ILUVIEN Intravitreal implant (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
ILUVIEN 190 micrograms intravitreal implant in applicator.
Qualitative and quantitative composition
Each implant contains 190 micrograms of fluocinolone acetonide. For a full list of excipients, see Section 6.1.
Pharmaceutical form
Intravitreal implant in applicator. Light brown coloured cylinder, approximately 3.5mm x 0.37mm in size. Implant applicator with 25 gauge needle.
Therapeutic indications
ILUVIEN is indicated for the treatment of vision impairment associated with chronic diabetic macular oedema, (DMO) considered insufficiently responsive to available therapies (see Section 5.1). ILUVIEN ...
Posology and method of administration
Posology The recommended dose is one ILUVIEN implant in the affected eye. Administration in both eyes concurrently is not recommended (see Section 4.4). Each ILUVIEN implant releases fluocinolone acetonide ...
Contraindications
An intravitreal implant with ILUVIEN is contraindicated in the presence of pre-existing glaucoma or active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, ...
Special warnings and precautions for use
Intravitreal injections have been associated with endophthalmitis, increase or decrease in intraocular pressure, retinal detachment and vitreous haemorrhage or detachment. Patients should be instructed ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
Pregnancy There are limited data from the use of intravitreally administered fluocinolone acetonide in pregnant women. Animal studies are insufficient with respect to the reproductive toxicity of intravitreally ...
Effects on ability to drive and use machines
ILUVIEN has minor influence on the ability to drive and use machines. Patients may experience temporarily reduced vision after administration of ILUVIEN and should refrain from driving or using machines ...
Undesirable effects
Summary of the safety profile Diabetic Macular Oedema Intravitreally administered fluocinolone acetonide was evaluated in 768 subjects (375 in the 0.2 µg/day/ILUVIEN group; 393 in the 0.5 µg/day group) ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: ANTIINFLAMMATORY AGENTS, corticosteroids, plain ATC code: S01BA15 Corticosteroids inhibit the inflammatory response to a variety of inciting agents. They inhibit the oedema, ...
Pharmacokinetic properties
In a human pharmacokinetic study (C-01-06-002, the FAMOUS Study) fluocinolone acetonide concentrations in plasma were below the lower limit of quantitation of the assay (100 pg/mL) at all time points from ...
Preclinical safety data
Fluocinolone acetonide has been shown to be teratogenic in mice and rabbits following systemic administration. No mutagenicity, carcinogenicity or developmental toxicity data are available for intravitreally ...
List of excipients
Polyvinyl alcohol Polyimide tube Silicone adhesive
Incompatibilities
Not applicable.
Shelf life
2 years. After first opening the lid, use immediately.
Special precautions for storage
Store below 30°C. Do not refrigerate or freeze. Do not open the sealed tray until just before application.
Nature and contents of container
The implant is supplied in a single use applicator with a 25 gauge needle. Each sterile applicator contains a light brown 3.5 mm long cylindrical implant. The applicator is packaged in a plastic tray sealed ...
Special precautions for disposal and other handling
Dispose of the applicator safely in a biohazard sharps container. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Alimera Sciences Limited, Royal Pavilion, Wellesley Road, Aldershot, Hampshire, GU11 1PZ, United Kingdom
Marketing authorization number(s)
PL 41472/0001
Date of first authorization / renewal of the authorization
04/05/2012
Date of revision of the text
22/03/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
