Australia - engelsk - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; water for injections; sodium chloride; sodium hydroxide; glycine; polysorbate 80 - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) 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.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: water for injections; citric acid monohydrate; polysorbate 80; sodium chloride; sodium hydroxide; glycine - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) 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.

USA - engelsk - NLM (National Library of Medicine)

imclone llc - cetuximab (unii: pqx0d8j21j) (cetuximab - unii:pqx0d8j21j) - cetuximab 2 mg in 1 ml - erbitux® is indicated: - in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (scchn). - in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic scchn. - as a single-agent for the treatment of patients with recurrent or metastatic scchn for whom prior platinum-based therapy has failed. erbitux is indicated for the treatment of k-ras wild-type, epidermal growth factor receptor (egfr)-expressing, metastatic colorectal cancer (mcrc) as determined by an fda-approved test [see dosage and administration (2.2)] : - in combination with folfiri (irinotecan, fluorouracil, leucovorin) for first-line treatment, - in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, - as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Israel - engelsk - Ministry of Health

merck serono ltd - cetuximab - solution for infusion - cetuximab 5 mg/ml - 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

Den europeiske union - italiensk - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - agenti antineoplastici - cetuximab è indicato per il trattamento di pazienti con epidermal growth factor receptor (egfr)-di esprimere, ras wild-type metastatico cancro del colon-retto:in combinazione con irinotecan a base di chemioterapia;in prima linea in combinazione con folfox;come agente singolo in pazienti che hanno fallito di oxaliplatino e irinotecan terapia di base e che siano intolleranti a irinotecan. per i dettagli, vedere la sezione 5. cetuximab è indicato per il trattamento di pazienti con carcinoma a cellule squamose della testa e del collo:in combinazione con radioterapia per la malattia localmente avanzata;in combinazione con chemioterapia a base di platino per la ricorrente e/o metastatica di malattia.

Den europeiske union - tsjekkisk - EMA (European Medicines Agency)

merck europe b.v.  - cetuximabem - head and neck neoplasms; colorectal neoplasms - antineoplastická činidla - erbitux je indikován k léčbě pacientů s receptor pro epidermální růstový faktor (egfr)-vyjádření, ras divokého typu metastazujícím kolorektálním karcinomem:v kombinaci s irinotekanem-based chemoterapie;v první linii v kombinaci s folfox;v monoterapii u pacientů, kteří neuspěli oxaliplatinu a irinotekan-založené terapie a kteří nesnáší irinotekan. pro podrobnosti, viz bod 5. erbitux je indikován k léčbě pacientů s spinocelulárním karcinomem hlavy a krku v kombinaci s radiační terapií k léčbě lokálně pokročilého onemocnění;v kombinaci s chemoterapií na bázi platiny pro recidivující a/nebo metastatické onemocnění.

Den europeiske union - svensk - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - antineoplastiska medel - erbitux är indicerat för behandling av patienter med epidermal growth factor receptor (egfr)-uttryckande, ras wild-type metastaserande kolorektal cancer:i kombination med irinotekan-baserad kemoterapi, i första raden i kombination med folfox, som monoterapi till patienter som har misslyckats med oxaliplatin och irinotekan-baserad terapi och som är intoleranta mot irinotekan. för detaljer, se avsnitt 5. erbitux är indicerat för behandling av patienter med skivepitelcancer i huvud och hals:halsen i kombination med strålbehandling för lokalt avancerad sjukdom, i kombination med platinum-baserad kemoterapi för återkommande och/eller metastaserande sjukdom.

Den europeiske union - dansk - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - antineoplastiske midler - erbitux er indiceret til behandling af patienter med epidermal growth factor receptor (egfr)-udtrykker, ras wildtype metastatisk kolorektal cancer:i kombination med irinotecan-baseret kemoterapi;i første linje i kombination med folfox;som en enkelt agent i patienter, der har undladt oxaliplatin - og irinotecan-baseret terapi og der er intolerante over for irinotecan. for detaljer, se afsnit 5. erbitux er indiceret til behandling af patienter med pladecellekræft i hoved og hals:i kombination med strålebehandling for lokalt avanceret sygdom, og i kombination med platin-baseret kemoterapi til tilbagevendende og/eller metastatisk sygdom.

Den europeiske union - rumensk - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - agenți antineoplazici - erbitux este indicat pentru tratamentul pacienților cu receptorul factorului de creștere epidermal (egfr)-exprimarea, ras de tip sălbatic cancer colorectal metastatic:în asociere cu irinotecan pe baza de chimioterapie;în prima linie, în asociere cu folfox;ca un singur agent, la pacienții care nu au reușit oxaliplatină și irinotecan pe baza de terapie și care au intoleranță la irinotecan. pentru detalii, a se vedea secțiunea 5. erbitux este indicat pentru tratamentul pacienților cu cancer cu celule scuamoase al capului și gâtului:în asociere cu radioterapia pentru boala avansată local;în asociere cu chimioterapie pe bază de platină pentru recidivante și/sau metastatice de boală.

Den europeiske union - ungarsk - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - daganatellenes szerek - az erbitux jelzi a kezelés a betegek epidermális növekedési faktor receptor (egfr)-kifejező, ras vad típusú metasztatikus colorectalis rák:kombinációban irinotecan-alapú kemoterápia;első sor kombinálva; folfox;mint egy ügynök olyan betegeknél, akiknek nem sikerült oxaliplatin - irinotecan-alapú terápia, aki intoleráns, hogy irinotecan. a részleteket lásd 5. az erbitux jelzi a kezelés a betegek laphámsejtes rák a fej-nyak:sugárkezeléssel kombinálva a lokálisan előrehaladott betegség;kombinálva platina-alapú kemoterápiához a visszatérő és/vagy metasztatikus betegség.