SYMBENDA 100mg Powder for Solution for Injection

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Bendamustine Hydrocloride 100mg (equivalent to Bendamustine 90.8 mg)

Disponible desde:

EISAI (SINGAPORE) PTE. LTD.

Código ATC:

L01AA09

Dosis:

100mg

formulario farmacéutico:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composición:

Bendamustine Hydrocloride 100mg (equivalent to Bendamustine 90.8 mg) 100mg

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricado por:

Cenexi-Laboratoires Thissen SA

Estado de Autorización:

ACTIVE

Fecha de autorización:

2010-01-20

Información para el usuario

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
$ISPOJD
MZNQIPDZUJD
MFVLFNJB
$-- 
&GGJDBDZ
SFMBUJWF
UP
GJSTU

line therapies other than chlorambucil has not been established. 
(1.1)
r
*OEPMFOU
#DFMM
OPO)PEHLJOT
MZNQIPNB
/)-
UIBU
IBT

progressed during or within six months of treatment with 
rituximab or a rituximab-containing regimen. (1.2)
DOSAGE AND ADMINISTRATION
'PS
$--
r

NHN
2

JOGVTFE
JOUSBWFOPVTMZ
PWFS

NJOVUFT
PO
%BZT


and 2 of a 28-day cycle, up to 6 cycles (2.1)
r
%PTF
NPEJGJDBUJPOT
GPS
IFNBUPMPHJD
UPYJDJUZ
GPS
(SBEF

PS

greater toxicity, reduce dose to 50 mg/m
2
 on Days 1 and 2; if 
(SBEF

PS
HSFBUFS
UPYJDJUZ
SFDVST
SFEVDF
EPTF
UP

NHN
2
 on 
Days 1 and 2. (2.1)
r
%PTF
NPEJGJDBUJPOT
GPS
OPOIFNBUPMPHJD
UPYJDJUZ
GPS
DMJOJDBMMZ

TJHOJGJDBOU
(SBEF

PS
HSFBUFS
UPYJDJUZ
SFEVDF
UIF
EPTF
UP
 
50 mg/m
2
 on Days 1 and 2 of each cycle. (2.1)
r
%PTF
SFFTDBMBUJPO
NBZ
CF
DPOTJEFSFE

For NHL:
r

NHN
2

JOGVTFE
JOUSBWFOPVTMZ
PWFS

NJOVUFT
PO
%BZT


and 2 of a 21-day cycle, up to 8 cycles (2.2)
r
%PTF
NPEJGJDBUJPOT
GPS
IFNBUPMPHJD
UPYJDJUZ
GPS
(SBEF

UPYJDJUZ

reduce the dose to 90 mg/m
2
 on Days 1 and 2 of each cycle; if 
(SBEF

UPYJDJUZ
SFDVST
SFEVDF
UIF
EPTF
UP

NHN
2
 on Days 1 
and 2 of each cycle. (2.2) 
r
%PTF
NPEJGJDBUJPOT
GPS
OPOIFNBUPMPHJD
UPYJDJUZ
GPS
(SBEF

PS

greater toxicity, reduce the dose to 90 mg/m
2
 on Days 1 and 2 of 
FBDI
DZDMF
JG
(SBEF

PS
HSFBUFS
UPYJDJUZ
SFDVST
SFEVDF
UIF
EPTF

to 60 mg/m
2
 on Days 1 and 2 of each cycle. (2.2)
(FOFSBM
%PTJOH

Ficha técnica

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