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MEDAC BCG粉和溶剂悬浮为膀胱内给药-用于治疗多种膀胱癌
MEDAC BCG粉和溶剂悬浮为膀胱内给药-用于治疗多种膀胱癌
BCG-medac，粉末和溶剂用于膀胱内使用的悬浮液
重构后，一个小瓶含有来源于种子1173-P2的BCG（Bacillus Calmette-Guérin）细菌种子RIVM，2×10 8至3×10 9个活单位。
赋形剂：粉末：聚乙二醇，无水葡萄糖和聚山梨酯80.溶剂：氯化钠和注射用水。
适应症：非侵入性尿路上皮性膀胱癌的治疗：
1）原位癌的治愈性治疗;
2）预防性治疗复发：
a）局限于粘膜的尿路上皮癌：如果多灶性和/或复发性肿瘤，则为Ta G1-G2，
b）在椎板中但不是膀胱肌肉（T1）的尿路上皮癌，
c）原位癌。
禁忌：对任何成分过敏。
BCG-medac不应用于免疫抑制患者或先天性或获得性免疫缺陷的患者，无论是由于并发疾病（例如阳性HIV血清学，白血病，淋巴瘤），癌症治疗（例如细胞抑制药物，放射）还是免疫抑制治疗例如皮质类固醇）。
BCG-medac不应给予活动性结核病患者。活动性结核病的风险必须通过适当的病历排除，如果根据当地指南通过诊断测试指示。膀胱放射治疗的历史。在哺乳期的妇女。
BCG-medac不能在TUR，膀胱活检或创伤性导管插入术后2至3周之前滴注
Medac GmbH Supports Guideline on Intravesical Instillations of BCG/MMC
Hamburg / Wedel (20 January 2015). medac GmbH has provided the European Association of Urology Nurses (EAUN) with an unrestricted educational grant to support the creation of a booklet “Guideline on intravesical instillations of BCG/MMC”.
Over the past 30 years medac has provided urologists with their expertise and products for the treatment and management of different diseases of the urogenital tract.
With this grant, which will enable a focus on non-muscle invasive bladder cancer (NMIBC), medac is widening its support to encompass other healthcare professionals in the area of NMIBC striving to support optimal patient care Europe wide.
The new Guideline will be presented during the EAUN Annual meeting in Madrid as a part of the EAUN congress program. The “Guideline on intravesical instillations of BCG/MMC“ will also be available as pocket book.
BCG-medac, powder and solvent for suspension for intravesical use
After reconstitution, one vial contains BCG (Bacillus Calmette-Guérin) bacteria seed RIVM derived from seed 1173-P2, 2 x 108 to 3 x 109 viable units. Excipients: Powder: polygeline, glucose anhydrous and polysorbate 80. Solvent: sodium chloride and water for injections. Indications: Treatment of non-invasive urothelial bladder carcinoma: 1) curative treatment of carcinoma in situ; 2) prophylactic treatment of recurrence of : a) urothelial carcinoma limited to mucosa : Ta G1-G2 if multifocal and/or recurrent tumour, Ta G3, b) urothelial carcinoma in lamina propia but not the muscular of the bladder (T1), c) carcinoma in situ. Contraindications: Hypersensitivity to any of the ingredients. BCG-medac should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., positive HIV serology, leukaemia, lymphoma), cancer therapy (e.g., cytostatic drugs, radiation) or immunosuppressive therapy (e.g. corticosteroids). BCG-medac should not be administered to persons with active tuberculosis. The risk of active tuberculosis must be ruled out by appropriate anamnesis and if indicated by diagnostic tests according to local guidelines. Past history of radiotherapy of the bladder. Women during lactation. BCG-medac must not be instilled before 2 to 3 weeks after TUR, bladder biopsy or traumatic catheterisation.
Perforation of the bladder. Acute urinary tract infection. Undesirable effects: Side effects of BCG-treatment are frequent but generally mild and transient. Adverse reactions usually increase with the number of BCG instillations.
Low grade fever, flu-like symptoms and general discomfort may occur. These symptoms usually subside within 24-48 hours and should be managed by standard symptomatic treatment. These reactions are signs of a starting immune reaction.
All patients receiving the product should be carefully monitored and advised to report all incidences of fever and other events outside the urinary tract. Systemic adverse reactions/infections are defined as: Fever > 39.5°C during at least 12 hours, fever > 38.5°C during at least 48 hours, miliary pneumonia due to BCG, granulomatous hepatitis, liver function test abnormalities, organic dysfunction (other than genito-urinary tract) with granulomatous inflammation at biopsy, Reiter’s syndrome. Severe systemic BCG reaction/infection can lead to BCG sepsis which is a life-threatening situation.
Infections, infestations: Very commonly cystitis and inflammatory reactions (granulomata) of the bladder. Uncommonly urinary tract infection, orchitis, severe systemic BCG reaction/infection, BCG sepsis, miliary pneumonitis, skin abscess, Reiter’s syndrome (conjunctivitis, asymmetrical oligoarthritis and cystitis). Rarely vascular infection (e. g. infected aneurysm), renal abscess. Very rarely BCG infection of implants and surrounding tissue (e.g. aortic graft infection, cardiac defibrillator, hip or knee arthroplasty), cervical lymphadenitis, regional lymph node infection, osteomyelitis, bone marrow infection, psoas abscess, infection of the glans penis, orchitis or epididymitis resistant to antituberculous therapy. Blood and lymphatic system: Uncommonly cytopenia, anemia. Immune system: Very commonly transient systemic BCG reaction (fever < 38.5°C, flu-like symptoms including malaise, fever, chills, general discomfort). Very rarely hypersensitivity reaction (e.g. oedema of eyelids, cough). Eye: Very rarely chorioretinitis, conjunctivitis, uveitis. Vascular: Very rarely vascular fistula. Respiratory, thoracic, mediastinal: Uncommonly pulmonary granuloma.
Gastrointestinal: Very commonly nausea. Very rarely vomiting, intestinal fistula, peritonitis. Hepatobiliary: Uncommonly hepatitis. Skin, subcutaneous tissue: Uncommonly skin rash. Musculoskeletal and connective tissue: Uncommonly arthritis, arthralgia. Renal, urinary: Very commonly frequent urination with discomfort and pain. Uncommonly macroscopic |
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