País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Bendamustine Hydrocloride 100mg (equivalent to Bendamustine 90.8 mg)
EISAI (SINGAPORE) PTE. LTD.
L01AA09
100mg
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Bendamustine Hydrocloride 100mg (equivalent to Bendamustine 90.8 mg) 100mg
INTRAVENOUS
Prescription Only
Cenexi-Laboratoires Thissen SA
ACTIVE
2010-01-20
128894 128894 Symbenda SB-Singapore LFT 330 x 500 mm LFT_ VTB 2579 Eq. to: N/A 24.08.2012 S T U D I O K E I J Z E R dl Black HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SYMBENDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYMBENDA. SYMBENDA ® (Bendamustine Hydrochloride) 25 mg & 100 mg Powder for solution for injection INDICATIONS AND USAGE SYMBENDA for Injection is an alkylating drug indicated for treatment of patients with: r$ISPOJDMZNQIPDZUJDMFVLFNJB $-- &GGJDBDZSFMBUJWFUPGJSTU line therapies other than chlorambucil has not been established. (1.1) r*OEPMFOU#DFMMOPO)PEHLJOTMZNQIPNB /)- UIBUIBT progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (1.2) DOSAGE AND ADMINISTRATION 'PS$-- rNHN 2 JOGVTFEJOUSBWFOPVTMZPWFSNJOVUFTPO%BZT and 2 of a 28-day cycle, up to 6 cycles (2.1) r%PTFNPEJGJDBUJPOTGPSIFNBUPMPHJDUPYJDJUZGPS(SBEFPS greater toxicity, reduce dose to 50 mg/m 2 on Days 1 and 2; if (SBEFPSHSFBUFSUPYJDJUZSFDVSTSFEVDFEPTFUPNHN 2 on Days 1 and 2. (2.1) r%PTFNPEJGJDBUJPOTGPSOPOIFNBUPMPHJDUPYJDJUZGPSDMJOJDBMMZ TJHOJGJDBOU(SBEFPSHSFBUFSUPYJDJUZSFEVDFUIFEPTFUP 50 mg/m 2 on Days 1 and 2 of each cycle. (2.1) r%PTFSFFTDBMBUJPONBZCFDPOTJEFSFE For NHL: rNHN 2 JOGVTFEJOUSBWFOPVTMZPWFSNJOVUFTPO%BZT and 2 of a 21-day cycle, up to 8 cycles (2.2) r%PTFNPEJGJDBUJPOTGPSIFNBUPMPHJDUPYJDJUZGPS(SBEFUPYJDJUZ reduce the dose to 90 mg/m 2 on Days 1 and 2 of each cycle; if (SBEFUPYJDJUZSFDVSTSFEVDFUIFEPTFUPNHN 2 on Days 1 and 2 of each cycle. (2.2) r%PTFNPEJGJDBUJPOTGPSOPOIFNBUPMPHJDUPYJDJUZGPS(SBEFPS greater toxicity, reduce the dose to 90 mg/m 2 on Days 1 and 2 of FBDIDZDMFJG(SBEFPSHSFBUFSUPYJDJUZSFDVSTSFEVDFUIFEPTF to 60 mg/m 2 on Days 1 and 2 of each cycle. (2.2) (FOFSBM%PTJOH Leia o documento completo
1 of 14 HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SYMBENDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYMBENDA. SYMBENDA ® (Bendamustine Hydrochloride) 25 mg & 100 mg Powder for solution for injection ----------------------------INDICATIONS AND USAGE--------------------------- SYMBENDA for Injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. (1.1) Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab- containing regimen. (1.2) ----------------------DOSAGE AND ADMINISTRATION------------------------ For CLL: 100 mg/m 2 infused intravenously over 30 minutes on Days 1 and 2 of a 28- day cycle, up to 6 cycles (2.1) Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce dose to 50 mg/m 2 on Days 1 and 2; if Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m 2 on Days 1 and 2. (2.1) Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m 2 on Days 1 and 2 of each cycle. (2.1) Dose re-escalation may be considered. (2.1) For NHL: 120 mg/m 2 infused intravenously over 60 minutes on Days 1 and 2 of a 21- day cycle, up to 8 cycles (2.2) Dose modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m 2 on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m 2 on Days 1 and 2 of each cycle. (2.2) Dose modifications for non-hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 90 mg/m 2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m 2 on Days 1 and 2 of each cycle. (2.2) General Dosing Considerations: Delay treatment for Grade 4 hematologic Leia o documento completo