Pre-filled Syringe(PFS)

Hulio® treatment should be initiated and supervised by specialist physicians. After proper training in injection technique, patients may self-inject with Hulio®.

Each pre-filled syringe is for single-use only and contains one 40 mg dose of adalimumab.

The components of PFS includes needle cap, fill marker and plunger rod.

Before injection

The PFSs should be stored in the refrigerator (2°C-8°C). A single PFS should be removed from the refrigerator at least 30 minutes before using it, so as to allow the contents to reach room temperature.

The patients should wash hands thoroughly and set up a pre-filled syringe of Hulio® and an alcohol pad on a clean surface.

The patient should:

  • Check for expiry date on the syringe and not use the product if the date has expired
  • Check for the change in colour and particles in the solution. If the solution is frozen, cloudy or discoloured, and has particles, then the syringe has to be discarded1

During injection

Step 1 - Choose and prepare injection site

Hulio® pre-filled syringe is for subcutaneous injection. It should be injected into the thigh or abdomen.

You should rotate and change your injection site each time, staying at least 3 cm from the previous site used.

If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.

  • DO NOT inject into skin that is red, hard, bruised, or tender.
  • DO NOT inject into scars or stretch marks.
  • If you have psoriasis, DO NOT inject into any raised, thick, red, or scaly skin patches, or lesions.
  • DO NOT inject through clothes. Roll back any clothing that may interfere with the injection site.

Step 2 - Wash hands

Wash your hands thoroughly with soap and water.

Step 3 - Prepare injection site

Wipe the skin at the chosen injection site with an alcohol swab.

  • Wait for it to dry on its own, do not blow dry it.
  • DO NOT touch this area again before giving the injection.

Step 4 - Uncap needle

Pull the needle cover straight off the syringe. A few drops of liquid may come out of the needle, this is normal. It is also normal to see air bubble(s).

  • DO NOT remove the needle cover until you are ready to inject.
  • DO NOT twist or bend the needle cover while removing it, this may damage the needle.
  • DO NOT touch or pull back on the plunger at any time.
  • DO NOT re-cap or touch the needle with your fingers, or let the needle touch anything.
  • DO NOT expel any air bubble(s).
  • DO NOT use the pre-filled syringe if dropped after uncapping.

Step 5 - Squeeze & hold injection site

Gently squeeze the injection site to create a raised area, and hold that area firmly.

Step 6 - Insert needle into site

At a 45° angle to the injection site, use a quick dart-like motion to insert the needle into the site. Be careful to insert the needle so that it will not inject into your fingers holding the injection site.

Step 7 - Inject Hulio®

After the needle is completely inserted, let go of the site you are squeezing.

Slowly push the plunger completely down until all the medicine is injected and the syringe is empty.

  • If the plunger is not pressed all the way the safety feature will not activate afterwards to cover the needle.
  • DO NOT move, twist, or rotate the syringe during injection.

Step 8 - End of injection, remove syringe

Pull the syringe away from the injection site at the same angle as inserted and release your thumb from the plunger. Each pre-filled syringe has a safety feature, this will retract and cover the needle after the plunger is released. If the needle did not retract, carefully place the used syringe into a sharps container to avoid injury.

After injection, if slight bleeding occurs from the injection site, press a gauze pad or cotton ball lightly against the skin for a few seconds - DO NOT rub the injection site. If needed, cover the injection site with a plaster.

Step 9 - Dispose syringe & cap

Dispose of the used syringe and cap in an approved sharps disposal container.

Check with your healthcare provider for instructions on how to properly dispose of a filled sharps container.

  • DO NOT re-use the syringe.
  • DO NOT re-cap the needle.
  • DO NOT throw the sharps container in your household bin.
  • DO NOT recycle your used sharps disposal container.
  • Always keep your sharps container out of the sight and reach of children.

After injection

The Hulio® syringe should never be re-used. The patient should never recap the needle. After injecting Hulio®, the syringe should be thrown in a special sharps container.1

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Report side effects

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events.

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