Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Catumaxomab
Neovii Biotech GmbH
L01XC09
catumaxomab
Other antineoplastic agents
Ascites; Cancer
Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.,
Revision: 5
Withdrawn
2009-04-20
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Removab 10 micrograms concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1 ml solution, corresponding to 0.1 mg/ml. *rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Removab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products. Posology Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4). Removab dosing schedule comprises the following four intraperitoneal infusions: 1 st dose 10 micrograms on day 0 2 nd dose 20 micrograms on day 3 3 rd dose 50 micrograms on day 7 4 th dose 150 micrograms on day 10 Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours. In clinical studies infusion times of 3 hours and 6 hours were investigated. For the first of the four doses an infusion time of 6 hours may be considered depending on the patient’s health condition. An interval of at least two infusion free calendar days must elapse between infusion days. The interval between the infusion days can be prolonged in case of relevant adverse reactions. The overall treatment period should not exceed 20 days. _ _ _Monitoring _ Adequate monitoring of the patient after end of Removab infusion is recommended. In the pivotal study patien Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Removab 10 micrograms concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1 ml solution, corresponding to 0.1 mg/ml. *rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Removab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products. Posology Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4). Removab dosing schedule comprises the following four intraperitoneal infusions: 1 st dose 10 micrograms on day 0 2 nd dose 20 micrograms on day 3 3 rd dose 50 micrograms on day 7 4 th dose 150 micrograms on day 10 Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours. In clinical studies infusion times of 3 hours and 6 hours were investigated. For the first of the four doses an infusion time of 6 hours may be considered depending on the patient’s health condition. An interval of at least two infusion free calendar days must elapse between infusion days. The interval between the infusion days can be prolonged in case of relevant adverse reactions. The overall treatment period should not exceed 20 days. _ _ _Monitoring _ Adequate monitoring of the patient after end of Removab infusion is recommended. In the pivotal study patien Przeczytaj cały dokument