Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
BENDAMUSTINE HYDROCHLORIDE
DOR PHARMACEUTICAL SERVICES LTD., ISRAEL
L01AA09
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BENDAMUSTINE HYDROCHLORIDE 100 MG/VIAL
I.V
Required
ZR PHARMA & GMBH
BENDAMUSTINE
First-line of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotheraphy is not appropiate. Indolent non-Hodgkin’s lymphomas as monotheraphy 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.
2019-06-30
,ה/דבכנ ת/חקור ה/אפור לש אפורל ןולעב ןוכדע לע ךעידוהל וננוצרב RIBOMUSTIN 25MG/100MG :ליעפ רמוח 25mg /100mg Bendamustine hydrochloride אפורל ןולעב םינוכדע ןלהל ( הרמחה ותועמשמ בוהצב ןמוסמ טסקט , ותומשמ קוריב ןמוסמ טסקט ןוכדע , טסקט הקיחמ ותועמשמ וק םע םודאב ) : […] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Ribomustin 25 mg contains 25 mg bendamustine hydrochloride. One vial of Ribomustin 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 a the full list of excipients, see section 6.1. […] 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Monotherapy for chronic lymphocytic leukaemia 100 mg/m² 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/m² body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks for at least 6 times. […] 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE […] Infections Serious and fatal infections have occurred with bendamustine hydrochloride, including bacterial (sepsis, pneumonia) and opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP), varicella zoster virus (VZV) and cytomegalovirus (CMV). Treatment with bendamustine hydrochloride may cause prolonged lymphocytopenia (< 600/μl) and low CD4- positive T-cell (T-helper cell) counts (< 200/μl) for at least 7–9 months after the completion of treatment. Lymphocytopenia and CD4-positive T-cell depletion are more pronounced when bendamustine is combined with rituximab Patients with lymphopenia and low CD4- positive T-cell count following treatment with bendamustine hydrochloride are more susceptible to (opportunistic) infections.. In case of low CD4-positive T-cell counts (< 200/μl) Pneumocystis jirov Lestu allt skjalið
1 of 14 1. NAME OF THE MEDICINAL PRODUCT Ribomustin 25 mg Ribomustin 100 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Ribomustin 25 mg contains 25 mg bendamustine hydrochloride. One vial of Ribomustin 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/m² 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 2 of 14 120 mg/m² 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 Ribomustin 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 1.2 - 3.0 mg/dl). No data is available in patients with severe hepatic impairment (serum bilirubin values of > 3.0 mg/dl) (see section 4.3). Renal impairment On the basis of pharmacokinetic data, Lestu allt skjalið