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英文药名: Immucyst(Bacillus Calmette-Guérin)
中文药名: 巴斯德BCG免疫治疗剂, 膀胱癌治疗用卡介苗
药品介绍
商品名: BCG IMMUNOTHERAPEUTIC
中文名: 巴斯德 BCG 免疫治疗剂
学名: BCG vaccine
类别: INT 剂量
结构式: 每瓶含有81mg(乾重) BCG和5% Monosodium glutamate。
BCG桿菌经重新调配后可存活，每剂含6.6-19.2 X 108菌落形成单位(CFC)。
药理作用
BCG免疫治疗剂促进膀胱处其有组织细胞及白血球细胞渗透的局部发炎。局部发炎作用因膀胱表面癌损伤之明显去除或减少而引起。其真正之机转未明。
适应症
本品(BCG免疫治疗剂)适用於膀胱内使用，治疗膀胱之初级復发性原位癌(CIS)，以降低肿瘤再发之频率。其适用於治疗伴有或未伴有乳头状肿瘤之原位癌。但不适用於治疗单独发生之乳头状瘤。本品亦用作膀胱对其他原位癌(CIS)治疗疗程无法反应后之补救疗法。
治疗及预防膀胱原发或復发性原位癌或经尿道切除后之表浅性乳头瘤（ＴＡ及Ｔ１）。
用法用量
膀胱内治疗及预防膀胱原位癌(CIS)应於切片检查或经尿道切除手术后7至14天开始。一次剂量3小瓶，本品(BCG免疫治疗剂)由膀胱内投举每週一次歷时6週(诱导疗法)。各次剂量(3瓶调製好小瓶)再用50毫升减菌，无防腐剂之食盐水稀释，总量为53毫升。尿道导管在无菌状况下插入膀胱内，引导膀胱内容物，然后藉重力缓慢将50毫升本品悬浮液灌入，之后取出导管。灌注后之第一小时内，患者应採俯卧、平躺及左右两侧躺15分鐘，然后患者可站立但再保持悬浮液60分鐘，总计达2小时，应教导其若需要以较少时间排尿。2小时终了时，为安全理由，所有患者以坐姿排尿。应教导患者保持足够之水份。达到最理想反应所需灌注之真正次数仍未知。大多数有反应之患者用6至12次灌注时达到。
不良反应
1. 大多数局部不良反应发生於第三次膀胱内灌注后，最常见者如下，排尿困难、频尿、血尿、膀胱炎、急迫、尿路感染、尿失禁及痉挛/疼痛、症状通常开始於灌注后2至4小时，持续24至72小时。
2. 每一次灌注后全身性反应一般持续1～3天，最常见者如下，身体不适、发热(>38℃)、发冷、贫血、噁心/呕吐、厌食、肌肉痛/关节痛/关节炎、腹泻、白血球过少、肾毒性及生殖器疼痛、颗粒肉牙肿性前列腺炎、副睪炎、睪丸炎以及肾肿疡已有报告已有报告挫伤性插管后或尿道感染之状况使用本品造成死亡。
3. 因使用本品所引起的刺激性小水泡副作用，可用phenazopyridinehy-drochlorid(Pyridium), probanthelia Bromide(ProBanthine)及 acetaminophen处理。
4. 全身性副作用(如身体不适，发烧及发冷)代表过敏反应，可用diphenhydraminhydrochloride治疗、用膀胱内本品偶而会发生因BCG菌种分佈所引起全身性感染、此种状况之处理於预防措施处提供。
禁忌
1. 正使用免疫抑制治疗的患者或免疫系统受损之患者不应接受ImmucCysTM(BCG免疫治疗剂)因有无法抵抗分枝桿菌而可能会造成全身性之败血症。
2. 骨髓抑制剂及/或免疫抑制剂及/或放射物之药物互相组合可能会损害本品之反应，而增加骨髓炎或散佈性BCG感染之危险性。
3. 除非发烧之原因已被测定且评估过，否则本品不应投药给发烧之患者、若发生之原因为感染，则应停用本品，直至烧退。
4. 尿路感染之患者不应接受本品治疗，因其会有造成散佈性BCG感染之危险性或增加膀胱刺激之危险性。
注意事项
1. 本品因含活的减毒分枝桿菌，以传染物处理。
2. 所有用以灌注本品进入膀胱的装置及材料(例如：针筒、导管)在使用后应立即置入胶袋内，袋上标有\"感染性废弃物\"并依据生物危险废弃物丢弃。
3. 使用本品(BCG免疫治疗剂)治疗膀胱原位癌时必须小心，不要引污染入尿道造成不当地伤害尿路粘膜。
4. 建议经尿道切除后一週内不可投用膀胱内本品，因为外伤性插管后使用本品已有死亡之报告。
5. 若医师相信膀胱插管已造成外伤(例如：引起出血或可能之歧道)，则不应使用本品，治疗至少须延后一过。接下去应用完所有本品剂量，即使曾暂时性停止投药亦是。
6. 若於治疗期间患者有发烧或严重的身体不适，应投用isoniazid，每天300mg，直至症状缓解止。若症状持续，则应停止BCG免疫法。以后任何重新灌注BCG前应开始Isoniazid预防性治疗。
7. 若有怀疑全身性BCG感染(即患者若发热超过39℃或发热高过 38℃时持续2天或严重身体不适)应开始用isoniazid每天300 mg Rifampicin 600mg/天，及ethambutol 120mg/天作快速作用抗结核病疗法。停止BCG疗法，且应请询传染病专家。应加 cycloserine 250～500mg 以对致命性感染作紧急治疗。应该知道假定性BCG全身感染仅少见地由阳性培养确定。
8. 怀孕时使用：尚未使用本品进行动物生殖研究。亦未知本品投用到怀孕妇女是否造成胎儿伤害，或是否会影响生育能力。只有清楚明确地需要本品方能给予怀孕妇女使用。
9. 哺乳母亲：全身性BCG感染之母亲会传染其餵乳之婴儿。未知本品是否排出在人类乳汁中。因此当投用本品至哺乳母亲时应小心。儿童使用：对儿童CIS之安全性及效力尚未确立。
孕妇用药分级
C 级：
在对照的动物研究试验中显示该药学物对胚胎有不良反应（致畸胎性或杀胚胎性或其他），但未进行人体怀孕妇女研究；或者尚无对照的人体怀孕妇女或动物研究试验。只有在可能的利益大於潜在的危险，才可使用此药物。
药品保存方式
药品应置於摄氏 2 ~ 8 度冰箱内(勿冷冻)；如发生变质或过期，不可再使用。
ImmuCyst
(bacillus Calmette-Guerin)
DIN (Drug Identification Number)
02194376 IMMUCYST 81MG/VIAL VACCINE
How does ImmuCyst work? What will it do for me?
Bacillus Calmette-Guérin (BCG) belongs to the group of cancer-fighting medications known as antineoplastics. BCG is thought to treat cancer in the bladder by stimulating the body's own defense system to attack the cancer cells.
Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
How should I use ImmuCyst?
BCG is always administered under direct supervision of a doctor. It is added to a solution that is instilled into the bladder through a catheter (tube). Before the fluid is instilled into your bladder, you will be asked to empty your bladder completely. The solution containing BCG should be held in your bladder for 2 hours.
Your doctor may ask you to change positions about every 15 minutes in order for the medication to come in contact with as much of the inside of the bladder as possible. When an instillation of BCG is finished, you should be sitting down to empty your bladder. To prevent bladder problems, you will need to drink extra fluids for several hours after each treatment so that more urine is passed. Make sure to empty your bladder as frequently as possible.
Because BCG is a live bacteria, it can cause infection. It is therefore important to disinfect any urine passed in the first 6 hours after treatment with an equal amount of undiluted household bleach. Allow the urine to sit with the bleach for 15 minutes in the toilet before flushing it.
This procedure is usually repeated once a week for 6 weeks, with additional instillations occurring at the 8th and 12th week, and then once a month for a year.
Many things can affect the dose and schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may decide on a schedule different than the one listed here.
It is important to use this medication exactly as prescribed by your doctor.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does ImmuCyst come in?
Each vial contains Bacillus Calmette-Guérin (BCG), substrain Connaught 81 mg and monosodium glutamate 150 mg. The diluent if provided consists of sodium chloride 25.5 mg, disodium hydrogen phosphate 7.5 mg, sodium dihydrogen phosphate 1.7 mg, polysorbate 80 0.75 mg, and water for injection up to 3 mL. This medication does not contain preservatives.
Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.
Who should NOT take ImmuCyst?
You should not use BCG if you:
•are hypersensitive to one of the ingredients
•are breast-feeding
•have a reduced immune response (chemotherapy, radiation)
•have a urinary tract infection, until the infection has cleared up
•have an active tuberculosis infection
•have current active infection
•have hematuria or blood in urine
•have tested positive for HIV
•have had a recent biopsy or traumatic bladder catherization
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原产地英文商品名:
IMMUCYST 81mg/vial
原产地英文药品名:
BACILLUS CALMETTE-GUERIN IMMUNOTHERAPEUTIC
中文参考商品译名:
巴斯德 81毫克/瓶
中文参考药品译名:
卡介苗免疫治疗剂
生产厂家中文参考译名:
赛诺菲
生产厂家英文名:
Sanofi
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