CALL US FOR REBATE INFO IF YOU ARE INTERESTED IN THIS PRODUCT.
RETISERT- fluocinolone acetonide implant
Bausch & Lomb Incorporated
1 INDICATIONS AND USAGE
RETISERT is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is implanted into the posterior segment of the affected eye through a pars plana incision.
The implant contains one tablet of 0.59 mg of fluocinolone acetonide. RETISERT is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 �g/day, decreasing over the first month to a steady state between 0.3-0.4 �g/day over approximately 30 months. Following depletion of fluocinolone acetonide as evidenced by recurrence of uveitis, RETISERT may be replaced.
2.2 Handling of Implant
Caution should be exercised in handling RETISERT in order to avoid damage to the implant, which may result in an increased rate of drug release from the implant. Thus, RETISERT should be handled only by the suture tab. Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
RETISERT should not be resterilized by any method.
3 DOSAGE FORMS AND STRENGTHS
0.59 mg fluocinolone acetonide intravitreal implant.
4 CONTRAINDICATIONS
4.1 Viral, Bacterial, Mycobacterial and Fungal Infections of Ocular Structures
Surgical placement of RETISERT is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye.
