Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients

•      Acid terminated 50:50 poly D,L-lactide-co-glycolide.
•      Ester terminated 50:50 poly D,L-lactide-co-glycolide.

6.2    Incompatibilities
Not applicable.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials..
6.4    Special precautions for storage

Store below 25˚C.

6.5    Nature and contents of container
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.

6.6    Special precautions for disposal and other handling

OZURDEX is for single use only.
Each applicator can only be used for the treatment of a single eye.
If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used.
Once the foil pouch is opened the applicator should be used immediately.
Administering OZURDEX

1)    Hold the long axis of the applicator parallel to the limbus.



2)    Allow the applicator to meet the sclera at an oblique angle with the bevel of the needle facing up, away from the sclera. Push the tip about 1 mm into the sclera, keeping it parallel to the limbus.


3)    Redirect towards the centre of the eye into the vitreous cavity.
This will create a shelved scleral path.
Advance the needle until you enter the vitreous cavity.
Do not advance the needle past the point where the sleeve of the applicator touches the conjunctiva.


4)   Depress the actuator button slowly until you hear a click.
Before withdrawing the applicator from the eye, make sure that the actuator button is fully depressed and has locked flush with the applicator surface.



5)   Withdraw the applicator in the same direction that you used to enter the vitreous.



6)   Dispose of the applicator safely immediately after treatment.
The OZURDEX applicator is for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.