Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
NELARABINE
NOVARTIS ISRAEL LTD
L01BB
SOLUTION FOR INFUSION
NELARABINE 5 MG/ML
I.V
Required
FAREVA UNTERACH GMBH, AUSTRIA
PURINE ANALOGUES
Atriance 5 mg/ml is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
2022-12-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת : 30.05.2013 םש רישכת תילגנאב רפסמו םושירה : ATRIANCE 5MG/ML (137-71-31525) םש לעב םושירה GLAXOSMITHKLINE (ISRAEL) LTD : ספוט הז דעוימ טורפל תורמחהה דבלב ! אפורל ןולעב אפורל ןולעב תורמחהה תושקובמה ןולעב קרפ יחכונ טסקט שדח טסקט ADVERSE EVENTS ------ Post – Marketing Data _…_ _Rare_: Rhabdomyolysis, blood creatine phosphokinase increased ב"צמ ובש ,ןולעה נמוסמ תו תורמחהה שקובמה תו םודאב . םייוניש םניאש רדגב תורמחה ונמוס )ןולעב( עבצב .קורי רבעוה ראודב ינורטקלא ךיראתב 30.05.2013 Přečtěte si celý dokument
ATR API AUG21 V1 EU SmPC 11.20 ATRIANCE ® 5 MG/ML 1. NAME OF THE MEDICINAL PRODUCT ATRIANCE ® 5 MG/ML 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 5 mg of nelarabine. Each vial contains 250 mg of nelarabine. Excipient with known effect Each ml of solution contains 1.770 mg (77 micromols) of sodium. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atriance is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents. Posology Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8). _Adults and adolescents (aged 16 years and older) _ The recommended dose of nelarabine for adults and adolescents aged 16 years and older is 1,500 mg/m 2 administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days. _ _ ATR API AUG21 V1 EU SmPC 11.20 _Children and adolescents (aged 21 years and younger) _ _ _ The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m 2 administered intravenously over one hour daily for 5 consecutive days, repeated every 21 days. In clinical studies, the 650 mg/m 2 and 1,500 mg/m 2 dose have both been used in patients in the age range 16 to 21 years. Efficacy and safety were similar for both regimens. The prescribing physician should consider which regimen is appropriate when treating patients in this age range. Limited clinical pharmacology data are available Přečtěte si celý dokument