Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
ERIBULIN AS MESILATE
NEOPHARM SCIENTIFIC LTD
L01XX41
SOLUTION FOR INJECTION
ERIBULIN AS MESILATE 0.44 MG/ML
I.V
Required
EISAI MANUFACTURING LIMITED, UK
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.
2017-04-30
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) :ךיראת 01/01/110/ םושיר רפסמו תילגנאב רישכת םש : 33511 - 18 - 148 Halaven :םושירה לעב םש Neopharm Scientific Ltd. ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4.8 UNDESIRABLE EFFECTS Summary of safety profile The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections. New onset or worsening of pre-existing peripheral neuropathy has also been reported. Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects. Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome. Tabulated list of adverse reactions Unless otherwise noted, the table shows the incidence rates of adverse reactions observed in breast cancer and soft tissue sarcoma patients who received the recommended dose in Phase 2 and Phase 3 studies. […] Summary of safety profile The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections. New onset or worsening of pre-existing peripheral neuropathy has also been reported. Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects. Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome. Tabulated list of adverse reactions Unle Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT HALAVEN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 (see section 5.1). 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 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HALAVEN should only be prescribed by a qualified physician experienced in the appropriate use of anti-cancer therapy. It should be administered by an appropriately qualified healthcare professional only. Posology The recommended dose of eribulin as the ready to use solution is 1.23 mg/m 2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle. PLEASE NOTE: In Israel and EU the recommended dose refers to the base of the active substance (eribulin). Calculation of the individual dose to be administered to a patient must be based on the strength of the ready to use solution that contains 0.44 mg/ml eribulin and the dose recommendation of 1.23 mg/m 2 . The dose reduction recommendations shown below are also shown as the dose of eribulin to be administered based on the strength of the ready to use solution. In the pivotal trials, the corresponding publications and in some other regions e.g. the United States and Switzerland, the recommended dos Pročitajte cijeli dokument