Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
CETUXIMAB
MERCK SERONO LTD
L01XC06
SOLUTION FOR INFUSION
CETUXIMAB 5 MG/ML
I.V
Required
MERCK HEALTHCARE KGAA, GERMANY
CETUXIMAB
CETUXIMAB
Erbitux® is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) - expressing, RAS wild-type metastatic colorectal cancer• In combination with irinotecan-based chemotherapy• In first-line in combination with FOLFOX• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecanErbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck (SCCHN)• in combination with radiation therapy for locally advanced disease• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease• as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease
2014-07-31
1 of 2 Merck Serono Ltd. www.merckserono.co.il 18 Kishon St. Yavne, Israel 81220 Tel: +972 8 9382610 Fax: +972 8 9403152 office.israel@merckgroup.com רבמצד 2018 ERBITUX 5MG/ML, SOLUTION FOR INFUSION סקוטיברא 5 ג"מ / הסימת ,ל"מ ל יוריע CETUXIMAB 5 MG/ML ת/חקור ,ה/אפור ,םידבכנ יאופר תווצו רישכתה לש אפורל ןולעה יכ םכעידוהל םישקבמ ונא ERBITUX 5MG/ML ןכדוע . :תורשואמה תויוותהה Erbitux ® is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) - expressing, RAS wild-type metastatic colorectal cancer • In combination with irinotecan-based chemotherapy • In first-line in combination with FOLFOX • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck (SCCHN) • in combination with radiation therapy for locally advanced disease • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease • as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease ל ןולעב םייונישה אפור םניה ףיעסב 4.4 Special warnings and precautions for use – Respiratory disorders Cases of interstitial lung disease (ILD), including fatal cases, have been reported, with the majority of patients from the Japanese population. Confounding or contributing factors, such as concomitant chemotherapy known to be associated with ILD, and pre-existing pulmonary diseases were frequent in fatal cases. Such patients should be closely monitored. In the event of symptoms (such as dyspnoea, cough, fever) or radiographic findings suggestive of ILD, prompt diagnostic investigation should occur. If interstitial lung disease is diagnosed, cetuximab must be discontinued and the patient be treated appropriately. ףיעס 4.8 – Undesirable effects Respiratory, Belgenin tamamını okuyun
1 PRESCRIBING INFORMATION ERBITUX ® 5 MG/ML 1. NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for infusion contains 5 mg cetuximab. Each vial of 20 mL contains 100 mg cetuximab. Each vial of 100 mL contains 500 mg cetuximab. Cetuximab is a chimeric monoclonal IgG 1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Colourless solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX, • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. _For details, see section 5.1._ Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck • in combination with radiation therapy for locally advanced disease, • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease , • as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion. Availability of resuscitation equipment must be ensured. 2 Posology Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab. This premedication is recommended prior to all subsequent infusions. In all indications, Erbitux is administered once a week. The initial dose is 400 mg c Belgenin tamamını okuyun