Instructions for use of the Erelzi® pre-filled syringe

Read ALL the way through these instructions before injecting

It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. The box contains Erelzi® pre-filled syringe(s) individually sealed in a plastic blister.

Do not use

In this configuration the needle guard is ACTIVATED – DO NOT USE the prefilled syringe

Ready to be used

In this configuration the needle guard is NOT ACTIVATED and the prefilled syringe is ready for use

Your Erelzi® pre-filled syringe with needle guard and addon finger flange

After the medicine has been injected, the needle guard will be activated to cover the needle. This is intended to aid in the protection of healthcare professionals, patients who selfinject doctor prescribed medicines and individuals who assist selfinjecting patients from accidental needle stick injuries.

What you additionally need for your injection: 

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container

Important safety information

Caution: Keep the syringe out of the sight and reach of children.

  1. Do not open the outer box until you are ready to use this medicine.
  2. Do not use this medicine if the seal of the blister is broken, as it may not be safe for you to use.
  3. Do not shake the syringe.
  4. Never leave the syringe lying around where others might tamper with it.
  5. The prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. Be careful not to touch the needle guard wings before use. By touching them, the needle guard may be activated too early.
  6. Do not remove the needle cap until just before you give the injection.
  7. The syringe cannot be reused. Dispose of the used syringe immediately after use in a sharps container.
  8. Do not use if the syringe has been dropped onto a hard surface or dropped after removing the needle cap.

Storage of the Erelzi® pre-filled syringe

  1. Store this medicine sealed in its outer box to protect itfrom light. Store in the refrigerator between 2 °C to 8 °C. DO NOT FREEZE.
  2. Remember to take the blister out of the refrigerator and allow it to reach room temperature before preparing it for injection (15–30 minutes).
  3. Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”. If it has expired, return the entire pack to the pharmacy.

The injection site

The injection site is the place on the body where you are going to use the pre-filled syringe.

  • The recommended site is the front of your thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
  • Choose a different site each time you give yourself an injection.
  • Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).

If a caregiver is giving you the injection, the outer upper arms may also be used.

Preparing the Erelzi® pre-filled syringe

  1. Take the blister out of the refrigerator and leave it unopened for about 15–30 minutes so that it reaches room temperature.
  2. When you are ready to use the syringe, open the blister and wash your hands thoroughly with soap and water.
  3. Clean the injection site with an alcohol swab.
  4. Take the syringe out of the blister.
  5. Inspect the syringe. The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. This appearance is normal for Erelzi. Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles. Do not use if the syringe is broken or the needle guard is activated. In all these cases, return the entire product pack to the pharmacy.

How to use the Erelzi® pre-filled syringe

Carefully remove the needle cap from the syringe. Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.

Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in to ensure that the medicine can be fully administered.

Hold the syringe finger flange as shown. Slowly press the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.

Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.

Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.

Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Disposal instructions

Dispose of the used syringe in a sharps container (closable, puncture‑resistant container). For the safety and health of you and others, needles and used syringes must never be re‑used.

If you have any questions

Please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.

Reference: Erelzi® Summary of Product Characteristics  https://www.ema.europa.eu/en/documents/product-information/erelzi-epar-product-information_en.pdf