מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
BENDAMUSTINE HYDROCHLORIDE
RAFA LABORATORIES LTD
L01AA09
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BENDAMUSTINE HYDROCHLORIDE 25 MG/VIAL
I.V
Required
INTAS PHARMACEUTICALS LTD, INDIA
BENDAMUSTINE
First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.Indolent non-Hodgkin’s lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.Follicular non-Hodgkin’s lymphoma as first line treatment in combination with rituximab.
2018-01-31
ינוי 2019 ,ה/דבכנ ת/חקור ,ה/אפור , DEMUSTIN 100 MG, DEMUSTIN 25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION רישכתה לש אפורל ןולעה ןכדוע יכ םכתעידיל איבהל תשקבמ אפר תודבעמ . ה ביכרמ ה ליעפ Demustin 25 mg contains 25 mg bendamustine hydrochloride/vial. Demustin 100 mg contains 100 mg bendamustine hydrochloride/vial. יוותה ה : First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Follicular non-Hodgkin’s lymphoma as first line treatment in combination with rituximab. :ןולעב םייתועמשמה םייונישה ףיעסב POSOLOGY )ןותחת וק םע בוהצב ןמוסמ( לק יוניש השענ _Monotherapy for chronic lymphocytic leukaemia_ _ _ 100 mg/m 2 body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks up to 6 times. _ _ _Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab_ _ _ 120 mg/m 2 body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks for at least 6 times. :יכ ןייוצ םימוהיזל תועגונה תורהזאב In case of low CD4-positive T-cell counts (< 200/μl) Pneumocystis jirovecii pneumonia (PJP) prophylaxis should be considered . :תוירוע תובוגת יבגל תורהזאב ףסוה DRESS (Drug reaction with eosinophilia and systemic symptoms :ןכו Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms. :יאוול תועפות :ופסוה Pneumonitis , Pulmonary alveolar haemorrhage , Urticaria , DRESS. ולעל רושיק ב"צמ ן כדועמה ן ב ו .םייתועמשמה םייונישה םי קרא את המסמך השלם
The content of this leaflet was approved by the Ministry of Health in November 2017, and updated according to the guidelines of the Ministry of Health in May 2019. Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT DEMUSTIN 25 MG DEMUSTIN 100 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Demustin 25 mg contains 25 mg bendamustine hydrochloride. One vial of Demustin 100 mg contains 100 mg bendamustine hydrochloride. 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride when reconstituted according to section 6.6. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion White, microcrystalline powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Follicular non-Hodgkin’s lymphoma as first line treatment in combination with rituximab. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Monotherapy for chronic lymphocytic leukaemia_ _ _ 100 mg/m 2 body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks up to 6 times. _ _ _Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab_ _ _ 120 mg/m 2 body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks for at least 6 times. _Follicular non-Hodgkin’s lymphoma: Combination with rituximab: _ The dose is 90 mg/m² body surface area Demustin I.V. on days 1 and 2 plus 375 mg/m² rituximab on day 1; repetition every 4 weeks. _Hepatic impairment_ _ _ On the basis of pharmacokinetic data, no dose adjustment is necessary in patients with mild hepatic impairment (serum bilirubin < 1.2mg/dl). A 30% dose reduction is recommended in patients with moderate hepatic impairment (serum bilirubin קרא את המסמך השלם