Label: Information for the Patient

Idacio 40 mg injectable solution in pre-filled syringe

adalimumab

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

• Keep this label, as you may need to read it again.
• Your doctor will give you a patient information leaflet, which contains important safety information that you need to know before and during treatment with Idacio.

Keep this patient information leaflet during your treatment and the 4 months after your last injection (or of your child) of Idacio.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Idacio contains adalimumab as its active substance, a medication that acts on the body's immune system (defense).

Idacio is indicated for the treatment of the following inflammatory diseases:

• Rheumatoid arthritis,
• Polyarticular juvenile idiopathic arthritis,
• Arthritis associated with enthesitis,
• Ankylosing spondylitis,
• Undifferentiated spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• Psoriatic arthritis,
• Poriasis,
• Hidradenitis supurativa,
• Crohn's disease,
• Ulcerative colitis,
• Non-infectious uveitis.

The active substance of Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attack a specific target in the body.

The target of adalimumab is another protein called tumor necrosis factor (TNFα), which is present in high levels in the above-mentioned inflammatory diseases. By attacking TNFα, Idacio blocks its action and reduces inflammation in those diseases.

Rheumatoid Arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Idacio is used to treat rheumatoid arthritis in adults. If you have active moderate to severe rheumatoid arthritis, you may be given other disease-modifying medications such as methotrexate first. If the effect of these medications is not sufficient, you will be given Idacio to treat your rheumatoid arthritis.

Idacio can also be used in the treatment of severe, active, and progressive rheumatoid arthritis without previous treatment with methotrexate.

Idacio can reduce the damage to the cartilage and bones of the joints caused by the disease and improve physical performance.

Idacio is usually used in combination with methotrexate. If your doctor considers methotrexate not suitable, Idacio can be administered alone.

Polyarticular Juvenile Idiopathic Arthritis and Arthritis Associated with Enthesitis

Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory diseases of the joints that usually appear for the first time in childhood.

Idacio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and arthritis associated with enthesitis in children aged 6 to 17 years. Patients may have received other disease-modifying medications, such as methotrexate, first. If the action of these medications is not sufficient, patients will receive Idacio to treat their polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.

Ankylosing Spondylitis and Undifferentiated Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis

Ankylosing spondylitis and undifferentiated spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases that affect the spine.

Idacio is used in adults to treat these diseases. If you have ankylosing spondylitis or undifferentiated spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will be treated first with other medications. If the action of these medications is not sufficient, you will receive Idacio to reduce the signs and symptoms of your disease.

Psoriatic Arthritis

Psiatic arthritis is an inflammatory disease of the joints associated with psoriasis.

Idacio is used to treat psoriatic arthritis in adults. Idacio can reduce the joint damage caused by the disease in cartilage and bone and improve physical performance.

Poriasis in Adults and Children

Poriasis is an inflammatory disease of the skin that causes red, scaly, crusty areas and plate-like scales. Poriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which can be painful. It is believed that psoriasis is caused by a defect in the body's immune system that leads to an increase in skin cell production.

Idacio is used to treat moderate to severe psoriasis in adults. Idacio is also used to treat severe psoriasis in children and adolescents aged 4 to 17 years who have not responded to or are not good candidates for topical medications or phototherapy.

Hidradenitis Supurativa in Adults and Adolescents

Hidradenitis supurativa (also known as inverse acne) is a long-lasting and often painful inflammatory skin disease. Symptoms can include sensitive nodules (bumps) and abscesses (boils) that can secrete pus. It usually affects specific areas of the skin, such as under the chest, armpits, inner thighs, groin, and buttocks. It can also leave scars in affected areas.

Idacio is used to treat hidradenitis supurativa in adults and adolescents aged 12 and over. Idacio can reduce the number of nodules and abscesses and the pain associated with this disease. You may have received other medications previously. If the action of these medications is not sufficient, you will receive Idacio.

Crohn's Disease in Adults and Children

Crohn's disease is an inflammatory disease of the intestine.

Idacio is used to treat Crohn's disease in adults and children aged 6 to 17 years. If you have Crohn's disease, you will be treated first with other medications. If you do not respond sufficiently to these medications, you will receive Idacio to reduce the signs and symptoms of Crohn's disease.

Ulcerative Colitis in Adults and Children

Ulcerative colitis is an inflammatory disease of the large intestine.

Idacio is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may be given other medications first. If the action of these medications is not sufficient, you will be given Idacio to reduce the signs and symptoms of your disease.

Non-infectious Uveitis in Adults and Children

Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.

• Adults with non-infectious uveitis with inflammation affecting the posterior part of the eye.
• Children aged 2 and over with chronic non-infectious uveitis with inflammation affecting the anterior part of the eye.

Inflammation can lead to a decrease in vision and/or the presence of spots in the eye (black dots or thin lines that move across the field of vision). Idacio acts by reducing this inflammation.

Idacio is used to treat:

• Adults with non-infectious uveitis with inflammation affecting the posterior part of the eye.
• Children aged 2 and over with chronic non-infectious uveitis with inflammation affecting the anterior part of the eye.

Do not use Idacio

• if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

• if you have a severe infection, including tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a weakened immune system). If you have symptoms of any infection, for example: fever, wounds, fatigue, dental problems, inform your doctor (see "Warnings and precautions").

• if you have moderate or severe heart failure. It is essential to inform your doctor if you have had or have any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Idacio.

Allergic reaction

• If you experience an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop administering Idacio and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infection

• If you have any infection, including chronic or localized infections (for example: a leg ulcer), consult your doctor before starting treatment with Idacio. If you are unsure, contact your doctor.

• With Idacio treatment, you may be more susceptible to infections. This risk may be higher if you have reduced lung function. These infections can be more severe and include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other unusual infectious organisms, and sepsis (blood infection). In rare cases, these infections can be life-threatening. Therefore, it is essential to inform your doctor if you have symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily stopping Idacio treatment.

Tuberculosis (TB)

• Since cases of tuberculosis have been reported in patients treated with Idacio, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with Idacio. This will include a thorough medical evaluation, including your medical history and diagnostic tests (such as chest X-ray and tuberculin test). The results of these tests should be recorded on your patient information card. It is essential to inform your doctor if you have had tuberculosis or have been in contact with a tuberculosis patient. You can develop tuberculosis during treatment, even if you have received preventive treatment for tuberculosis. If you experience symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection during or after treatment, contact your doctor immediately.

Travel or recurrent infection

• Inform your doctor if you have lived or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.

• Inform your doctor if you have a history of recurrent infections or other conditions or factors that increase the risk of infections.

Hepatitis B virus

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection, or if you think you may be at risk of contracting HBV. Your doctor should perform a test for HBV. Adalimumab can reactivate HBV infection in people who are carriers of this virus. In rare cases, especially if you are taking other medications that suppress the immune system, reactivation of HBV infection can be life-threatening.

Patients over 65 years

• If you are over 65 years old, you may be more susceptible to infections while taking Idacio. Both you and your doctor should pay special attention to the appearance of infection symptoms while you are being treated with Idacio. It is essential to inform your doctor if you have symptoms of infections, such as fever, wounds, fatigue, or dental problems.

Surgical or dental interventions

• If you are to undergo a surgical or dental procedure, inform your doctor that you are using Idacio. Your doctor may recommend temporarily stopping Idacio treatment.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Idacio. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccinations

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during Idacio treatment if these vaccines cause infections. Consult your doctor before receiving any type of vaccine. If possible, it is recommended that children receive all established vaccinations on their vaccination schedule before starting Idacio treatment. If you receive Idacio while pregnant, your child may have a higher risk of contracting infections for about 5 months after the last dose you received during pregnancy. It is essential to inform your child's doctor and other healthcare professionals about your use of Idacio during pregnancy, so they can decide whether your child should receive any vaccine.

Heart failure

• It is essential to inform your doctor if you have had or have serious heart problems. If you have mild heart failure and are being treated with Idacio, your doctor should continue to monitor your heart failure. If you experience new symptoms of heart failure or worsening existing symptoms (for example: difficulty breathing, swelling of the feet), contact your doctor immediately.

Fever, rashes, bleeding, or pale appearance

• In some patients, the body may be unable to produce enough of the type of white blood cells that fight infections (white blood cells) or the platelets that contribute to stopping bleeding. If you have persistent fever, experience rashes, bleed easily, or appear pale, consult your doctor immediately. Your doctor may decide to stop treatment.

Cancer

• In very rare cases, cases of certain types of cancer have been reported in children and adults treated with adalimumab or other TNFα blockers. People with more severe rheumatoid arthritis and who have had the disease for a long time may have a higher risk than the general population of developing lymphoma and leukemia (cancers that affect the blood and bone marrow). If you are being treated with Idacio, the risk of developing lymphoma, leukemia, and other types of cancer may increase. In rare cases, a specific and severe type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine.

Inform your doctor if you are taking azathioprine or 6-mercaptopurine with adalimumab.

• Additionally, cases of skin cancer (non-melanoma) have been reported in patients using adalimumab. Inform your doctor if you experience new skin damage or if existing skin damage changes appearance during or after treatment.

• Cancers, other than lymphoma, have been reported in patients with a specific lung disease, called chronic obstructive pulmonary disease (COPD), treated with another TNFα blocker. If you have COPD or smoke heavily, consult your doctor if treatment with a TNFα blocker is suitable for you.

Lupus-like syndrome

• In rare cases, treatment with Idacio may lead to a lupus-like syndrome. Contact your doctor if you experience symptoms such as persistent rash without explanation, fever, joint pain, or fatigue.

Children and adolescents

• Vaccination: If possible, your child should receive all established vaccinations before using Idacio.
• Do not administer Idacio to children under 2 years old with juvenile idiopathic polyarticular arthritis.
• Do not use the 40 mg pre-filled syringe or the 40 mg pre-filled pen if different doses of 40 mg are recommended.

Other medications and Idacio

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Idacio can be taken with methotrexate or certain disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold preparations), corticosteroids, or pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs).

Do not use Idacio with medications whose active ingredients are anakinra or abatacept due to an increased risk of severe infections. The combination of adalimumab and other TNFα antagonists and anakinra or abatacept is not recommended due to the possible increase in the risk of infections, including severe infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is recommended to avoid becoming pregnant and use suitable contraceptive methods during Idacio treatment and continue using them for at least 5 months after the last administration of Idacio. If you become pregnant, you should consult your doctor.

• Idacio should only be used during pregnancy if necessary.
• According to a study in pregnancy, there was no increased risk of congenital defects when the mother had received adalimumab treatment during pregnancy compared to mothers with the same disease who did not receive adalimumab treatment.
• Idacio can be used during breastfeeding.
• If you use Idacio while pregnant, your child may have a higher risk of contracting an infection.
• It is essential to inform your child's doctor and other healthcare professionals about your use of Idacio during pregnancy before your child receives any vaccine (for more information on vaccinations, see the "Vaccination" section).

Driving and using machines

The influence of Idacio on the ability to drive, ride a bike, or use machines is small. You may experience a sensation of the room spinning and visual disturbances after using Idacio.

Idacio contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 0.8 ml dose, which is essentially "sodium-free".

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

Idacio is injected under the skin (subcutaneously). Patients who need a dose less than 40 mg should use the 40 mg vial presentation of Idacio.

The recommended dose of Idacio for each of the approved uses is shown in the following table.

Form and Route of Administration

Idacio is administered by subcutaneous injection under the skin. For usage instructions, see section 7 “Usage Instructions”.

If you use more Idacio than you should

If you accidentally inject Idacio more frequently than you need, inform your doctor or pharmacist. Always carry the medication box with you, even if it is empty.

If you forget to use Idacio

If you forget to administer an injection, inject the next dose of Idacio as soon as you remember. Then, administer the next dose as usual, as if you had not forgotten a dose.

If you interrupt treatment with Idacio

The decision to stop using Idacio should be discussed with your doctor. Your symptoms may return after interrupting treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects can appear up to 4 months after or more than the last Idacio injection.

Seek immediate medical attention if you notice any of the following signs of allergic reaction or heart failure:

• severe rash, urticaria;
• swelling of the face, hands, feet;
• difficulty breathing, swallowing;
• shortness of breath when exercising or lying down, or swelling of the feet.

Get in touch with your doctor as soon as possible if you notice any of the following effects:

• signs and symptoms of infection such as fever, nausea, wounds, dental problems, burning sensation while urinating;
• feeling weak or tired, coughing;
• symptoms of nervous system problems such as tingling, numbness, double vision, or weakness in arms or legs;
• signs of skin cancer such as a lump or an open wound that does not heal;
• signs and symptoms of blood disorders such as persistent fever, petechiae, bleeding, and pallor.

The following side effects have been observed with adalimumab:

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness, or itching);
• lower respiratory tract infections (including colds, coughing, sinusitis, pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• pruritus;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and flu);
• gastrointestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes);
• ear infection;
• oral infections (including dental infection and cold sore);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• drowsiness and difficulty sleeping;
• sensorial alterations such as tingling, itching, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back and leg pain);
• visual disturbances;
• conjunctivitis;
• conjunctival and eyelid edema;
• dizziness (feeling the room is spinning);
• feeling of rapid pulse;
• high blood pressure;
• flushing;
• hematomas (a palpable swelling with coagulated blood);
• coughing;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion, bloating, and heartburn;
• acid reflux;
• Sjögren's syndrome (including dry eyes and mouth);
• itching;
• pruritic papular eruption;
• bruising;
• dermatitis (skin inflammation);
• hand and foot nail breakage;
• excessive sweating;
• hair loss;
• new-onset or worsening psoriasis;
• muscle spasms;
• blood in urine;
• renal problems;
• chest pain;
• edema (accumulation of fluid in the body causing swelling of the affected tissue);
• fever;
• decreased platelet count in blood, increasing the risk of bleeding or bruising;
• wound healing problems.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when resistance to disease decreases;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);

• cancer; including lymphoma (cancer affecting the lymphatic system) and melanoma (a type of skin cancer);
• immunological disorders that can affect the lungs, skin, and lymph nodes (more frequently as a disease called sarcoidosis);

• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• cerebral hemorrhage;
• double vision;
• hearing loss, tinnitus;
• feeling of irregular pulse like skipping;
• heart problems that can cause difficulty breathing or swelling of the ankles;
• heart attack;
• sac in the wall of a major artery, inflammation and coagulation in a vein, blockage of a blood vessel;
• pulmonary diseases that can cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis (inflammation of the pancreas causing severe abdominal and back pain);
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation; gallstones;
• fat accumulation in the liver (accumulation of fat in liver cells);
• nocturnal sweating;
• scars;
• abnormal muscle cramps;
• systemic lupus erythematosus (a disorder of the immune system that includes skin, heart, lung, joint, and other organ inflammation);
• sleep interruptions;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1000 people)

• leukemia (cancer affecting the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scar tissue in the lungs);
• intestinal perforation (hole in the intestinal wall);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B virus;
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (potentially fatal reaction with symptoms similar to flu and pruritic papular eruption);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• syndrome similar to lupus;
• angioedema (localized inflammation of the skin);
• erythema nodosum (pruritic papular eruption with red-brown color);

Frequency not known(cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (rare blood cancer often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• hepatic failure;
• worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness).

Some side effects observed in clinical trials with adalimumab can only be identified by blood analysis and do not have symptoms. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• high lipid levels in blood;
• high liver enzyme levels.

Common(may affect up to 1 in 10 people)

• high white blood cell count;
• low platelet count;
• high uric acid levels in blood;
• abnormal sodium levels in blood;
• low calcium levels in blood;
• low phosphate levels in blood;
• high blood sugar;
• high lactate dehydrogenase levels in blood;
• presence of autoantibodies in blood;
• low potassium levels in blood.

Uncommon(may affect up to 1 in 100 people)

• high bilirubin levels (liver function test).

Rare(may affect up to 1 in 1000 people)

• low counts in blood for white cells, red cells, and platelets.

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 theAppendix V. 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 the Idacio pre-filled pen after the expiration date that appears on the label/box 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 pre-filled pen in the outer packaging to protect it from light.

Alternative Storage:

When necessary (for example, when traveling), you may store a single Idacio pre-filled pen at room temperature (up to 25°C) for a maximum period of 28 days (ensure it is protected from light). Once removed from the refrigerator for storage at room temperature, the pre-filled penmust be used within the next 28 days or discarded, even if it is returned to the refrigerator later.

You must note the date when you removed the pen from the refrigerator, and the date after which it must be discarded.

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

Composition of Idacio

The active ingredient is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.

The other components are: Sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polisorbate 80, sodium hydroxide, and water for injection.

Appearance of the product and contents of the pack

Idacio 40 mg solution for injection in pre-filled syringe is supplied as 0.8 ml of a sterile, colourless and clear solution of 40 mg of adalimumab.

The pre-filled syringe of Idacio contains a pre-filled syringe with Idacio. Each pack contains 2 or 6 pre-filled syringes with 2 or 6 alcohol-impregnated wipes.

Idacio may be available in vial, pre-filled syringe and pre-filled pen.

Marketing authorisation holder

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.Höhe

Germany

Responsible for manufacturing

Fresenius Kabi Austria GmbH

Hafnerstraße 36,

8055 Graz

Austria

Merck Serono S.p.A.

Via delle Magnolie 15

I-70026 Modugno (Bari)

Italy

Last update of this leaflet

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

7. Instructions for use

Make sure to read, understand and follow these instructions for use before injecting Idacio. Your doctor should show you how to prepare and inject Idacio using the pre-filled syringe before using the medicine for the first time. Consult your doctor if you have any doubts.

Note: Images are for illustrative purposes only

Read carefully these instructions before using your Idacio pre-filled syringe.

Important information

• Only use the Idacio pre-filled syringe if your healthcare professional has taught you how to use it correctly.

• Idacio pre-filled syringe is a pre-filled syringe ready for single use for a full dose of adalimumab.

• Always inject using the technique taught by your healthcare professional.

• Children under 12 years old cannot inject themselves and the injection must be performed by an adult trained.

• Keep the Idacio pre-filled syringe out of the reach of children.

• Do not insert your fingers into the safety guard.

• Do not use an Idacio pre-filled syringe that has been frozen or exposed to direct sunlight.

• Speak with your healthcare professional if you have any questions or concerns.

Storage information

• Keep the pre-filled syringe in its original box to protect it from light.

• Store the pre-filled syringe in the refrigerator, between 2°C and 8°C.

• If necessary, for example when traveling, a single pre-filled syringe can be stored at room temperature for up to 14 days.

Familiarise yourself with your Idacio pre-filled syringe

After use

Step 1: Prepare your injection

Each box of Idacio pre-filled syringe comes with two or six pre-filled syringes.

1.1Prepare a flat and clean surface, such as a table or countertop, in a well-lit area.

?a alcohol-impregnated wipe (included in the box)?a cotton ball or gauze, and

?a container for disposing of sharp objects.

Figure A

1.3Take the box out of the refrigerator (Figure B).

Figure B

1.4Check the expiration date on the side of the box (Figure C).

Figure C

Warning: Do not use if the expiration date has passed

1.5Take a pre-filled syringe out of the original packaging:

• place two fingers on the area of the label
• pull the pre-filled syringe upwards and out of the packaging (Figure D).

Figure D

Place it on a flat and clean surface.

1.6Place the rest of the pre-filled syringes in their original box in the refrigerator (Figure E).

Figure E

See the storage information to know how to store your unused pre-filled syringe(s).

1.7Leave the pre-filled syringe at room temperature for at least 30 minutes to allow the medicine to come to room temperature. (Figure F).

Figure F

Injecting cold medicines can be painful.

Warning: Do notheat the pre-filled syringe in any other way, such as in a microwave, hot water or direct sunlight.

Warning: Do notremove the needle cap until you are ready to inject.

Step 2: Wash your hands

2.1Wash your hands with soap and water and dry them well. (Figure G).

Warning:Guards do not replace the need to wash your hands.

Step 3: Check the pre-filled syringe

3.1Check the transparent cartridge of the syringe to ensure that:

• The liquid is transparent, colourless and free of particles (Figure H).
• The glass syringe is not cracked or broken (Figure H).

Figure H

Warning: Do notuse the pre-filled syringe if the liquid contains particles, is cloudy or coloured, has scales or shows any sign of damage.

If so, dispose of it in a sharps container and contact your healthcare professional or pharmacist.

• The name on the pre-filled syringe is Idacio (Figure I).
• The expiration date on the pre-filled syringe has not passed (Figure I).

Figure I

Warning: Do notuse the pre-filled syringe if the name on the label is not Idacio and/or if the expiration date on the label has passed.

If so, dispose of the pre-filled syringe in a sharps container and contact your healthcare professional or pharmacist.

Step 4: Choose the injection site

• The front of the thighs.
• Abdomen (inject at least 5 cm away from the navel).

Figure J

4.2Choose a different site (at least 2.5 cm away from the last injection site) each time to reduce redness, irritation or other skin problems.

Warning: Do notinject in an area that is painful (sensitive), has bruises, is red, hard, has scars or has stretch marks.

Warning:If you have psoriasis,do notinject in any lesions or red, thickened, raised or scaly areas.

Step 5: Clean the injection site

5.1Wipe the skin at the injection site with an alcohol-impregnated wipe. (Figure K).

Warning: Do not blow or touch the injection site after cleaning.

Figure K

Step 6: Administer your injection

• Hold the pre-filled syringe upwards and pull the needle cap out. (Figure L)

Figure L

You may see droplets of liquid at the tip of the needle.

• Dispose of the needle cap.

Warning:Do notrotate the cap.

Warning:Do notput the needle cap back on the pre-filled syringe.

• Hold the pre-filled syringe so that you can see the transparent cartridge of the syringe.
• Place your thumb on top (withouttouching) of the yellow injection button (Figure M).

Figure M

• Place the pre-filled syringe against your skin at a 90° angle (Figure N).

Figure NBefore injection

• Push and hold the pre-filled syringe firmly against your skin until the safety guard is pressed in completely. This will unlock the injection button (Figure O).

Figure OBefore injection

• Press theinjection button (Figure P).
• You will hear a click, which means that the injection has started.
• Continue holding the pre-filled syringe firmly.
• LOOK at the plunger of the syringe to ensure that it moves to the bottom. (Figure P).

Figure PAfter injection

Warning:Do notlift the pre-filled syringe from the skin until the plunger has moved to the bottom and all the liquid has been injected.

• When the plunger of the syringe has moved to the bottom and stopped moving, continue holding it for 5 seconds.
• Lift the pre-filled syringe from the skin (Figure Q).

The safety guard will slide down and lock in place to protect the needle. (Figure Q).

Figure Q

Warning: Contact your doctor or pharmacist if you have any problems.

6.4If there is blood or liquid on the skin, treat the injection site by gently pressing a cotton ball or gauze on the site (Figure R).

Figure R

Step 7: Dispose of your pre-filled syringe

7.1Dispose of your used pre-filled syringe in a sharps container immediately after use (Figure S).

Figure S

Warning:Keep the sharps container out of the reach of children.

Warning:Do not throw the pre-filled syringe in household waste.

If you do not have a sharps container, you can use a household container that is:

• Made of puncture-resistant plastic;
• Can be closed with a tight-fitting lid and puncture-resistant; this will prevent the sharps from coming out.
• Vertical and stable during use,
• Puncture-resistant and
• Properly labelled to warn of the presence of hazardous waste inside the container.

7.2When your sharps container is almost full, you will need to follow local guidelines for the correct disposal of the container.

Do notrecycle your used sharps container.

Step 8: Record your injection

8.1To help you remember when and where to administer your next injection, you must keep a record of the dates and injection sites used for your injections (Figure T).

Figure T