Active ingredients: Dexamethasone
OZURDEX 700 micrograms intravitreal implant in applicator.
Intravitreal implant in applicator.
Disposable injection device, containing a rod-shaped implant. which is not visible. The implant is approximately 0.46 mm in diameter and 6 mm in length.
One implant contains 700 micrograms of dexamethasone.
For the full list of excipients, see section 6.1.
Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.
Ester terminated 50:50 poly D,L-lactide-co-glycolide
Acid terminated 50:50 poly D,L-lactide-co-glycolide
Each pack contains:
One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator.
The applicator consists of a plunger (stainless steel) within a needle where the implant is held in place by a sleeve (silicone). The plunger is controlled by a lever on the side of the applicator body. The needle is protected by a cap and the lever by a safety tab.
The applicator containing the implant is packaged in a sealed foil pouch containing desiccant.
Allergan Pharmaceuticals Ireland, Castlebar Road, Co. Mayo, Westport, Ireland
Date of first authorisation: 27/07/2010
Date of latest renewal: 23/03/2015