The detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Important instructions for use. Read carefully.
HOW TO USE
ORENCIA 50mg
ORENCIA 87.5mg
ORENCIA 125mg
injectable solution in pre-filled syringe with needle guard
Abatacept
Subcutaneous route
Read these instructions before using ORENCIA pre-filled syringe.
Before using the pre-filled syringe for the first time, make sure your doctor, nurse or pharmacist has shown you how to use it.
Keep the pre-filled syringe refrigerated until you are ready to use it.DO NOT FREEZE.
If you have any questions about this product, please read the leaflet.
BEFORE YOU START:
Get to know the pre-filled syringe
There are3types of pre-filled syringes:
The type of pre-filled syringe you will receive depends on the dose prescribed by your doctor. The 125mg/ml pre-filled syringe is shown below.
Before use
After use
The pre-filled syringe has anextender plungerthat makes it easier to hold and inject, and aneedle guardthat automatically covers the needle after the injection is complete.
DO NOTremove the needle cap until you are ready to inject.
DO NOTpull the plunger back at any time.
DO NOTput the needle cap back on the pre-filled syringe at any time, as this may damage, bend or break the needle.
Always hold the pre-filled syringe by the barrel.
Proceed to Step 1
Step1: Preparing for the injection of ORENCIA
Assemble everything you need for your injection on a clean and flat surface.
In the pack, you will only find the pre-filled syringe:
Alcohol swab
Swab
Cotton ball or swab
Pre-filled syringe with passive needle guard
Sharps container
Let the pre-filled syringe come to room temperature.
Take a pre-filled syringe out of the fridge and wait30minutesfor it to reach room temperature.
Do notaccelerate the warming process in any way, for example, by using the microwave or heating the syringe in warm water.
Do notremove the needle cap while the syringe is warming up.
Wash your hands thoroughly with soap and water to prepare for the injection.
Proceed to Step2
Step2: Examine the pre-filled syringe
Hold the pre-filled syringe by the barrel with the needle cap pointing downwards as shown.
Check the expiry date printed on the label. Do notuse it if the expiry date has passed.
Check if the pre-filled syringe is damaged. Do notuse it if it is cracked or broken.
Check the liquid
Check the liquidin the pre-filled syringe through the inspection window. It should be clear and colourless to pale yellow.
You may see a small air bubble.Do nottry to remove it.
Do notinject if the liquid is cloudy, has changed colour or has visible particles.
Nota: The figure shows the 50mg
Proceed to Step3
Step3:Check the dose in the pre-filled syringe
Hold the pre-filled syringe up to your eyes to make sure the amount of liquid in the pre-filled syringeis above or almost above the fill linefor your prescribed dose.
Do notuse it if the pre-filled syringe does not have the correct amount of liquid. Contact your doctor, nurse, or pharmacist for further instructions.
Proceed to Step4
Step4: Choose and prepare the injection site
Choose the injection sitein theabdomen, front of thethighsor the outer part of theforearm(only if administered by a caregiver).
Change the injection site
You can use the same area of the body each week, but choose a different injection site in that area.
Do notinject in areas where the skin is soft, red, swollen, or hard. Do not administer the injection in any area with scars or stretch marks.
Record the date, time and injection site.
Clean the injection site
Clean the injection site with an alcohol swab in a circular motion.
Do nottouch the injection site again before administering the injection.
Do notfan or blow on the cleaned area.
Remove the needle capby holding the barrel of the pre-filled syringe with one hand and pulling the needle cap straight off with your other hand.
Do notput the needle cap back on the pre-filled syringe at any time.
Do notuse the pre-filled syringe if it drips after removing the needle cap.
Do notuse the pre-filled syringe if the needle is damaged or bent.
Nota: It is normal to see a small drop of liquid coming out of the needle.
Proceed to Step5
Step5: Inject your dose of ORENCIA
Hold the barrelof the pre-filled syringe in your hand using your thumb and index finger. With your other hand,pinch the cleaned skinfirmly.
Insert the needle
Insert the needlequickly into the pinched skin at a 45-degree angle.
Complete ALL the steps to administer your full dose of medicine
Remove the needle guard: lift the plunger slowly to activate the needle guard.
Confirm:after completing the injection,the needle guard will cover the needleand you will hear a click.
Remove the pre-filled syringefrom the injection site and release the pinched skin.
Proceed to Step6
Step6: After the injection
Care for the injection site:
You may see a small amount of bleeding at the injection site. You can press on the injection site with a cotton ball or swab.
Do notrub the injection site.
If necessary, you can cover the injection site with a small bandage.
Dispose of the used pre-filled syringein the sharps container immediately after use. If you are unsure, ask your pharmacist.
For more information on disposal, see theleaflet.
If the injection is administered by a caregiver, this person should also handle the pre-filled syringe with care to avoid accidental needlestick injuries and potential infection transmission.
Keep this medicine and the sharps container out of the reach and sight of children.
Important instructions for use
Read these instructions carefully and follow them step by step.
You will receive instructions from your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.
Do not attempt to self-inject until you are sure you understand how to prepare and administer the injection. After proper training, you can administer the injection yourself or have someone else administer it, for example, a family member or friend.
Before you start – things to do and not to do
Do
Always handle the ORENCIA pre-filled syringe carefully, especially when near others or children.
Always hold the pre-filled syringe by the barrel.
Keep unused pre-filled syringes in the fridge in their original packaging.
Have additional injection supplies ready before injecting yourself.
Checklist of supplies: alcohol swabs, cotton ball or swab, bandage, sharps container.
The sharps containers are puncture-resistant disposal bins that can be purchased at many pharmacies.
Do not
Do notremove the needle guard (cap) until you are ready to inject.
Do notpull the plunger back at any time.
Do notshake the pre-filled syringe, as this may damage the ORENCIA medicine.
DO NOTput the needle cap back on the needle.
STEP 1: Have the pre-filled syringe ready
A.Check the expiry date and batch number on the box
The expiry date can be found on the ORENCIA box and on each pre-filled syringe.
Do not use the pre-filled syringes if the expiry date has passed. Contact your doctor or pharmacist if you need help.
B.Let the pre-filled syringe warm up
Find a comfortable place with a clean and flat work surface.
Take the pre-filled syringe out of the fridge. Keep any unused pre-filled syringes in their original packaging in the fridge.
Check that the expiry date and batch number on the box match the ones on the pre-filled syringe.
Inspect the pre-filled syringe for any obvious defects, butdo notremove the needle cap.
Let the pre-filled syringe rest at room temperature for 30 to 60minutes before injecting.
Do notaccelerate the warming process in any way, for example, by using the microwave or heating the syringe in warm water.
C.Check the liquid in the pre-filled syringe
Hold the pre-filled syringe by the barrel, with the needle cap pointing downwards.
Figure2
Look at the liquid in the pre-filled syringe (Figure2). The liquid should be clear and colourless to pale yellow.
Do notinject if the liquid is cloudy or has changed colour or has visible particles.
It is normal to see a small air bubble and there is no need to remove it. You should inject the entire contents of the pre-filled syringe.
D.Get your additional supplies ready and keep them within reach
E.Wash your hands thoroughly with soap and water
STEP 2: Choose and prepare the injection site
Have the pre-filled syringe ready to use immediately after preparing the injection site.
A.Choose a site on the body for the injection (injection site)
You can use:
The front of the thigh
The abdomen, except for the area within 5 cm of the navel (Figure3).
Figure3
Choose a different injection site for each new injection. You can use the same thigh for weekly injections, as long as each injection site is about 2.5cm away from the previous one.
Do notinject in areas where the skin is painful, red, swollen, or hard. Avoid areas with scars or stretch marks.
B.Prepare the injection site
Clean the injection site with an alcohol swab in a circular motion.
Let the skin dry before injecting.
Do nottouch the injection site again before administering the injection.
Do notfan or blow on the cleaned area.
STEP 3: Inject ORENCIA
A.Remove the needle cap (cap) only when you are ready to administer the injection
Hold the pre-filled syringe by the barrel with one hand and pull the needle cap straight off with your other hand (Figure4).
Figure4
You may see a small air bubble in the liquid of the pre-filled syringe. There is no need to remove it.
You may see a small drop of liquid coming out of the needle. This is normal and will not affect the dose.
Do nottouch the plunger while removing the needle cap.
Do notremove the needle cap until you are ready to inject ORENCIA.
Do nottouch the needle or let it touch any surface.
Do notuse the pre-filled syringe if it falls without the needle cap in place.
Do notput the needle cap back on the needle once it has been removed.
Do notuse the pre-filled syringe if there are visible signs that the needle is damaged or bent.
B.Place the pre-filled syringe and inject ORENCIA
Hold the pre-filled syringe by the barrel in one hand between your thumb and index finger (Figure5).
Do notpress the plunger head until the injection starts.
Do notpull the plunger back at any time.
Using your other hand, pinch the cleaned skin firmly. Hold it firmly.
Insert the needle quickly into the pinched skin at a 45-degree angle (Figure5).
Use your thumb to push the plunger down, pressing firmly until the plunger no longer moves and the entire dose has been injected (Figure6).
Remove the needle from the skin and release the pinched skin.
Do notput the needle cap back on the needle.
Press a cotton ball or swab on the injection site and hold the pressure for 10 seconds.
Do notrub the injection site. It is normal to see a small amount of bleeding.
If necessary, you can apply a small bandage to the injection site.
STEP 4: Dispose of the pre-filled syringe and record
A.Dispose of the used pre-filled syringe in a sharps container
Ask your doctor, nurse, or pharmacist about the national and local laws regarding the proper disposal of medical products containing needles.
Always keep your sharps container out of the reach of children and animals.
Do notthrow the used pre-filled syringes in the household waste or recycling bins.
B.Keep a record of the injection
Write down the date, time, and specific part of the body where you injected. It may also be helpful to write down any questions or concerns you have about the injection, so you can ask your doctor, nurse, or pharmacist.
Medicines should not be disposed of by flushing down the toilet or throwing in the household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. By doing so, you will help protect the environment.
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