EYLEA SOLUTION FOR INJECTION IN VIAL 2MG

Country: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

Aflibercept

Disponibbli minn:

BAYER (SOUTH EAST ASIA) PTE LTD

Kodiċi ATC:

S01LA05

Dożaġġ:

2.0mg/50mcl

Għamla farmaċewtika:

INJECTION, SOLUTION

Kompożizzjoni:

Aflibercept 2.0mg/50mcl

Rotta amministrattiva:

INTRAVITREOUS

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

Vetter Pharma-Fertigung GmbH & Co. KG (Mnf, pri packing, In-process testing, QC testing of final DP)

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2013-04-29

Fuljett ta 'informazzjoni

Page 1 of 25

EYLEA PFS & VIAL _CCDS 6_20 June 2014 

1. 
NAME OF THE MEDICINAL PRODUCT 

EYLEA, 40mg/ml solution for injection 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One milliliter solution for injection contains 40 mg aflibercept. 

Each single-dose, pre-filled syringe provides a usable amount to
deliver a single dose of 
50 microliters containing 2 mg aflibercept. 

Each vial provides a usable amount to deliver a single
dose of 50 microliters containing 2 
mg aflibercept. 

For a full list of excipients
see section "List of excipients". 

3. 
PHARMACEUTICAL FORM 

Solution for injection. 

Clear, colorless to pale yellow, iso-osmotic solution, pH 6.2. 

4. 
CLINICAL PARTICULARS 

4.1 
INDICATION(S) 

EYLEA is indicated for the treatment of  


neovascular (wet) age-related macular
degeneration (wet AMD) (see section 5.1 
“Pharmacodynamic properties”). 


macular edema secondary to central retinal vein occlusion (CRVO). 

4.2 
DOSAGE AND METHOD OF ADMINISTRATION 

EYLEA is for intravitreal injection only. 

It must only be administered by a qualified physician
experienced in administering 
intravitreal injections. 

4.2.1 
DOSAGE REGIMEN 

_4.2.1.1 _
_NEOVASCULAR (WET) AGE-RELATED DEGENERATION (WET AMD) _

The recommended dose for EYLEA is 2 mg aflibercept, equivalent
to 50 microlitres.

EYLEA treatment is initiated with one injection per month
for three consecutive months, 
followed by one injection every 2 months. There is
no requirement for monitoring between 
injections. 

Page 2 of 25

EYLEA PFS & VIAL _CCDS 6_20 June 2014 

After the first 12 months of treatment with EYLEA, the treatment
interval may be extended based 
on visual and anatomic outcomes. In this case the schedule
for monitoring should be determined by 
the treating phy

Karatteristiċi tal-prodott

Page 1 of 42
1.
NAME OF THE MEDICINAL PRODUCT
EYLEA, 40mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One milliliter solution for injection contains 40 mg aflibercept.
Each single-dose, pre-filled syringe or vial provides a usable amount
to deliver a single
dose of 50 microliters containing 2 mg aflibercept.
For the full list of excipients see section "List of excipients".
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless to pale yellow, iso-osmotic solution, pH 6.2.
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
EYLEA is indicated for the treatment of
•
neovascular (wet) age-related macular degeneration (wet AMD) (see
section 5.1
“Pharmacodynamic properties”).
•
macular edema secondary to retinal vein occlusion (branch RVO or
central RVO).
•
diabetic macular edema (DME).
•
myopic choroidal neovascularization (myopic CNV)
4.2
DOSAGE AND METHOD OF ADMINISTRATION
EYLEA is for intravitreal injection only.
It must only be administered by a qualified physician experienced in
administering
intravitreal injections.
4.2.1
DOSAGE REGIMEN
_4.2.1.1 _
_NEOVASCULAR (WET) AGE-RELATED DEGENERATION (WET AMD) _
The recommended dose for EYLEA is 2 mg aflibercept, equivalent to 50
microlitres.
EYLEA treatment is initiated with one injection per month for three
consecutive doses, followed
by one injection every two months.
Based on the physician’s judgement of visual and/or anatomic
outcomes, the treatment interval
may be maintained at two months or further extended, such as with
using a treat-and-extend
Page 2 of 42
dosing regimen, where treatment injection intervals are increased in
2- or 4-weekly increments to
maintain stable visual and/or anatomic outcomes.. If visual and/or
anatomic outcomes deteriorate,
the treatment interval should be shortened accordingly.
There is no requirement for monitoring between injections. Based on
the physician’s judgement
the schedule of monitoring visits may be more frequent than the
injections visits.
Treatment intervals greater than 4 months (16