The Vitrasert Implant is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

The diagnosis of CMV retinitis is opthalmologic and should be made by indirect ophthalmoscopy. Other conditions in the differential diagnosis of CMV retinitis include candidiasis, toxoplasmosis, histoplasmosis, retinal scars, and cotton wool spots, any of which may produce a retinal appearance similar to CMV. For this reason, it is essential that the diagnosis of CMV be established by a physician familiar with the retinal presentation of these conditions.

The Vitrasert Implant is for intravitreal implantation only.

Each Vitrasert Implant contains a minimum of 4.5 mg of ganciclovir, and is designed to release the drug over a 5 to 8 month period of time. Following depletion of ganciclovir from the Vitrasert Implant, as evidenced by progression of retinitis, the Vitrasert Implant may be removed and replaced.

Handling and Disposal

Caution should be exercised in handling of the Vitrasert Implant in order to avoid damage to the polymer coating on the implant, which may result in an increased rate of drug release from the implant. Thus, the Vitrasert Implant should be handled only by the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implatation procedure.

Because the Vitrasert Implant contains ganciclovir, which shares some of the properties of anti-tumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal of the Vitrasert Implant according to guidelines issued for antineoplastic drugs.

The Vitrasert Implant is supplied in individual unit boxes in a sterile Tyvek package (NDC 61772-002-01). Store at room temperature, 15-30°C (59-86°F). Protect from freezing, excessive heat and light.

Manufacutred by: Bausch & Lomb Surgical, Inc.
9342 Jeronimo Road
Irvine, CA 92618-1903
800/338-2020
USA

*Trademarks of Bausch & Lomb Incorporated.

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