Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
DOCETAXEL
NOVARTIS ISRAEL LTD
L01CD02
CONCENTRATE FOR SOLUTION FOR INFUSION
DOCETAXEL 10 MG / 1 ML
I.V
Required
EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA
DOCETAXEL
DOCETAXEL
Breast cancer: docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer. docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. docetaxel monotherapy is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease. docetaxel in combination with capecitabine is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an an
2016-07-31
1 _ _ _ הרמחה לע העדוה_ _-_ _ _ _אפורל ןולעב תוחיטב עדימ_ ךיראת .16 2 1 12. : :תילגנאב רישכת םש DOCETAXEL EBEWE 10 MG/1ML :םושיר רפסמ 146-55-33269-00 : םושירה לעב םש PHARMALOGIC LTD. ! דבלב תורמחהה טורפל דעוימ הז ספוט !!תורמחה קרו ךא בוהצב םינמוסמ )םיחפסנכ ופרוצ תואלבט( תושקובמ תורמחה שדח טסקט ןשי טסקט ןולעב קרפ Special poulation Paediatric population The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established. There is no relevant use of docetaxel in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma. _CHILDREN AND ADOLESCENTS _ Docetaxel Ebewe is not recommended for use in children due to insufficient data on safety and efficacy. POSOLOGY AND METHOD OF ADMINISTRATION 2 Respiratory disorders: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome. Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy. If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated. Interruption of docetaxel therapy is recommended until diagnosis is available. Early use of supportive care measures may help improve the condition. The benefit of resuming docetaxel treatment must be carefully evaluated. EYE DISORDERS Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case CMO is diagnosed, docetaxel treatment should be disconti Lesen Sie das vollständige Dokument
1. NAME OF THE MEDICINAL PRODUCT DOCETAXEL EBEWE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION WARNINGS_ _ DOCETAXEL EBEWE CONCENTRATE FOR SOLUTION FOR INFUSION SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN THE USE OF ANTINEOPLASTIC AGENTS. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, AND FLUID RETENTION THE INCIDENCE OF TREATMENT-RELATED MORTALITY ASSOCIATED WITH DOCETAXEL THERAPY IS INCREASED IN PATIENTS WITH ABNORMAL LIVER FUNCTION, IN PATIENTS RECEIVING HIGHER DOSES, AND IN PATIENTS WITH NON-SMALL CELL LUNG CARCINOMA AND A HISTORY OF PRIOR TREATMENT WITH PLATINUM-BASED CHEMOTHERAPY WHO RECEIVE DOCETAXEL AS A SINGLE AGENT AT A DOSE OF 100 MG/M 2 . DOCETAXEL SHOULD NOT BE GIVEN TO PATIENTS WITH BILIRUBIN > UPPER LIMIT OF NORMAL (ULN), OR TO PATIENTS WITH AST AND/OR ALT > 1.5 × ULN CONCOMITANT WITH ALKALINE PHOSPHATASE > 2.5 × ULN. PATIENTS WITH ELEVATIONS OF BILIRUBIN OR ABNORMALITIES OF TRANSAMINASE CONCURRENT WITH ALKALINE PHOSPHATASE ARE AT INCREASED RISK FOR THE DEVELOPMENT OF GRADE 4 NEUTROPENIA, FEBRILE NEUTROPENIA, INFECTIONS, SEVERE THROMBOCYTOPENIA, SEVERE STOMATITIS, SEVERE SKIN TOXICITY, AND TOXIC DEATH. PATIENTS WITH ISOLATED ELEVATIONS OF TRANSAMINASE > 1.5 × ULN ALSO HAD A HIGHER RATE OF FEBRILE NEUTROPENIA GRADE 4 BUT DID NOT HAVE AN INCREASED INCIDENCE OF TOXIC DEATH. BILIRUBIN, AST OR ALT, AND ALKALINE PHOSPHATASE VALUES SHOULD BE OBTAINED PRIOR TO EACH CYCLE OF DOCETAXEL THERAPY. DOCETAXEL THERAPY SHOULD NOT BE GIVEN TO PATIENTS WITH NEUTROPHIL COUNTS OF < 1,500 CELLS/MM. IN ORDER TO MONITOR THE OCCURRENCE OF NEUTROPENIA, WHICH MAY BE SEVERE AND RESULT IN INFECTION, FREQUENT BLOOD CELL COUNTS SHOULD BE PERFORMED ON ALL PATIENTS RECEIVING DOCETAXEL. SEVERE HYPERSENSITIVITY REACTIONS CHARACTERIZED BY GENERALIZED RASH/ERYTHEMA, HYPOTENSION AND/OR BRONCHOSPASM, OR VERY RARELY FATAL ANAPHYLAXIS, HAVE BEEN REPORTED IN PATIENTS WHO RECEIVED A 3-DAY DEXAMETHASONE PREMEDICATION. HYPERSENSITIVITY REACTIONS REQUIRE IMMEDIATE DISCONTINUAT Lesen Sie das vollständige Dokument