Orencia 125 mg solucion inyectable en jeringa precargada

Product Information for the User

ORENCIA50mg Pre-filled Syringe

ORENCIA87,5mg Pre-filled Syringe

ORENCIA125mg Pre-filled Syringe

abatacept

Please read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1.What is ORENCIA and how is it used

2.What you need to know before starting to use ORENCIA

3.How to use ORENCIA

4.Possible adverse effects

5.Storage of ORENCIA

6.Contents of the package and additional information

ORENCIA contains the active ingredient abatacept, a protein obtained through cell cultures. ORENCIA reduces the immune system's attack on normal tissues by interfering with immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T lymphocytes that participate in the inflammatory response of the immune system.

ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults, as well as polyarticular juvenile idiopathic arthritis in children aged 2 years and older.

Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, long-term systemic disease that, if left untreated, can have severe consequences, such as joint destruction, increased disability, and inability to perform daily activities. In people with rheumatoid arthritis, the body's own immune system attacks normal tissues, producing pain and swelling in the joints, which can damage the joints. Rheumatoid arthritis (RA) affects each person differently. In most people, joint symptoms develop gradually over several years. However, in some patients, RA can progress rapidly, and others may have RA for a limited period and then enter a period of remission. RA is usually a chronic (long-term), progressive disease. This means that, although you receive treatment, you may still have symptoms, and RA could continue to damage your joints. With the best treatment plan for you, you may be able to delay this disease process, which could help reduce long-term joint damage, as well as pain and fatigue, and improve your overall quality of life.

ORENCIA is used to treat active moderate to severe rheumatoid arthritis when you do not respond sufficiently to treatment with other disease-modifying medications or with another group of medications called "tumor necrosis factor (TNF) inhibitors." It is used in combination with a medication called methotrexate.

ORENCIA can also be used with methotrexate to treat progressive rheumatoid arthritis and high-activity rheumatoid arthritis without prior methotrexate treatment.

ORENCIA is used for:

• to delay joint damage
• to improve your physical function

Psiatic Arthritis

Psiatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, an inflammatory skin disease. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond sufficiently well to these medications, you may be administered ORENCIA to:

• reduce the signs and symptoms of your disease.
• reduce damage to your bones and joints.
• improve your physical function and ability to perform daily normal activities.

ORENCIA alone or in combination with methotrexate is used to treat psoriatic arthritis.

Polyarticular Juvenile Idiopathic Arthritis

Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease that affects one or more joints in children and adolescents.

ORENCIA prefilled syringe is used in children and adolescents aged 2 to 17 years when a previous treatment with a disease-modifying medication has not worked well or is not suitable for them. ORENCIA is usually used in combination with methotrexate, although ORENCIA can also be used alone if methotrexate treatment is inadequate.

ORENCIA is used for:

• to delay joint damage
• to improve physical function
• to improve other signs and symptoms of polyarticular juvenile idiopathic arthritis

Do not use ORENCIA

• if you are allergicto abatacept or to any of the other components of this medication (listed in section6).
• if you have a severe or uncontrolled infection, do not start treatment with ORENCIA. Having an infection may put you at risk of serious side effects from ORENCIA.

Warnings and precautions

Consult your doctor, pharmacist, or nurse:

• if you experience allergic reactionssuch as chest tightness, asthma, severe dizziness or vertigo, swelling, or skin rashinform your doctor immediately.
• if you experience any type of infection, including prolonged or localized infection, or if you frequently get infections orif you have symptoms of an infection (such as fever, discomfort, dental problems), it is essential to inform your doctor.ORENCIA may reduce your body's ability to fight an infection and treatment may make you more prone to acquiring infections or worsening any existing infection.
• if you have had tuberculosis (TB)or are experiencing TB symptoms (persistent cough, weight loss, apathy, mild fever)inform your doctor. Before using ORENCIA, your doctor will perform a TB test or a skin test.
• if you have viral hepatitisinform your doctor. Before using ORENCIA, your doctor may perform a hepatitis test.
• if you have cancer,your doctor will decide if you can receive ORENCIA.
• if you have recently been vaccinatedor are planning to get vaccinated,inform your doctor.Some vaccines should not be administered while you are on ORENCIA treatment.Consult with your doctor before receiving any vaccine.Certain vaccines may cause infections. If you received ORENCIA during your pregnancy, your baby may be at a higher risk of contracting the infection during approximately the 14 weeks after the last dose you received during your pregnancy. It is essential to inform your doctors about your baby and other healthcare professionals about the use of ORENCIA during your pregnancy so that they can decide when to administer any vaccine to your baby.

Your doctor may also perform blood tests to examine your blood values.

Children and adolescents

ORENCIA injectable solution in pre-filled syringe has not been studied in children and adolescents under 2years. Therefore, the use of ORENCIA injectable solution in pre-filled syringe is not recommended in this patient population.

Using ORENCIA with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

ORENCIA should not be usedwith biologic medications for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend its administration with anakinra and rituximab.

ORENCIA can be usedwith other medications commonly used to treat rheumatoid arthritis, such as steroids or analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac.

Seek advice from your doctor or pharmacist before taking any other medication while using ORENCIA.

Pregnancy and breastfeeding

The effects of ORENCIA on pregnancy are unknown, therefore do not use ORENCIA if you are pregnant unless your doctor recommends it explicitly.

• if you are a woman who may become pregnant, you should use reliable contraceptive methods (birth control) while using ORENCIA and for 14weeks after the last dose. Your doctor will advise on suitable methods.
• if you become pregnant during ORENCIA treatment, inform your doctor.

• If you received ORENCIA during your pregnancy, your baby may be at a higher risk of contracting an infection. It is essential to inform your doctors about your baby and other healthcare professionals about the use of ORENCIA during your pregnancy before administering any vaccine (for more information, see the section on vaccination).

The passage of ORENCIA into breast milk is unknown.You should stop breastfeedingif you are being treated with ORENCIA for 14weeks after the last dose.

Driving and operating machinery

It is not expected that the use of ORENCIA will affect your ability to drive, ride a bike, or use machines. However, if you feel tired or unwell after receiving ORENCIA, do not drive, ride a bike, or operate any machinery.

ORENCIA contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose, that is, essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

ORENCIA injectable solution is injected under the skin (subcutaneously).

Recommended dose in adults

The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg per week regardless of weight.

Your doctor may start your treatment with ORENCIA with or without a single dose of powder for concentrate for solution for infusion (which is administered in the vein, usually in the arm, for a period of 30 minutes). If you are administered a single intravenous dose to start treatment, the first subcutaneous injection of ORENCIA should be administered within a day from the IV infusion, followed by weekly subcutaneous injections of 125 mg.

ORENCIA can be used in adults over 65 years without changing the dose.

Use in children and adolescents

For patients 2 to 17 years old with juvenile idiopathic polyarticular arthritis, the recommended weekly dose of ORENCIA injectable solution in pre-filled syringe is based on the patient's body weight:

If you are already receiving ORENCIA intravenously and want to switch to ORENCIA subcutaneously, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.

Your doctor will inform you about the duration of treatment and which other medications, including other disease-modifying medications, if any, you may continue to take while on ORENCIA treatment.

At the beginning, your doctor or nurse may inject ORENCIA for you. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will be instructed on how to inject ORENCIA yourself.

Consult your doctor if you have any doubts about administering the injection. You will find detailed instructions for preparing and administering ORENCIA at the end of this leaflet (see“Important use instructions”).

If you use more ORENCIA than you should

If this happens, contact your doctor immediately, who will monitor you for any signs or symptoms of adverse effects and treat them if necessary.

If you forgot to use ORENCIA

Keep track of your next dose. It is very important to use ORENCIA exactly as your doctor tells you. If you forgot your dose within three days of when it was due, administer the dose as soon as you remember and then follow your original dosing schedule on the chosen day. If you forget your dose for more than three days, ask your doctor when to administer the next dose.

If you interrupt ORENCIA treatment

The decision to interrupt ORENCIA treatment should be discussed with your doctor.

If you have any other questions about the use of this medication,ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The most common side effects that occur with ORENCIA are upper respiratory tract infections (including nose and throat infections), headaches, and nausea. ORENCIA can cause serious side effects that may require treatment.

Possible serious side effectsinclude severe infections, malignant neoplasms (cancer), and allergic reactions, as listed below.

Inform your doctor immediatelyif you notice any of the following symptoms:

• severe rash, urticaria, or other signs of allergic reaction
• swollen face, hands, or feet
• difficulty breathing or swallowing
• fever, persistent cough, weight loss, fatigue

Inform your doctor immediatelyif you notice any of the following:

• general feeling of illness, dental problems, burning sensation while urinating, painful skin rash, painful blisters on the skin, cough

The symptoms described above may be signs of the side effects listed below, which have been observed with ORENCIA in clinical trials in adults:

List of side effects:

Very common(may affect more than 1 in 10patients):

• upper respiratory tract infections (including nose, throat, and nasal sinus infections)

Common(may affect up to 1 in 10patients):

• lung infections, urinary tract infections, painful blisters on the skin (herpes), flu
• headaches, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhea, nausea, stomach discomfort, mouth sores, vomiting
• skin rash
• fatigue, weakness, injection site reactions
• abnormal liver function tests

Uncommon(may affect up to 1 in 100patients):

• dental infection, fungal nail infection, muscle infection, bloodstream infection, abscess under the skin, kidney infection, ear infection
• low white blood cell count
• skin cancer, warts
• low platelet count
• allergic reactions
• depression, anxiety, sleep disturbance
• migraines
• numbness
• dry eyes, decreased vision
• eye inflammation
• palpitations, rapid heart rate, slow heart rate
• low blood pressure, hot flashes, inflammation of blood vessels, flushing
• difficulty breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• throat constriction
• rhinitis
• increased tendency to develop petechiae, dry skin, psoriasis, skin redness, excessive sweating, acne
• hair loss, itching, urticaria
• joint pain
• limb pain
• amenorrhea, heavy menstrual bleeding
• influenza-like syndrome, weight gain

Rare(may affect up to 1 in 1000patients):

• tuberculosis
• inflammation of the uterus, Fallopian tubes, and/or ovaries
• gastrointestinal infection
• leukemia, lung cancer

Children and adolescents with polyarticular juvenile idiopathic arthritis

The side effects in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults, as described above, with the following differences:

Common(may affect up to 1 in 10patients):

• upper respiratory tract infections (including nose, throat, and nasal sinus infections)
• fever

Uncommon(may affect up to 1 in 100patients):

• blood in urine
• ear infection

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after EXP and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Do not use this medication if the liquid is cloudy or discolored, or has large particles. The liquid should be colorless to pale yellow.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of ORENCIA

ORENCIA50mg injectable solution in pre-filled syringe

• The active ingredient is abatacept.
• Each pre-filled syringe contains 50mg of abatacept in 0.4ml.

ORENCIA87.5mg injectable solution in pre-filled syringe

• The active ingredient is abatacept.
• Each pre-filled syringe contains 87.5mg of abatacept in 0.7ml.

ORENCIA125mg injectable solution in pre-filled syringe

• The active ingredient is abatacept.
• Each pre-filled syringe contains 125mg of abatacept in 1 ml.

• The other components are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injection (see section2 "ORENCIA contains sodium").

Appearance of the product and contents of the pack

ORENCIA injectable solution (injection) is a clear, colourless to pale yellow solution.

ORENCIA is available in the following presentations:

ORENCIA50mg injectable solution in pre-filled syringe with white plunger

• pack of 4 pre-filled syringes with needle guard.

ORENCIA87.5mg injectable solution in pre-filled syringe with light blue plunger

• pack of 4 pre-filled syringes with needle guard.

ORENCIA125mg injectable solution in pre-filled syringe with orange plunger

• packs of 1, 3 or 4 pre-filled syringes with needle guard and multiple pack of 12 pre-filled syringes with needle guard (3 packs of 4).
• packs of 1, 3 or 4 pre-filled syringes with needle guard and multiple pack of 12 pre-filled syringes with needle guard (3 packs of 4).

Only some pack sizes may be marketed.

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Responsible person for manufacturing

CATALENT ANAGNI S.R.L.

Loc. Fontana del Ceraso snc

Strada Provinciale 12 Casilina, 41

03012 Anagni (FR)

Italy

Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15
Ireland

Last update date of this leaflet

Other sources of information

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.