DOSAGE AND ADMINISTRATION
Dosage for Treatment of Ophthalmic Diseases
The initial recommended dose of TRIESENCE™ is 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
Dosage for Visualization during Vitrectomy
The recommended dose of TRIESENCE™ is 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally.
Preparation for Administration
STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be vigorously shaken for 10 seconds before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, TRIESENCE™ should be injected without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing organisms that can cause infection.
The injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.
Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before TRIESENCE™ is administered to the other eye.
DOSAGE FORMS AND STRENGTHS
Single use 1 mL vial containing 40 mg/mL of sterile triamcinolone acetonide suspension.