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, as 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 others, 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.

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 bind to a specific target in the body.

The target of adalimumab is another protein called tumor necrosis factor-alpha (TNFα), which is present in elevated 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 prior 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 effect 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 effect 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 the 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 covered with silver 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 or are not good candidates for topical medications or light therapy.

Hidradenitis Supurativa in Adults and Adolescents

Hidradenitis supurativa (also known as inverse acne) is a long-lasting and often painful inflammatory disease of the skin. 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 cause scarring in affected areas.

Idacio is used to treat hidradenitis supurativa in adults and adolescents aged 12 and older. 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 effect 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 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 effect 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.

• The 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 back of the eye.
• Children aged 2 and older with chronic non-infectious uveitis with inflammation affecting the front of the eye.

Do not use Idacio

• If you are allergic to adalimumab or any of the other components of this medication (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, such as 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 hives, discontinue Idacio administration 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 (e.g., a leg ulcer), consult your doctor before starting treatment with Idacio. If 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, infections caused by viruses, fungi, parasites, or bacteria, 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 discontinuing 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 (e.g., 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 scheduled for a surgical or dental procedure, inform your doctor that you are taking Idacio. Your doctor may recommend temporarily discontinuing 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 administering any type of vaccine. If possible, it is recommended that children receive all established vaccinations on their vaccination calendar 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 closely monitor your heart failure. If you experience new symptoms of heart failure or worsening existing symptoms (e.g., difficulty breathing, swelling of the feet), contact your doctor immediately.

Fever, petechiae, 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 type of cells that help stop bleeding (platelets). If you have persistent fever, experience petechiae, bleed easily, or appear pale, consult your doctor immediately. Your doctor may decide to discontinue treatment.

Cancer

• In rare cases, 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 those 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 blood cells 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 mercaptopurine with adalimumab.

• Additionally, cases of skin cancer (non-melanoma) have been reported in patients taking 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 about whether 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 on their vaccination calendar before starting Idacio treatment.
• 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 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 appropriate contraceptive methods during Idacio treatment and continue using them for at least 5 months after the last administration of Idacio. If you become pregnant, 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 treatment with adalimumab during pregnancy compared to mothers with the same disease who did not receive treatment with adalimumab.

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, see the "Vaccination" section).

Driving and operating machinery

The influence of Idacio on the ability to drive, ride a bike, or operate machinery is small. You may experience dizziness 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 since the last injection of Idacio.

Seek urgent medical attentionif you notice any of the following signs of allergic reaction or heart failure:

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

Contact your doctor as soon as possibleif you notice any of the following effects:

• signs and symptoms of infection such as fever, nausea, wounds, dental problems, burning sensation while urinating;
• feeling of weakness or fatigue, cough;
• 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 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(can 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 (stomach);
• nausea and vomiting;
• hives;
• muscle pain.

Common(can 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;
• difficulty sleeping;
• sensory 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 heartbeat;
• high blood pressure;
• flushing;
• hematomas (palpable swelling with coagulated blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion, bloating, and heartburn;
• acid reflux;
• Sjögren's syndrome (including dry eyes and mouth);
• itching;
• hives with itching;
• bruises;
• skin inflammation (such as eczema);
• hand and foot nail breakage;
• excessive sweating;
• hair loss;
• new-onset or worsening psoriasis;
• muscle spasms;
• blood in urine;
• kidney 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(can 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 (a type of 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 heartbeat 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;
• lung 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 crisis;
• systemic lupus erythematosus (a disorder of the immune system that includes skin, heart, lung, joint, and other organ inflammation);
• sleep interruptions;
• impotence;
• inflammations.

Rare(can 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 nerve inflammation 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 (a potentially life-threatening disease with flu-like symptoms and blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• lupus-like syndrome;
• angioedema (localized inflammation of the skin);
• lichenoid reaction in the skin (red, itchy rash)

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);
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions.
• hepatic failure;
• worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness).
• Weight gain (for most patients, weight gain was reduced)

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

Very common(can 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(can 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(can affect up to 1 in 100 people)

• high bilirubin levels (liver function test).

Rare(can 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 throughthe 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 this medication 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 syringe in the outer packaging to protect it from light.

Alternative Storage:

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

You must note the date when you removed the syringe 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: Dihydrogen phosphate of sodium dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polisorbate 80, sodium hydroxide, and water for injection preparations.

Appearance of the product and contents of the package

Idacio 40 mg injectable solution (injectable) in pre-filled syringe is presented as 0.8 ml of a sterile, colorless, and clear solution of 40 mg of adalimumab.

The pre-filled syringe of Idacio is presented in a glass syringe with a needle protector and finger grip wings. Each package contains 2 or 6 pre-filled syringes and 2 or 6 alcohol-soaked wipes.

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

Marketing Authorization 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

Last review date of this leaflet

The detailed information of 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 properly using the pre-filled syringe before using the medicine for the first time. Consult your doctor if you have any doubts.

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

Important information

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

• Idacio is a single-use pre-filled syringe.

• The pre-filled syringe of Idacio has a transparent needle protector that covers the needle after the injection is complete.

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

• Keep the pre-filled syringe of Idacio and the container for disposing of sharp objects out of reach and sight of children.

• Do notshake. Shaking may damage the pre-filled syringe and the medicine.

• Do notuse the pre-filled syringe of Idacio if the liquid is cloudy or changes color, or if it has particles or scales. The liquid must be clear and colorless.

• Do nottry to activate the transparent needle protector before injecting yourself.

• Do notinsert your fingers into the opening of the transparent needle protector.

• Do notuse a pre-filled syringe of Idacio that has been frozen or exposed to direct sunlight.

• Do notuse the pre-filled syringe of Idacio if it has fallen or been crushed, as the pre-filled syringe may break even if you cannot see the break.

Use a new pre-filled syringe instead.

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 28 days.

Familiarize yourself with your pre-filled syringe of Idacio

Before use

After use

Step 1: Prepare your injection

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

• a wipe soaked in alcohol (included in the package)
• a cotton ball or gauze, and
• a container for disposing of sharp objects.

Open your container for disposing of sharp objects so it is ready for use.

Figure A

Warning: Do notuse if the expiration date has passed.

Figure B

Take a syringe out of the original package:

• place two fingers in the center of the transparent needle protector
• pull the syringe upwards and out of the packaging (Figure C).

Put it on a flat and clean surface.

Figure C

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

Figure D

Injecting cold medicines can be painful (Figure E).

Figure E

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

Warning: Do notremove the needle protector while the syringe is warming up.

Step 2: Wash your hands

1. Wash your hands with soap and water and dry them well. (Figure F)

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

Figure F

Step 3: Check the pre-filled syringe

1. Check the syringe to make sure:

• The syringe, the transparent needle protector, and the needle cap are not cracked or damaged (Figure G).

Figure G

• The needle protector is securely attached (Figure H).

Figure H

• The plunger rod is not extended (Figure I).

Figure I

Warning: Do notuse the syringe if it shows any signs of damage.

If so, dispose of the syringe in a container for disposing of sharp objects and contact your doctor or pharmacist.

3.2Check the liquid to make sure it is:

• Transparent, colorless, and free of particles (Figure J).

Warning:Do not use the syringe if the liquid contains particles, is cloudy, is colored, or has scales.

Figure J

• The name on the syringe says Idacio (Figure K).
• The expiration date of the syringe has not passed (Figure K).

Figure K

Warning: Do notuse the syringe if:

• The name on the syringe is not Idacio.
• The expiration date of the syringe has passed.

If so, dispose of the syringe in a container for disposing of sharp objects and contact your doctor or pharmacist.

Step 4: Choose the injection site

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

Figure L

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, is 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

5.1Clean the skin at the injection site with an alcohol-soaked wipe (Figure M)

Warning: Do notsneeze or touch the injection site after cleaning.

Figure M

Step 6: Administer your injection

6.1Remove the needle protector

• Always hold the syringe by the transparent needle protector.
• Hold the syringe upwards and pull the needle protector outwards (Figure N).

Figure N

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

• Dispose of the needle protector.

Warning: Do nottouch the needle.

6.2Pinch the skin

• Hold the syringe as if holding a pen.
• With the other hand, pinch the skin (without squeezing) to avoid injecting into a muscle (Figure O).

Figure O

• With a quick and short movement, push the needle to the bottom of the skin at an angle of 45° to 90° (Figure P).

Figure P

• After inserting the needle, release the pinched skin.

• Use your thumb to push the plunger downwards gently (Figure Q).

Figure Q

• Push the plunger again to make sure the full dose has been injected (Figure R).
• Hold the syringe firmly without moving it, at the same angle (Figure R).

Figure R

Do notremove the needle from the skin when the plunger reaches the end.

Release your thumb slowly upwards.

This will allow the needle to move upwards inside the transparent needle protector and cover the entire needle. (Figure S).

Figure S

Warning:Call your doctor or pharmacist if:

• You did not inject the full dose or
• The transparent needle protector did not activate after the injection.

Warning: Do notre-use a syringe in case of partial injection.

Do nottry to re-cap the needle, as you may prick yourself

Figure T

Step 7: Dispose of your syringe

7.1.Dispose of the used syringe in a container for disposing of sharp objects immediately after use (Figure U).

Figure U

Warning:Keep the container for disposing of sharp objects out of reach of children.

Warning: Do notthrow the syringe in household trash.

If you do not have a container for disposing of sharp objects, you can use a household container that is:

• Made of puncture-resistant plastic;
• Can be closed with a tight-fitting lid and puncture-resistant, which will prevent objects from escaping,
• Vertical and stable during use,

• Puncture-resistant and
• Properly labeled to warn of the presence of hazardous waste inside the container.

7.2When your container for disposing of sharp objects is almost full, you will need to follow local guidelines for proper disposal of the container.

Do notrecycle your used container for disposing of sharp objects.

Step 8: Record your injection

Figure V