REC33012, 32918, 32919 (Var-95)

 Note:

Text in black = unchanged text

Text in blue = added text

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

[….]

 Excipient with known effect

 Each ml solution for injection contains 0.3 mg polysorbate 20 (E 432).

 For the full list of excipients, see section 6.1.

[….]

4.4      Special warnings and precautions for use

[….]

Information about excipients

This medicinal product contains 0.021 mg of polysorbate 20 in each 0.07 ml dose which is equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions.

[….]

4.8      Undesirable effects

[….]

 Tabulated list of adverse reactions

 A total of 1 217 patients treated with Eylea 114.3 mg/ml constituted the safety population in 3 clinical phase II/III studies (CANDELA, PULSAR, PHOTON).

The safety data described below include all adverse reactions with a reasonable possibility of causality to the injection procedure or medicinal product reported.

The adverse reactions are listed by system organ class and frequency using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1: All treatment‑emergent adverse reactions reported in patients with nAMD or DME treated with Eylea 114.3 mg/ml in phase II/III studies or during post‑marketing surveillance

System organ class  Frequency  Adverse reaction

Immune system disorders  Common  Hypersensitivity*

Eye disorders Common Cataract, Intraocular pressure increased, Vitreous floaters, Vitreous detachment, Vitreous haemorrhage, Retinal haemorrhage, Visual acuity reduced, Eye pain, Conjunctival haemorrhage,

Punctate keratitis, Corneal abrasion

Uncommon Retinal detachment, Retinal tear, Retinal pigment epithelial tear, Detachment of the retinal pigment epithelium, Uveitis, Iritis, Iridocyclitis, Vitritis, Cataract cortical, Cataract nuclear,

Cataract subcapsular, Corneal erosion, Vision blurred, Injection site pain, Foreign body sensation in eyes, Lacrimation increased, Injection site haemorrhage, Conjunctival hyperaemia, Eyelid oedema,

Ocular hyperaemia, Injection site irritation

Rare Corneal oedema, Lenticular opacities, Retinal degeneration, Eyelid irritation

Not known Scleritis**

*       Reports of hypersensitivity included rash, pruritus, urticaria.

**       From post‑marketing reporting

REC33012, 32918, 32919 (Var-95)

Note:

Text in black = unchanged text

Text in blue = added text

2.      What you need to know before you receive Eylea

[….]

 Eylea contains polysorbate 20

This medicine contains 0.021 mg of polysorbate 20 in each 0.07 ml dose which is equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

[….]

4.        Possible side effects

 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.

[….]

 Not known (frequency cannot be estimated from the available data):

-                inflammation of the white part of the eye associated with redness and pain (scleritis)

[….]

6.        Contents of the pack and other information

 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.

 See ‘Eylea contains polysorbate 20’ in section 2 for more information.

REC33044: Deletion of local representative UK (Northern Ireland)