ZALTRAP CONCENTRATE FOR SOLUTION FOR INFUSION 25 MGML

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Aflibercept

Dostupno od:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC koda:

Pending

Doziranje:

25.0 mg/ml

Farmaceutski oblik:

INFUSION, SOLUTION CONCENTRATE

Sastav:

Aflibercept 25.0 mg/ml

Administracija rute:

INTRAVENOUS

Tip recepta:

Prescription Only

Proizveden od:

Sanofi-Aventis Deutschland GmbH

Status autorizacije:

ACTIVE

Datum autorizacije:

2014-08-21

Uputa o lijeku

1 

NAME OF THE MEDICINAL PRODUCT 
ZALTRAP 25 mg/ml Concentrate for Solution for Infusion 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
One ml of concentrate for solution for infusion contains 25
mg aflibercept* 
One vial of 4 ml of concentrate contains 100
mg of aflibercept 
One vial of 8 ml of concentrate contains 200
mg of aflibercept 

* Aflibercept is produced in
a Chinese hamster ovary (CHO) K-1 mammalian expression system 
by recombinant DNA technology. 

For the full list of excipients, see section List
of Excipients. 

PHARMACEUTICAL FORM 
Concentrate for solution for infusion (sterile concentrate) 
The concentrate is a clear colourless to pale yellow solution 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
ZALTRAP in combination with
irinotecan/5-fluorouracil/folinic  acid (FOLFIRI) chemotherapy 
is  indicated in adults with metastatic colorectal
cancer (MCRC) that is resistant to or has 
progressed after an oxaliplatin-containing regimen. 

POSOLOGY AND METHOD OF ADMINISTRATION 
ZALTRAP should be administered under the supervision
of a physician experienced in the use of 
antineoplastic medicinal products. 

Posology 
The recommended dose of ZALTRAP, administered as an
intravenous infusion over 1 hour, is 4 
mg/kg of body weight, followed by the FOLFIRI regimen.
This is considered as one treatment 
cycle. 

The FOLFIRI regimen to be used is irinotecan 180 mg/m
2
 intravenous infusion over 90 minutes 
and folinic acid (dl racemic) 400 mg/m² intravenous infusion
over 2 hours at the same time on 
day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400
mg/m² intravenous bolus, followed 
by 5-FU 2400 mg/m² continuous intravenous infusion over 46
hours. 

The treatment cycle is repeated every 2 weeks. 

ZALTRAP treatment should be continued until disease progression
or unacceptable toxicity 

Svojstava lijeka

1
NAME OF THE MEDICINAL PRODUCT
ZALTRAP 25 mg/ml Concentrate for Solution for Infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate for solution for infusion contains 25 mg
aflibercept*
One vial of 4 ml of concentrate contains 100 mg of aflibercept
One vial of 8 ml of concentrate contains 200 mg of aflibercept
* Aflibercept is produced in a Chinese hamster ovary (CHO) K-1
mammalian expression system
by recombinant DNA technology.
For the full list of excipients, see section List of Excipients.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
The concentrate is a clear colourless to pale yellow solution
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid
(FOLFIRI) chemotherapy
is indicated in adults with metastatic colorectal cancer (MCRC) that
is resistant to or has
progressed after an oxaliplatin-containing regimen.
POSOLOGY AND METHOD OF ADMINISTRATION
ZALTRAP should be administered under the supervision of a physician
experienced in the use of
antineoplastic medicinal products.
Posology
The recommended dose of ZALTRAP, administered as an intravenous
infusion over 1 hour, is 4
mg/kg of body weight, followed by the FOLFIRI regimen. This is
considered as one treatment
cycle.
The FOLFIRI regimen to be used is irinotecan 180 mg/m
2
intravenous infusion over 90 minutes
and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2
hours at the same time on
day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg/m²
intravenous bolus, followed
by 5-FU 2400 mg/m² continuous intravenous infusion over 46 hours.
The treatment cycle is repeated every 2 weeks.
ZALTRAP treatment should be continued until disease progression or
unacceptable toxicity
occurs.
_Dose Modification _
ZALTRAP should be discontinued for (see section Special Warnings and
Precautions for Use):

Severe haemorrhage
2

Gastrointestinal (GI) perforation

Fistula formation

Hypertension
that
is
not
adequately
controlled
wit