EYLEA INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

40,0 mg

Pharmaceutical form:

INJECTION

Composition:

EACH 1,0 ml SOLUTION CONTAINS AFLIBERCEPT 40,0 mg

Authorization status:

Registered

Authorization date:

2018-05-07

Patient Information leaflet

APPROVED EYLEA SOLUTION PATIENT INFORMATION LEAFLET
BAYER (PTY) LTD APPROVAL DATE: 16 OCTOBER 2023
Page 1 of 5
CCDS17/16.12.2021/SA07/10.2023
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
EYLEA Solution for Injection
Aflibercept
Contains sugar (sucrose)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TREATMENT WITH
EYLEA INJECTION

Keep this leaflet. You may need to read it again.

This leaflet will provide information about the benefits and risks of
using EYLEA. It will also
advise you on how you will be given EYLEA properly and when to tell
your doctor about health-
related conditions. If you have further questions, please ask your
doctor, professional health care
provider, or your pharmacist.

EYLEA has been prescribed for you personally.
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 are 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 called

Neovascular (wet) age-related macular degeneration, commonly referred
to as wet AMD

Macular oedema following central retinal vein occlusion (CRVO)

Macular oedema secondary to branch retinal vein occlusion (BRVO)

Diabetic macular oedema (DME)

Myopic choroidal neovascularization (myopic CNV).
Aflibercept, the active substance in EYLEA, blocks the activity of a
group of factors (known as VEGF-A
and PIGF) which, in excess, trigger the abnormal formation of new
blood vessels in the eye.
EYLEA has been shown to stop the growth of new abnormal blood vessels
in the eye and reduce the amount
of fluid and blood leaked into the retina. EYLEA can help to
stabilise, and in many cases, improve the
vision loss related to wet AMD, CRVO, BRVO, DME and myopic CNV.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EYLEA
You will NOT be given EYLEA if you:

Are allergic (hypersensitive) to aflibercept or an

Summary of Product characteristics

APPROVED PROFESSIONAL INFORMATION - EYLEA SOLUTION FOR INJECTION
BAYER (PTY) LTD APPROVAL DATE: 16 OCTOBER 2023
CCDS17/16.12.2021/SA07/10.2023
Page 1 of 12
SCHEDULING STATUS:
S4
1. PROPRIETARY NAME AND DOSAGE FORM:
EYLEA, Solution for intravitreal Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One milliliter solution for intravitreal injection contains 40 mg
aflibercept.
Each pre-filled syringe contains a nominal volume of 90 microlitres,
equivalent to 3.6 mg aflibercept.
Each single dose vial contains an extractable volume of 100
microlitres, equivalent to 4.0 mg aflibercept.
This product contains less than 1 mmol sodium (23 mg) per dose, i.e
essentially “sodium-free”.
Contains sugar: sucrose
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
EYLEA, Solution for Injection
EYLEA is a sterile, clear, and colourless to pale yellow solution for
injection which has no visible
particulate matter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
EYLEA is indicated for the treatment of

neovascular (wet) age-related macular degeneration (AMD).

macular oedema following central retinal vein occlusion (CRVO)

macular oedema secondary to branch retinal vein occlusion (BRVO)

diabetic macular oedema (DME)

myopic choroidal neovascularisation (myopic CNV)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
EYLEA is for intravitreal injection. It must only be administered by a
doctor experienced in
administering intravitreal injections.
POSOLOGY:
_NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (WET AMD) _
APPROVED PROFESSIONAL INFORMATION - EYLEA SOLUTION FOR INJECTION
BAYER (PTY) LTD APPROVAL DATE: 16 OCTOBER 2023
CCDS17/16.12.2021/SA07/10.2023
Page 2 of 12
The recommended dose for EYLEA is 2 mg aflibercept (equivalent to 50
microliters solution for
injection).
EYLEA treatment is initiated with one injection per month (every 4
weeks) for three consecutive doses,
followed by one injection every 2 months. (every 8 weeks)
Based on the medical practitioner’s judgement of visual and/or