Instructions for Use or Handling: Persons sensitive to latex should not handle the needle cap on the single use prefilled syringe, which contains dry natural rubber (a derivative of latex).
Before administration, the Denosumab (Prolia) solution should be inspected for particulate matter and discolouration. The solution should not be used if cloudy or discoloured.
Do not shake.
To avoid discomfort at the site of injection, allow the pre-filled syringe to reach room temperature (up to 25°C) before injecting and inject slowly. Inject the entire contents of the pre-filled syringe. Dispose of any medicinal product remaining in the pre-filled syringe.
Instruction for self-administration by subcutaneous injection is included in the package leaflet.
Any unused product or waste material should be disposed of in accordance with local requirements.
Instructions for Injecting with Denosumab (Prolia) Pre-Filled Syringe with a Manual Needle Guard: Important: In order to minimize accidental needlesticks, the Denosumab (Prolia) single-use pre-filled syringe will have a green safety guard; manually activate the safety guard after the injection is given.
Do not slide the green safety guard forward over the needle before administering the injection; it will lock in place and prevent injection.
Activate the green safety guard (slide over the needle) after the injection.
The grey needle cap on the single-use pre-filled syringe contains dry natural rubber (a derivative of latex); people sensitive to latex should not handle the cap.
Step 1: Remove grey needle cap.
Step 2: Administer injection. Insert the needle and inject all the liquid. Do not put the grey needle cap back on the needle.
Step 3: Immediately slide the green safety guard over the needle. With the needle pointed away, hold the pre-filled syringe by the clear plastic finger grip with one hand. Then, with the other hand, grasp the green safety guard by its base and gently slide it towards the needle until the green safety guard locks securely in place and/or a "click" is heard. Do not grip the green safety guard too firmly-it will move easily if held and slide it gently.
Immediately dispose of the syringe and needle cap in the nearest sharps container. Do not put the needle cap back on the used syringe.