Eylea solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

aflibercept

Available from:

Bayer AG

ATC code:

S01LA05

INN (International Name):

aflibercept

Dosage:

40mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(1) glass vial 0.278ml and needle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-03-11

Summary of Product characteristics

1
RESTRICTED
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
32
RESTRICTED
1.
NAME OF THE MEDICINAL PRODUCT
Eylea 40 mg/ml solution for injection in a vial.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 40 mg aflibercept*.
Each vial contains 100 microlitres, equivalent to 4 mg aflibercept.
This provides a usable amount to
deliver a single dose of 50 microlitres 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 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).
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 50
microlitres.
Eylea treatment is initiated with one injection per month for three
consecutive doses. The treatment
interval is then extended to 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 using a treat-and-extend
dosing regimen, where
injection intervals are increased in 2- or 4-weekly increments to