IMRALDI 40 мг Инъекционный раствор

Содержание инструкции

1. Imraldi 40 mg injectable solution in pre-filled syringe
   1. What is Imraldi and what is it used for
   2. What you need to know before using Imraldi
   3. How to use Imraldi
   4. Possible side effects
   5. How to store Imraldi
   6. Package contents and other information
   7. Instructions for use
   8. Gather the necessary items
   9. Wait 15-30 minutes
   10. Check the medicine and the expiry date
   11. Choose an injection site and clean the skin
   12. Remove the needle cap
   13. Pinch the skin between your fingers and insert the needle
   14. Push the plunger all the way down
   15. Remove and dispose of the syringe
2. Imraldi 40 mg solution for injection in pre-filled pen
   1. What is Imraldi and what is it used for
   2. What you need to know before using Imraldi
   3. How to use Imraldi
   4. Possible side effects
   5. How to store Imraldi
   6. Package contents and other information
   7. Instructions for Use
   8. Gather the necessary items
   9. Wait 15-30 minutes
   10. Check the medicine and the expiry date
   11. Choose an injection site and clean the skin
   12. Remove the transparent cap from the needle
   13. Place the green base, press and hold
   14. Continue to hold down
   15. Confirm completion of the injection and dispose of the pen
3. Imraldi 40 mg/0.8 ml injectable solution
   1. What is Imraldi and what is it used for
   2. What you need to know before your child uses Imraldi
   3. How to use Imraldi
   4. Possible side effects
   5. How to store Imraldi
   6. Package contents and other information
   7. Instructions for Use
4. Imraldi 40 mg injectable solution in pre-filled syringe
   1. What is Imraldi and what is it used for
   2. What you need to know before using Imraldi
   3. How to use Imraldi
   4. Possible side effects
   5. How to store Imraldi
   6. Contents of the pack and other information
   7. Instructions for Use
   8. Gather the necessary items
   9. Wait 15-30 minutes
   10. Check the medicine and the expiry date
   11. Choose an injection site and clean the skin
   12. Remove the needle cap
   13. Take a fold of skin between your fingers and insert the needle
   14. Push the plunger all the way in
   15. Remove and dispose of the syringe
5. Imraldi 40 mg solution for injection in pre-filled pen
   1. What is Imraldi and what is it used for
   2. What you need to know before using Imraldi
   3. How to use Imraldi
   4. Possible side effects
   5. How to store Imraldi
   6. Package contents and other information
   7. Instructions for Use
   8. Gather the necessary items
   9. Wait 15-30 minutes
   10. Check the medicine and the expiry date
   11. Choose an injection site and clean the skin
   12. Remove the transparent cap from the needle
   13. Place the green base, press and hold
   14. Keep holding down
   15. Confirm completion of the injection and dispose of the pen

Imraldi 40 mg injectable solution in pre-filled syringe

adalimumab

Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you a Patient Reminder Card containing important safety information, which you need to know before administering Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card during treatment and for 4 months after the last Imraldi injection (yours or your child's).
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Imraldi is and what it is used for
• 2. What you need to know before you use Imraldi
• 3. How to use Imraldi
• 4. Possible side effects
• 5. How to store Imraldi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Imraldi and what is it used for

Imraldi contains the active substance adalimumab, a medicine that works on the immune system
(the body's defense system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis.

The active ingredient of Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNF α) which is
present at high levels in the inflammatory diseases described above. By binding to TNF α, Imraldi
reduces the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as methotrexate, may be given initially. If these drugs do not work adequately, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi can also be used to treat severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Imraldi is able to slow the progression of damage to the cartilage and bones of the
joints, caused by the disease, and to improve physical function.
Generally Imraldi is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Imraldi may be given 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 typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as methotrexate, may be given at diagnosis. If these drugs do not work adequately, patients will be given
Imraldi for the treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with
enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of spondylitis
are inflammations of the spine.
Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of spondylitis, you will first take other
medicines. If these medicines do not work adequately, you will take Imraldi to
reduce the signs and symptoms of the disease.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi is able to slow the damage to the
cartilage and bones of the joints, caused by the disease, and to improve physical function.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect
the nails causing them to crumble, become thicker and lift off the nail bed, which can
be painful. Psoriasis is thought to be caused by a problem with the body's immune system
that leads to an increased production of skin cells.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is
also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or more in whom topical therapy and phototherapies have not worked optimally or
are not indicated.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-lasting, often painful inflammatory skin disease. Symptoms may include painful nodules and abscesses (cysts) that
may drain pus. It most frequently affects specific areas of the skin, such as the
submammary region, armpits, inner thighs, groin and buttocks. Scars can also form in the affected areas.
Imraldi is used to treat Hidradenitis Suppurativa in adults and adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses you have and the pain that is often associated with
this disease. Initially, you may receive other medicines. If you do not respond sufficiently
well to these medicines, you will receive Imraldi.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If
you suffer from Crohn’s disease, you will first be given other medicines. If these medicines do not
work adequately, you will be given Imraldi to reduce the typical symptoms
of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Imraldi 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 take other medicines first. If these medicines
do not work adequately, you will take Imraldi to reduce the signs and symptoms of the disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of mobile bodies
in the eye (black spots or thin lines that move across the field of vision). Imraldi works
by reducing this inflammation.

2. What you need to know before using Imraldi

Do not use Imraldi

• 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 (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi
Allergic reaction

• If you experience allergic reactionswith symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infection

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Imraldi. If you have any doubts, contact your doctor.
• You may be more likely to get infections during treatment with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning). In rare cases, these infections can be life-threatening. It is important to tell your doctor about symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Imraldi.

Tuberculosis

• Because cases of tuberculosishave occurred in patients treated with Imraldi, your doctor will need to check if you have signs or symptoms of tuberculosis before starting therapy with Imraldi. This will involve collecting a detailed medical assessment including your medical history and clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV),if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting the hepatitis virus
• B. Your doctor should test you for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection while you are being treated

with Imraldi. It is important to inform your doctor if symptoms of infections such as fever,
wounds, feeling tired or dental problems appear.
Surgery or dental procedure

• Before a surgery or dental procedures, tell your doctor that you are taking Imraldi. Your doctor may advise you to temporarily stop Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease(diseases that affect the coating of the nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Imraldi. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccines

• Certain vaccinescontain bacteria or viruses that cause diseases in a weakened form, but are live, and should not be administered during treatment with Imraldi. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to implement the vaccination schedule appropriate for their age group before starting treatment with Imraldi. If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose you received during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• If you have mild heart failureand are receiving concomitant treatment with Imraldi, your doctor will need to carefully assess and monitor your heart condition. It is important to inform your doctor about any heart problems, past or present. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately. The doctor will decide whether you can take Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have fever, bruisingor easy bleedingor paleness, see your doctor immediately. The latter may decide to stop therapy.

Cancer

• Very rarely, some types of cancerhave occurred in children and adults treated with Imraldi or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma(a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow). If you take Imraldi, your risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients undergoing therapy with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• In addition, cases of non-melanoma skin cancerhave been observed in patients taking Imraldi. If new skin lesions appear during or

after therapy or if the appearance of existing lesions or damaged areas changes,
report it to your doctor.

• There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti- TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Imraldi to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not use the pre-filled syringe of 40 mg if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Imraldi can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last injection of Imraldi.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Imraldi can be used during breastfeeding.
• If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, before the baby receives any type of vaccination (for more information on vaccinations, see “Warnings and precautions”).

Driving and using machines
Imraldi may affect your ability to drive, ride a bicycle or use machines, although only to a slight extent. After taking Imraldi, you may experience visual disturbances and a sensation that the environment around you is spinning (dizziness).

Imraldi contains sodium and sorbitol

Sorbitol
This medicine contains 20 mg of sorbitol per pre-filled syringe. If your
doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, which is
essentially ‘sodium-free’.

3. How to use Imraldi

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without
evidence of radiographic ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are available exclusively with a dose
of 40 mg. Therefore, the pre-filled syringe and the pre-filled pen of Imraldi cannot be
used for pediatric patients requiring less than the full dose of 40 mg. If an alternative dose is needed, other products offering this possibility must be used.
Imraldi should be injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis and for patients with psoriatic arthritis is 40 mg of adalimumab every other week,
administered in a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Imraldi. If the
doctor decides that methotrexate is not appropriate, Imraldi can be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in association with treatment with Imraldi,
your doctor may decide to prescribe 40 mg of adalimumab every week or 80 mg every other week.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents starting from 2 years of age and weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 2 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Children, adolescents and adults with arthritis associated with enthesitis

Children and adolescents starting from 6 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 6 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two
40 mg injections on the same day), followed by a dose of 40 mg, administered every other week, to
begin the week after the initial dose. You must continue treatment
with Imraldi for the time indicated by your doctor. If this dose does not work satisfactorily, your
doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with plaque psoriasis

Children and adolescents between the ages of 4 and 17 years and weighing between 15 kg and less than

30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the
week after. Subsequently, the usual dose is 20 mg every other week.

Children and adolescents between the ages of 4 and 17 years and weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the
week after. Subsequently, the usual dose is 40 mg every other week.
Adults with hidradenitis suppurativa
The usual dose for Hidradenitis Suppurativa is an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by a
dose of 80 mg (via two 40 mg injections on the same day) two weeks later. After another two
weeks, continue with a dose of 40 mg per week or 80 mg every other week, as prescribed
by your doctor. It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adolescents with hidradenitis suppurativa between the ages of 12 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two 40 mg injections on a
day), followed by 40 mg every two weeks starting one week later. If this dose does not
work satisfactorily at 40 mg of Imraldi every other week, your doctor may increase the
dose to 40 mg every week or 80 mg every other week.
It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adults with Crohn’s disease
The usual dose in case of Crohn’s disease is initially 80 mg (via two 40 mg injections
on the same day) followed by 40 mg every other week, after two weeks. If a
faster response is needed, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections
on the same day or two 40 mg injections per day for two consecutive days) followed by 80 mg
(via two 40 mg injections on the same day) after two weeks, and subsequently 40 mg
every other week. If this dose does not work satisfactorily, your doctor may increase the
dose to 40 mg every week or 80 mg every other week.
Children and adolescents with Crohn’s disease

Children and adolescents between the ages of 6 and 17 years and weighing less than 40 kg
The usual dose is initially 40 mg followed by 20 mg after two weeks. If it is necessary to induce
a faster response, your doctor may prescribe an initial dose of 80 mg (via two 40 mg injections
on the same day) followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work satisfactorily, your doctor may increase the frequency of the dose to 20 mg every week.

Children and adolescents between the ages of 6 and 17 years and weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections on the same day) followed by
40 mg after two weeks. If it is necessary to induce a faster response, your doctor may prescribe
an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections
on the same day) followed by 80 mg (via two 40 mg injections on the same day) after two
weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work
satisfactorily, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four 40 mg injections
on the same day or two 40 mg injections per day for two consecutive days) at week 0 and 80 mg (via two 40 mg injections on the same day) at week 2 and subsequently 40 mg
every other week. If this dose does not work satisfactorily, your doctor may increase the
dosage to 40 mg every week or 80 mg every other week.
Children and adolescents with ulcerative colitis

Children and adolescents starting from 6 years of age and weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two 40 mg injections on a day), followed by 40 mg
(via a single 40 mg injection) two weeks later. Subsequently, the usual dose is
40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the
prescribed dose.

Children and adolescents starting from 6 years of age and weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four 40 mg injections on a day or two
40 mg injections per day for two consecutive days) followed by 80 mg (via two 40 mg injections
on the same day) after two weeks. Subsequently the usual dose is 80 mg every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the
prescribed dose.
Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two
injections on the same day), followed by 40 mg administered every two weeks starting one week
after the initial dose. Continue to inject Imraldi for as long as indicated by your doctor.
In non-infectious uveitis, corticosteroids or other drugs that affect the immune system
may be continued during treatment with Imraldi. Imraldi can also be administered
as monotherapy.
Children and adolescents with chronic non-infectious uveitis starting from 2 years of age

Children and adolescents starting from 2 years of age and weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg that can be
administered one week before starting the usual dose.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg that can be administered one
week before starting the usual dose.

How to administer and route of administration
Imraldi is given by injection under the skin (for subcutaneous injection). For instructions for use, see
section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Imraldi
If you forget to give an injection, you should inject the next dose of Imraldi as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop taking Imraldi
The decision to stop using Imraldi should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention urgentlyif you notice any of the following reactions:

• severe skin rash, hives or other signs of an allergic reaction;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness of the arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting the onset of blood disorders, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which 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);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• skin rash;
• muscle pain.

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

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• nerve root compression symptoms (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• inflammation of the eyelids and swelling of the eyes;
• dizziness (a sensation of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flushes;
• bruise (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• indigestion (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (a build-up of fluid in the body that causes swelling of the affected tissues);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

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

• opportunistic infections (including tuberculosis and other infections that occur when immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, tinnitus;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial swelling;
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people):

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve of the eye and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
• facial swelling associated with allergic reactions;
• multiforme erythema (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-purple rash).

Not known(frequency cannot be estimated based on available data):

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness); Weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests.
These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

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

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• decreased calcium in the blood;
• decreased phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• decreased potassium in the blood.

Uncommon(may affect up to 1 in 100)

• high levels of bilirubin in the blood (liver blood test).

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

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through the national
reporting system as detailed in Annex V. By reporting side effects you can contribute
to providing more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack label after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe may be
stored at room temperature (up to 25°C) for a maximum period of 28 days – ensure that you
protect the medicine from light. Once removed from the refrigerator for storage at
room temperature, the syringe must be used within 28 days or discarded, even if it is placed back in
the refrigerator.
You must record the date on which the syringe is removed from the refrigerator for the first time and the date after which
the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other ingredients are sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and package contents
Imraldi 40 mg solution for injection in pre-filled syringes is supplied as 0.8 ml of solution from
clear to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (type I glass)
with a stainless steel needle, a rigid cap, a rubber plunger, a rod, a
protective cover and a finger flange for patient use and, respectively, 2, 2, 4 or 6 alcohol swabs included in the pack.
Not all pack sizes may be marketed.

Marketing authorisation holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
Netherlands
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/S.A
Tél/Tel: + 32 2 2191218

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
Ewopharma AG Representative Office
Teл.: + 35929621200

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: + 420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: + 36 1 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: + 45 77 41 57 57

Malta
Pharma.MT Ltd
Tel: + 35621337008

Deutschland
Biogen GmbH
Tel: + 49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: + 31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: + 372 618 9551

Norge
Biogen Norway AS
Tlf: + 47 23 40 01 00

Ελλάδα
Genesis Pharma S.A.
Τηλ: + 302108771500

Österreich
Biogen Austria GmbH
Tel: + 43 1 484 46 13

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel.: + 48 22 351 51 00

France
Biogen France SAS
Tél: + 33 (0)1 776 968 14

Portugal
Biogen Portugal Sociedade Farmacêutica,
Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska
Ewopharma d.o.o
Tel: + 385 (0)1 6646 563

România
Ewopharma Romania SRL
Tel: + 40212601344

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: + 386 1 511 02 90

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel: + 421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: + 39 02 584 99 010

Suomi/Finland
Biogen Finland Oy
Puh/Tel: + 358 207 401 200

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: + 357 22 76 57 15

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

7. Instructions for use

Follow these instructions carefully: you will quickly become familiar with them and be able to administer the
injections with confidence.

• Before administering injections, ask your doctor or nurse to show you how to use the prefilled syringe. Your doctor or nurse must check that you are able to use the syringe correctly.

Appearance of the single-dose prefilled syringe

After pressing the plunger all the way down, the needle retracts, thus preventing needle stick injuries.

Using the prefilled syringe
Storage of the syringe

• Store the syringe in a refrigerator, but do not freeze it.
• Keep the syringe in its box, protected from light.
• Keep the syringe out of the sight and reach of children.

Disposal of the syringe

• Use each syringe only once. Never reuse a syringe.
• Dispose of the used syringe in a special container, as explained by your doctor, nurse or pharmacist.

Caution

• If the syringe falls with the cap INSERTED, it can still be used. If the syringe falls WITHOUT the cap inserted, do not use it anymore. The needle may be dirty or damaged.
• Do not use a damaged syringe.

Preparing the injection site

• For the injection, choose an area rich in fat: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are easier to pinch between your fingers and are suitable for correct needle insertion.
• Choose a different injection site each time: When choosing an injection site, look for an area that has not been used recently, in order to avoid injury and bruising.
• Press the plunger slowly: Sometimes, fast injections can be painful. By pressing the plunger slowly, the injection will be less uncomfortable.

How to administer the injection with the prefilled syringe

1. Gather the necessary items

Place the prefilled syringe and alcohol swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15-30 minutes

Wait 15-30 minutes to bring the prefilled syringe to room temperature, in order to reduce
pain during the injection.

• Do not remove the cap yet!

3. Check the medicine and the expiry date

Always check that the medicine is clear to opalescent, colourless to light brown, free of particles and not expired. If the medicine is not clear to opalescent, colourless to light brown and free of particles or if it is expired, do not use it.
One or more air bubbles may be present, which is not a problem. There is no need to remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with a swab soaked in alcohol. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, scaling or red spots.

5. Remove the needle cap

Carefully remove the needle cap.
It is normal for a few drops of liquid to escape from the needle.
If you remove the needle cap before you are ready to administer the injection, do not put it back on. Otherwise, you risk bending or damaging the needle. You also risk accidentally pricking yourself or
spilling some of the medicine.

6. Pinch the skin between your fingers and insert the needle

Carefully pinch the skin between your fingers and insert the needle all the way in, at an angle
of approximately 45 degrees.

7. Push the plunger all the way down

Hold the syringe steady and push the plunger all the way down.
Then lift your thumb so that the needle retracts into the body of the syringe.

8. Remove and dispose of the syringe

Remove the syringe from the skin.
After injecting Imraldi, check that the needle has retracted and immediately dispose of the used syringe
in a special container, as explained by your doctor, nurse or pharmacist.

• Are you unsure if you received the dose? Contact your doctor, nurse or pharmacist.

Imraldi 40 mg solution for injection in pre-filled pen

adalimumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you a Patient Reminder Card containing important safety information, which you need to know before administering Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card during treatment and for 4 months after the last injection of Imraldi (yours or your child's).
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Imraldi is and what it is used for
• 2. What you need to know before you use Imraldi
• 3. How to use Imraldi
• 4. Possible side effects
• 5. How to store Imraldi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Imraldi and what is it used for

Imraldi contains the active substance adalimumab, a medicine that works on the immune system
(the body's defense system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis.

The active ingredient of Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNF α) which is
present at high levels in the inflammatory diseases described above. By binding to TNF α, Imraldi
reduces the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as methotrexate, may be given initially. If these drugs do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi can also be used to treat severe, active and progressive rheumatoid arthritis
without previous treatment with methotrexate.
Imraldi is able to slow the progression of damage to the cartilage and bones of the
joints, caused by the disease, and to improve physical function.
Generally Imraldi is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Imraldi may be given 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 typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years. Other disease-modifying drugs, such as
methotrexate, may be given at diagnosis. If these drugs do not work satisfactorily, patients will be given
Imraldi for the treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with
enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Spondylitis
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Spondylitis
Ankylosing Spondylitis are inflammations of the spine.
Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence
of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medicines. If these medicines do not work satisfactorily, you will take Imraldi to
reduce the signs and symptoms of the disease.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory condition of the joints associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi is able to slow the damage to the
cartilage and bones of the joints, caused by the disease, and to improve physical function.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect
the nails causing them to crumble, become thicker and lift off the nail bed, which can
be painful. Psoriasis is thought to be caused by a problem with the body's immune system that leads to an increase in skin cell production.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is
also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or more in whom topical therapy and phototherapy have not worked optimally or
are not indicated.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-lasting, often painful inflammatory skin disease. Symptoms may include painful nodules and abscesses (cysts) that
can drain pus. It most frequently affects specific areas of the skin, such as the underarm area, armpits, inner thighs, groin, and buttocks. Scarring can also form in the affected areas.
Imraldi is used to treat Hidradenitis Suppurativa in adults and adolescents 12 years of age and older. Imraldi can reduce the number of nodules and abscesses you have, and the pain that is often associated
with this disease. Initially, you may receive other medicines. If you do not respond well enough
to these medicines, you will receive Imraldi.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If
you suffer from Crohn’s disease, you will first be given other medicines. If these medicines do not
work satisfactorily, you will be given Imraldi to reduce the typical symptoms
of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Imraldi 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 first take other medicines. If these medicines
do not work satisfactorily, you will take Imraldi to reduce the signs and symptoms of the disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of moving bodies
in the eye (black spots or thin lines that move across the field of vision). Imraldi works
by reducing this inflammation.

2. What you need to know before using Imraldi

Do not use Imraldi

• 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 (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi
Allergic reaction

• If you experience allergic reactionswith symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infection

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Imraldi. If you have any doubts, contact your doctor.
• You may be more likely to get infections during treatment with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning). In rare cases, these infections can be life-threatening. It is important to tell your doctor if you have symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Imraldi.

Tuberculosis

• Because cases of tuberculosishave occurred in patients treated with Imraldi, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Imraldi. This will involve collecting a detailed medical assessment including your medical history and clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection or if you think you may be at risk of contracting the hepatitis virus
• B. Your doctor should test you for hepatitis B virus infection. Taking Imraldi can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection while you are being treated with Imraldi. It is important to tell your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedure

• Before surgery or dental procedures, tell your doctor that you are taking Imraldi. Your doctor may advise you to temporarily stop Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease(diseases that affect the myelin sheath of the nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Imraldi. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccines

• Certain vaccinescontain bacteria or viruses responsible for diseases in an attenuated, but live form, and should not be administered during treatment with Imraldi. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to implement the vaccination schedule appropriate for the relevant age group before starting treatment with Imraldi. If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose you received during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• In case of mild heart failureand concomitant treatment with Imraldi, the doctor must carefully assess and monitor the state of your heart. It is important to inform the doctor about any heart problems, both past and present. If new symptoms of heart failure or if existing symptoms should worsen (for example, shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide if you can take Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have fever, bruisingor ease of bleedingor paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• Very rarely, some types of cancerhave occurred in children and adults treated with Imraldi or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma(a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow). If you are taking Imraldi, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients undergoing therapy with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• In addition, cases of non-melanoma skin cancerhave been observed in patients taking Imraldi. If new areas of skin damage appear during or after therapy, or if the appearance of existing lesions or damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti- TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Imraldi to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not use the pre-filled pen of 40 mg if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Imraldi can be taken with methotrexate and other disease-modifying antirheumatic drugs
(sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi must not be taken in conjunction with medicines containing the active ingredients anakinra or
abatacept due to the increased risk of having serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last injection of Imraldi.
• If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Imraldi can be used during breastfeeding.
• If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, before the baby receives any type of vaccination (for more information on vaccinations, see “Warnings and precautions”).

Driving and using machines
Imraldi may affect, albeit only to a modest extent, your ability to drive, ride a bicycle or
use machines. After taking Imraldi, you may experience visual disturbances and a sensation that
the environment around you is rotating (dizziness).

Imraldi contains sodium and sorbitol

Sorbitol
This medicine contains 20 mg of sorbitol per pre-filled pen. If your doctor has diagnosed
you with intolerance to certain sugars, consult him before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, which is
essentially ‘sodium-free’.

3. How to use Imraldi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without
radiographic evidence of ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are only available with a dose
of 40 mg. Therefore, the pre-filled syringe and the pre-filled pen of Imraldi cannot be
used for pediatric patients who require less than the full 40 mg dose. If an alternative dose is needed, other products that offer this possibility must be used.
Imraldi should be injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis, and for patients with psoriatic arthritis is 40 mg of adalimumab every other week,
administered as a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Imraldi. If the
doctor decides that methotrexate is not appropriate, Imraldi can be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with treatment with Imraldi,
your doctor may decide to prescribe 40 mg of adalimumab every week or 80 mg every other week.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents starting from 2 years of age and weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 2 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Children, adolescents and adults with arthritis associated with enthesitis

Children andadolescents starting from 6 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 6 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two
injections on the same day), followed by a dose of 40 mg, administered every other week, starting
the week after the initial dose. You must continue treatment with
Imraldi for the time indicated by your doctor. If this dose does not work satisfactorily, your doctor
may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with plaque psoriasis

Children and adolescents between the ages of 4 and 17 and weighing between 15 kg and less than

30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the
following week. Subsequently, the usual dose is 20 mg every other week.

Children and adolescents between the ages of 4 and 17 and weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the
following week. Subsequently, the usual dose is 40 mg every other week.
Adults with hidradenitis suppurativa
The usual dose in case of Hidradenitis Suppurativa is an initial dose of 160 mg (via
four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days),
followed by a dose of 80 mg (via two 40 mg injections on the same day) two weeks later. After
another two weeks, continue with a dose of 40 mg per week or 80 mg every other week, as
prescribed by your doctor. It is recommended to use an antiseptic cleansing solution daily
on the affected areas.
Adolescents with hidradenitis suppurativa between the ages of 12 and 17, weighing 30 kg or more)
The recommended dose of Imraldi is an initial dose of 80 mg (via two 40 mg injections on one
day), followed by 40 mg every two weeks starting one week later. If this dose does not
work satisfactorily with 40 mg of Imraldi every other week, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adults with Crohn's disease
The usual dose in case of Crohn's disease is initially 80 mg (via two 40 mg injections
on the same day) followed by 40 mg every other week, after two weeks. If a
faster response is needed, the doctor may prescribe an initial dose of 160 mg (via four injections of
40 mg on the same day or two 40 mg injections per day for two consecutive days) followed by 80 mg
(via two 40 mg injections on the same day) after two weeks, and then 40 mg
every other week. If this dose does not work satisfactorily, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
Children and adolescents with Crohn's disease

Children and adolescents between the ages of 6 and 17 and weighing less than 40 kg
The usual dose is initially 40 mg followed by 20 mg after two weeks. If it is necessary to induce
a faster response, the doctor may prescribe an initial dose of 80 mg (via two injections of
40 mg on the same day) followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work
satisfactorily, the doctor may increase the frequency of the dose to 20 mg every week.

Children and adolescentsbetween the ages of 6 and 17 and weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections on the same day) followed by
40 mg after two weeks. If it is necessary to induce a faster response, the doctor may prescribe
an initial dose of 160 mg (via four 40 mg injections on the same day or as two 40 mg injections
per day for two consecutive days) followed by 80 mg (via two 40 mg injections on a
day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work
satisfactorily, the doctor may increase the dose to 40 mg every week or 80 mg every other week.
Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four 40 mg injections
on the same day or two 40 mg injections per day for two consecutive days) at week 0 and 80 mg
(via two 40 mg injections on the same day) at week 2 and subsequently 40 mg
every other week. If this dose does not work satisfactorily, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
Children and adolescents with ulcerative colitis

Children and adolescents starting from 6 years of age and weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two 40 mg injections on the same day), followed by 40 mg
(via a single 40 mg injection) two weeks later. Subsequently, the usual dose is
40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the
prescribed dose.

Children and adolescents starting from 6 years of age and weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four 40 mg injections on the same day or two
40 mg injections per day for two consecutive days) followed by 80 mg (via two 40 mg injections
on the same day) after two weeks. Subsequently, the usual dose is 80 mg every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the
prescribed dose.
Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two
injections on the same day), followed by 40 mg administered every two weeks starting one week
after the initial dose. Continue to inject Imraldi for as long as indicated by your doctor.
In non-infectious uveitis, corticosteroids or other drugs that affect the immune system
may be continued during treatment with Imraldi. Imraldi can also be administered
as monotherapy.
Children and adolescents with chronic non-infectious uveitis starting from 2 years of age

Children and adolescents starting from 2 years of age and weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child's doctor may also prescribe an initial dose of 40 mg that can be
administered one week before starting the usual dose.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
The doctor may also prescribe an initial dose of 80 mg that can be administered one
week before starting the usual dose.

How to administer and route of administration
Imraldi is given by injection under the skin (subcutaneous injection). For instructions for use, see
section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of
the medicine, even if empty.

If you forget to use Imraldi
If you forget to give an injection, you should inject the next dose of Imraldi as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop taking Imraldi
The decision to stop using Imraldi should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention urgentlyif you notice any of the following reactions:

• severe skin rash, hives or other signs of an allergic reaction;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness of the arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, pallor.

The symptoms described above may be signs of the following side effects, which 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);
• respiratory tract infections (including colds, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

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

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections affecting the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• nerve root compression symptoms (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (a sensation of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flushes;
• bruise (a solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• indigestion (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy skin rash;
• contusion;
• skin inflammation (such as eczema);
• nail breakage of the hands and feet;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (an accumulation of fluid in the body that causes tissues to swell);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

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

• opportunistic infections (including tuberculosis and other infections that occur when immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling in the ankles;
• myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and a blood clot in a vein, blockage of a blood vessel;
• lung disease that causes shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema;
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people):

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve of the eye and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated based on available data):

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• Weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests.
These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

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

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people):

• low white blood cell, red blood cell and platelet count.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack label after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled pen can be stored
at room temperature (up to 25 °C) for a maximum period of 28 days – ensure that the medicine is protected
from light. Once removed from the refrigerator for storage at
room temperature, the pen must be used within 28 days or discarded, even if it is placed back in the
refrigerator.
You must record the date when the pen is removed from the refrigerator for the first time and the date after which
the pen must be discarded.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other ingredients are sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in pre-filled pen is supplied as 0.8 ml of solution from clear
to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a
pre-filled syringe (type I glass) with a stainless steel needle, a rigid cap, a rubber plunger
for patient use and, respectively, 2, 2, 4 or 6 alcohol swabs
included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Biogen Belgium NV/S.A
Tél/Tel: + 32 2 2191218

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
Ewopharma AG Representative Office
Тел.: + 35929621200

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: + 420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: + 36 1 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: + 45 77 41 57 57

Malta
Pharma.MT Ltd
Tel: + 35621337008

Deutschland
Biogen GmbH
Tel: + 49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: + 31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: + 372 618 9551

Norge
Biogen Norway AS
Tlf: + 47 23 40 01 00

Ελλάδα
Genesis Pharma S.A.
Τηλ: + 302108771500

Österreich
Biogen Austria GmbH
Tel: + 43 1 484 46 13

Polska
Biogen Poland Sp. z o.o.
Tel.: + 48 22 351 51 00

France
Biogen France SAS
Tél: + 33 (0)1 776 968 14

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Portugal
Biogen Portugal Sociedade Farmacêutica,
Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska
Ewopharma d.o.o
Tel: + 385 (0)1 6646 563

România
Ewopharma Romania SRL
Tel: + 40212601344

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: + 386 1 511 02 90

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel: + 421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: + 39 02 584 99 010

Suomi/Finland
Biogen Finland Oy
Puh/Tel: + 358 207 401 200

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: + 357 22 76 57 15

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

7. Instructions for Use

Follow these instructions carefully: you will quickly become familiar with them and be able to perform the
injections with confidence.

• Before performing the injections, ask your doctor or nurse to show you how to use the prefilled pen. Your doctor or nurse must check that you are able to use the pen correctly.

Appearance of the single-dose prefilled pen

The prefilled pen does not have a button.
The needle is hidden under the green base. When you press the prefilled pen firmly against the skin,
the injection starts automatically.

Using the prefilled pen
Storing the pen

• Store the pen in a refrigerator, but do not freeze it.
• Keep the pen in its box, protected from light.
• Keep the pen out of the sight and reach of children.

Disposing of the pen

• Use each pen only once. Never reuse the same pen.
• Dispose of the used pen in a special container, as explained by your doctor, nurse or pharmacist.

Caution

• If the pen falls with the CAP INSERTED, it can still be used. If the pen falls WITHOUT the cap inserted, do not use it anymore. The needle may be dirty or damaged.
• Do not use a damaged pen.

Preparing the injection site

• For the injection, choose an area rich in fat: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are suitable for correct needle insertion.
• Choose a different injection site each time: When choosing an injection site, look for an area that has not been used recently, in order to avoid injury and bruising.

How to perform the injection with the prefilled pen

1. Gather the necessary items

Place the prefilled pen and alcohol-soaked swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15-30 minutes

Wait 15-30 minutes to bring the pen to room temperature, in order to reduce pain
during the injection.

• Do not remove the cap yet!

3. Check the medicine and the expiry date

Check that the medicine is from clear to opalescent, from colourless to light brown, free of
particles and that it has not expired. If the medicine is not from clear to opalescent, from colourless to
light brown and free of particles or if it is expired, do not use it.
One or more air bubbles may be present, which do not constitute a problem. There is no reason to
remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with a swab soaked in alcohol. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, scaling or red spots.

5. Remove the transparent cap from the needle

Carefully remove the transparent cap of the needle with the metal central part from the pen.
It is normal for a few drops of liquid to come out of the needle.
If you remove the needle cap before you are ready to administer the injection, do not put it back on. Otherwise, you risk bending or damaging the needle. You also risk accidentally pricking yourself or
spilling some of the medicine.

6. Place the green base, press and hold

Place the green base straight (90 degrees) on the skin and press the prefilled pen firmly
downwards to start the injection.

• When pressing down, the injection begins. You may hear a 1 click.

7. Continue to hold down

Keep the pen pressed on the skin until the yellow indicator has filled the inspection window and has stopped moving.

• After a few seconds you may hear a 2 click.

8. Confirm completion of the injection and dispose of the pen

After injecting Imraldi, check that the entire inspection window is yellow.
Dispose of the used pen in a special container, as explained by your doctor, nurse
or pharmacist.

• Are you unsure if you received the dose? Contact your doctor, nurse or pharmacist.

Imraldi 40 mg/0.8 ml injectable solution

adalimumab

Read this leaflet carefully before your child uses this medicine as it contains
important information.

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you a Patient Reminder Card containing important safety information, which you need to know before giving Imraldi to your child and during treatment with Imraldi. Keep this Patient Reminder Card during your child's treatment and for 4 months after your child's last Imraldi injection.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if their symptoms are the same as those of your child, as it could be dangerous.
• If your child gets any side effects, even those not listed in this leaflet, tell your child’s doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Imraldi is and what it is used for
• 2. What you need to know before your child uses Imraldi
• 3. How to use Imraldi
• 4. Possible side effects
• 5. How to store Imraldi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Imraldi and what is it used for

Imraldi contains the active substance adalimumab, a medicine that works on the immune system
(the body's defense system).
Imraldi is indicated for the treatment:

• of polyarticular juvenile idiopathic arthritis,
• of arthritis associated with enthesitis,
• of pediatric plaque psoriasis,
• of hidradenitis suppurativa in adolescents,
• of pediatric Crohn's disease,
• of ulcerative colitis in pediatric patients,
• of pediatric uveitis.

The active ingredient of Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNF α) which is
present at high levels in the inflammatory diseases described above. By binding to TNF α, Imraldi
reduces the inflammatory process in these diseases.
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 typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis.
Other disease-modifying drugs, such as methotrexate, may be given at diagnosis.
If these drugs do not work satisfactorily, patients will be given Imraldi for the
treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.
Pediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red,
scaly and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect
the nails, causing them to crumble, become thicker and lift off the nail bed, which can
be painful. Psoriasis is thought to be caused by a problem with the body's immune system
that leads to increased production of skin cells.
Imraldi is used to treat severe plaque psoriasis in children and adolescents aged 4 to
17 years in whom topical therapy and phototherapies have not worked optimally or are not
indicated.
Hidradenitis Suppurativa in adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-lasting, often painful inflammatory skin
disease. Symptoms may include painful nodules and abscesses (cysts) that
can drain pus. It most frequently affects specific areas of the skin, such as the
submammary region, armpits, inner thighs, groin, and buttocks. Scars can also form
in the affected areas.
Imraldi is used to treat Hidradenitis Suppurativa in adolescents aged 12 years and older. Imraldi
can reduce the number of nodules and abscesses you have and the pain that is often associated with this
disease. Initially, you may receive other medicines. If you do not respond well enough to
these medicines, you will receive Imraldi.
Pediatric Crohn's disease
Crohn's disease is inflammation of the intestine.
Imraldi is indicated for the treatment of Crohn's disease in children aged 6 to 17 years. Patients may first be given other drugs. If these drugs do not work in a
satisfactory manner, patients will be given Imraldi to reduce the typical symptoms of the
disease.
Ulcerative colitis in pediatric patients
Ulcerative colitis is an inflammatory disease of the large intestine. Imraldi is used to treat
moderate to severe ulcerative colitis in children aged 6 to 17 years. The child may
initially be given other medicines. If these medicines do not work well
enough, the child will be given Imraldi to reduce the signs and symptoms of the disease.
Pediatric uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Imraldi is used for the treatment of children aged 2 years and older with chronic non-infectious uveitis with
inflammation affecting the front of the eye. This inflammation can lead to a
decrease in vision and/or the presence of mobile bodies in the eye (black spots or thin lines that
move across the field of vision). Imraldi works by reducing this inflammation.

2. What you need to know before your child uses Imraldi

Do not use Imraldi

• If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If your child has a serious infection, including tuberculosis (see “Warnings and precautions”). It is important to tell your doctor if your child has signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems.
• If your child has moderate or severe heart failure. It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your child’s doctor or pharmacist before using Imraldi
Allergic reaction

• If your child has allergic reactionswith symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infection

• If your child has an infection,including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Imraldi. If you have doubts, contact your doctor.
• Your child may be more likely to contract infections during treatment with Imraldi. This risk may increase if their lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning). In rare cases, these infections can be life-threatening to the patient. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems in your child. Your doctor may advise temporarily stopping Imraldi.

Tuberculosis

• Because cases of tuberculosishave occurred in patients treated with Imraldi, the doctor will need to check if your child presents signs or symptoms typical of tuberculosis before starting therapy with Imraldi. This will involve collecting a detailed medical assessment including your child’s medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded in your child’s Patient Reminder Card. It is very important to tell your doctor if your child has ever had tuberculosis, or if they have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if your child has received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if your child has lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are endemic.
• Tell your doctor if your child has had recurrent infections or if they have conditions that increase the risk of infection.

Hepatitis B virus

• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV),if they have an active infection with the hepatitis B virus or if you think your child may be at risk of contracting the hepatitis B virus. Your child’s doctor should test your child for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if your child is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can endanger the patient’s life.

Surgery or dental procedure

• Before surgery or dental procedures, tell your doctor that your child is taking Imraldi. Your doctor may advise temporarily stopping Imraldi.

Demyelinating disease

• If your child suffers from or develops a demyelinating disease(diseases affecting the myelin sheath of the nerves, such as multiple sclerosis), the doctor will decide whether it is appropriate to start or continue treatment with Imraldi. Tell your doctor immediately if your child experiences symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccines

• Certain vaccinescontain bacteria or viruses responsible for diseases in an attenuated, but live, form, and should not be administered during treatment with Imraldi. Consult your doctor before your child is vaccinated. In children, it is advisable, if possible, to implement the vaccination schedule appropriate for the relevant age group before starting treatment with Imraldi. If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose you received during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• In the case of mild heart failurein your child and concomitant treatment with Imraldi, the doctor will need to carefully assess and monitor the condition of your heart. It is important to inform the doctor about any heart problems your child has, both past and present. If new symptoms of heart failure appear or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide whether your child can take Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help them fight infections or stop bleeding. If your child has fever, bruisingor a tendency to bleedor paleness, seek medical attention immediately. The doctor may decide to stop therapy.

Cancer

• Very rarely, some types of cancerhave occurred in children and adults treated with Imraldi or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma(a cancer affecting the lymphatic system) and leukemia (a cancer affecting the blood and bone marrow). If your child takes Imraldi, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also undergoing therapy with azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Imraldi.

In addition, cases of non-melanoma skin cancerhave been observed in patients taking Imraldi. If new areas of skin damage appear during or after therapy, or if the appearance of existing lesions or damaged areas changes, report it to your doctor.

• There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti- TNFα. If your child suffers from COPD, or smokes heavily, they should discuss with their doctor whether treatment with an anti-TNFα is appropriate for their child.

Lupus-like syndrome

• Rarely, treatment with Imraldi can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Other medicines and Imraldi
Tell your child’s doctor or pharmacist if your child is taking, has recently taken or
may take any other medicine.
Imraldi can be taken with methotrexate and other disease-modifying antirheumatic drugs
(sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).

Imraldi should not be taken by your child at the same time as medicines containing the active
ingredients anakinra or abatacept due to the increased risk of having serious infections. If you
have doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraception to prevent pregnancy and continue using it for at least 5 months after the last injection of Imraldi.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Imraldi can be used during breastfeeding.
• If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection. It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, before the baby receives any type of vaccination (for more information on vaccinations, see “Warnings and precautions”).

Driving and using machines
Imraldi may affect, albeit only to a modest extent, the ability to drive, ride a bicycle or
use machines. After taking Imraldi, you may experience visual disturbances and a
sensation that the environment around you is rotating (dizziness).

Imraldi contains sodium and sorbitol

Sorbitol
This medicine contains 20 mg of sorbitol per vial. If your doctor has diagnosed your
child with intolerance to certain sugars, contact them before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, i.e. it is
essentially ‘sodium-free’.

3. How to use Imraldi

Use this medicine following the instructions of your child’s doctor or pharmacist exactly. If you have any doubts about the instructions or any questions, consult your child’s doctor or pharmacist. The doctor may prescribe a different dosage of Imraldi if your child needs a different dose.
Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents starting from 2 years of age and weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Children, adolescents and adults with enthesitis-related arthritis

Children and adolescents starting from 6 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 6 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Children and adolescents with plaque psoriasis

Children and adolescents between 4 and 17 years of age and weighing between 15 kg and less than

30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the following week. Subsequently, the usual dose is 20 mg every other week.

Children and adolescents between 4 and 17 years of age and weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the following week. Subsequently, the usual dose is 40 mg every other week.
Adolescents with hidradenitis suppurativa aged between 12 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two 40 mg injections on one day), followed by 40 mg every two weeks starting one week later. If this dose does not work satisfactorily with 40 mg of Imraldi every other week, the doctor may increase the dose to 40 mg every week or 80 mg every other week.
It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Children and adolescents with Crohn’s disease

Children and adolescents between 6 and 17 years of age and weighing less than 40 kg
The usual dose is initially 40 mg followed by 20 mg after two weeks. If a faster response needs to be induced, your child’s doctor may prescribe an initial dose of 80 mg (via two 40 mg injections on 1 day) followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work satisfactorily, your child’s doctor may increase the dose frequency to 20 mg every week.

Children and adolescents between 6 and 17 years of age and weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections on one day) followed by 40 mg after two weeks. If a faster response needs to be induced, your child’s doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on one day or two 40 mg injections on one day) followed by 80 mg (via two 40 mg injections on one day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work satisfactorily, your child’s doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with ulcerative colitis

Children and adolescents starting from 6 years of age and weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two 40 mg injections on one day) followed by 40 mg (via a single 40 mg injection) after two weeks. Subsequently, the usual dose is 40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the prescribed dose.

Children and adolescents starting from 6 years of age and weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four 40 mg injections on one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (via two 40 mg injections on one day) after two weeks. Subsequently, the usual dose is 80 mg every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the prescribed dose.
Children and adolescents with non-infectious chronic uveitis starting from 2 years of age

Children and adolescents starting from 2 years of age and weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate. Your child’s doctor may also prescribe an initial dose of 40 mg that can be administered one week before the start of the usual dose.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate. Your child’s doctor may also prescribe an initial dose of 80 mg that can be administered one week before the start of the usual dose.

How to administer and route of administration
Imraldi is given by injection under the skin (subcutaneous injection). For instructions for use, please refer to section 7.

If you use more Imraldi than you should
If you accidentally inject a greater amount of Imraldi liquid or if you inject Imraldi more frequently than you should, contact your child’s doctor or pharmacist explaining that your child has taken more medicine than they should. Always keep the box or vial of the medicine, even if empty.

If you use less Imraldi than you should
If you accidentally inject a smaller amount of Imraldi liquid or if you inject Imraldi less frequently than you should, contact your child’s doctor or pharmacist explaining that your child has taken less medicine. Always keep the box or vial of the medicine, even if empty.

If you forget to use Imraldi
If you forget to give your child an injection, you should inject the Imraldi dose as soon as you remember. Then resume your child’s dose regularly according to the established dosage schedule.

If you stop the treatment with Imraldi
The decision to stop using Imraldi should be discussed with your child’s doctor. Your child’s symptoms may return after stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention urgentlyif you notice any of the following reactions:

• severe skin rash, hives or other signs of an allergic reaction;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness of the arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting the onset of blood disorders, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which 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);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• skin rash;
• muscle pain.

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

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections affecting the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• nerve root compression symptoms (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (a sensation of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (a build-up of fluid in the body that causes swelling of the affected tissues);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

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

• opportunistic infections (which include tuberculosis and other infections that occur when the immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial swelling;
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people):

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve of the eye and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
• facial swelling associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated based on available data):

• T-cell lymphoma-hepatosplenic (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• Weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests.
These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

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

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• altered sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100)

• high levels of bilirubin in the blood (liver blood test).

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

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If your child experiences any side effects, including those not listed in this leaflet,
consult your child’s doctor or pharmacist. You can also report side effects
directly through the national reporting system detailed in Annex V. By reporting
side effects, you can help provide more information on the safety of this
medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack label after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other ingredients are sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in a vial is supplied as 0.8 ml of solution from clear to
opalescent and from colourless to light brown.
The vial of Imraldi is a glass vial containing a solution of adalimumab. One
pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle,
1 vial adapter and 2 alcohol swabs.
Imraldi may be available in the form of a vial, pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/S.A
Tél/Tel: + 32 2 2191218

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
Ewopharma AG Representative Office
Teл.: + 35929621200

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: + 420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: + 36 1 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: + 45 77 41 57 57

Malta
Pharma.MT Ltd
Tel: + 35621337008

Deutschland
Biogen GmbH
Tel: + 49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: + 31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: + 372 618 9551

Norge
Biogen Norway AS
Tlf: + 47 23 40 01 00

Ελλάδα
Genesis Pharma S.A.
Τηλ: + 302108771500

Österreich
Biogen Austria GmbH
Tel: + 43 1 484 46 13

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel.: + 48 22 351 51 00

France
Biogen France SAS
Tél: + 33 (0)1 776 968 14

Portugal
Biogen Portugal Sociedade Farmacêutica,
Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska
Ewopharma d.o.o
Tel: + 385 (0)1 6646 563

România
Ewopharma Romania SRL
Tel: + 40212601344

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: + 386 1 511 02 90

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel: + 421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: + 39 02 584 99 010

Suomi/Finland
Biogen Finland Oy
Puh/Tel: + 358 207 401 200

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: + 357 22 76 57 15

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

7. Instructions for Use

The following instructions explain how to inject Imraldi. Read the instructions carefully and follow them
step by step. You will receive instructions from your doctor or their assistant on the administration technique and the amount to administer to the child. Do not proceed with the injection until you
are sure you understand how to prepare and perform the administration. After adequate instructions
the injection can be performed by you or by other people such as, for example, a family member or a friend.
Failure to follow these instructions, as described, may result in contamination
which could in turn cause infections in the child.
The contents of the syringe must not be mixed with other drugs in the same syringe or in the
vial.

Use of the vial
Vial storage

• Store the vial in the refrigerator, but do not freeze it.
• Keep the vial in its box, protected from light.
• Keep the vial out of the sight and reach of children.

Vial disposal

• Use each vial only once. Never reuse the same vial and other components.
• Dispose of the used vial in a special container, as explained by your doctor, nurse or pharmacist.

Preparation of the injection site

• For the injection, choose an area rich in fat: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Areas rich in fat are easier to grasp between the fingers and suitable for correct needle insertion.
• Choose a different injection site each time: When choosing an injection site, look for an area that has not been used recently, in order to avoid injury and bruising.
• Press the plunger slowly: Sometimes, quick injections can be painful. By pressing the plunger slowly, the injection will be less uncomfortable.

How to perform the injection with the vial

• 1)Preparation
• Make sure you know the appropriate amount (volume) needed for the dose. If you do not know the amount, STOPand contact your doctor for further instructions.
• You will need a special waste container, such as a sharps container or as instructed by your nurse, doctor or pharmacist. Place the container on your work surface.
• Wash your hands thoroughly.
• Remove from the package a box containing a syringe, a vial adapter, a vial, 2 alcohol-soaked swabs and a needle. If there is a second box in the package to be used for the next administration, put it back in the refrigerator immediately.
• Check the expiration date on the box. DO NOTuse any of the items in the box after the expiration date.
• Arrange the following items on a clean surface, WITHOUTyet removing any item from its packaging.

o 1) A 1 ml syringe
o 2) A vial adapter
o 3) A pediatric-use vial of Imraldi injectable solution
o 4) Two alcohol-soaked swabs
o 5) A needle

• Imraldi is a liquid from clear to opalescent and from colorless to light brown. DO NOTuse it if the liquid is not from clear to opalescent, from colorless to light brown or if it is not free of particles.
• 2)Preparation of the Imraldi dose for injection

General instructions: DO NOTdispose of any item until the injection is complete.

• Prepare the needle by partially opening the packaging at the end closest to the yellow connector of the syringe. Open the packaging just enough to expose the yellow connector of the syringe. Place the packaging with the clear side facing up.

• Remove the plastic cap from the vial until you can see the top of the vial stopper.

• Use one of the alcohol-soaked swabs to clean the vial stopper. DO NOTtouch the vial stopper after cleaning it with the swab.
• Remove the cover of the vial adapter packaging without pulling it out of the packaging.

• Hold the vial with the stopper facing up.
• With the vial adapter still in the transparent packaging, attach it to the vial stopper by pushing it until the adapter clicks into place.
• When you are sure that the adapter is attached to the vial, pull the packaging away from it.
• Gently place the vial and adapter on a clean work surface, being careful not to drop it. DO NOTtouch the adapter.

• Prepare the syringe by partially opening the packaging at the end closest to the white plunger.
• Open the transparent packaging just enough to expose the white plunger without pulling the syringe out of its packaging.
• Keeping the syringe packaging, slowly push the plunger 0.1 ml above the prescribed dose (for example, if the prescribed dose is 0.5 ml, push the plunger to 0.6 ml). Do not exceed NEVERthe position corresponding to 0.9 ml regardless of the prescribed dose.
• The volume will be adjusted to the prescribed dose in a later step.
• DO NOTpush the white plunger completely out of the syringe.

NOTE:
If the white plunger is pushed completely out of the syringe, discard the syringe and contact the
Imraldi supplier for a replacement. DO NOTtry to reinsert the white plunger.
Dose + 0.1 ml

• DO NOTuse the white plunger to remove the syringe from the packaging. Hold the syringe on the graduated part and pull it out of its packaging. DO NOTput the syringe down at any time.
• Holding the adapter firmly, insert the tip of the syringe into the adapter and rotate the syringe clockwise with one hand until it is firm. DO NOTovertighten.

• Holding the vial, push the white plunger all the way down. This step is important to draw the correct dose. Keep the white plunger inside and turn the vial and syringe upside down.

• Slowly pull the white plunger back to 0.1 ml above the prescribed dose. This is important to draw the appropriate dose. The volume equivalent to the prescribed dose will be established in step 4 (Dose Preparation). If the prescribed dose is 0.5 ml, pull the white plunger to a volume of 0.6 ml. The liquid will pass from the vial into the syringe.

• Push the white plunger back to the end to return the liquid to the vial. Again, slowly pull the white plunger until it reaches 0.1 ml above the prescribed dose; it is important to draw the appropriate dose and prevent the formation of air bubbles or voids in the liquid. The volume equivalent to the prescribed dose will be established in step 4 (Dose Preparation).

• If air bubbles or voids remain in the syringe, you can repeat this operation up to three times. DO NOTshake the syringe.

NOTE:
If the white plunger is pushed completely out of the syringe, discard the syringe and contact the
supplier of Imraldi for a replacement. DO NOTattempt to reinsert the white plunger.

• Holding the syringe still in an upright position by the graduated side, remove the adapter with the vial by unscrewing the adapter with the other hand. Make sure to remove the adapter with the vial from the syringe. DO NOTtouch the tip of the syringe.

• If you notice a large air bubble or an empty space near the tip of the syringe, push the white plunger into the syringe SLOWLYuntil fluid

begins to enter the tip of the syringe. DO NOTpush the white plunger once
past the position corresponding to the dose.

• For example, if the prescribed dose is 0.5 ml, DO NOTpush the white plunger beyond the 0.5 ml position.
• Verify that the fluid remaining in the syringe is at least equivalent to the prescribed dose. If it is less, DO NOTuse the syringe and contact your healthcare provider.
• With your free hand, pick up the needle package with the yellow syringe connector facing down.
• Keeping the syringe facing upwards, insert the tip of the syringe into the yellow connector and rotate the syringe as indicated by the arrow in the figure until it stops. The needle is now attached to the syringe.

• Pull the needle out of the package, but DO NOTremove the clear needle cap.
• Place the syringe on a clean work surface. Immediately proceed with the injection site and dose preparation steps.
• 3)Choosing and preparing an injection site
• Choose a spot on your thigh or abdomen, except for the area around the navel. DO NOTuse the same site that was used for the last injection.
• The new injection must be administered at least 3 cm from the last injection site.

• DO NOTinject into areas where the skin has lesions, bruises, scars, scales, or red patches. This may indicate an infection; therefore, you should contact your doctor.
• To reduce the possibility of infection, rub the injection site with the other alcohol swab. DO NOTtouch the area again before the injection.
• 4)Preparing the dose
• Pick up the syringe with the needle pointing upwards.
• Use your other hand to turn the pink needle cover towards the syringe.

• Remove the clear needle cap by pulling it upwards with your other hand.

• The needle is clean.
• DO NOTtouch the needle.
• DO NOTpoint the syringe downwards after the clear needle cap has been removed.
• DO NOTtry to put the clear needle cap back on the needle.
• Hold the syringe at eye level with the needle pointing upwards to clearly see the amount of liquid. Be careful not to spray the medicine into your eyes.
• Double-check the amount of medicine drawn up.
• Gently push the white plunger into the syringe until the syringe contains the prescribed amount of medicine. Excess liquid may leak from the needle as the plunger is pressed. DO NOTremove the needle or syringe.
• 5)Injecting Imraldi
• With your free hand, gently grasp the area already rubbed with alcohol and hold it firm.
• With the other hand, hold the syringe at a 45° angle to the injection point.
• With a firm, quick motion, push the entire needle into the skin.
• Release the skin with your hand.
• Push the white plunger to inject the medicine until the syringe is empty.
• When the syringe is empty, remove the needle from the skin by pulling it out at the same angle it was inserted.

• Gently turn the pink needle cover upwards, over the needle, and snap it on, and place the syringe with the needle on the work surface. DO NOTput the clear needle cap back on the needle.

• With a piece of gauze, apply pressure to the injection site for 10 seconds. You may experience some minor bleeding. DO NOTmassage the injection site. If desired, apply a bandage.
• 6)Disposing of materials
• You will need a special waste container, such as a sharps container, or according to the instructions of the nurse, doctor, or pharmacist.
• Reposition the syringe with the needle, the vial, and the adapter in a special sharps container. DO NOTput these items in your household trash can.
• The syringe, needle, vial, and adapter MUST NEVERbe reused.
• Keep this container always out of sight and reach of children.
• Dispose of all other materials used in the household trash can.

Imraldi 40 mg injectable solution in pre-filled syringe

adalimumab

Read this leaflet carefully before you start to use this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you a Patient Reminder Card containing important safety information, which you need to know before administering Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card during treatment and for 4 months after the last injection of Imraldi (yours or your child’s).
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Imraldi is and what it is used for
• 2. What you need to know before you use Imraldi
• 3. How to use Imraldi
• 4. Possible side effects
• 5. How to store Imraldi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Imraldi and what is it used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system
(the body's defense system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis.

The active ingredient of Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNF α) which is
present at high levels in the inflammatory diseases described above. By binding to TNF α, Imraldi
reduces the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as methotrexate, may be given initially. If these drugs do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi can also be used to treat severe, active and progressive rheumatoid arthritis
without previous treatment with methotrexate.
Imraldi is able to slow the progression of damage to the cartilage and bones of the
joints, caused by the disease, and to improve physical function.
Generally Imraldi is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Imraldi may be given 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 typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as methotrexate, may be given at diagnosis. If these drugs do not work satisfactorily, patients will be given
Imraldi for the treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with
enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing
Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence
of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medicines. If these medicines do not work satisfactorily, you will take Imraldi to
reduce the signs and symptoms of the disease.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi is able to slow the damage to the
cartilage and bones of the joints, caused by the disease, and to improve physical function.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect
the nails causing them to crumble, become thicker and lift off the nail bed, which can
be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to increased production of skin cells.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is
also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or more in whom topical therapies and phototherapies have not worked optimally or
are not indicated.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-lasting, often painful inflammatory skin disease. Symptoms may include painful nodules and abscesses (cysts) that
can drain pus. It most frequently affects specific areas of the skin, such as the underarm region, armpits, inner thighs, groin and buttocks. Scars can also form in the affected areas.
Imraldi is used to treat Hidradenitis Suppurativa in adults and adolescents from 12 years
of age. Imraldi can reduce the number of nodules and abscesses you have and the pain that is often associated with
this disease. Initially, you may receive other medicines. If you do not respond sufficiently
well to these medicines, you will receive Imraldi.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If
you suffer from Crohn’s disease, you will first be given other medicines. If these medicines do not
work satisfactorily, you will be given Imraldi to reduce the typical symptoms
of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Imraldi is used to treat moderate to severe ulcerative colitis in adults and children aged from
6 to 17 years. If you have ulcerative colitis you may first take other medicines. If these medicines
do not work satisfactorily, you will take Imraldi to reduce the signs and symptoms of the disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects some parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of moving bodies
in the eye (black spots or thin lines that move across the visual field). Imraldi works
by reducing this inflammation.

2. What you need to know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi
Allergic reaction

• If you experience allergic reactionswith symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Imraldi. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning). In rare cases, these infections can be life-threatening. It is important to tell your doctor if you have symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Imraldi.

Tuberculosis

• Because cases of tuberculosishave occurred in patients treated with Imraldi, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Imraldi. This will involve collecting a detailed medical assessment including your medical history and clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection or if you think you may be at risk of contracting the hepatitis virus
• Your doctor should test you for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection while you are being treated

with Imraldi. It is important to inform your doctor if symptoms of infections such as fever,
wounds, feeling tired or dental problems appear.
Surgery or dental procedure

• Before a surgery or dental procedures, tell your doctor that you are taking Imraldi. Your doctor may advise you to temporarily stop Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease(diseases that affect the myelin sheath of the nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Imraldi. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccines

• Certain vaccinescontain bacteria or viruses that cause diseases in an attenuated, but live form, and should not be administered during treatment with Imraldi. Consult your doctor before getting vaccinated. In children, it is advisable, if possible, to implement the vaccination schedule recommended for the relevant age group before starting treatment with Imraldi. If you receive Imraldi during pregnancy, the baby may have an increased risk of contracting an infection up to about 5 months after the last dose you received during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• If you have mild heart failureand are receiving concomitant treatment with Imraldi, your doctor will need to carefully assess and monitor your heart condition. It is important to inform your doctor about any heart problems, past or present. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately. The doctor will decide whether you can take Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help them fight infections or stop bleeding. If you have fever, bruisingor easy bleedingor paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• Very rarely, some types of cancerhave occurred in children and adults treated with Imraldi or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma(a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow). If you take Imraldi, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• In addition, cases of non-melanoma skin cancerhave been observed in patients taking Imraldi. If new skin lesions appear during or after therapy or if the appearance of existing lesions or damaged areas changes, report it to your doctor.

Lupus-like syndrome

• Rarely, treatment with Imraldi can lead to the manifestation of a syndrome similar to lupus. Tell your doctor if you experience symptoms such as a persistent unexplained rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Imraldi to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not use the pre-filled syringe of 40 mg if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Imraldi can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. If you have doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last injection of Imraldi.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Imraldi can be used during breastfeeding.
• If you receive Imraldi during pregnancy, the baby may have an increased risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, before the baby receives any type of vaccination (for more information on vaccinations, see “Warnings and precautions”).

Driving and using machines
Imraldi may affect your ability to drive, ride a bicycle or use machines, although only to a slight extent. After taking Imraldi, you may experience visual disturbances and a sensation that the environment around you is rotating (dizziness).

Imraldi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.4 ml dose, i.e.
it is essentially ‘sodium-free’.

3. How to use Imraldi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
doubts, consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without
evidence of radiographic ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are available exclusively with a dose
of 40 mg. Therefore, the pre-filled syringe and the pre-filled pen of Imraldi cannot be
used for pediatric patients who require less than the full 40 mg dose. If an alternative dose is needed,
other products that offer this possibility must be used.
Imraldi should be injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis and for patients with psoriatic arthritis is 40 mg of adalimumab every other week,
administered in a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Imraldi. If the
doctor decides that methotrexate is not appropriate, Imraldi can be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with treatment with Imraldi,
your doctor may decide to prescribe 40 mg of adalimumab every week or 80 mg every other week.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents starting from 2 years of age and weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 2 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Children, adolescents and adults with arthritis associated with enthesitis

Children and adolescents starting from 6 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 6 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two
40 mg injections on the same day), followed by a dose of 40 mg, administered every other week,
starting the week after the initial dose. You should continue treatment
with Imraldi for the time indicated by your doctor. If this dose does not work satisfactorily, your
doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with plaque psoriasis

Children and adolescents between the ages of 4 and 17 years and weighing between 15 kg and less than

30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the
following week. Subsequently, the usual dose is 20 mg every other week.

Children and adolescents between the ages of 4 and 17 years and weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the
following week. Subsequently, the usual dose is 40 mg every other week.
Adults with hidradenitis suppurativa
The usual dose for Hidradenitis Suppurativa is an initial dose of 160 mg (via four injections
of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by a
dose of 80 mg (via two injections of 40 mg on the same day) two weeks later. After another two
weeks, continue with a dose of 40 mg per week or 80 mg every other week, as prescribed
by your doctor. It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adolescents with hidradenitis suppurativa between the ages of 12 and 17, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two injections of 40 mg on a
day), followed by 40 mg every two weeks starting one week later. If this dose does not
work satisfactorily with 40 mg of Imraldi every other week, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adults with Crohn’s disease
The usual dose in case of Crohn’s disease is initially 80 mg (via two 40 mg injections
on the same day) followed by 40 mg every other week, after two weeks. If a
faster response is needed, the doctor may prescribe an initial dose of 160 mg (via four injections of
40 mg on the same day or two injections of 40 mg per day for two consecutive days) followed by 80 mg
(via two injections of 40 mg on the same day) after two weeks, and subsequently 40 mg
every other week. If this dose does not work satisfactorily, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
Children and adolescents with Crohn’s disease

Children and adolescents between the ages of 6 and 17 years and weighing less than 40 kg
The usual dose is initially 40 mg followed by 20 mg after two weeks. If it is necessary to induce
a faster response, the doctor may prescribe an initial dose of 80 mg (via two injections of
40 mg on the same day) followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work
satisfactorily, the doctor may increase the frequency of the dose to 20 mg every week.

Children and adolescents between the ages of 6 and 17 years and weighing 40 kg or more
The usual dose is initially 80 mg (via two injections of 40 mg on the same day) followed by
40 mg after two weeks. If it is necessary to induce a faster response, the doctor may prescribe
an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg
on the same day) followed by 80 mg (via two injections of 40 mg on the same day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work
satisfactorily, the doctor may increase the dose to 40 mg every week or 80 mg every other week.
Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four injections of
40 mg on the same day or two injections of 40 mg per day for two consecutive days) at week 0 and 80 mg
(via two injections of 40 mg on the same day) at week 2 and subsequently 40 mg
every other week. If this dose does not work satisfactorily, the doctor may increase the
dosage to 40 mg every week or 80 mg every other week.
Children and adolescents with ulcerative colitis

Children and adolescents starting from 6 years of age and weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two injections of 40 mg on the same day), followed by 40 mg
(via a single 40 mg injection) two weeks later. Subsequently, the usual dose is
40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the
prescribed dose.

Children and adolescents starting from 6 years of age and weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four injections of 40 mg on the same day or two
injections of 40 mg per day for two consecutive days) followed by 80 mg (via two injections of
40 mg on the same day) after two weeks. Subsequently the usual dose is 80 mg
every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the
prescribed dose.
Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two
injections on the same day), followed by 40 mg administered every two weeks starting one week
after the initial dose. Continue to inject Imraldi for as long as indicated by your doctor.
In non-infectious uveitis, corticosteroids or other drugs that affect the immune system
may be continued during treatment with Imraldi. Imraldi can also be administered
as monotherapy.
Children and adolescents with chronic non-infectious uveitis starting from 2 years of age

Children and adolescents starting from 2 years of age and weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg which may be
administered one week before starting the usual dose.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
The doctor may also prescribe an initial dose of 80 mg which may be administered one
week before starting the usual dose.

How and route of administration
Imraldi is given by injection under the skin (for subcutaneous injection). For instructions for use
please refer to section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Imraldi
If you forget to give an injection, you should inject the next dose of Imraldi as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop taking Imraldi
The decision to stop using Imraldi should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention urgentlyif you notice any of the following reactions:

• severe skin rash, hives or other signs of an allergic reaction;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness of the arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting the onset of blood disorders, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which 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);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle pain.

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

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections affecting the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• nerve root compression symptoms (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (a sensation of spinning);
• fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• indigestion (including bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (a build-up of fluid in the body that causes swelling of the affected tissues);
• fever;
• decreased platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

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

• opportunistic infections (which include tuberculosis and other infections that occur when the immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, tinnitus;
• irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease that causes shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial swelling;
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people):

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve of the eye and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
• facial swelling associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated based on available data):

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness); Weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests.
These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

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

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• altered sodium in the blood;
• decreased calcium in the blood;
• decreased phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• decreased potassium in the blood.

Uncommon(may affect up to 1 in 100)

• high levels of bilirubin in the blood (liver blood test).

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

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack label after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe may be
stored at room temperature (up to 25 °C) for a maximum period of 31 days – ensure to
protect the medicine from light. Once removed from the refrigerator for storage at
room temperature, the syringe must be used within 31 days or discarded, even if it is placed back in
the refrigerator.
You must record the date on which the syringe is removed from the refrigerator for the first time and the date after which
the syringe must be discarded.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Imraldi contains

• The active substance is adalimumab.
• The other ingredients are monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, succinic acid, dibasic sodium succinate, histidine, histidine hydrochloride monohydrate, mannitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in pre-filled syringes is supplied as 0.4 ml of solution which is
clear to opalescent and colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (type I glass)
with a stainless steel needle, a rigid needle shield, a rubber plunger, a rod, a
protective cover and a finger flange for patient use and, respectively, 2, 2, 4 or 6 alcohol swabs included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/S.A
Tél/Tel: + 32 2 2191218

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
Ewopharma AG Representative Office
Teл.: + 35929621200

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: + 420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: + 36 1 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: + 45 77 41 57 57

Malta
Pharma.MT Ltd
Tel: + 35621337008

Deutschland
Biogen GmbH
Tel: + 49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: + 31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: + 372 618 9551

Norge
Biogen Norway AS
Tlf: + 47 23 40 01 00

Ελλάδα
Genesis Pharma S.A.
Τηλ: + 302108771500

Österreich
Biogen Austria GmbH
Tel: + 43 1 484 46 13

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel.: + 48 22 351 51 00

France
Biogen France SAS
Tél: + 33 (0)1 776 968 14

Portugal
Biogen Portugal Sociedade Farmacêutica,
Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska
Ewopharma d.o.o
Tel: + 385 (0)1 6646 563

România
Ewopharma Romania SRL
Tel: + 40212601344

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: + 386 1 511 02 90

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel: + 421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: + 39 02 584 99 010

Suomi/Finland
Biogen Finland Oy
Puh/Tel: + 358 207 401 200

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: + 357 22 76 57 15

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .

7. Instructions for Use

Follow these instructions carefully: you will quickly become familiar with them and will be able to perform the
injections with confidence.

• Before performing the injections, ask your doctor or nurse to show you how to use the prefilled syringe. Your doctor or nurse must check that you are able to use the syringe correctly.

Appearance of the single-dose prefilled syringe

After pressing the plunger all the way down, the needle retracts, thus preventing needle-stick injuries
.

Using the prefilled syringe
Storage of the syringe

• Store the syringe in a refrigerator, but do not freeze it.
• Keep the syringe in its box, protected from light.
• Keep the syringe out of the sight and reach of children.

Disposal of the syringe

• Use each syringe only once. Never reuse the same syringe.
• Dispose of the used syringe in a special container, as explained by your doctor, nurse or pharmacist.

Caution

• If the syringe falls with the CAP INSERTED, it can still be used. If the syringe falls WITHOUT the cap inserted, do not use it anymore. The needle may be dirty or damaged.
• Do not use a damaged syringe.

Preparation of the injection site

• For the injection, choose an area rich in fat: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are easier to pinch between your fingers and are suitable for correct needle insertion.
• Choose a different injection site each time: When choosing an injection site, look for an area that has not been used recently, in order to avoid injury and bruising.
• Press the plunger slowly: Sometimes, quick injections can be painful. By pressing the plunger slowly, the injection will be less uncomfortable.

How to perform the injection with the prefilled syringe

1. Gather the necessary items

Place the pre-filled syringe and alcohol swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15-30 minutes

Wait 15-30 minutes to bring the pre-filled syringe to room temperature, in order to reduce
pain during the injection.

• Do not remove the cap yet!

3. Check the medicine and the expiry date

Always check that the medicine is from clear to opalescent, from colorless to light brown, free of
particles and that it has not expired. If the medicine is not from clear to opalescent, from colorless to
light brown and free of particles or if it is expired, do not use it.
One or more air bubbles may be present, which do not constitute a problem. There is no reason to
remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with a swab soaked in alcohol. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, scaling or red spots.

5. Remove the needle cap

Carefully remove the needle cap.
It is normal for a few drops of liquid to come out of the needle.
If you remove the needle cap before you are ready to administer the injection, do not replace it. Otherwise, you risk bending or damaging the needle. You also risk accidental puncture or
spilling some of the medicine.

6. Take a fold of skin between your fingers and insert the needle

Carefully take a fold of skin between your fingers and insert the needle all the way in, at an angle of approximately 45 degrees.

7. Push the plunger all the way in

Hold the syringe steady and push the plunger all the way in.
Then lift your thumb so that the needle retracts into the body of the syringe.

8. Remove and dispose of the syringe

Remove the syringe from the skin.
After injecting Imraldi, check that the needle has retracted and immediately dispose of the used syringe
in a special container, as explained by your doctor, nurse or pharmacist.

• Are you unsure if you received the dose? Contact your doctor, nurse or pharmacist.

Imraldi 40 mg solution for injection in pre-filled pen

adalimumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you a Patient Reminder Card containing important safety information, which you need to know before administering Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card during treatment and for 4 months after the last Imraldi injection (yours or your child’s).
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Imraldi is and what it is used for
• 2. What you need to know before you use Imraldi
• 3. How to use Imraldi
• 4. Possible side effects
• 5. How to store Imraldi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Imraldi and what is it used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system
(the body's defense system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis.

The active ingredient of Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNF α) which is
present at high levels in the inflammatory diseases described above. By binding to TNF α, Imraldi
reduces the inflammatory process in these diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as methotrexate, may be initially given. If these drugs do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi can also be used for the treatment of severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Imraldi is able to slow the progression of damage to the cartilage and bones of the
joints, caused by the disease, and to improve physical function.
Generally Imraldi is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Imraldi may be given 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 typically manifest for the first time in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as methotrexate, may be given at diagnosis. If these drugs do not work satisfactorily, patients will be given
Imraldi for the treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with
enthesitis.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medicines. If these medicines do not work satisfactorily, you will take Imraldi to
reduce the signs and symptoms of the disease.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi is able to slow the damage to the
cartilage and bones of the joints, caused by the disease, and to improve physical function.
Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect
the nails causing them to crumble, become thicker and lift off the nail bed, which can
be painful. Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increase in skin cell production.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is
also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or more in whom topical therapies and phototherapies have not worked optimally or
are not indicated.
Hidradenitis Suppurativa in adults and adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-lasting, often painful inflammatory skin disease. Symptoms may include painful nodules and abscesses (cysts) that
can drain pus. It most frequently affects specific areas of the skin, such as the underarm region, armpits, inner thighs, groin, and buttocks. Scars can also form in the affected areas.
Imraldi is used to treat Hidradenitis Suppurativa in adults and adolescents from 12 years of
age. Imraldi can reduce the number of nodules and abscesses you have, and the pain that is often associated
with this disease. Initially, you may receive other medicines. If you do not respond sufficiently
well to these medicines, you will receive Imraldi.
Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If
you suffer from Crohn’s disease, you will first be given other medicines. If these drugs do not
work satisfactorily, you will be given Imraldi to reduce the typical symptoms
of Crohn’s disease.
Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Imraldi is used to treat moderate to severe ulcerative colitis in adults and children aged from
6 to 17 years. If you have ulcerative colitis you may first take other medicines. If these medicines
do not work satisfactorily, you will take Imraldi to reduce the signs and symptoms of the disease.
Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of mobile bodies
in the eye (black spots or thin lines that move across the field of vision). Imraldi works
by reducing this inflammation.

2. What you need to know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi
Allergic reaction

• If you experience allergic reactionswith symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions can, in rare cases, be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Imraldi. If you have any doubts, contact your doctor.
• You may be more likely to get infections during treatment with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning). In rare cases, these infections can be life-threatening. It is important to tell your doctor if you have symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Imraldi.

Tuberculosis

• Because cases of tuberculosishave occurred in patients treated with Imraldi, your doctor will need to check if you have signs or symptoms of tuberculosis before starting therapy with Imraldi. This will involve collecting a detailed medical assessment including your medical history and clinical tests (e.g., a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurring infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection or if you think you may be at risk of contracting the hepatitis virus.
• Your doctor should test you for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection while you are being treated with Imraldi. It is important to inform your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedure

• Before surgery or dental procedures, tell your doctor that you are taking Imraldi. Your doctor may advise you to temporarily stop Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease(diseases that affect the myelin sheath around nerves, such as multiple sclerosis), your doctor will decide whether or not to start or continue treatment with Imraldi. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccines

• Certain vaccinescontain bacteria or viruses that cause mild, but live, forms of disease and should not be given during treatment with Imraldi. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to implement the vaccination schedule appropriate for their age group before starting treatment with Imraldi. If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose you received during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• If you have mild heart failureand are receiving concomitant treatment with Imraldi, your doctor should carefully assess and monitor the condition of your heart. It is important to inform your doctor about any heart problems, past or present. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide if you can take Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have fever, bruisingor a tendency to bleedor paleness, see your doctor immediately. The latter may decide to discontinue therapy.

Cancer

• Very rarely, some types of cancerhave occurred in children and adults treated with Imraldi or other anti-TNFα drugs. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma(a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow). If you take Imraldi, your risk of developing lymphoma, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also being treated with azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• In addition, cases of non-melanoma skin cancerhave been observed in patients taking Imraldi. If new skin lesions appear during or after therapy, or if the appearance of existing lesions or damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi can lead to the development of a syndrome similar to lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Imraldi to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not use the pre-filled pen if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Imraldi can be taken with methotrexate and other disease-modifying antirheumatic drugs
(sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi should not be taken at the same time as medicines containing the active ingredients
anakinra or abatacept due to the increased risk of serious infections. If you have any doubts, ask your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last injection of Imraldi.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother received adalimumab during pregnancy, compared to mothers with the same condition who did not receive adalimumab.
• Imraldi can be used during breastfeeding.
• If you receive Imraldi during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Imraldi during pregnancy, before the baby receives any type of vaccination (for more information on vaccinations, see “Warnings and precautions”).

Driving and using machines
Imraldi may affect your ability to drive, ride a bicycle or use machines, although only to a
minor extent. After taking Imraldi, you may experience vision disturbances and a feeling that the
environment around you is spinning (dizziness).

Imraldi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.4 ml dose, i.e.
it is essentially ‘sodium-free’.

3. How to use Imraldi

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without
evidence of radiographic ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are available exclusively with a dose
of 40 mg. Therefore, the pre-filled syringe and the pre-filled pen of Imraldi cannot be
used for pediatric patients requiring less than the full dose of 40 mg. If an alternative dose is needed,
other products offering this possibility must be used.
Imraldi should be injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis, and for patients with psoriatic arthritis is 40 mg of adalimumab every other week,
administered in a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Imraldi. If the
doctor decides that methotrexate is not appropriate, Imraldi can be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in association with treatment with Imraldi,
your doctor may decide to prescribe 40 mg of adalimumab every week or 80 mg every other week.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents starting from 2 years of age and weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 2 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Children, adolescents and adults with arthritis associated with enthesitis

Children and adolescents starting from 6 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents and adults starting from 6 years of age and weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.
Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two
injections in one day), followed by a dose of 40 mg, administered every other week, starting
from the week following the initial dose. You must continue treatment with
Imraldi for the time indicated by your doctor. If this dose does not work satisfactorily, your doctor
may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with plaque psoriasis

Children and adolescents between the ages of 4 and 17 and weighing between 15 kg and less than

30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the
week following. Subsequently, the usual dose is 20 mg every other week.

Children and adolescents between the ages of 4 and 17 and weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the
week following. Subsequently, the usual dose is 40 mg every other week.
Adults with hidradenitis suppurativa
The usual dose in case of Hidradenitis Suppurativa is an initial dose of 160 mg (via
four 40 mg injections in one day or two 40 mg injections per day for two consecutive days),
followed by a dose of 80 mg (via two 40 mg injections in one day) two weeks later. After
another two weeks, continue with a dose of 40 mg per week or 80 mg every other week, as
prescribed by your doctor. It is recommended to use an antiseptic cleansing solution daily
on the affected areas.
Adolescents with hidradenitis suppurativa aged between 12 and 17, weighing 30 kg or more)
The recommended dose of Imraldi is an initial dose of 80 mg (via two 40 mg injections in one
day), followed by 40 mg every two weeks starting one week later. If this dose does not
work satisfactorily with 40 mg of Imraldi every other week, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adults with Crohn's disease
The usual dose in case of Crohn's disease is initially 80 mg (via two 40 mg injections
in one day) followed by 40 mg every other week, after two weeks. If a
faster response is needed, the doctor may prescribe an initial dose of 160 mg (via four injections of
40 mg in one day or two 40 mg injections per day for two consecutive days) followed by 80 mg
(via two 40 mg injections in one day) after two weeks, and subsequently 40 mg every
other week. If this dose does not work satisfactorily, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
Children and adolescents with Crohn's disease

Children and adolescents between the ages of 6 and 17 and weighing less than 40 kg
The usual dose is initially 40 mg followed by 20 mg after two weeks. If it is necessary to induce
a faster response, the doctor may prescribe an initial dose of 80 mg (via two 40 mg injections
in one day) followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work
satisfactorily, the doctor may increase the frequency of the dose to 20 mg every week.

Children and adolescents between the ages of 6 and 17 and weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections in one day) followed by
40 mg after two weeks. If it is necessary to induce a faster response, the doctor may prescribe
an initial dose of 160 mg (via four 40 mg injections in one day or as two 40 mg injections
per day for two consecutive days) followed by 80 mg (via two 40 mg injections in one
day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work
satisfactorily, the doctor may increase the dose to 40 mg every week or 80 mg every
other week.
Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four 40 mg injections
in one day or two 40 mg injections per day for two consecutive days) at week 0 and 80 mg (via two 40 mg injections in one day) at week 2 and subsequently 40 mg every
other week. If this dose does not work satisfactorily, the doctor may increase the
dose to 40 mg every week or 80 mg every other week.
Children and adolescents with ulcerative colitis

Children and adolescents starting from 6 years of age and weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two 40 mg injections in one day), followed by 40 mg
(via a single 40 mg injection) two weeks later. Subsequently, the usual dose is
40 mg every other week.
Patients who turn 18 while taking 40 mg every other week should continue the
prescribed dose.

Children and adolescents starting from 6 years of age and weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four 40 mg injections in one day or two
40 mg injections per day for two consecutive days) followed by 80 mg (via two 40 mg injections
in one day) after two weeks. Subsequently the usual dose is 80 mg every other week.
Patients who turn 18 while taking 80 mg every other week should continue the
prescribed dose.
Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two
injections in one day), followed by 40 mg administered every two weeks starting one week
after the initial dose. Continue to inject Imraldi for as long as indicated by your doctor.
In non-infectious uveitis, corticosteroids or other drugs that affect the immune system
may be continued during treatment with Imraldi. Imraldi can also be administered
as monotherapy.
Children and adolescents with chronic non-infectious uveitis starting from 2 years of age

Children and adolescents starting from 2 years of age and weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child's doctor may also prescribe an initial dose of 40 mg that can be
administered one week before the start of the usual dose.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
The doctor may also prescribe an initial dose of 80 mg that can be administered one
week before the start of the usual dose.

How to administer and route of administration
Imraldi is given by injection under the skin (for subcutaneous injection). For instructions for use, see
section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Imraldi
If you forget to give an injection, you should inject the next dose of Imraldi as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop taking Imraldi
The decision to stop using Imraldi should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention urgentlyif you notice any of the following reactions:

• severe skin rash, hives or other signs of an allergic reaction;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness of the arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting the onset of blood disorders, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which 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);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle pain.

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

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• nerve root compression symptoms (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• inflammation of the eyelids and swelling of the eyes;
• dizziness (a sensation of spinning);
• feeling of a racing heartbeat;
• high blood pressure;
• hot flashes;
• bruise (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• indigestion (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• contusion;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (a build-up of fluid in the body that causes swelling of the affected tissues);
• fever;
• decreased platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

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

• opportunistic infections (which include tuberculosis and other infections that occur when immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, tinnitus;
• feeling of an irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease that causes shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema;
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people):

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve of the eye and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin)
• lichenoid skin reaction (itchy reddish-purple rash).

Not known(frequency cannot be estimated based on available data):

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• Weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

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

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• decreased calcium in the blood;
• decreased phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• decreased potassium in the blood.

Uncommon(may affect up to 1 in 100)

• high levels of bilirubin in the blood (liver blood test).

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

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack label after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled pen can be stored
at room temperature (up to 25 °C) for a maximum period of 31 days – ensure the
medicine is protected from light. Once removed from the refrigerator for storage at
room temperature, the pen must be used within 31 days or discarded, even if it is placed back
into the refrigerator.
You must record the date when the pen is removed from the refrigerator for the first time and the date after which
the pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other ingredients are monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, succinic acid, dibasic sodium succinate, histidine, histidine hydrochloride monohydrate, mannitol, polysorbate 20 and water for injections.

Description of Imraldi and package contents
Imraldi 40 mg solution for injection in pre-filled pen is supplied as 0.4 ml of solution from clear
to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a
pre-filled syringe (type I glass) with a stainless steel needle, a rigid cap, a rubber plunger
for patient use and, respectively, 2, 2, 4 or 6 alcohol swabs
included in the package.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/S.A
Tél/Tel: + 32 2 2191218

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
Ewopharma AG Representative Office
Teл.: + 35929621200

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: + 420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: + 36 1 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: + 45 77 41 57 57

Malta
Pharma.MT Ltd
Tel: + 35621337008

Deutschland
Biogen GmbH
Tel: + 49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: + 31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: + 372 618 9551

Norge
Biogen Norway AS
Tlf: + 47 23 40 01 00

Ελλάδα
Genesis Pharma S.A.
Τηλ: + 302108771500

Österreich
Biogen Austria GmbH
Tel: + 43 1 484 46 13

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel.: + 48 22 351 51 00

France
Biogen France SAS
Tél: + 33 (0)1 776 968 14

Portugal
Biogen Portugal Sociedade Farmacêutica,
Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska
Ewopharma d.o.o
Tel: + 385 (0)1 6646 563

România
Ewopharma Romania SRL
Tel: + 40212601344

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: + 386 1 511 02 90

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel: + 421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: + 39 02 584 99 010

Suomi/Finland
Biogen Finland Oy
Puh/Tel: + 358 207 401 200

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: + 357 22 76 57 15

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .

7. Instructions for Use

Follow these instructions carefully: you will quickly become familiar with them and will be able to perform the
injections with confidence.

• Before performing injections, ask your doctor or nurse to show you how to use the prefilled pen. Your doctor or nurse must check that you are able to use the pen correctly.

Appearance of the single-dose prefilled pen

The prefilled pen does not have a button.
The needle is hidden under the green base. When you press the prefilled pen firmly against the skin,
the injection starts automatically.

Using the prefilled pen
Storing the pen

• Store the pen in the refrigerator, but do not freeze it.
• Keep the pen in its box, protected from light.
• Keep the pen out of the sight and reach of children.

Disposing of the pen

• Use each pen only once. Never reuse the same pen.
• Dispose of the used pen in a special container, as explained by your doctor, nurse or pharmacist.

Caution

• If the pen falls with the cap INSERTED, it can still be used. If the pen falls WITHOUT the cap being inserted, do not use it anymore. The needle may be dirty or damaged.
• Do not use a damaged pen.

Preparing the injection site

• For the injection, choose an area rich in fat: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are suitable for correct needle insertion.
• Choose a different injection site each time: When choosing an injection site, look for an area that has not been used recently, in order to avoid injury and bruising.

How to perform the injection with the prefilled pen

1. Gather the necessary items

Place the prefilled pen and alcohol swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15-30 minutes

Wait 15-30 minutes to bring the pen to room temperature, in order to reduce pain
during the injection.

• Do not remove the cap yet!

3. Check the medicine and the expiry date

Check that the medicine is from clear to opalescent, from colorless to light brown, free of
particles and that it has not expired. If the medicine is not from clear to opalescent, from colorless to
light brown and free of particles or if it is expired, do not use it.
One or more air bubbles may be present, which do not constitute a problem. There is no need to
remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with a swab soaked in alcohol. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, scaling or red spots.

5. Remove the transparent cap from the needle

Carefully remove the transparent cap of the needle with the metal central part from the pen.
It is normal for a few drops of liquid to come out of the needle.
If you remove the needle cap before you are ready to administer the injection, do not replace it. Otherwise you risk bending or damaging the needle. You also risk accidental puncture or
spilling some of the medicine.

6. Place the green base, press and hold

Place the green base straight (90 degrees) on the skin and press the prefilled pen firmly
downwards to start the injection.

• When pressing down, the injection begins. You may hear a 1 click.

7. Keep holding down

Keep the pen pressed on the skin until the yellow indicator has filled the inspection window and has stopped moving.

• After a few seconds you may hear a 2 click.

8. Confirm completion of the injection and dispose of the pen

After injecting Imraldi, check that the entire inspection window is yellow.
Dispose of the used pen in a special container, as explained by your doctor, nurse
or pharmacist.

• Are you unsure if you received the dose? Contact your doctor, nurse or pharmacist.