EYLEA Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Eylea 40 mg/ml solution for injection in a vial.
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 ...
Pharmaceutical form
Solution for injection (injection). The solution is a clear, colourless to pale yellow and iso-osmotic solution.
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 ...
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 ...
Contraindications
Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1. Active or suspected ocular or periocular infection. Active severe intraocular inflammation.
Special warnings and precautions for use
Intravitreal injection-related reactions Intravitreal injections, including those with Eylea, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept (see ...
Effects on ability to drive and use machines
Injection with Eylea has a minor influence on the ability to drive and use machines due to possible temporary visual disturbances associated either with the injection or the eye examination. Patients should ...
Undesirable effects
Summary of the safety profile A total of 3,102 patients constituted the safety population in the eight phase III studies. Among those, 2,501 patients were treated with the recommended dose of 2 mg. Serious ...
Overdose
In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred. Overdosing with increased injection volume may increase intraocular pressure. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals/Antineovascularisation agents ATC code: S01LA05 Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular ...
Pharmacokinetic properties
Eylea is administered directly into the vitreous to exert local effects in the eye. Absorption/Distribution Aflibercept is slowly absorbed from the eye into the systemic circulation after intravitreal ...
Preclinical safety data
Effects in non-clinical studies on repeated dose toxicity were observed only at systemic exposures considered substantially in excess of the maximum human exposure after intravitreal administration at ...
List of excipients
Polysorbate 20 Sodium dihydrogen phosphate, monohydrate (for pH adjustment) Disodium hydrogen phosphate, heptahydrate (for pH adjustment) Sodium chloride Sucrose Water for injection
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. Prior to usage, the unopened vial of Eylea may be stored at room temperature (below ...
Nature and contents of container
100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle. Pack size of 1.
Special precautions for disposal and other handling
The pre-filled syringe is for single use in one eye only. Do not open the sterile pre-filled blister outside the clean administration room. Since the pre-filled syringe contains more volume (90 microlitres) ...
Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
Marketing authorization number(s)
EU/1/12/797/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 November 2012 Date of latest renewal: 13 July 2017
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