COMPOSITION:
VITRAXTMis a sterile, non-pyrogenic, viscoelastic preparation of sodium hyaluronatein a balanced salt solution. It is supplied in pre-filled disposable glass syringes of 0,65 mL.
Each 1 mL of VITRAXTM contains 30 mg sodium hyaluronate. The viscosity of VITRAXTM is approximately 50 000 centipoise when dissolved in a physiological buffered salt solution. The solution has an osmolality of approximately 320 mOsm/kg.
PHARMACOLOGICAL CLASSIFICATION A 15.4 Ophthalmic preparations. Other.
PHARMACOLOGICAL ACTION The viscoelastic nature of VITRAXTM maintains the depth of the anterior chamber. It has no pharmacological activity. VITRAXTM aids in filling space left by the loss of ocular fluid of tissues during or after surgical procedures by acting as a protective layer, reducing endothelial trauma from instruments or intraocular lens touch. VITRAXTM is withdrawn from the anterior chamber of the eye at the end of the surgical procedure and any excess is eliminated by the Schlemm canal.
INDICATIONS
VITRAXTM is indicated for use as a surgical aid in the following ophthalmic surgicalprocedures:
•
Cataract surgery with an intraocular lens
•
Cataract surgery without an intraocular lens
•
Secondary intraocular lens implantation
•
Corneal transplant surgery
•
Glaucoma filtration surgery
CONTRA-INDICATIONS There are no known contra-indications for the use of VITRAXTM, other than contra-indications for the specific surgical procedure.
Hypersensitivity to any of the ingredients.
WARNINGS For intraocular use only.
DOSAGE AND DIRECTIONS FOR USE
Cataract Surgery and IOL Implantation The required amount of VITRAXTM is slowly infused through a needle or cannula into the anterior chamber. The protective effect of VITRAXTM as an aid is optimised when the injection is preformed prior to cataract extraction and insertion of the IOL and may be performed prior to both intra- and extra-capsular cataract procedures. VITRAXTM may also be used to coat surgical instruments and the IOL prior to insertion. VITRAXTM may be injected during surgery to replace any that is lost during manipulation.
Corneal Transplant Surgery The corneal button is removed and the anterior chamber filled with VITRAXTM until it is level with the surface of the cornea. The donor graft is then placed on top of the VITRAXTM and sutured into place.
Additional VITRAXTM can be used as required to aid in the surgical procedure
Glaucoma Filtration Surgery
VITRAXTM is injected through a corneal paracentesis to restore and maintain the anterior chamber volume during the performance of the trabeculectomy. Additional VITRAXTM can be used as required to aid in the surgical procedure.
SIDE EFFECTS AND SPECIAL PRECAUTIONS The following adverse reaction have been reported following the use of sodium hyaluronate:
Increased intraocular pressure, secondary glaucoma and postoperative inflammatory reactions.
Those precautions normally considered during ophthalmic surgical procedures are recommended.
There have been reports of significantly increased intraocular pressure following the use of sodium hyaluronate as an ophthalmic surgical aid. For this reason the following precautions should be considered:
The intraocular pressure of postoperative patients should be carefully monitored.
An excess quantity of VITRAXTM should not be used.
VITRAXTM should be removed from the anterior chamber at the end of surgery by irrigation or aspiration.
If the postoperative intraocular pressure increases above expected values, correcting therapy should be administered.
A single use cannula such as the one provided in this package should be used when instilling VITRAXTM into the eye as denaturation and particulate formation can occur with the repeated use of a canula.
Because VITRAXTM is a highly purified fraction extracted from avian tissues and may contain minute amounts of protein, the physician should be aware of potential risks of the type that can occur with the injection of biological material.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT None known. Treatment is supportive and symptomatic.
IDENTIFICATION Disposable glass syringes containing sodium hyaluronate dissolved in a balanced salt solution. The solution is clear and colourless.
PRESENTATION
VITRAXTM is available in a pre-filled disposable glass single use sterile syringe containing 0,65 mL. Do not open until just before use.
A single use, 23 gauge blunt tip cannula is also included in the package.
STORAGE INSTRUCTIONS Store below 30ºC. DO NOT FREEZE. Protect from light.
STERILE
Sterility not guaranteed if package has been opened or damaged.
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER 29/15.4/0097
NAME AND BUSINESS ADDRESS OF THE APPLICANT Genop Healthcare (Pty) Ltd
30 New Road
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA
For Advanced Medical Optics (AMO) Inc. U.S.A.
DATE OF PUBLICATION OF THIS PACKAGE INSERT 9 August 1994
VITRAX –Trade name in South Africa VITRAX II –Trade name in USA
New addition to this site: February 2008
Source: Pharmaceutical Industry
VITRAX ™ Intraocular Injectable Solution