Imuldosa

Package leaflet: Information for the user

IMULDOSA 130 mg concentrate for solution for infusion

ustekinumab

This medicinal product is subject to additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any adverse reactions you experience while taking
this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who take this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What IMULDOSA is and what it is used for
2. What you need to know before using IMULDOSA
3. How IMULDOSA will be used
4. Possible side effects
5. How to store IMULDOSA
6. Contents of the pack and other information

1. What IMULDOSA is and what it is used for

What IMULDOSA is
IMULDOSA contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
IMULDOSA belongs to a group of medicines called "immunosuppressants". These medicines reduce the activity of the immune system.

What IMULDOSA is used for
IMULDOSA is used to treat the following inflammatory diseases:

• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these medicines, IMULDOSA may be given to reduce the signs and symptoms of your disease.

2. What you should know before using IMULDOSA

Do not use IMULDOSA

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6)
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using IMULDOSA.

Warnings and precautions

Talk to your doctor or pharmacist before using IMULDOSA. Your doctor will check your health status before starting treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Additionally, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering IMULDOSA. If your doctor believes you are at risk for tuberculosis, you may be given medicines to treat it.

Be aware of serious side effects

IMULDOSA can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking IMULDOSA. See "Serious side effects" in section 4 for a complete list of these side effects.

Before using IMULDOSA, contact your doctor

• If you have ever had an allergic reaction to IMULDOSA. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like IMULDOSA partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or have recently had an infection or if you have abnormal openings on the skin (fistulas).
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce immune system activity. The concomitant use of these therapies with IMULDOSA has not been studied. However, it may increase the possibility of conditions related to a weakened immune system.
• If you are using or have ever used injections for the treatment of allergies – it is not known whether IMULDOSA may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with IMULDOSA.

During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.

Heart attack and stroke

In a study of psoriasis patients treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents

IMULDOSA is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease, as it has not been studied in this age group.

Other medicines, vaccines, and IMULDOSA

Inform your doctor or pharmacist:

• If you are taking, have recently taken, or might take any other medicines
• If you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using IMULDOSA.
• If you received IMULDOSA during pregnancy, inform your child’s paediatrician about the IMULDOSA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received IMULDOSA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• In newborns exposed to Imuldosa in the womb, no increased risk of congenital malformations has been observed. However, experience with Imuldosa in pregnant women is limited. Therefore, it is preferable to avoid using Imuldosa during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Imuldosa and for at least 15 weeks after stopping treatment with Imuldosa.
• Imuldosa can cross the placenta and reach the unborn child. If you received Imuldosa during pregnancy, your child may have an increased risk of developing an infection.
• If you received Imuldosa during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Imuldosa during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Imuldosa. You cannot do both.

Driving and using machines

IMULDOSA does not alter or alters negligibly the ability to drive or use machines.

IMULDOSA contains Polysorbate 80

IMULDOSA contains 11.1 mg of polysorbate 80 (E433) per dose, equivalent to 10.40 mg in the 130 mg dosage.

Polysorbates may cause allergic reactions. If you have any known allergy, consult your doctor.

IMULDOSA contains sodium

IMULDOSA contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free". However, before administration, IMULDOSA is mixed with a solution containing sodium. Talk to your doctor if you are on a low-salt diet.

3. How IMULDOSA will be used

IMULDOSA is intended for use under the guidance and supervision of a physician experienced in the
diagnosis and treatment of Crohn's disease.
IMULDOSA 130 mg concentrate for solution for infusion will be administered by your doctor
through an intravenous drip into a vein in your arm (intravenous infusion) for at least one hour. Discuss with your
doctor when you should have your infusions and follow-up visits.
How much IMULDOSA is administered
Your doctor will decide how much IMULDOSA you need and for how long.
Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose for you based on your body weight.

Your body weight	Dose
≤55 kg	260 mg
> 55 kg to ≤85 kg	390 mg
> 85 kg	520 mg

• After the initial intravenous dose, you will receive the next dose of 90 mg of IMULDOSA as an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.

Children with Crohn's disease weighing at least 40 kg

• Your doctor will calculate the recommended intravenous infusion dose based on body weight.

Body weight Dose
≥40 to ≤55 kg 260 mg

 55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of Imuldosa as an injection under the skin (subcutaneous injection), then continue every 12 weeks.

How IMULDOSA is administered
The first dose of IMULDOSA for the treatment of Crohn's disease is administered by your doctor
as an intravenous infusion (a drip into your arm).
Inform your doctor if you have any questions regarding the use of IMULDOSA.
If you forget to use IMULDOSA
If you forget or miss your scheduled dose appointment, contact your doctor to
arrange a new appointment.
If you stop using IMULDOSA
It is not dangerous to stop using IMULDOSA. However, if you discontinue treatment,
your symptoms may return.
If you have any further questions 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 everybody gets them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking IMULDOSA (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure, which may cause dizziness or lightheadedness, or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Infusion-related reactions – If you are being treated for Crohn's disease, your first dose of IMULDOSA is administered via an intravenous infusion. Some patients have experienced severe allergic reactions during the infusion.
Allergic lung reactions and lung inflammation have been reported in rare cases in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use IMULDOSA again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue under the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

IMULDOSA may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that typically occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while taking IMULDOSA. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which may lead to serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop IMULDOSA until the infection resolves. Also, inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

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

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes accompanied by joint pain).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store IMULDOSA

• IMULDOSA 130 mg concentrate for solution for infusion is administered in a hospital or clinic setting, and patients do not need to handle or store it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C – 8°C). Do not freeze.
• Keep the vial in its outer packaging to protect the medicine from light.
• Do not shake IMULDOSA vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp.”. The expiry date refers to the last day of that month.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of IMULDOSA and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been vigorously shaken.
• If the seal is broken.

IMULDOSA is for single use only. Any unused diluted solution for infusion remaining in the vial and syringe must be disposed of according to local regulations.

6. Package contents and other information

What IMULDOSA contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: disodium edetate dihydrate (E385), L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of IMULDOSA and contents of the pack
IMULDOSA is a solution for infusion, colourless to slightly yellow and clear to slightly opalescent. It is supplied in a cardboard pack containing one single dose in a 30 mL glass vial. Each vial contains 130 mg of ustekinumab in 26 mL of concentrate for solution for infusion.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6a Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200, Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

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

The following information is intended exclusively for healthcare professionals.

Traceability
To improve the traceability of biological medicinal products, the trade name and batch number of the administered product must be clearly documented.

Instructions for dilution
IMULDOSA concentrate for solution for infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and number of IMULDOSA vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL vial of IMULDOSA contains 130 mg of ustekinumab.
2. Remove and discard a volume of 9 mg/mL (0.9%) sodium chloride solution from the 250 mL infusion bag equal to the volume of IMULDOSA to be added (discard 26 mL of sodium chloride for each required IMULDOSA vial; for 2 vials, discard 52 mL; for 3 vials, discard 78 mL; for 4 vials, discard 104 mL).
3. Withdraw 26 mL of IMULDOSA from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Mix gently.
4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration, or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within 24 hours of dilution in the infusion bag.
6. Use a single infusion set with a sterile, non-pyrogenic, low protein-binding in-line filter (pore size 0.2 micrometers).
7. Each vial is for single use only. Any unused medicinal product must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution may be stored at room temperature. The infusion must be completed within 24 hours of dilution in the infusion bag. Do not freeze.

Package leaflet: Information for the user

IMULDOSA 45 mg solution for injection in pre-filled syringe

ustekinumab

This medicinal product is subject to additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while taking this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information
for you.
This leaflet is intended for people taking this medicine. If you are a parent or caregiver of a child
who is to be given IMULDOSA, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What IMULDOSA is and what it is used for

What IMULDOSA is
IMULDOSA contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
IMULDOSA belongs to a group of medicines called “immunosuppressants”. These medicines reduce the activity of the immune system to some extent.

What IMULDOSA is used for
IMULDOSA is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderately to severely active Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
IMULDOSA will reduce inflammation and other signs of the disease.
IMULDOSA is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or in whom these treatments have not worked.
IMULDOSA is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given IMULDOSA to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, IMULDOSA may be given to reduce the signs and symptoms of your disease.

2. What you should know before using IMULDOSA

Do not use IMULDOSA

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the above conditions apply to you, speak with your doctor or
pharmacist before using IMULDOSA.
Warnings and precautions
Talk to your doctor or pharmacist before using IMULDOSA. Your doctor will check your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. In addition, inform your doctor if you have recently been in contact with
people who may have had tuberculosis. Your doctor will examine you and perform tests for
tuberculosis before administering IMULDOSA. If your doctor believes you are at risk of tuberculosis,
you may be given medicines to treat tuberculosis.
Be aware of serious side effects
IMULDOSA may cause serious side effects, including allergic reactions and infections. You should
pay attention to certain signs of illness while taking IMULDOSA. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using IMULDOSA, contact your doctor:

• If you have ever had an allergic reaction to IMULDOSA. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like IMULDOSA partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are taking any other type of treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce the activity of the immune system. The concomitant use of these therapies with IMULDOSA has not been studied. However, it could increase the likelihood of diseases related to a

weakening of the immune system.

• If you are using or have ever used allergy injections – it is not known whether IMULDOSA could affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before starting treatment with IMULDOSA.
During treatment with ustekinumab, some patients have developed lupus-like reactions,
including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your
doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on
sun-exposed skin areas or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and
stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
IMULDOSA is not recommended for the treatment of children under 6 years of age with psoriasis, children with Crohn’s disease weighing less than 40 kg, or for the treatment of children under 18 years of age with psoriatic arthritis and Crohn’s disease, as it has not been studied in these age groups.
Other medicines, vaccines and IMULDOSA
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using IMULDOSA.
• if you received IMULDOSA during pregnancy, inform your child’s paediatrician about the IMULDOSA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received IMULDOSA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• In newborns exposed to IMULDOSA in utero, no increased risk of congenital malformations has been observed. However, experience with IMULDOSA in pregnant women is limited. Therefore, it is preferable to avoid using IMULDOSA during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with IMULDOSA and for at least 15 weeks after stopping treatment with IMULDOSA.
• Ustekinumab may cross the placenta and reach the unborn child. If you received IMULDOSA during pregnancy, your child may have an increased risk of developing an infection.
• If you received IMULDOSA during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received IMULDOSA during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether
  you should breastfeed or use IMULDOSA. You cannot do both.
  Driving and using machines
  IMULDOSA does not affect or has a negligible effect on the ability to drive vehicles or operate
  machinery.
  IMULDOSA contains Polysorbate 80
  IMULDOSA contains 0.02 of polysorbate 80 (E433) per single dose, equivalent to 0.04 mg/ml.
  Polysorbates may cause allergic reactions. If you have any known allergy, consult your doctor.

3. How to use IMULDOSA

IMULDOSA is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which IMULDOSA is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive your injections and follow-up visits.

How much IMULDOSA is administered
Your doctor will determine the appropriate dose of IMULDOSA and the duration of treatment.

Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of IMULDOSA. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, the next dose is administered 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of IMULDOSA is administered by your doctor via an intravenous infusion into your arm. After the initial dose, you will receive the next dose of 90 mg of IMULDOSA after 8 weeks, followed by doses every 12 weeks via subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of IMULDOSA may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of IMULDOSA to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time of each administration.
• There is no IMULDOSA formulation available for children weighing less than 60 kg; therefore, if body weight is below 60 kg, other ustekinumab-containing medicines must be used.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of IMULDOSA.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of IMULDOSA.
• After the initial dose, the next dose should be administered 4 weeks later, and then every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of IMULDOSA is administered by your doctor via intravenous infusion into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of IMULDOSA, followed by doses every 12 weeks via subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of IMULDOSA may be administered every 8 weeks. Your doctor will decide when the next dose should be administered.

How IMULDOSA is administered
IMULDOSA is administered via subcutaneous injection ("subcutaneous route"). At the beginning of
treatment, medical or nursing staff may administer IMULDOSA to you.

• However, you and your doctor may decide whether you can self-inject IMULDOSA. In this case, you will be trained on how to self-administer IMULDOSA.
• For instructions on how to inject IMULDOSA, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions regarding self-injection.

If you use more IMULDOSA than you should
If you have used or received too much IMULDOSA, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use IMULDOSA
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using IMULDOSA
Stopping treatment with IMULDOSA is not dangerous. However, if you discontinue treatment, symptoms may return.

If you have further questions 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 gets them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek
immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking IMULDOSA (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure, which may cause dizziness or lightheadedness, or swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients
receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as
cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use
IMULDOSA again.
Infections – these may require urgent treatment, so contact your doctor immediately if you
notice any of the following signs.

• Nasal, throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue under the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

IMULDOSA may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while using IMULDOSA. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, pain, or a painful blistering rash on the skin
• burning sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which may have serious complications. Consult your doctor if you have any type of infection that persists or keeps recurring. Your doctor may decide to stop IMULDOSA until the infection resolves. Also, inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be
symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions.
If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

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

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed skin areas, sometimes with joint pain).

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

5. How to store IMULDOSA

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled syringe in its outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of IMULDOSA may also be stored at room temperature up to 30°C for a single period of up to 30 days, remaining in the outer packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date when it should be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first. Do not shake the pre-filled syringes of IMULDOSA. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp.”. The expiry date refers to the last day of that month.
• If the solution changes colour, becomes cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of IMULDOSA and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

IMULDOSA is for single use only. Any unused product remaining in the vial and syringe must be discarded. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What IMULDOSA contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of IMULDOSA and contents of the pack
IMULDOSA is a solution that ranges from colourless to slightly yellow and from clear to slightly opalescent.
It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe.
Each pre-filled syringe contains a dose of 45 mg ustekinumab in 0.5 mL of solution for injection.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center. Moll De Barcelona, s/n
Edifici Est, 6a Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200, Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

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

Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide that you can self-inject IMULDOSA. In this case, you will be taught how to self-inject IMULDOSA. Inform your doctor if you have any questions about self-injection.

• Do not mix IMULDOSA with other injectable liquids.
• Do not shake the pre-filled syringes of IMULDOSA, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe.

Figure 1

1. Check the number of pre-filled syringes and prepare materials:

Getting ready to use the pre-filled syringes

• Remove the pre-filled syringe or multiple pre-filled syringes from the refrigerator. Leave the pre-filled syringe outside the refrigerator for about half an hour. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the pre-filled syringe by its barrel with the covered needle pointing upwards.
• Do not hold it by the plunger head, the plunger, the needle shield wings, or the needle protective cap.
• Under no circumstances should you pull back the plunger.
• Do not remove the needle cap from the pre-filled syringe until it is needed.
• Do not touch the activation clips of the safety shield to prevent premature needle covering by the needle safety shield.

Inspect the pre-filled syringe to ensure that:

• the number of pre-filled syringes and the dose are correct; if your dose is 45 mg, you will use one 45 mg pre-filled syringe of IMULDOSA; if your dose is 90 mg, you will use two 45 mg pre-filled syringes of IMULDOSA and you will need to perform two injections. Choose two different body sites for these injections (e.g., one injection in the right thigh and the other in the left thigh), and carry out the injections one after the other.
• the medicine is the correct one.
• the medicine has not expired.
• the pre-filled syringe is not damaged.
• the solution in the pre-filled syringe is colorless to slightly yellow and clear to slightly opalescent.
• the liquid in the pre-filled syringe does not have a changed or cloudy color and does not contain foreign particles.
• the solution in the pre-filled syringe is not frozen.

Gather all necessary supplies and place them on a clean surface. You will need antiseptic wipes, a cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• IMULDOSA is administered by injection under the skin (subcutaneously).
• A suitable injection site is the upper part of the thigh or the area around the abdomen (abdomen), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you during the injection, the upper arm may also be used as an injection site.

*The grey areas indicate the recommended injection sites.
Figure 2
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the skin at the intended injection site with an antiseptic swab.
• Do not touch this area again before administering the injection.

3. Remove the needle protective cap (see Figure 3):

• The needle protective cap must not be removed until you are ready to inject the dose
• Hold the pre-filled syringe by its body with one hand
• Remove and discard the needle protective cap. Do not touch the plunger during this operation

Figure 3

• If you notice an air bubble in the pre-filled syringe or a drop of liquid at the needle tip, this is normal. Do not remove them
• Do not touch the needle, and do not let the needle touch any surface
• Do not use the pre-filled syringe if it is removed without the needle protective cap in place. If this happens, consult your doctor or pharmacist
• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose:

• Hold the pre-filled syringe in one hand between the middle finger and index finger, placing the thumb on the plunger head. Use the other hand to gently pinch the cleaned area of skin, holding it between the thumb and index finger. Do not squeeze too forcefully.
• Never pull back the plunger at any time.
• With one swift motion, insert the needle into the skin as far as possible (see Figure 4).

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely within the needle guard wings (see Figure 5).

WINGS OF
PROTECTION

NEEDLE
Figure 5

• Push the plunger to the end of its travel, and continue to keep pressure on the plunger head while withdrawing the needle and gently releasing the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head, allowing the empty syringe to rise upward and the needle to be fully covered by the safety guard, as shown in Figure 7:

Figure 7

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• You may see slight bleeding at the injection site. This is normal.
• You may press a cotton ball or gauze on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if necessary.

6. Disposal

• Syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be disposed of in regular waste.

Figure 8

Package leaflet: Information for the user

IMULDOSA 90 mg solution for injection in pre-filled syringe

ustekinumab

This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people taking this medicine. If you are the parent or caregiver of a child who is to be given IMULDOSA, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What IMULDOSA is and what it is used for

What IMULDOSA is
IMULDOSA contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
IMULDOSA belongs to a group of medicines called “immunosuppressants”. These medicines reduce the activity of the immune system to some extent.

What IMULDOSA is used for
IMULDOSA is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
IMULDOSA will reduce inflammation and other signs of the disease.
IMULDOSA is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments are ineffective.
IMULDOSA is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given IMULDOSA to:

• reduce the signs and symptoms of the disease,
• improve physical function,
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, IMULDOSA may be given to reduce the signs and symptoms of your disease.

2. What you should know before using IMULDOSA

Do not use IMULDOSA

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, discuss this with your
doctor or pharmacist before using IMULDOSA.
Warnings and precautions
Talk to your doctor or pharmacist before using IMULDOSA. Your doctor will check your health status
before each treatment. Make sure to inform your doctor, before each treatment, about any diseases you
have. In addition, inform your doctor if you have recently been in contact with people who might have
had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering
IMULDOSA to you. If your doctor believes you are at risk of tuberculosis, you may be given medicines
to treat tuberculosis.
Be aware of serious side effects
IMULDOSA can cause serious side effects, including allergic reactions and infections. You should
watch for certain signs of illness while taking IMULDOSA. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using IMULDOSA, contact your doctor

• If you have ever had an allergic reaction to IMULDOSA. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants such as IMULDOSA partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also reduce the activity of the immune system to some extent. The concomitant use of these therapies with IMULDOSA has not been studied. However, it may increase the likelihood of conditions related to

weakening of the immune system.

• If you are using or have ever used injections for allergy treatment – it is not known whether IMULDOSA may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before starting treatment with IMULDOSA.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including
cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you
develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or
if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your
doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately
managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensation
on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
IMULDOSA is not recommended for the treatment of children under 6 years of age with psoriasis, for
children with Crohn’s disease weighing less than 40 kg, or for children under 18 years of age with
psoriatic arthritis and Crohn’s disease, as it has not been studied in these age groups.
Other medicines, vaccines, and IMULDOSA
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using IMULDOSA.
• if you received IMULDOSA during pregnancy, inform your child’s paediatrician about the IMULDOSA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received IMULDOSA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• In newborns exposed to IMULDOSA in utero, no increased risk of congenital malformations has been observed. However, experience with IMULDOSA in pregnant women is limited. Therefore, it is preferable to avoid using IMULDOSA during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with IMULDOSA and for at least 15 weeks after stopping treatment with IMULDOSA.
• IMULDOSA can cross the placenta and reach the unborn child. If you received IMULDOSA during pregnancy, your child may have an increased risk of developing infections.
• If you received IMULDOSA during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received IMULDOSA during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use IMULDOSA. You cannot do both.
  Driving and using machines
  IMULDOSA does not affect or has a negligible effect on the ability to drive vehicles and use machinery.
  IMULDOSA contains Polysorbate 80
  IMULDOSA contains 0.04 mg of polysorbate 80 (E433) per single dose, equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. If you have any known allergy, consult your doctor.

3. How to use IMULDOSA

IMULDOSA is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which IMULDOSA is indicated.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up appointments.

How much IMULDOSA is administered

Your doctor will decide how much IMULDOSA you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of IMULDOSA. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of IMULDOSA is administered by your doctor via an intravenous infusion into your arm. After the initial dose, you will receive the next dose of 90 mg of IMULDOSA 8 weeks later, then every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of IMULDOSA may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents from 6 years of age

Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of IMULDOSA to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time each dose is given.
• There is no IMULDOSA formulation available for children weighing less than 60 kg; therefore, if body weight is below 60 kg, other ustekinumab-containing medicines must be used.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of IMULDOSA.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of IMULDOSA.
• After the initial dose, the next dose should be administered 4 weeks later, and then every 12 weeks.

Children weighing at least 40 kg

Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of IMULDOSA is administered by your doctor via intravenous infusion into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of IMULDOSA, followed by subsequent doses every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of IMULDOSA may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How IMULDOSA is administered

IMULDOSA is administered via subcutaneous injection ("subcutaneously").
At the beginning of treatment, medical or nursing staff may administer IMULDOSA to you.

• However, you and your doctor may decide whether you can self-inject IMULDOSA. In this case, you will be taught how to self-inject IMULDOSA.
• For instructions on how to inject IMULDOSA, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more IMULDOSA than you should

If you have used or received too much IMULDOSA, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use IMULDOSA

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using IMULDOSA

It is not dangerous to stop using IMULDOSA. However, if you stop treatment, your symptoms may return.

If you have any further questions 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.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek immediate medical assistance if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking IMULDOSA (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure, which may cause dizziness or lightheadedness, or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use IMULDOSA again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

IMULDOSA may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including those causing tuberculosis), or parasites, including infections that primarily occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be alert for signs of infection while using IMULDOSA. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop IMULDOSA until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

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

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small, yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain).

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

5. How to store IMULDOSA

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of IMULDOSA may also be stored at room temperature up to 30°C for a single period of maximum 30 days, while remaining in the outer packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date when it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of IMULDOSA. Vigorous and prolonged shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after "Exp". The expiry date refers to the last day of that month.
• If the solution changes colour, becomes cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of IMULDOSA and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously.

IMULDOSA is for single use only. Any unused product remaining in the syringe must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What IMULDOSA contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of IMULDOSA and contents of the pack
IMULDOSA is a solution for injection, from colourless to slightly yellow and clear to slightly opalescent. It is supplied in a cardboard pack containing one single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains a dose of 90 mg ustekinumab in 1 mL of solution for injection.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll De Barcelona, s/n
Edifici Est, 6a Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200, Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64

EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

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

Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide that you can self-inject IMULDOSA. In this case, you will be taught how to self-administer IMULDOSA. Inform your doctor if you have any questions regarding self-injection.

• Do not mix IMULDOSA with other injectable liquids.
• Do not shake the pre-filled syringes of IMULDOSA, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe

Figure 1

1. Check the number of prefilled syringes and prepare materials

Prepare for the use of prefilled syringes.

• Remove the prefilled syringe or multiple prefilled syringes from the refrigerator. Leave the prefilled syringe outside the carton for about 30 minutes. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the prefilled syringe by its barrel with the covered needle pointing upwards.
• Do not hold the syringe by the plunger head, plunger rod, needle safety wing, or needle protective cap.
• Under no circumstances should the plunger be pulled back.
• Do not remove the needle cap from the prefilled syringe until it is needed.
• Do not touch the safety activation clip to prevent premature covering of the needle by the needle safety wing.

Inspect the prefilled syringe to ensure that:

• the number of prefilled syringes and the dose are correct; if your dose is 90 mg, you will use one prefilled syringe containing 90 mg of IMULDOSA
• the medicine is the correct one
• the medicine has not expired
• the prefilled syringe is not damaged
• the solution in the prefilled syringe is colorless to slightly yellow and clear to slightly opalescent
• the liquid in the prefilled syringe does not have a changed or cloudy color and does not contain foreign particles
• the solution in the prefilled syringe is not frozen

Gather all necessary supplies and place them on a clean surface. Supplies should include antiseptic wipes, a cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• IMULDOSA is administered by injection under the skin (subcutaneously).
• A suitable place for the injection is the upper part of the thigh or around the abdomen (abdominal area), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you during the injection, the upper arm may also be used as an injection site.

*The grey areas indicate the recommended injection sites.
Figure 2
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the skin at the intended injection site with an antiseptic swab.
• Do not touch this area again before administering the injection.

3. Remove the needle protective cap (see Figure 3)

• The needle protective cap must not be removed until you are ready to inject the dose.
• Take the pre-filled syringe and hold it by the barrel with one hand.
• Remove and discard the needle protective cap. Do not touch the plunger during this step.

Figure 3

• If you notice an air bubble in the pre-filled syringe or a drop of liquid at the needle tip, this is normal. Do not remove them.
• Do not touch the needle and avoid letting the needle touch any surface.
• Do not use the pre-filled syringe if it is removed without the needle protective cap in place. If this happens, consult your doctor or pharmacist.
• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose

• Hold the pre-filled syringe in one hand between the middle finger and index finger, placing the thumb on the plunger head. With the other hand, gently pinch the cleaned area of skin between the thumb and index finger. Do not pinch too tightly.
• Do not pull back the plunger in any way.
• With one quick, smooth motion, insert the needle into the skin as far as possible (see Figure 4).

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely within the needle guard wings (see Figure 5).

WINGS
OF
NEEDLE
GUARD

Figure 5

• Push the plunger until it reaches the end of its travel and continue to keep pressure on the plunger head while removing the needle and gently releasing the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty syringe to rise upward, so that the needle is completely covered by the needle guard wings, as shown in Figure 7.

Figure 7

5. After the injection

• Press a swab of antiseptic on the injection site for a few seconds after the injection.
• You may see slight bleeding at the injection site. This is normal.
• You may press a cotton ball or gauze on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if necessary.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your health and safety and for the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be discarded in regular waste.

Figure 8