Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - eylea

Document Subject

Generated Narrative: MedicinalProductDefinition mp448b528bf3d067b64074ee9859a8f881

identifier: http://ema.europa.eu/identifier/EU/1/12/797/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Eylea 40 mg/mL solution for injection in pre-filled syringe.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-448b528bf3d067b64074ee9859a8f881

identifier: http://ema.europa.eu/identifier/EU/1/12/797/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - eylea

Attesters

What is in this leaflet

1. What Eylea is and what it is used for
2. What you need to know before you receive Eylea
3. How Eylea will be given
4. Possible side effects
5. How to store Eylea
6. Contents of the pack and other information

What Eylea is Eylea contains the active substance aflibercept. It belongs to a group of medicines called antineovascularistion agents.

Your doctor will inject Eylea into your eye to treat eye disorders in adults called:

• wet age-related macular degeneration (wet AMD)
• visual impairment due to diabetic macular oedema (DME).

These disorders affect the macula. The macula is the central part of the light sensitive membrane at the back of the eye. It is responsible for clear vision. Wet AMD is caused when abnormal blood vessels form and grow below the macula. The abnormal blood vessels may leak fluid or blood into the eye. Leaky blood vessels that cause swelling of the macula cause DME. Both disorders may impact your vision.

How Eylea works Eylea stops growth of new abnormal blood vessels in the eye. Eylea can help to stabilise and often improve vision.

You will not receive Eylea if you

• are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6)
• have an infection in or around the eye
• have pain or redness in your eye (severe eye inflammation).

Warnings and precautions
Talk to your doctor before receiving Eylea if you:

• have glaucoma an eye condition caused by high pressure in the eye
• have a history of seeing flashes of light or dark floating spots and if their size or number suddenly increases
• had eye surgery in the last 4 weeks or eye surgery is planned in the next 4 weeks.

Tell your doctor immediately if you develop:

• redness of the eye
• eye pain
• increased discomfort
• blurred or decreased vision
• increased sensitivity to light These may be symptoms of an inflammation or infection and your doctor may stop giving you Eylea.

Furthermore, it is important for you to know that:

• the safety and efficacy of Eylea when administered to both eyes at the same time have not been studied and such use may increase risk of experiencing side effects.
• injections with Eylea may cause an increase in eye pressure in some patients within 60 minutes of the injection. Your doctor will monitor this after each injection.
• your doctor will check for other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye. In such cases your doctor will give you Eylea with caution.
• women who could become pregnant must use effective birth control during treatment and for at least 4 months after the last injection of Eylea.

The use of substances similar to those contained in Eylea is potentially related to the risk of blood clots blocking blood vessels, which may lead to heart attack or stroke. Theoretically, this could also happen after an injection of Eylea into the eye. If you had a stroke, a mini-stroke or a heart attack within the last 6 months, your doctor will give you Eylea with caution.

Children and adolescents The use of Eylea in children or adolescents under 18 has not been studied because the diseases indicated occur mainly in adults. Therefore, its use in this age group is not relevant.

Other medicines and Eylea Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

• Women who could become pregnant must use effective birth control during treatment and for at least 4 months after the last injection of Eylea.
• There is no experience on the use of Eylea in pregnant women. Women should not receive Eylea during pregnancy unless the potential benefit to the woman outweighs the potential risk to the unborn child.
• Small amounts of Eylea may pass into human milk. The effect on breast-fed newborns/infants are unknown. Eylea is not recommended during breast-feeding. Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine.

Driving and using machines After receiving Eylea, you may experience some temporary vision problems. Do not drive or use machines as long as these last.

The recommended dose is 8 mg aflibercept per injection.

• You will receive 1 injection every month for the first 3 months.
• After that, you may receive injections up to every 5 months. Your doctor will decide on the frequency based on the condition of your eye.

Method of administration Your doctor will inject Eylea into your eye (intravitreal injection).

Before the injection, your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your doctor will give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the injection.

If you missed a dose of Eylea Make a new appointment with your doctor as soon as possible.

Before stopping Eylea treatment Speak with your doctor before stopping treatment. Stopping treatment may increase your risk of vision loss and your vision may worsen.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of Eylea injection are either from the medicine itself or from the injection procedure and mostly affect the eye.

Some side effects could be serious Contact your doctor immediately if you have any of the following:

• common side effect, which may affect up to 1 in 10 people
• clouding of the lens (cataract)
• bleeding in the back of the eye (retinal haemorrhage)
• increase of pressure inside the eye
• bleeding inside the eye (vitreous haemorrhage)
• uncommon side effect, which may affect up to 1 in 100 people
• certain forms of clouding of the lens (cataract subcapsular)
• detachment, tear or bleeding of the light-sensitive layer at the back of the eye, resulting in flashes of light with floaters, sometimes progressing to a loss of vision (retinal detachment or tear)

Other possible side effects Common (may affect up to 1 in 10 people):

• moving spot in your vision (vitreous floaters)
• detachment of the gel-like substance inside the eye (vitreous detachment)
• reduced sharpness of vision
• eye pain
• bleeding inside the eye (conjunctival haemorrhage)
• damage to the clear layer of the eyeball in front of the iris (punctate keratitis)

Uncommon (may affect up to 1 in 100 people):

• allergic reactions
• detachment or tear of one of the layers in the back of the eye, resulting in flashes of light with floaters, sometimes progressing to a loss of vision (retinal pigment epithelial tear/detachment;)
• inflammation in the iris, of other parts of the eye, or the gel-like substance inside the eye (iritis, iridocyclitis, vitritis)
• certain forms of clouding of the lens (cataract cortical/nuclear)
• damage to the front layer of the eyeball (corneal abrasion/erosion)
• blurred vision
• eye pain at injection site
• a feeling of having something in the eye
• increased tear production
• bleeding at the injection site
• redness of the eye

Rare (may affect up to 1 in 1 000 people):

• blindness
• inflammation of other parts of the eye (uveitis)
• swelling of the eyelid
• irritation at injection site
• swelling of the front layer of the eyeball (corneal oedema)

Besides the above the following side effects may occur although they have not been reported in clinical studies:

• redness of the eye (ocular hyperaemia)
• degeneration of the light sensitive membrane at the back of the eye (retinal degeneration)
• abnormal sensation in eye
• clouding of the lens (lenticular opacities), clouding of the lens due to injury (traumatic cataract)
• damage to the surface of the clear front layer of the eye (corneal epithelium defect)
• inflammation of other parts of the eye (anterior chamber flare)
• eyelid irritation
• serious inflammation or infection inside the eye (endophthalmitis)
• pus in the eye (hypopyon)
• severe allergic reactions

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 C 8 C). Do not freeze.
• Keep the vial in the outer carton in order to protect from light.

What Eylea contains

• The active substance is aflibercept. 1 ml solution contains 114.3 mg aflibercept. Each vial contains 0.263 ml. This provides a usable amount to deliver a single dose of 0.07 ml containing 8 mg aflibercept.
• The other ingredients are: sucrose, arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, water for injections.

What Eylea looks like and contents of the pack Eylea is a solution for injection (injection). The solution is colourless to pale yellow. Pack size: 1 vial + 1 filter needle.

Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany

Manufacturer Bayer AG M llerstra e 13353 Berlin Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel. +37 05 23 36

T .: +359 (0)2 4247Luxembourg/Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria KFT Tel:+36 14 87-41 Danmark Bayer A/S Tlf: +45 45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 Nederland Bayer B.V. Tel: +31-23 799 1Eesti Bayer O
Tel: +372 655 8Norge Bayer AS Tlf: +47 23 13 05
Bayer
: +30-210-61 87 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel: +48 22 572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 Rom nia SC Bayer SRL Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 (0)1 58 14 sland Icepharma hf. S mi: +354 540 8Slovensk republika Bayer spol. s r.o. Tel. +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39 02 397 8 1 Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785
NOVAGEM Limited T : +357 22 48 38 Sverige Bayer AB Tel: +46 (0) 8 580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: