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Annex: SELF-INJECTION PROCEDURE

The following instructions are intended to explain how to prepare Extavia for administration and how to inject Extavia yourself. Please read the instructions carefully and follow them step by step. Your doctor or his/her assistant will help you to learn the process of self-administration. Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.

PART I: STEP BY STEP INSTRUCTIONS

The instructions include the following main steps:

A) General advice

B) Getting ready to inject

C) Reconstituting the solution, step by step

D) Drawing up the injection

E) Making the injection manually (to make an injection with an auto-injector, refer to the instructions for use provided with the auto-injector)

F) Quick review of the process

A) General advice

◾Getting off to a good start!

You will find that within a few weeks your treatment will become a natural part of your routine. As you get started, you may find the following tips helpful:

◾Set up a permanent storage area in a convenient location out of the reach of children so that your Extavia and other supplies are always easy to find. For details on storage conditions see section 5 of the leaflet, ?How to store Extavia?.

◾Try to give yourself the injection at the same time each day. This makes it easier to remember and easier to plan a block of time when you will not be interrupted. Please refer to section 3 of the leaflet, ?How to use Extavia?, for further details on how to use Extavia.

◾Prepare each dose only when you are ready for an injection. After mixing Extavia, you should administer the injection immediately (if Extavia is not used immediately, see section 5 of the leaflet, ?How to store Extavia?).

◾Important tips to keep in mind

◾Be consistent - use Extavia as described in section 3 of the leaflet, ?How to use Extavia?. Always double-check your dosage.

◾Keep your syringes and syringe disposal unit out of the reach of children; lock the supplies if possible.

◾Never re-use syringes or needles.