e side of the vial to allow the liquid to run down the inside of the vial.
Injecting solvent directly onto the powder will cause excess foaming.
Transfer all the solvent to the vial. Release the plunger.
8 - After the solvent in the syringe has been completely injected into the Extavia vial, hold the vial between your thumb, forefinger and middle finger with the needle and syringe resting against your hand and swirl the vial gently to completely dissolve the powder of Extavia.
Do not shake the vial.
9 - Examine the solution carefully. It should be clear and contain no particles. If the solution is discoloured or contains particles, discard it and start again with a syringe and vial out of your package.
If foam is present ?- which can happen if the vial is shaken or swirled too vigorously ? let the vial sit undisturbed until the foam settles.
D) Drawing up the solution for injection
10 - In order to redraw the solution back into the syringe, turn the syringe-vial-assembly, needle pointing upwards. Redraw the needle a little bit back within the vial so that the needle tip rests at the lowest point of the vial.
Keep he needle tip in the liquid, and slowly pull the plunger back all the way to withdraw the solution into the syringe.
11 - Any excessive air rises to the top of the solution. Remove the air bubbles by gently tapping the syringe and pushing the plunger to the 1 ml mark, or to the volume prescribed by your doctor.
If too much solution goes into the vial along with the air bubbles, pull the plunger back a little to withdraw the solution back from the vial into the syringe. Do this until all the air is gone and there is 1 ml of reconstituted solution in the syringe.
12 - Disconnect the syringe and the needle. Leave the needle in the vial.
13 - Take the 30-gauge needle out of its wrapping and place it firmly onto the tip (nozzle) of the syringe.
14 - Dispose of the vial and the remaining unused portion of the solution into the disposal unit.
15 - You are now ready to inject.
If, for some reason, you are not able to inject Extavia immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using. Make sure the needle cap is fixed properly while the syringe is stored in the fridge. Do not freeze the solution, and do not wait longer than 3 hours to inject it. If more than 3 hours pass, discard the medicine and prepare a new injection. When you use the solution, warm it up in your hands before injecting to avoid pain.
E) Making the injection manually (to make an injection with an auto-injector, refer to the instructions for use provided with the auto-injector)
1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
2 - Use an alcohol swab to clean the skin at the injection site. Let the skin air-dry. Throw the swab away. For skin disinfection use an appropriate disinfectant.
3 - Remove the cap from the needle by pulling and not twisting it.
4 - Gently pinch the skin together around the disinfected injection site to raise it up a little. 5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90 angle with a quick, firm motion. 6 - Inject the medicine using a slow, steady push on the plunger. Push the plunger all the way in until the syringe is empty.
7 - Discard the syringe in the disposal unit.
F) Quick review of the process
1. Take out the contents needed (1 vial, 1 pre-filled syri