毫克/瓶+3mLdiluent 　中文参考药品译名：卡介苗和卡介苗(BCG)的杆菌灌注 曾用名： 简介：部份中文IMMUCYST灌注处方资料(仅供参考)治疗类别名称其他生物制品抗肿瘤药商標名IMMUCYST一般名BCG・コンノート株Bacillus of Calmette and Guerin(BCG)・Connaught strain性　状牛结核病细菌，这是减毒，具有防酸杆菌，显示了该代码生成。条件批准为了进一步澄清这种药物的国家的有效性和安全性的目的，开展全国商用适当后的临床试验。 适应病症 浅表性膀胱癌，原位膀胱癌 用法用量 小瓶(81毫克)附液3mL均匀的悬浮液，其还与生理盐水40毫升稀释，以制备均匀的卡介苗稀释剂。•浅表性膀胱癌，原位膀胱癌导尿管在膀胱无菌条件下插入时，卡介苗稀释液排出后缓慢注入残余尿，尽量保持关于在膀胱尽可能两小时。每星期重复一次，共8周。•浅表性膀胱癌导尿管在膀胱无菌条件下插入时，卡介苗稀释液排出后缓慢注入残余尿，尽量保持关于在膀胱尽可能两小时。此经尿道膀胱肿瘤切除，具有至少14天的间隔，每周一次重复6周，从这种药物开始日期的使用3,6，12和18个月后重复进一步3周每星期一次。此外，在适当根据患者的情况，随后停药。 主要副作用 通过刺激膀胱，大多数人，尿频和排尿疼痛，排尿困难，这将是血尿Nadogami。此外，间质性肺炎和过敏反应症状，萎缩性膀胱，还存在一种可能性，即，可能会发生莱特尔氏综合征，如肾衰竭。 使用注意事项 在人或结核病史结核菌素反应请求人就出来了强烈的还有上述副作用延长。 包装规格 81毫克×1小瓶(具有所附溶液)生产和销售赛诺菲公司联盟SANOFI PASTEUR•Imunoburada(日本BCG)•Imushisuto(日本化药)BCG已被用于世界各地的结核病防治与减毒牛分枝杆菌制成的疫苗。虽然疫苗本身是抗癌效果并不，刺激是导致在膀胱炎的免疫系统，免疫系统已产生针对膀胱癌的抗癌效果。膀胱注射治疗，一直被视为浅表性膀胱癌的初始治疗的首选。在高复发风险的患者常用的，80%到90%德感细胞已经被说成是完全消失。 卡介苗和卡介苗(BCG)的杆菌灌注英文版说明书 Efficiency classification nameOther biological productsAntineoplastic agentsBrand NameImushisuto intravesical for 81mgcompositionImushisuto intravesical for 81mgIngredients: Active Ingredients: one portion of the vialLive bacillus Calmette-Guerin (BCG) · Connaught strain (as dry cell weight): 81mgIngredients: Additives: one portion of the vialL- glutamic acid sodium hydrate: 166mgAttached solutionIngredients: Additives: one portion of a vial (3mL)Sodium chloridepH adjusting agent 2 componentPolysorbate 80: 0.75mgContraindicationAIDS, leukemia, malignant lymphoma, etc. concurrent disease or anti-cancer therapy (for example cytotoxic antineoplastic agents, radiation therapy) by, lowering the patient, the patient [immune response of congenital or acquired immunodeficiency that are immunosuppressed state the effect of this drug could attenuate, which may further lead to disseminated BCG infection by]May attenuate the effects of this drug due to a decrease in the patient [immune response are administered steroids or other immunosuppressive agents of HIV carriers and immune suppression quantity, which may further lead to disseminated BCG infection]Active tuberculosis diseases which may cause deterioration of the apparent patient [serious side effects or conditions]Febrile illness Cause is not specified, bacterial urinary tract infection, which may lead to deterioration of the patient [serious side effects or the symptoms of gross hematuria]Which may lead to patients' serious side effects with a history of BCG systemic hypersensitivity reaction]Women suspected of being pregnant or pregnant [Refer to the section "6. pregnant women, maternal, administration to nursing women, etc."]Efficacy or effectSuperficial bladder cancer, bladder carcinoma in situThis drug is not a cancer preventive agent.This agent is not efficacy as a tuberculosis vaccine.Since the invasive bladder cancer (histological depth of invasion T2 or more) is an adaptive outside of this drug, to be used after confirming that it is not invasive prior to administration.Efficacy and safety of maintenance therapy for those who were cured by therapeutic administration in the dosage regimen of this drug has not been established.In addition to this product one vial (81mg) to the accompanying solution 3mL a uniform suspension, which further diluted with the day stations saline 40mL, to prepare a uniform BCG diluent.Superficial bladder cancer, bladder carcinoma in situThe urethral catheter is inserted under sterile conditions in the bladder, the BCG diluted solution was injected slowly after discharge the residual urine, try to hold on for two hours in the bladder as much as possible. This is repeated usually once a week for 8 weeks.Superficial bladder cancerThe urethral catheter is inserted under sterile conditions in the bladder, the BCG diluted solution was injected slowly after discharge the residual urine, try to hold on for two hours in the bladder as much as possible. This transurethral bladder tumor resection, with an interval of at least 14 days, once a week repeated 6 weeks, repeated a further three weeks once each week after 3, 6, 12 and 18 months from the administration of this drug start date . It should be noted that, as appropriate followed by withdrawal from medication according to the patient's condition.This drug was suspended in the accompanying solution of 3mL, until finely uniform suspension, shaking gently 10? 20 times the vial. Since the becomes impossible suction exact dosage foamy, foaming should be avoided. So that the bacteria are uniformly dispersed, the suspension of this drug be done always in the accompanying solution. Aspirated from the vial on the total amount of the suspension in the syringe barrel, further diluted with Japanese Pharmacopoeia physiological saline 40mL, to prepare a uniform BCG diluent shaken in quiet again. This is referred to as a single dose.The drug is used only for injection into the bladder, transdermal vaccination or any route (intradermal, subcutaneous, intramuscular, intravenous, etc.) it may not be administered to.The patients undergoing antimicrobial therapy for other diseases, to postpone the administration of this drug to the therapy is finished.The time of administrationUpon administration of this drug, so as not to damage the urinary tract mucosa, also, enough attention should be given to urinary tract infection.Administration rateInjection of this agent is not carried out rapidly, it is carried out slowly.Immediately after administrationFor the agent into contact with the entire bladder, the first 15 minutes be prone to the patient. Then it may be got up.During urinationA viable formulation, to prevent the scattering of urine, it is desirable to perform in the sitting position.Urination processingThe first urination after the injection is placed in a suitable container (urine collection container, etc.), after disinfection so that there is no risk of BCG infection, be discarded. As a method for disinfection, there is a method of placing for 15 minutes by adding 10% sodium hypochlorite solution half a (hypo write, etc.) to urination.In order to facilitate the discharge of the BCG, after the administration, it is desirable to guide the appropriate drinking water and the like.Careful administrationResponse of the patient or tuberculin reaction strongly positive with tuberculosis history for the patient [this drug and there is a violently appears fear]Patients who have caused the drug allergyCystitis symptoms of low patient [strength of bladder capacity, there is a possibility that the atrophy bladder appears]Aneurysm and surgery history site after BCG injection in patients [overseas with vascular surgery history, such as aneurysm, artificial organs (arterial grafts, heart devices, artificial joints, etc.) have been reported ectopic BCG infection in]There is a possibility that the increased risk of disseminated infection in a patient [systemic side effects and ascending with vesicoureteral reflux (VUR).]Clinically significant adverse reactionsBCG infection(Frequency unknown)Disseminated, it has been reported locality and ectopic BCG infection. If the BCG infection is suspected, discontinue administration of this drug, with the diagnosis of infectious diseases, be carried out isoniazid, rifampicin, an anti-tuberculosis therapy such as ethambutol. In addition, it is used in combination with steroids, if necessary. In addition, this drug has a sensitivity for most of the anti-tuberculosis agent, but there is no sensitive to pyrazinamide.Disseminated BCG infection(Frequency unknown)By BCG administration after that caused the trauma by catheterization, etc., sepsis is considered that due to the disseminated BCG infection deaths (low blood pressure, disseminated intravascular coagulation, septic shock due to respiratory failure), pneumonia, hepatitis It has been reported. Fever that lasts more than 48 hours accompanied by flu-like symptoms, 39 ℃ or more of high fever, abnormal systemic symptoms or persistent liver function test values ​​exacerbated by repeated administration is intended to suggest the disseminated BCG infection.Locality BCG infection(Frequency unknown)Epididymitis which lasts 2? 3 days or more as the local symptoms, orchitis, prostatitis may be due to locality BCG infection.Ectopic BCG infection(Frequency unknown)Ectopic BCG infection in the aneurysm or arterial grafts and the like have been reported.Interstitial pneumonia(1%)Fever, chest X-ray abnormalities, have been observed interstitial pneumonia with hypoxemia and abnormal liver function tests. If such symptoms appear, immediately discontinue administration of this drug, performs a diagnosis of disseminated BCG infection, such as administration of promptly steroids, to carry out an anti-tuberculosis drug therapy with appropriate measures .Systemic hypersensitivity reactions(Incidence unknown Note 1))Dyspnea, cyanosis, anaphylactic-like symptoms accompanied by anaphylactic shock or cough and rash with low blood pressure have been reported. In this way if the symptoms are observed such, discontinue administration of this drug, with the diagnosis of disseminated BCG infection, immediately to carry out the administration and anti-tuberculosis therapy of antihistamines or steroids.Contracted bladder(Frequency unknown)Because it may atrophy bladder appears anti, frequent urination and bladder irritation symptoms, enough to observe, such as bladder capacity done, discontinue administration of this drug in the case of atrophy bladder is suspected, with the administration of antibacterial antibiotics to carry out tuberculosis therapy. Further, by performing the administration of the steroids when necessary.Reiter's syndrome(Frequency unknown)Arthritis, eye symptoms (conjunctivitis, iritis, keratitis, uveitis, retinitis, etc.), Reiter's syndrome have been observed, which was accompanied by urethritis. If such symptoms are observed, discontinue administration of this drug, the administration of antihistamines or non-steroidal anti-inflammatory analgesic. Furthermore, administration of steroids when necessary, performing the anti-tuberculosis therapy.kidney failure(Frequency unknown)Because there is that renal failure may occur, regularly carefully monitored, such as performing a renal function test, discontinue administration of this drug, if any abnormalities are observed, do the diagnosis of disseminated BCG infection, promptly along with the appropriate measures to, to carry out the anti-tuberculosis therapy.PharmacologyAntitumor actionBy the mouse bladder transitional cell carcinoma cell line MB49 or MBT-2 is mixed with this agent subcutaneous implantation, growth and engraftment of tumor is suppressed.In murine bladder cancer model that the processed MB49 cells bladder inner wall with hydrochloric acid was prepared and injected into the bladder of a mouse, this drug observed significant prolongation of survival time by injecting into the bladder after cancer cell transplantation 2 days obtained.Mechanism of actionA clear mechanism of action has not been elucidated, this drug is taken, such as tumor cells and macrophages via the adhesive 1) of the extracellular matrix protein fibronectin, activating the immune cells such as macrophages and T lymphocytes and 2). Anti-tumor cytokine with these activated immunocompetent cells to injury directly cancer cells (tumor necrosis factor, such as interferon -γ) secretion to the injure the cancer cells. This drug, because it shows no direct killing effect on human bladder cancer cells, by the induction of the above such immune response has been speculated to exhibit an anti-tumor effect in bladder cancer cells.Physicochemical knowledge of active ingredientGeneric nameBCG · Connaught Ltd.Bacillus of Calmette and Guerin (BCG) · Connaught strainSex-likeA cattle tuberculosis bacteria, which was attenuated, with anti-acid bacilli, shows the code formation.