EYLEA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AFLIBERCEPT

Available from:

BAYER ISRAEL LTD

ATC code:

S01LA05

Pharmaceutical form:

SOLUTION FOR INTRAVITREAL INJECTION

Composition:

AFLIBERCEPT 40 MG/ML

Administration route:

INTRAVITREAL

Prescription type:

Required

Manufactured by:

BAYER AG, GERMANY

Therapeutic area:

AFLIBERCEPT

Therapeutic indications:

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 CRVO or central RVO)• visual impairment due to diabetic macular oedema (DME)• visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Authorization date:

2018-11-30

Patient Information leaflet

Draft 1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
EYLEA
Solution for injection into the eye
Each vial contains: An extractable volume of at least 0.1 ml,
equivalent to at least 4 mg aflibercept.
Inactive ingredients and allergens in this medicine: see section 6
‘Additional information’ and section 2
under ‘Important information about some of this medicine’s
ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
In addition to the patient information leaflet, Eylea also has a
patient safety information guide.
This guide contains important safety information that you need to know
and that you should follow
before you start and during treatment with Eylea. Carefully read the
patient safety information guide
and patient information leaflet before using this medicine. Keep the
guide in case you need to read it
again.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Eylea is intended to treat adults who have:
-
neovascular age-related macular degeneration (wet AMD)
-
impaired vision due to macular edema secondary to retinal vein
occlusion (branch RVO [BRVO] or
central RVO [CRVO])
-
impaired vision due to diabetic macular edema (DME)
-
impaired vision due to myopic choroidal neovascularisation (myopic
CNV).
THERAPEUTIC GROUP: ophthalmologicals / anti angiogenics.
Aflibercept, the active ingredient 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 in short-sighted patients who have myopic
CNV, these factors, in excess,
are involved in the abnormal formation of

Summary of Product characteristics

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.
*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 intravitreal injection.
The solution is a clear, colourless to pale yellow and iso-osmotic
solution.
Patient safety information guide
The marketing of Eylea is subject to a risk management plan (RMP)
including a patient guide. The 'patient
safety information guide', emphasizes important safety information
that the patient should be aware of
before and during treatment. Please explain to the patient the need to
review the guide before starting
treatment.
Prescriber guide and video
This product is marketed with prescriber guide and prescriber video
providing recommendations for the
risk minimization in the use of Eylea. Please ensure you are familiar
with these materials as they contain
important safety information.
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).
4.2
Posology and method of administration
Eylea is for intravitreal injection only.
Eylea mu