SYMBENDA 25 mg Powder for Solution for Injection
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
12-09-2012
Summary of Product characteristics
(SPC)
05-10-2017
Active ingredient:
Bendamustine Hydrocloride 25mg (equivalent to Bendamustine 22.7mg)
Available from:
EISAI (SINGAPORE) PTE. LTD.
ATC code:
L01AA09
Dosage:
25 mg
Pharmaceutical form:
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Composition:
Bendamustine Hydrocloride 25mg (equivalent to Bendamustine 22.7mg) 25 mg
Administration route:
INTRAVENOUS
Prescription type:
Prescription Only
Manufactured by:
Cenexi-Laboratoires Thissen SA
Authorization status:
ACTIVE
Authorization date:
2010-01-20
Patient Information leaflet
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:
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line therapies other than chlorambucil has not been established.
(1.1)
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progressed during or within six months of treatment with
rituximab or a rituximab-containing regimen. (1.2)
DOSAGE AND ADMINISTRATION
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2
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and 2 of a 28-day cycle, up to 6 cycles (2.1)
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greater toxicity, reduce dose to 50 mg/m
2
on Days 1 and 2; if
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2
on
Days 1 and 2. (2.1)
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TJHOJGJDBOU(SBEFPSHSFBUFSUPYJDJUZSFEVDFUIFEPTFUP
50 mg/m
2
on Days 1 and 2 of each cycle. (2.1)
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For NHL:
rNHN
2
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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)
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greater toxicity, reduce the dose to 90 mg/m
2
on Days 1 and 2 of
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to 60 mg/m
2
on Days 1 and 2 of each cycle. (2.2)
(FOFSBM%PTJOH
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Summary of Product characteristics
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
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