Prospecto: information for the user

Simponi 100mg pre-filled syringe solution

golimumab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed to you alone, and you must not give it to other people 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 prospect. See section4.

In addition, your doctor will give you a Patient Information Leaflet, which contains important safety information that you need to know before and during treatment with Simponi.

1.What Simponi is and what it is used for

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

3.How to use Simponi

4.Possible side effects

5.Storage of Simponi

6.Contents of the pack and additional information

Simponi contains an active ingredient called golimumab.

Simponi belongs to a group of medicines called “TNF inhibitors”. It is usedin adultsfor the treatment of the following inflammatory diseases:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Axial Spondyloarthritis, which includes Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
• Ulcerative Colitis

Simponi acts by blocking theaction of a protein called “tumor necrosis factor-alpha” (TNF‑α).This protein is involved in the body's inflammatory processes, and its blockade can reduce inflammation in your body.

Rheumatoid Arthritis

Rheumatoid Arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will be given other medicines first. If you do not respond adequately to those medicines, you may be given Simponi in combination with another medicine called methotrexate to:

• Reduce the signs and symptoms of your disease.
• Slow down damage to your bones and joints.
• Improve your physical condition.

Psoriatic Arthritis

Psoriatic Arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis, you will be given other medicines first. If you do not respond adequately to those medicines, you may be given Simponi to:

• Reduce the signs and symptoms of your disease.
• Slow down damage to your bones and joints.
• Improve your physical condition.

Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis

Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will be given other medicines first. If you do not respond adequately to those medicines, you may be given Simponi to:

• Reduce the signs and symptoms of your disease
• Improve your physical condition.

Ulcerative Colitis

Ulcerative Colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will be given other medicines first. If you do not respond adequately to these medicines, you will be given Simponi to treat your disease.

No use Simponi

• If you are allergic (hypersensitive) to golimumab or to any of the other components of this medicine (including those listed in section6).
• If you have tuberculosis (TB) or any other serious infection.
• If you have moderate or severe heart failure.

If you are unsure whether you are affected by any of the above, consult your doctor, pharmacist or nurse before using Simponi.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Simponi.

Infections

Inform your doctor immediately if you already have or develop any symptoms of infection, during or after treatment with Simponi.Among thesymptoms of infection are fever, cough, difficulty breathing, flu-like symptoms, diarrhea, wounds, dental problems or a burning sensation while urinating.

• You may be more susceptible to infections while using Simponi.
• Infections may progress more quickly and be more severe. Additionally, some previous infections may recur.

Tuberculosis (TB)

Inform your doctor immediately if you develop symptoms of TB during or after treatment. Among the symptoms of TB are persistent cough, weight loss, fatigue, fever or night sweats.

• Cases of tuberculosis have been reported in patients treated with Simponi, and in rare cases even in patients who have been treated with TB medications. Your doctor will perform tests to see if you have TB. Your doctor will note these tests on your Patient Information Card.
• It is very important that you inform your doctor if you have ever had TB, or if you have had close contact with someone who has had or has TB.
• If your doctor believes you are at risk of contracting TB, they may treat you with TB medications before starting treatment with Simponi.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier or if you have or have had hepatitis B before receiving Simponi.
• Tell your doctor if you think you may be at risk of contracting HBV.
• Your doctor should perform HBV tests.
• Treatment with TNF blockers like Simponi can cause reactivation of the hepatitis B virus in people who are carriers of this virus, which in some cases can be potentially fatal.

Invasive fungal infections

You must inform your doctor immediately if you have lived in or traveled to an area where certain types of fungi that can affect the lungs or other parts of your body are common (called histoplasmosis, coccidioidomycosis or blastomycosis). If you do not know if these infections are common in the area where you have lived or traveled, consult your doctor.

Cancer and lymphoma

Inform your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before using Simponi.

• If you use Simponi or another TNF blocker, the risk of developing lymphoma or other cancer may be increased.
• Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may have a higher risk than average of developing lymphoma.
• In children and adolescents treated with TNF blockers, there have been cases of cancers, some of which are rare, that in some cases have led to death.
• In rare cases, a specific type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF blockers. Most of these patients were male adolescents or young adults. This type of cancer is usually fatal. Almost all of these patients had also received medications such as azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD) or chronic smokers may have a higher risk of developing cancer when treated with Simponi. If you have severe persistent asthma, COPD or are a chronic smoker, you should consult with your doctor to determine if treatment with a TNF blocker is suitable for you.
• Some patients treated with golimumab have developed certain types of skin cancer. Inform your doctor if you develop any changes in the appearance of your skin or abnormal skin growth during or after treatment.

Heart failure

Inform your doctor immediately if you develop new symptoms of heart failure or if your existing symptoms worsen. Among the symptoms of heart failure are difficulty breathing or swelling of the feet.

• During treatment with TNF blockers, including Simponi, there have been reports of the onset or worsening of congestive heart failure. Some of these patients died.
• If you have mild heart failure and are being treated with Simponi, your doctor should monitor you closely.

Neurological disorders

Inform your doctor immediately if you have ever been diagnosed with or have developed symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in your vision, weakness in your arms or legs, or numbness or tingling in any part of your body. Your doctor will decide if you should receive Simponi.

Surgeries or dental procedures

• Inform your doctor if you are undergoing any surgery or dental procedure.
• Inform the surgeon or dentist performing the procedure that you are being treated with Simponi and show them your Patient Information Card.

Autoimmune diseases

Inform your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent skin rash, fever, joint pain and fatigue.

• In rare cases, people treated with TNF blockers have developed lupus.

Blood disorders

In some patients, the body may stop producing enough blood cells that help your body fight infections or stop bleeding. If you develop persistent fever, petechiae or bleed easily or present pallor, inform your doctor immediately. Your doctor may decide to suspend treatment.

If you are unsure whether you are affected by any of the above, consult your doctor or pharmacist before using Simponi.

Vaccinations

Inform your doctor if you have been vaccinated or are to be vaccinated.

• You should not be vaccinated with certain live vaccines while using Simponi.
• Some vaccines may cause infections. If you received Simponi treatment during your pregnancy, your baby may have a higher risk of contracting these infections until approximately six months after your last dose received during pregnancy. It is essential that you inform your baby's doctors and other healthcare professionals about your Simponi treatment so that they can decide when your baby should be vaccinated.

Therapeutic infectious agents

Inform your doctor if you have recently received or are to receive treatment with therapeutic infectious agents (such as a BCG instillation used for cancer treatment).

Allergic reactions

Inform your doctor immediately if you develop symptoms of an allergic reaction after treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat that may cause difficulty swallowing or breathing, skin rash, urticaria, swelling of the hands, feet or ankles.

• Some of these reactions may be severe or, in rare cases, potentially fatal.
• Some of these reactions occurred after the first administration of Simponi.

Children and adolescents

Simponi 100 mg is not recommended for children and adolescents (under 18 years).

Other medicines and Simponi

• Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including other medicines for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
• You should not use Simponi with medicines that contain the active ingredient anakinra or abatacept. These medicines are used to treat rheumatic diseases.
• Inform your doctor or pharmacist if you are using any other medicine that affects your immune system.
• You should not receive certain live vaccines while you are being treated with Simponi.

If you are unsure whether you use any of the medicines mentioned above, consult your doctor or pharmacist before using Simponi.

Pregnancy and breastfeeding

Consult your doctor before using Simponi if:

• You are pregnant or intend to become pregnant while using Simponi.There is limited information onthe effects of this medicine on pregnant women. If you are being treated with Simponi, you should avoid pregnancy using appropriate contraceptive methods during your treatment and for at least 6 months after your last Simponi injection.You should only use Simponi during pregnancy if it is strictly necessary for you.
• Before starting breastfeeding, at least 6 months should have passed since your last Simponi treatment. You should stop breastfeeding if you are to be administered Simponi.
• If you received Simponi treatment during your pregnancy, your baby may have a higher risk of contracting an infection. It is essential that you inform your baby's doctors and other healthcare professionals about your Simponi treatment before your baby is vaccinated (for more information, see the section on vaccinations).

If you are pregnant or breastfeeding, intend to become pregnant or have any concerns, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Simponi has a small effect on your ability to drive and use tools or machinery. However, dizziness may occur after administration of Simponi. If this happens, do not drive or use any tools or machinery.

Simponi contains latex and sorbitol

Latex sensitivity

A part of the pre-filled syringe, the needle cap contains latex. As latex can cause severe allergic reactions, consult your doctor before using Simponi if you or your caregiver are allergic to latex.

Sorbitol intolerance

This medicine contains 41 mg of sorbitol (E-420) in each pre-filled syringe.

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

How much Simponi is administered

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:

• The recommended dose is 50 mg administered once a month, on the same day of each month.
• Consult your doctor before the fourth dose is administered. Your doctor will determine if you should continue treatment with Simponi.
• • If you weigh more than 100 kg, the dose may be increased to 100 mg (the content of 1 pre-filled syringe) administered once a month, on the same day of each month.

Ulcerative colitis

• The following table shows how you will usually use this medication.

How to administer Simponi

• Simponi is administered by subcutaneous injection.
• Initially, your doctor or nurse may administer Simponi. However, you and your doctor may decide that you can self-administer Simponi. In this case, you will be instructed on how to self-administer Simponi.

Consult your doctor if you have any doubts about how to self-administer an injection. At the end of this prospectus, you will find detailed “Instructions for Use”.

If you use more Simponi than you should

If you have used or have been administered too much Simponi (injecting too much at one time or using it too frequently), consult your doctor or pharmacist immediately. Always carry the outer packaging, even if it is empty, and this prospectus with you.

If you forget to useSimponi

If you forget to use Simponi on the scheduled date, inject the missed dose as soon as you remember.

Do not administer a double dose to compensate for the missed doses.

When to inject the next dose:

• If the dose is delayed less than 2 weeks, inject the missed dose as soon as you remember and maintain your original schedule.
• If the dose is delayed more than 2 weeks, inject the missed dose as soon as you remember and consult your doctor or pharmacist on when the next dose should be administered.

If you are unsure what to do, consult your doctor or pharmacist.

If you interrupt treatment withSimponi

If you are thinking of interrupting treatment with Simponi, consult your doctor or pharmacist first.

If you have any other doubts 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. Some patients may experience severe side effects that may require treatment. The risk of certain side effects is higher with the 100 mg dose compared to the 50 mg dose. Side effects may appear several months after the last injection.

Inform your doctor immediately if you notice any of the serious side effects of Simponi, which include:

• allergic reactions that can be severe, or rarely, potentially life-threatening (rare).Symptoms of an allergic reaction that may include swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing, skin rash, hives, swelling of the hands, feet, or ankles. Some of these reactions occurred after the first administration of Simponi.
• serious infections (including tuberculosis, bacterial infections that include severe blood infections and pneumonia, severe fungal infections, and other opportunistic infections) (frequent).Symptoms of an infection that may include fever, fatigue, persistent cough, difficulty breathing, flu-like symptoms, weight loss, night sweats, diarrhea, wounds, dental problems, and a burning sensation while urinating.
• reactivation of the hepatitis B virus if you are a carrier or have had hepatitis B in the past (rare).Symptoms that may include yellowing of the eyes and skin, dark brown urine, abdominal pain on the right side, fever, dizziness, vomiting, and feeling extremely tired.
• neurological disorders such as multiple sclerosis (rare).Symptoms of neurological disorders that may include vision changes, weakness in arms or legs, numbness or tingling in any part of your body.
• lymph node cancer (lymphoma) (rare).Symptoms of lymphoma that may include swelling of the lymph nodes, weight loss, or fever.
• heart failure (rare).Symptoms of heart failure that may include difficulty breathing or swelling of your feet.
• signs of immune system disorders called:

• lupus (rare).Symptoms that may include joint pain or a skin rash on the cheeks or arms that is sensitive to the sun.
• sarcoidosis (rare).Symptoms that may include persistent cough, shortness of breath, chest pain, fever, swelling of the lymph nodes, weight loss, skin rashes, and blurred vision.

• inflammation of small blood vessels (vasculitis) (rare).Symptoms may include fever, headache, weight loss, night sweats, skin rash, and nerve problems such as numbness and tingling.
• skin cancer (infrequent).Symptoms of skin cancer may include changes in the appearance of the skin or abnormal growth of the skin.
• blood disorders (frequent).Symptoms of blood disorders that may include persistent fever, petechiae, or easy bruising or bleeding, or paleness.
• blood cancer (leukemia) (rare).Symptoms of leukemia may include fever, feeling tired, frequent infections, easy bruising or bleeding, or night sweats.

Inform your doctor immediately if you notice any of the above symptoms.

The following additional side effects have been observed with Simponi:

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

• upper respiratory tract infections, sore throat, or runny nose

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

• liver function test abnormalities detected during blood tests requested by your doctor
• dizziness
• headache
• numbness or tingling
• superficial fungal infections
• abscess
• bacterial infections (such as cellulitis)
• low red blood cell count
• low white blood cell count
• positive lupus test in blood
• allergic reactions
• indigestion
• stomach pain
• dizziness (nausea)
• flu
• bronchitis
• sinusitis
• herpes
• high blood pressure
• fever
• asthma, feeling of choking, difficulty breathing
• gastrointestinal and intestinal disorders that include inflammation of the inner lining of the stomach and colon that may cause fever
• mouth pain and sores
• reactions at the injection site (which may include redness, hardness, pain, petechiae, itching, numbness, or irritation)
• hair loss
• skin rash and itching
• difficulty sleeping
• depression
• weakness
• bone fractures
• chest discomfort

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

• kidney infection
• cancers, such as skin cancer and non-cancerous tumors, including moles
• skin blisters
• severe infection throughout the body (sepsis), which sometimes includes low blood pressure (septic shock)
• psoriasis (including on the palms of the hands and/or soles of the feet and/or the type that presents skin blisters)
• low platelet count
• low combined platelet, red blood cell, and white blood cell count
• thyroid disorders
• increased blood sugar levels
• increased cholesterol levels in the blood
• balance disorders
• visual disturbances
• conjunctivitis (inflammation in the eye)
• allergy in the eye
• irregular heartbeat
• coronary artery constriction
• blood clots
• flushing
• constipation
• chronic inflammatory lung disease
• reflux
• gallstones
• liver disorders
• breast disorders
• menstrual cycle disorders

Rare side effects (may affect up to 1 in 1,000 patients):

• failure of the bone marrow to produce blood cells
• severe decrease in white blood cell count
• infection of the joints or surrounding tissue
• problems with wound healing
• inflammation of blood vessels in internal organs
• leukemia
• melanoma (a type of skin cancer)
• carcinoma of Merkel cells (a type of skin cancer)
• lichenoid reactions (erythematous, pruritic, red, and/or purple rash on mucous membranes)
• peeling and scaly skin
• immune system disorders that may affect the lungs, skin, and lymph nodes (usually presenting as sarcoidosis)
• pain and discoloration in the fingers of the hands or feet
• alterations in taste
• urinary tract disorders
• kidney disorders
• inflammation of blood vessels in the skin that causes a rash

Side effects of unknown frequency:

• a rare blood cancer that mainly affects young people (hepatosplenic T-cell lymphoma)
• Kaposi's sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi's sarcoma usually manifests as purple skin lesions
• aggravation of a disease called dermatomyositis (which presents as a skin rash accompanied by muscle weakness)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 theAppendixV.By reporting side effects, you can contribute to providing more information on 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 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 the preloaded pen in the outer packaging to protect it from light.
• This medication can also be stored outside the refrigerator at a temperature of up to a maximum of 25°C for a single period of up to 30 days, but not beyond the initial expiration date printed on the box. Write the new expiration date on the box including day/month/year (not more than 30 days after the medication is removed from the refrigerator). If it has reached room temperature, do not return this medication to the refrigerator. Dispose of this medication if it has not been used by the new expiration date or the expiration date printed on the box, whichever occurs first.
• Do not use this medication if you observe that the liquid is not transparent or yellowish, cloudy, or contains foreign particles.
• Medications should not be disposed of through drains or in the trash. Ask your doctor or pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofSimponi

The active ingredient is golimumab. A pre-filled syringe of 1ml contains 100mg of golimumab.

The other components are sorbitol (E‑420), histidine, hydrochloride monohydrate of histidine, polisorbate80 and water for injection. For more information on sorbitol (E‑420), see section2.

Appearance of the product and contents of the pack

Simponi is presented as a solution for injection in a pre-filled syringe for single use. Simponi is available in packs containing 1pre-filled syringe and multiple packs containing 3pre-filled syringes (3packs of1). Only some pack sizes may be marketed.

The solution is between transparent and slightly opalescent (with a pearlescent sheen), colourless to pale yellow and may contain small, translucent or white protein particles. Do not use Simponi if the solution changes colour, is cloudy or contains unusual particles.

Marketing authorisation holder and responsible manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333CB Leiden

Netherlands

For more information about this medicinal product, contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

INSTRUCTIONS FOR USE

If you are going to inject Simponi yourself, it is necessary that a healthcare professional teaches you how to prepare the injection and how to inject it. If you have not been taught, contact your doctor, nurse or pharmacist to schedule a training session.

In these instructions:

1.Preparation for using the pre-filled syringe

2.Selection and preparation of the injection site

3.Injection of the medicine

4.After the injection

The following drawing (see figure1) shows what the pre-filled syringe “SmartJect” looks like.

Figure1

1.Preparation for using the pre-filled syringe

• Do not shake the pre-filled syringe at any time.
• Do not remove the cap from the pre-filled syringe until immediately before the injection.
• Do not put the cap back on the pre-filled syringe if you have removed it, to avoid bending the needle.

Check the number of pre-filled syringes

Check the pre-filled syringes to make sure that

• The number of pre-filled syringes and the dose is correct
• • If your dose is 100mg, you will receive a pre-filled syringe of 100mg
  • If your dose is 200mg, you will receive two pre-filled syringes of 100mg and you will have to administer two injections to yourself. Choose different sites for these injections and administer the injections one after the other.

Check the expiry date

• Check the expiry date printed or written on the box.
• Check the expiry date (indicated by “CAD”) on the pre-filled syringe.
• Do not use the pre-filled syringe if the expiry date has passed. The expiry date printed is the last day of the month indicated. Consult your doctor or pharmacist.

Check the safety seal

• Check the safety seal around the cap of the pre-filled syringe.
• Do not use the pre-filled syringe if the safety seal is broken. Consult your doctor or pharmacist.

Wait 30minutes to allow the pre-filled syringe to reach room temperature

• To ensure that the injection is correct, leave the pre-filled syringe at room temperature outside the box for 30minutes, out of the reach of children.
• Do not use any other method to heat the pre-filled syringe (e.g. do not heat it in the microwave or in hot water).
• Do not remove the cap from the pre-filled syringe while waiting for it to reach room temperature.

Prepare the rest of the material

• While waiting, prepare the rest of the material you need, such as cotton wool soaked in alcohol, a cotton ball or a gauze and a sharps container.

Check the liquid in the pre-filled syringe

• Look through the viewfinder to check that the liquid in the pre-filled syringe is transparent to slightly opalescent (with a pearlescent sheen), colourless to pale yellow. The solution can be used if it contains small, translucent or white protein particles.
• You will also see a bubble of air, which is normal.
• Do not use the pre-filled syringe if the liquid has an abnormal colour, is cloudy or contains large particles.In this case, inform your doctor or pharmacist.

2.Selection and preparation of the injection site (see figure2)

• The medicine can be injected in the middle part of the front of the thigh.
• It can also be injected in the abdomen below the navel, except in the area of approximately 5cm immediately below the navel.
• Do not inject in areas where the skin is sensitive, bruised, red, flaky, hard, or has scars or stretch marks.
• If multiple injections are needed for a single administration, the injections will be administered in different injection sites.

Figure2

DO NOTinject in the arm to avoid failure of the pre-filled syringe and/or accidental injuries.

Wash your hands and clean the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site with cotton wool soaked in alcohol.
• Let the skin dry before the injection. Do not fan or blow on the cleaned skin.
• Do not touch that area again until the injection is applied.

3.Injection of the medicine

• Do not remove the cap until you are ready to inject the medicine.
• The medicine must be injected within 5minutes of removing the cap.

Remove the cap (see figure3)

• When you are ready to inject, turn the cap slightly to break the safety seal.
• Remove the cap and dispose of it after the injection.
• Do not put the cap back on the pre-filled syringe because it may damage the needle inside the pre-filled syringe.
• Do not use the pre-filled syringe if it has fallen without the cap. If this happens, inform your doctor or pharmacist.

Figure3

Push the pre-filled syringe against the skin (see figures4 and5)

Figure4

• Hold the pre-filled syringe loosely withone handabove the blue button.
• Make sure the green safety guard is stable and as flat as possible against your skin. If the pre-filled syringe is not stable during the injection, you risk bending the needle.
• DO NOT pinch the skin to avoid accidental needle injuries.
• DO NOTtouch or press the blue button while placing the pre-filled syringe on your skin.

Figure5

• Push the open end of the pre-filled syringe against the skin with a 90degree angle. Press hard enough to slide the green safety guard up and keep it inside the transparent cover. Only the widest part of the green safety guard remains outside the transparent cover.
• DO NOT press the blue button until the safety guard is fully retracted against the skin. Pressing the blue button before the safety guard is retracted may cause the pre-filled syringe to fail.
• Administer the injection without pinching the skin.

Press the injection button (see figures6 and7)

Figure6Figure7

• Hold the pre-filled syringe against the skin.To start the injection,use your other handto press the protruding part of the blue button. Do not press the button unless the pre-filled syringe is pressed against the skin and the safety guard is fully retracted.
• Once the button is pressed, it will remain pressed and it is not necessary to continue pressing it.
• If it seems difficult to press the button, do not press the button harder. Release the button, lift the pre-filled syringe and start again. Make sure there is no pressure on the button until the safety guard is fully retracted against the skin, then press the protruding part of the blue button.
• You will hear a loud sound, a “click”‑do not be alarmed. The first “click” indicates that the needle has been inserted and the injection has started. You do not have to feel the pinch at this time.

Do not lift the pre-filled syringe from the skin. If you remove the pre-filled syringe from the skin, the full dose may not be injected.

Continue holding until the second “click” (see figure8), this usually takes between 3and 6seconds, but it may take up to 15secondsto hear the second “click”.

Figure8

• Hold the pre-filled syringe against the skin until you hear a second “click”(which indicates that the injection has finished and the needle has returned to the pre-filled syringe).
• Lift the pre-filled syringe from the injection site.
• Nota: If you do not hear the second “click”, wait 15seconds from the first time you pressed the button and then lift the auto-injector from the injection site.

4.After the injection

Use a cotton ball or gauze

• You may see a little blood or liquid at the injection site. This is normal.
• With a cotton ball or gauze, press on the injection site for 10seconds.
• If necessary, cover the injection site with a small adhesive plaster.
• Do not rub the skin.

Check the viewfinder‑an amber indicator confirms the correct administration (see figure9)

• The amber indicator is connected to the plunger of the pre-filled syringe. If the amber indicator does not appear in the viewfinder, the plunger has not moved properly, and the injection has not occurred.
• The amber indicator will fill almost half of the viewfinder. This is normal.
• If the amber indicator does not appear in the viewfinder, or if you suspect that you may not have received a full dose, inform your doctor or pharmacist. Do not administer a second dose without consulting your doctor.

Figure9

Dispose of the pre-filled syringe (see figure10)

• Next, place the pre-filled syringe in a sharps container. Follow the instructions from your doctor or nurse to dispose of the container when it is full.

If you think something has gone wrong during the injection or have any doubts, inform your doctor or pharmacist.

Figure10