DESCRIPTION :
IXIUM NaHA 2.0% is a visco-elastic high molecular weight solution of
a non-inflammatory, highly purified grade of Sodium hyaluronate,
clear, isotonic, sterile and non-pyrogenic for intraocular injection
during surgery of the anterior segment of the eye. IXIUM NaHA 2.0%
is a sterile preparation supplied in a 1,0 mL pre-filled glass syringe
with disposable cannula, Luer lock.

CHARACTERISTICS :
The sodium hyaluronate used for the manufacturing of IXIUM NaHA 2.0%
is a pharmaceutical quality polysaccharide with a high molecular
weight composed of sodium glucoronate and N-acetylglucosamine
and is obtained by fermentation of a bacterial origin. Sodium
hyaluronate is a physiological substance present in large quantities
in numerous conjunctive tissues in man and animals, in particular,
in the vitreous, the synovial liquid and the umbilical cord.
IXIUM NaHA 2.0% is a medical device to assist in surgery of the anterior
segment of the eye, the rheological and lubricating characteristics
of which are completely adapted to the different operating phases
of cataract surgery.
IXIUM NaHA 2.0% :
• maintains the endoocular space of the anterior segment of the
eye and preserves the integrity of the tissues.
• has outstanding rheological properties, that ease capsulorhexis
and lens insertion.
• allows excellent visibility of the operating space.
• is simple to remove from the anterior chamber.
• does not interfere with the process of cicatrisation.
• is not antigenic and is well tolerated by the human eye.

COMPOSITION :
name function
Sodium hyaluronate 2000 mg viscosity
Sodium chlorid 900 mg isotonicity
Water for injection to 100 ml dissolution

PROPERTIES :
1• IXIUM NaHA 2.0% is a clear, isotonic, sterile, non-pyrogenic,
visco-elastic solution, iso-osmotic with aqueous humour, which
contains 2 percent by weight of a highly purified grade of
sodium hyaluronate of high molecular weight (around 2 400 000
dalton).
2• IXIUM NaHA 2.0% is a visco-elastic gel, whose properties of
elasticity, cohesion and coatibility provide ideal conditions for
intraocular surgery. On account of its visco-elastic properties,
IXIUM NaHA 2.0% ensures protection of intraocular tissues, especially
the endothelium of the cornea, during surgery.
3• IXIUM NaHA 2.0% is used to maintain the depth and integrity of
the anterior chamber of the eye, thus facilitating surgery.
4• IXIUM NaHA 2.0% is apyrogenic and nonantigenic and is well
tolerated by the human eye.

INDICATIONS : IXIUM NaHA 2.0% is indicated as a surgical aid (medical
device) during surgical procedures involving the anterior chamber
of the eye, including extraction of the lens and insertion of
intraocular lenses. IXIUM NaHA 2.0% maintains the depth of the anterior
chamber during the whole surgical procedure and permits greater
operative precision without the risk of damaging the endothelium
of the cornea or other intraocular tissues.

USAGE PRECAUTIONS : The following usage precautions are
recommended during surgery of the anterior segment :
• Check the integrity of the packaging before use to ensure the
product has remained sterile.
• The cannula and the syringe are for single intraocular use only.
• The normal precautions associated
• The quantity injected into the anterior chamber of the eye
must be adjusted according to the volume of the aqueous
humour and the anatomical structure to be protected.
• Remove all the product by irrigation and/or aspiration at the
end of the procedure; mechanical blockage of drainage at the
trabecular level may cause a transient increase in intraocular
pressure after surgery.
• The product must be administered with care and under close
monitoring, particularly in patients with pre-existing glaucoma
and in cases of glaucoma surgery and where surgery is combined
with extraction of the lens. If intraocular pressure rises above
normal after surgery, appropriate treatment should be prescribed.
• All post-operative inflammatory reactions (iritis, hypopyon, uveitis)
and oedematous corneal decompensation are inherent in surgical
procedures involving the anterior chamber of the eye, and no
relationship with the product has been established.

INCOMPATIBILITIES : Do not use quaternary ammonium
(benzalkonium chloride) with IXIUM NaHA 2.0%, since sodium
hyaluronate precipitates in the presence of quaternary ammonium.

CONTRA-INDICATIONS : There is no contra-indication to the use
of IXIUM NaHA 2.0%, if used as instructed in the product information.

CLINICAL APPLICATIONS : In surgery involving the anterior
segment, IXIUM NaHA 2.0% should be carefully and slowly injected
into the anterior chamber using a single-use Luer lock cannula
(in no case should a reusable cannula be used, even if it is well
cleaned, rinsed and resterilized since it could release particles
during injection.) IXIUM NaHA 2.0% is injected before the crystalline
lens is removed to perform the capsulorhexis procedure, so that
its protective effect will be optimized. At this stage of the operation,
IXIUM NaHA 2.0% protects the endothelium of the cornea from
potential damage by surgical instruments. IXIUM NaHA 2.0% may be
injected into the anterior chamber several times during surgery
to replace the product lost during the surgical procedure. At the
end of the operation, IXIUM NaHA 2.0% should be aspirated completely
using an automatic irrigator/aspirator or an irrigation syringe.
Never use the original IXIUM NaHA 2.0% syringe.

MODE OF ADMINISTRATION AND ASSEMBLY OF THE SYRINGE
Use a sterile opening technique when removing from the individual
sterility protective pack. Open the pack and place the contents
on the sterile operating field. Connect the Luer lock cannula to
the hub of the syringe by twisting down to the base and confirm
correct assembly. Press down on the plunger gently to expel a
few drops of the product to prevent the introduction of air bubbles
into the anterior chamber of the eye. The syringe is ready to use.
STORAGE : At room temperature, do not expose to excessive
temperatures. Protect from light.
IXIUM NaHA 2.0% is a medical device, CE 0120
Produced in France by LCA SA.
9 Allée Prométhée, F-28000 Chartres, France
For professional use only.
Date of revision of the product information : 10/2007