The package insert of the medicine Eylia

the package insert of the medicine Eylia. Active principles Aflibercepte.

what For?

Eylia is indicated for the treatment of age-related macular degeneration, neovascular (AMD) (wet).

adult Use – Use intravítrea

Pharmacokinetics

How it works?

Eylia is a solution that is injected into the eye to treat a condition of the eye called age-related macular degeneration (AMD), type neovascular, or wet, commonly referred to as AMD wet.

The aflibercepte, the active substance of Eylia, blocks the activity of a group of factors known as Vascular Endothelial Growth Factor A (VEGF-A) and the Growth Factor Placental (PlGF).

In patients with AMD damp, these factors, in excess, cause the formation of abnormal new blood vessels in the eye. These new blood vessels can cause extravasation of blood components into the eye and possible injury to the tissues of the eye responsible for vision.

Eylia has shown to stop the growth of new abnormal blood vessels in the eye and reduce the amount of fluid and blood that leaked into the retina. Eylia can help stabilize, and in many cases, improve the vision due to AMD wet.

Side Effects

What are the evils that can cause me?

Like all medicines, Eylia can cause side effects, although not all people are affected.

For patients with AMD moist With the administration of Eylia, there may be some side effects due to the procedure of injection. Some of them can be serious and include infection or inflammation inside the eye (endoftalmite), opacities lenticular, due to injuries (cataract, traumatic) and a temporary increase of pressure within the eye (a temporary increase in intraocular pressure). These serious side effects occurred in less than 1 in every 1000 injections in clinical studies.

List of side effects reported in patients with AMD damp below is a list of reported side effects possibly related to the procedure of injection or medicine.

don’t be alarmed, it may be that you do not have any of these effects. Always discuss any suspected side effects with your doctor.

side-Effects very common:

    the

  • red eye caused by bleeding from small blood vessels in the outer layers of the eye (hemorragia subconjuntival)
  • the

  • pain in the eye

common side Effects of:

    the

  • decreased sharpness of vision (detachment of the retina, rupture of the epithelium pigmentary of the retina, detachment of the epithelium pigmentary of the retina)*
  • the

  • certain forms of clouding of the crystalline lens (cataract, cataract nuclear, cataract subcapsular)
  • the

  • injury to the layer of the front of the eyeball (abrasion of the cornea)
  • the

  • increased eye pressure (increased intraocular pressure)
  • the

  • blurred vision
  • the

  • spots moving in the vision (fly wheels)
  • the

  • swelling of the layer of the front of the eyeball (edema of the cornea)
  • the

  • detachment of the vitreous (a gel-like substance in the interior of the eye anterior to the retina)
  • the

  • pain at the site of injection
  • the

  • sensation of cisco in the eye (foreign body sensation in eyes)
  • the

  • increased tear production (increased tearing)
  • the

  • swelling of the eyelid (edema of the eyelid)
  • the

  • bleeding in the site of injection (bleeding at the injection site)
  • the

  • redness of the eyes (hyperemia conjunctival, hyperemia of the eye)

side Effects are not very frequent:

    the

  • infection or inflammation inside the eye (endoftalmite)
  • the

  • blurred vision / impaired (tear in the retina)
  • the

  • allergic reactions generalised hypersensitivity)
  • the

  • certain forms of clouding of the lens (cortical cataracts, opacity, lenticular)
  • the

  • injury to the layer of the front of the eyeball (the defect of the epithelium of the cornea, erosion of the cornea)
  • the

  • inflammation in certain parts of the eye (vitreíte, uveitis, iritis, iridocyclitis, opacity in the anterior chamber)

side Effects rare:

    the

  • pus in eyes (hipópio)

The use of inhibitors of VEGF systemic, substances similar to those contained in Eylia, is potentially related to the risk of thromboembolic events arterial (blood clots blocking blood vessels), which can cause heart attack or stroke.

There is a theoretical risk of such effects when performing injections Eylia inside of the eye.

as with all therapeutic proteins, there is a possibility of an immune reaction (formation of antibodies) with Eylia.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this package leaflet, please inform your doctor.

Attention: this product is a new drug, and while surveys have indicated the effectiveness and acceptable safety, even if indicated and used correctly, you may experience adverse events of unpredictable or unknown.

in This case, tell your doctor or dentist.

Contraindications

When should I not use?

Eylia should not be used if you:

    the

  • you Are allergic to aflibercepte or any of the other components of Eylia.
  • the

  • you Have inflammation in the eye (indicated by pain or redness).
  • the

  • Have an infection in or around your eye (infection ocular or periocular).

Warnings and Precautions

what should I know before using?

Injections of Eylia may cause an increase in eye pressure (intraocular pressure) in some patients within 60 minutes after the injection.

Your doctor will monitor this after each injection.

If you have glaucoma, please tell your doctor.

Injections into the eye, including those with Eylia, have been associated with infection or inflammation of the eye. Such infections or inflammations may be associated with eye pain or increasing discomfort, increased redness of the eyes, blurred vision, or decreased vision, and increased sensitivity to light (photophobia).

please Report immediately to your doctor if you develop any of these signs or symptoms, it is important to have any symptoms diagnosed and treated as soon as possible.

There is a theoretical risk of occurrence of thromboembolic events arterial with the use of substances similar to Eylia.

Talk with your doctor for more information.

No specific study in patients with problems in the liver and/or kidneys was conducted with Eylia.

the Elderly: no special considerations are necessary.

The safety and effectiveness of the Eylia not been studied in children and adolescents.

Eylia in pregnancy and lactation there are no experiments on the use of Eylia in pregnant women. Therefore, Eylia is not recommended during pregnancy unless the potential benefits outweigh the potential risk to the fetus.

If you are pregnant or plan to become pregnant, talk with your doctor before treatment with Eylia. Women of childbearing age should use an effective method of contraception during treatment.

Eylia is not recommended during breast-feeding because it is not known if the aflibercepte passes into the breast milk.

Ask your doctor before you start treatment with Eylia.

you Should make a decision as to the discontinuity of breastfeeding or the suspension of therapy with Eylia.

there May be visual disturbances temporary after the injection of Eylia. You should not drive or operate machinery until the vision has been sufficiently recovered.

Drug Interactions

Tell your doctor if you are taking or have recently taken any other medicine, including medicines obtained without a prescription or doctor prescription.

Overdose

what to do if someone use a larger amount than is recommended?

Superdose with injection volumes greater can increase the pressure within the eye.

Therefore, in the case of a superdose, the pressure within the eye should be monitored and if the responsible physician deems it necessary, you should start appropriate treatment.