Eylea
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
20-03-2024
Produktets egenskaber
(SPC)
20-03-2024
Offentlige vurderingsrapport
(PAR)
10-01-2023
Aktiv bestanddel:
aflibercept
Tilgængelig fra:
Bayer AG
ATC-kode:
S01LA05
INN (International Name):
aflibercept
Terapeutisk gruppe:
Ophthalmologicals
Terapeutisk område:
Wet Macular Degeneration; Macular Edema; Diabetes Complications
Terapeutiske indikationer:
Eylea is indicated for adults for the treatment of:neovascular (wet) age-related macular degeneration (AMD);visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO);visual impairment due to diabetic macular oedema (DME);visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Produkt oversigt:
Revision: 30
Autorisation status:
Authorised
Autorisation dato:
2012-11-21
Indlægsseddel
100
B. PACKAGE LEAFLET
101
PACKAGE LEAFLET: INFORMATION FOR THE ADULT PATIENT
_ _
EYLEA 40 MG/ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
aflibercept
ADULTS
For information for guardians of babies born prematurely, please see
the other side of this package
leaflet. [applicable for 1 language]
For information for guardians of babies born prematurely, please see
further down the page.
[applicable for 2 or more languages]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Eylea is and what it is used for
2.
What you need to know before you are given Eylea
3.
How you will be given Eylea
4.
Possible side effects
5.
How to store Eylea
6.
Contents of the pack and other information
1.
WHAT EYLEA IS AND WHAT IT IS USED FOR
Eylea is a solution which is injected into the eye to treat eye
conditions in adults called
-
neovascular (wet) age-related macular degeneration (wet AMD),
-
impaired vision due to macular oedema secondary to retinal vein
occlusion (branch RVO
(BRVO) or central RVO (CRVO)),
-
impaired vision due to diabetic macular oedema (DME),
-
impaired vision due to myopic choroidal neovascularisation (myopic
CNV).
Aflibercept, the active substance in Eylea, blocks the activity of a
group of factors, known as Vascular
Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor
(PlGF).
In patients with wet AMD and myopic CNV, these factors, in excess are
involved in the abnormal
formation of new blood vessels in the eye. These new blood vessels can
cause the leak of blood
components into the eye and eventual damage to tissues in the eye
responsible for vision.
In patients with CRVO, a blockage occurs in the main blood vessel that
transports blood away from
the retin
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eylea 40 mg/mL solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution for injection contains 40 mg aflibercept*.
One pre-filled syringe contains an extractable volume of at least 0.09
mL, equivalent to at least 3.6 mg
aflibercept. This provides a usable amount to deliver a single dose of
0.05 mL containing 2 mg
aflibercept to adult patients or a single dose of 0.01 mL containing
0.4 mg aflibercept to preterm
infants.
*Fusion protein consisting of portions of human VEGF (Vascular
Endothelial Growth Factor)
receptors 1 and 2 extracellular domains fused to the Fc portion of
human IgG1 and produced in
Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
The solution is a clear, colourless to pale yellow and iso-osmotic
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eylea is indicated for adults for the treatment of
•
neovascular (wet) age-related macular degeneration (AMD) (see section
5.1),
•
visual impairment due to macular oedema secondary to retinal vein
occlusion (branch RVO or
central RVO) (see section 5.1),
•
visual impairment due to diabetic macular oedema (DME) (see section
5.1),
•
visual impairment due to myopic choroidal neovascularisation (myopic
CNV) (see section 5.1).
EYLEA is indicated in preterm infants for the treatment of
•
retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+),
zone II (stage 2+ or 3+) or
AP-ROP (aggressive posterior ROP) disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Eylea is for intravitreal injection only.
Eylea must only be administered by a qualified physician experienced
in administering intravitreal
injections.
Posology
_wet AMD _
_ _
The recommended dose for Eylea is 2 mg aflibercept, equivalent to 0.05
mL.
Eylea treatment is initiated with one injection per month for three
consecutiv
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