Fidial® Plus - Fidia Farmaceutici S.p.A.

FIDIAL® PLUS

COHESIVE VISCOELASTIC SOLUTION FOR INTRAOCULAR USE

DESCRIPTION

Fidial® plus is a cohesive, sterile, non-pyrogenic, highly viscous solution of sodium hyaluronate, indicated as an adjuvant in surgery of anterior and posterior eye segments.

The product is presented in pre-filled syringes with Luer Lock and it is enclosed in a blister pack. Hyaluronic acid is a biological polysaccharide which is a physiological constituent of intraocular fluids.

During eye surgery, Fidial® plus provides effective protection of exposed tissues and permits easy reconstruction of the anatomical form of the operation site. Furthermore, as opposed to other viscoelastic substances utilised in ocular surgery, Fidial® plus may be left in the eye since it is rapidly eliminated by physiological mechanisms.

This property is very useful especially during perforating keratoplasty or surgery for other eye lesions where the removal of the substance introduced is technically impractical.

INDICATION

Adjuvant in surgery of anterior and posterior eye segments: cataract extraction, both intra- and extra-capsular, with or without intraocular lens implantation, phacoemulsification, keratoplasty and deep lamellar keratoplasty (DLKP), vitreous-retinal surgery, glaucoma surgery and post-traumatic surgery.

COMPOSITION

Sodium hyaluronate 1.8%.

AVAILABLE
FORMULATION

Sodium hyaluronate solution (20 mg/1.1 ml) in pre-filled syringe.

DOSING,
ADMINISTRATION
AND INSTRUCTION FOR USE

Fidial® plus is for intraocular use and it is injected into the anterior or posterior segment of the eye in a quantity adequate to the type of surgery and surgical manoeuvres to be carried out. It has to be used only by specialists in hospitals or similar institutions.

REFERENCES
Fidial Plus® Package Insert.