Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Allergan Pharmaceuticals Ireland, Castlebar Road, Co. Mayo, Westport, Ireland
OZURDEX 700 micrograms intravitreal implant in applicator.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient | Description | |
|---|---|---|
| Dexamethasone |
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. |
| List of Excipients |
|---|
|
Ester 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
EU/1/10/638/001
Date of first authorisation: 27/07/2010
Date of latest renewal: 23/03/2015
| Drug | Countries | |
|---|---|---|
| OZURDEX | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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