İsrail - İngilizce - Ministry of Health

roche pharmaceuticals (israel) ltd - erlotinib as dihydrochloride - film coated tablets - erlotinib as dihydrochloride 100 mg - erlotinib - erlotinib - non-small cell lung cancer (nsclc):tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations.tarceva is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy.tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer:tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

İsrail - İngilizce - Ministry of Health

eisai israel ltd., israel - eribulin as mesilate - solution for injection - eribulin as mesilate 0.44 mg/ml - eribulin - eribulin - halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

İsrail - İngilizce - Ministry of Health

amgen europe b.v. - filgrastim - solution for injection - filgrastim 30 mu/ml - filgrastim - filgrastim - neupogen is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of neupogen are similar in adults and children receiving cytotoxic chemotherapy.neupogen is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 × 109/l, and a history of severe or recurrent infections, long term administration of neupogen is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.neupogen is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 × 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

İsrail - İngilizce - Ministry of Health

amgen europe b.v. - filgrastim - solution for injection - filgrastim 48 mu / 0.5 ml - filgrastim - filgrastim - neupogen is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of neupogen are similar in adults and children receiving cytotoxic chemotherapy.neupogen is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 × 109/l, and a history of severe or recurrent infections, long term administration of neupogen is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.neupogen is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 × 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

İsrail - İngilizce - Ministry of Health

amgen europe b.v. - filgrastim - solution for injection - filgrastim 30 mu / 0.5 ml - filgrastim - filgrastim - neupogen is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of neupogen are similar in adults and children receiving cytotoxic chemotherapy.neupogen is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 × 109/l, and a history of severe or recurrent infections, long term administration of neupogen is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.neupogen is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 × 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

İsrail - İngilizce - Ministry of Health

teva israel ltd - filgrastim - solution for injection / infusion - filgrastim 0.6 mg/ml - filgrastim - filgrastim - tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes ) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of tevagrastim are similar in adults and children receiving cytotoxic chemotherapy. tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). in patients children or adults with severe congenital neutropenia cyclic or idiopathic neutropenia with an absolute nuetrophil count (anc) less than or equal to 0.5 x 1000000000 /l and a history of severe or recurrent infections long term administration of tevagrastim is indicated to increase neutophil count and to reduce the incidence and duration of infection-related events. tevagrastim in indicated for the treatment of persistent neutopenia (anc less than or equal to 1.0 x 1000000000/l ) in patients with advanced hiv infection in order to reduce the risk of bacterial infections when other options to manage neutopenia are inappropriate.

İsrail - İngilizce - Ministry of Health

amgen europe b.v. - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml ml - pegfilgrastim - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy. ( with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd - gemcitabine as hydrochloride - lyophilic powder for concentrated infusion - gemcitabine as hydrochloride 1 g/vial - pyrimidine analogues - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer. gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

İsrail - İngilizce - Ministry of Health

eli lilly israel ltd - gemcitabine as hydrochloride - lyophilic powder for concentrated infusion - gemcitabine as hydrochloride 1 g/vial - pyrimidine analogues - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer. gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

medice arzneimittel pütter gmbh co. kg - epoetin alfa - anemia; kidney failure, chronic; cancer - antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients:treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy).abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. its use in this indication must be balanced against the reported risk of thromboembolic events. treatment should only be given to patients with moderate anaemia (haemoglobin (hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. use should be restricted to patients with moderate anaemia (e.g. hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.