ABSIMKY 45 mg Roztwór Do Wstrzykiwań W Wstępnie Napełnionej Strzykawce

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1. ABSIMKY 130 mg concentrate for solution for infusion
   1. What is ABSIMKY and what is it used for
   2. What you need to know before you use ABSIMKY
   3. How ABSIMKY will be used
   4. Possible side effects
   5. How to store ABSIMKY
   6. Package Contents and Other Information
2. ABSIMKY 45 mg injectable solution in pre-filled syringe
   1. What is ABSIMKY and what is it used for
   2. What you need to know before using ABSIMKY
   3. How to use ABSIMKY
   4. Possible side effects
   5. How to store ABSIMKY
   6. Package Contents and Other Information
   7. Check the number of prefilled syringes and prepare the materials
   8. Choose the injection site and prepare it
   9. Remove the protective cap from the needle (see Figure 3):
   10. Inject the dose:
   11. After the injection
   12. Disposal
3. ABSIMKY 90 mg injectable solution in pre-filled syringe
   1. What is ABSIMKY and what is it used for
   2. What you need to know before using ABSIMKY
   3. How to use ABSIMKY
   4. Possible side effects
   5. How to store ABSIMKY
   6. FURTHER INFORMATION
   7. Check the number of pre-filled syringes and prepare the materials
   8. Choose the injection site and prepare it
   9. Remove the protective cap from the needle (see Figure 3)
   10. Inject the dose
   11. After the injection
   12. Disposal

ABSIMKY 130 mg concentrate for solution for infusion

ustekinumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.
This leaflet is written for people who are taking 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is ABSIMKY and what is it used for

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

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

• moderate to severe Crohn’s disease in adults;
• moderate to severe ulcerative colitis in adults.

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

Ulcerative Colitis
Ulcerative colitis is an inflammatory bowel disease. If you suffer from ulcerative colitis, you will be treated
first with other medicines. If you do not respond well enough or are intolerant to these medicines,
you may be given ABSIMKY to reduce the signs and symptoms of your disease.

2. What you need to know before you use ABSIMKY

Do not use ABSIMKY

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

If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using ABSIMKY.

Warnings and precautions
Talk to your doctor or pharmacist before using ABSIMKY. Your doctor will check your health before starting treatment. Make sure to tell your doctor about any medical conditions you have before each treatment. Also, tell 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 giving you ABSIMKY. If your doctor thinks you are at risk of tuberculosis, they may give you medicines to treat it.

Be aware of serious side effects
ABSIMKY can cause serious side effects, including allergic reactions and infections. You should be aware of certain signs of illness while taking ABSIMKY. See “Serious side effects” in section 4 for a complete list of these side effects.

Contact your doctor before using ABSIMKY

• If you have ever had an allergic reaction to ABSIMKY. Ask your doctor if you are not sure.
• If you have ever had any type of cancer - this is because immunosuppressants like ABSIMKY weaken the immune system to some extent. This can increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicinal product derived from a biological source and usually given by injection) - the risk of cancer may be higher.
• If you have or have had a recent infection or if you have abnormal openings in your 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 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 can also reduce the activity of the immune system to some extent. The simultaneous use of these therapies with ABSIMKY has not been studied. However, it is possible that 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 ABSIMKY can have an effect on them.
• If you are 65 years of age or older - you may have a greater chance of getting infections.

If you are not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before undergoing treatment with ABSIMKY.
During treatment with ustekinumab, some patients have developed reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly check your risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of your body, facial drooping, or abnormalities in speech or vision.

Children and adolescents
ABSIMKY is not recommended for the treatment of children under the age of 18 years with Crohn’s disease or ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and ABSIMKY
Tell 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 about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using ABSIMKY.
• if you received ABSIMKY during pregnancy, tell your child’s pediatrician about the ABSIMKY treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received ABSIMKY during pregnancy, live vaccines are not recommended for your child in the first twelve months after birth, unless your child’s pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• No increased risk of birth defects has been observed in newborns exposed to ABSIMKY in the womb. However, there is limited experience with ABSIMKY in pregnant women. Therefore, it is preferable to avoid the use of ABSIMKY during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during use of ABSIMKY and for at least 15 weeks after stopping treatment with ABSIMKY.
• Ustekinumab can cross the placenta to the unborn child. If you received ABSIMKY during pregnancy, your child may have an increased risk of infection.
• If you received ABSIMKY during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received ABSIMKY during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first twelve months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab can be excreted in small amounts in breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use ABSIMKY. You cannot do both.

Driving and using machines
ABSIMKY does not impair or negligibly impairs the ability to drive and operate machines.

ABSIMKY contains polysorbate
ABSIMKY contains 11.1 mg of polysorbate 80 in each unit volume, equivalent to 10.4 mg per 130 mg dose.
Polysorbates can cause allergic reactions. If you have any known allergies, consult your doctor.

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

3. How ABSIMKY will be used

ABSIMKY is intended for use under the guidance and supervision of a physician experienced in the
diagnosis and treatment of Crohn's disease or ulcerative colitis.
ABSIMKY 130 mg concentrate for solution for infusion will be administered to you by the physician,
through an intravenous drip in the arm vein (intravenous infusion) for at least one hour. Discuss with the
physician when you will need to undergo the injections and subsequent follow-up visits.

How much ABSIMKY is administered
The physician will decide how much ABSIMKY you need and for how long.

Adults starting from 18years

• The physician 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 take the next dose of 90 mg ABSIMKY with an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks.

How ABSIMKY is administered

• The first dose of ABSIMKY for the treatment of Crohn's disease or ulcerative colitis is administered by the physician through an intravenous drip in a vein in your arm (intravenous infusion).

Inform the physician if you have any questions about the use of ABSIMKY.

If you forget to use ABSIMKY
If you forget or miss the appointment for administering the dose, contact the physician to
schedule a new appointment.

If you stop taking ABSIMKY
It is not dangerous to stop using ABSIMKY. However, if you stop treatment, the
symptoms may reappear.
If you have further questions about the use of this medicine, ask your physician 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 urgent medical attention if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ABSIMKY (affecting up to 1 in 1,000 patients). Signs include:

o difficulty breathing or swallowing
o low blood pressure, which can cause dizziness or lightheadedness
o 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 or ulcerative colitis,
the first dose of ABSIMKY is administered through an intravenous drip (intravenous infusion).
Some patients have experienced severe allergic reactions during the infusion.

In rare cases, allergic lung reactions and lung inflammation have been reported in patients
receiving ustekinumab. Immediately inform your doctor 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
ABSIMKY again.

Infections – these may require urgent treatment, so contact your doctor immediately if you
notice any of the following signs.

• Nasal and throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (can affect up to 1 in 100 patients)
• Inflammation of the subcutaneous tissue (‘cellulitis’) is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful skin rash with blisters) is uncommon (affects up to 1 in 100 patients).

ABSIMKY may decrease your ability to fight infections. Some infections may become serious and
may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites,
including infections that occur primarily 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 attentive to signs of infection while using ABSIMKY. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warm, red and painful skin, or a painful, blistering rash
• burning when urinating
• diarrhea
• visual disturbance or loss of vision
• headache, stiff neck, sensitivity to light, nausea or confusion

Immediately inform your doctor if you notice any of these signs of infection. These may be signs
of infection such as chest infections, skin infections, herpes zoster or opportunistic infections that
can have serious complications. See your doctor if you have any type of infection that persists or
continues to recur. Your doctor may decide to stop ABSIMKY until the infection resolves. Also
inform your doctor if you have any cuts or open wounds that may 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, you should inform your doctor immediately.

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

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• 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 infection
• 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 bumps, 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 can lead to a skin 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 with possible redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised and scaly rash on areas of skin exposed to the sun, sometimes with joint pain).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 ABSIMKY

• ABSIMKY 130 mg concentrate for solution for infusion is administered in hospital or clinic 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 the outer packaging to protect the medicine from light.
• Do not shake the vials of ABSIMKY. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date that is stated on the label and the carton after “Exp.”. The expiry date refers to the last day of that month.
• If the liquid has a change in colour, is cloudy or if you see foreign particles floating (see section 6 “Description of ABSIMKY and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (for example, accidentally frozen or heated).
• If the product has been shaken vigorously.
• If the seal is broken.

ABSIMKY is for single use. Any unused diluted solution for infusion remaining in the vial and the
syringe must be disposed of in accordance with local regulations.

6. Package Contents and Other Information

What ABSIMKY contains

• The active ingredient is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: Disodium edetate dihydrate (E385), L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80 (E433), Sucrose, Water for injections.

Description of ABSIMKY and package contents
ABSIMKY is a solution for infusion ranging from colorless to slightly yellow and from clear to slightly
opalescent. It is supplied in a carton containing 1 single-dose vial of glass with a volume of
30 mL. Each vial contains 130 mg of ustekinumab in 26 mL of concentrate for solution for
infusion.

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,
Netherlands
For further information on 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.
Τηλ: +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 for healthcare professionals only.
Traceability:
In order to improve the traceability of biological medicines, the trade name and batch number
of the administered product must be clearly recorded.
Dilution instructions:
ABSIMKY concentrate for solution for infusion must be diluted, prepared and infused by a
healthcare professional using aseptic technique.

• 1. Calculate the dose and the number of ABSIMKY vials needed based on the patient's weight (see section 3, Table 1). Each 26 mL vial of ABSIMKY contains 130 mg of ustekinumab.
• 2. Withdraw and discard a volume of sodium chloride 0.9% solution (0.9%) from the 250 mL infusion bag equal to the volume of ABSIMKY to be added (discard 26 mL of sodium chloride for each ABSIMKY vial needed, for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
• 3. Withdraw 26 mL of ABSIMKY from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Mix gently.
• 4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, color change 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 only one sterile, non-pyrogenic, low protein-binding infusion set with an in-line filter (pore size 0.2 micrometers).
• 7. Each vial is for single use and unused medicinal product must be disposed of in accordance with current local regulations.

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

ABSIMKY 45 mg injectable solution in pre-filled syringe

ustekinumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.
This leaflet is written for people who are taking this medicine. If you are the parent or
carer of a child to whom ABSIMKY needs to be administered, read
these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• 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 they have the same symptoms as you, as it may be harmful.
• 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 ABSIMKY is and what it is used for
• 2. What you need to know before you use ABSIMKY
• 3. How to use ABSIMKY
• 4. Possible side effects
• 5. How to store ABSIMKY
• 6. Contents of the pack and other information

1. What is ABSIMKY and what is it used for

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

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

• plaque psoriasis (in adults and children starting from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
ABSIMKY will reduce inflammation and other signs of the disease.
ABSIMKY is used in adults with moderate to severe plaque psoriasis, who cannot use
cyclosporine, methotrexate or phototherapy, or in whom these treatments do not work.

ABSIMKY is used in children and adolescents starting 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 worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis. If you have active psoriatic arthritis you will first be treated with other medicines. If you should
not respond adequately to these medicines, you may take ABSIMKY to:

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

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

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you suffer from ulcerative colitis, you will be treated
first with other medicines. If you do not respond well enough or are intolerant to these medicines,
you may be given ABSIMKY to reduce the signs and symptoms of your disease.

2. What you need to know before using ABSIMKY

Do not use ABSIMKY

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

If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using ABSIMKY.

Warnings and precautions
Talk to your doctor or pharmacist before using ABSIMKY. The doctor will check your health status before each treatment. Make sure to inform the doctor, before each treatment, about any illnesses you have. Also, tell your doctor if you have recently been in contact with people who may have had tuberculosis. The doctor will examine you and perform tests for tuberculosis before giving you ABSIMKY. If the doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

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

Contact your doctor before using ABSIMKY:

• If you have ever had an allergic reaction to ABSIMKY. Ask your doctor if you are unsure.
• If you have ever had any type of cancer- this is because immunosuppressants like ABSIMKY partially weaken the immune system. This can increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicinal productderived from a biological source and usually administered by injection)- the risk of cancer may be higher.
• If you have or have had a recent infection.
• If you have ever had any new or changed lesionwithin the area of psoriasis or on normal skin.

If you are taking 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 the activity of the immune system. The simultaneous use of these therapies with ABSIMKY has not been studied. However, it is possible that 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 ABSIMKY can have an effect on them.
• If you are 65 years of age or older- you may have a greater likelihood of contracting infections.

If you are not sure if any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before undergoing treatment with ABSIMKY.
During treatment with ustekinumab, some patients have developed reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, and scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. The doctor will regularly check your risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or abnormalities in speech or vision.

Children and adolescents
ABSIMKY is not recommended for the treatment of children with psoriasis under the age of 6, or for the treatment of children under the age of 18 with psoriatic arthritis, Crohn's disease or ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and ABSIMKY
Tell 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 about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using ABSIMKY.
• if you received ABSIMKY during pregnancy, inform your child's pediatrician about the ABSIMKY treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received ABSIMKY during pregnancy, live vaccines are not recommended for your child in the first twelve months after birth, unless your child's pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• No increased risk of birth defects has been observed in newborns exposed to ABSIMKY in the womb. However, there is limited experience with ABSIMKY in pregnant women. Therefore, it is preferable to avoid the use of ABSIMKY during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during use of ABSIMKY and for at least 15 weeks after stopping treatment with ABSIMKY.
• Ustekinumab can reach the unborn child through the placenta. If you have received ABSIMKY during pregnancy, your child may have an increased risk of contracting an infection.
• If you received ABSIMKY during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received ABSIMKY during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first twelve months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab can be excreted in small amounts in breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use ABSIMKY. You cannot do both.

Driving and using machines
ABSIMKY does not alter or negligibly alters the ability to drive vehicles and use machines.

ABSIMKY contains polysorbate
ABSIMKY contains 0.02 mg of polysorbate 80 in each unit volume, equivalent to 0.02 mg per 45 mg dose.
Polysorbate can cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use ABSIMKY

ABSIMKY is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which ABSIMKY is indicated.
Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor. Discuss with your doctor when you will need to undergo the injections and subsequent check-up
visits.

How much ABSIMKY is administered
Your doctor will decide how much ABSIMKY you need and for how long.

Adults starting from 18 years of age
Psoriasis and psoriatic arthritis

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

Crohn's disease or ulcerative colitis

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

Children and adolescents starting from 6 years of age
Psoriasis

• The doctor will calculate the correct dose, including the amount (volume) of ABSIMKY that must be injected to ensure the administration of the correct dose. The correct dose will depend on the child's body weight at the time of each dose administration.
• There is no ABSIMKY formulation for children with a body weight less than 60 kg, therefore if the body weight is less than 60 kg, other medicines containing ustekinumab must be used.
• If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of ABSIMKY.
• If the weight exceeds 100 kg, the recommended dose is 90 mg of ABSIMKY.
• After the initial dose, you will need to receive the next dose after 4 weeks, and subsequently every 12 weeks.

How ABSIMKY is administered

• ABSIMKY is administered by a subcutaneous injection (“by the subcutaneous route”). At the beginning of treatment, medical or nursing staff may inject ABSIMKY for you.
• However, you and your doctor can decide whether you can inject ABSIMKY yourself. In this case, you will be taught how to inject ABSIMKY yourself.
• For instructions on how to inject ABSIMKY, see “Instructions for Use” at

Inform your doctor if you have any questions about the injection to be performed yourself.

If you use more ABSIMKY than you should
If you have used or received too much ABSIMKY, 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 ABSIMKY
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for
the missed dose.

If you stop using ABSIMKY
It is not dangerous to stop using ABSIMKY. However, if you stop treatment, the
symptoms may reappear.
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 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 attention if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ABSIMKY (affecting up to 1 in 1,000 patients). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or lightheadedness o 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 pulmonary inflammation have been reported in patients receiving ustekinumab. Immediately inform your doctor 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 ABSIMKY again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal and 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 subcutaneous tissue (‘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).

ABSIMKY may decrease your ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur primarily 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 attentive to signs of infection while using ABSIMKY. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warm, red, and painful skin, or a painful blistering rash
• burning when urinating
• diarrhea
• blurred vision or loss of vision
• headache, stiff neck, sensitivity to light, nausea, or confusion

Immediately inform your doctor 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 that can have serious complications. See your doctor if you have any type of infection that persists or keeps recurring. Your doctor may decide to stop ABSIMKY until the infection resolves. Also, inform your doctor if you have any cuts or open wounds that may 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, you should immediately inform your doctor.
Other side effects
Common side effects(affecting up to 1 in 10 patients)

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

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

• Dental infection
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle relaxation 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(affecting 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 can lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

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

• Blistering skin formation with possible redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, and scaly rash on areas of skin exposed to the sun, sometimes with joint pain).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your 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 ABSIMKY

• Keep this medicine out of the sight and reach of children.
• 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.
• If necessary, individual pre-filled syringes of ABSIMKY can also be stored at room temperature up to 30°C for a single period of a maximum of 30 days in the original packaging in order to protect them from light. Record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date on which it should be discarded in the spaces provided 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 is earlier.
• Do not shake the pre-filled syringes of ABSIMKY. Vigorous prolonged shaking may damage the medicine.

Do not use this medicine

• After the expiry date that is stated on the label and the packaging after “Exp.”. The expiry date refers to the last day of that month.
• If the liquid has a change in colour, is cloudy or if you see foreign particles floating (see section 6 “Description of ABSIMKY 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.

ABSIMKY is for single use. Any unused product remaining in 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 ABSIMKY 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 hydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of ABSIMKY and package contents
ABSIMKY is a solution from colourless to slightly yellow and from clear to slightly opalescent. It is
supplied in a carton containing 1 single dose, in a 1 mL glass pre-filled syringe.
Each pre-filled syringe contains a dose of ustekinumab 45 mg 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,
Netherlands
For further information on 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.
Τηλ: +30 210 74 88 821
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu /.

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

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

Figure 1 shows the appearance of the pre-filled syringe
SPRING OF THE
SAFETY
DEVICE

NEEDLE
PROTECTION
WINGS
PROTECTIVE
CAP
NEEDLE BODY
LABEL
PLUNGER HEAD
NEEDLE
EXTENDED
FLANGES FOR
FINGERS
PLUNGER
SHIELD ACTIVATION
CLIP
Figure 1

1. Check the number of prefilled syringes and prepare the materials

Prepare for the use of the prefilled syringes

• Remove the prefilled syringe or prefilled syringes from the refrigerator. Leave the prefilled syringe out of the refrigerator for about half an hour. This will allow the liquid to reach a comfortable temperature for injection (room temperature). Do not remove the needle protective cap while waiting to reach room temperature
• Hold the prefilled syringe by the body of the syringe with the covered needle pointing upwards
• Do not hold by the plunger head, the plunger, the needle protection wings or the needle protective cap
• Do not pull back the plunger under any circumstances
• Do not remove the needle cap from the prefilled syringe until it is necessary
• Do not touch the activation clips of the protection to prevent premature covering of the needle with the needle protection wing.

Check the prefilled syringe to make sure that:

• the number of prefilled syringes and the dose are correct or if your dose is 45 mg you will take one prefilled syringe of 45 mg of ABSIMKY or if your dose is 90 mg you will take two prefilled syringes of 45 mg of ABSIMKY and you will need to perform two injections. Choose two different body sites for these injections (e.g., one injection on the right thigh and the other injection on the left thigh), and proceed with the injections one after the other.
• the medicine is the correct one
• the medicine has not expired
• the prefilled syringe is not damaged
• the solution in the prefilled syringe is from colorless to slightly yellow and from clear to slightly opalescent
• the liquid in the prefilled syringe does not have an altered or opaque color and that it does not contain foreign particles
• the solution in the prefilled syringe is not frozen.

Take everything you need and place it on a clean surface. There should be antiseptic wipes, a
cotton ball or gauze and a sharps container.

2. Choose the injection site and prepare it

Choose a site for the injection (see Figure 2).

• ABSIMKY is administered by injection under the skin (subcutaneously).
• A good place for the injection is the upper thigh or around the abdomen (belly) at least 5 cm away from the navel.
• If possible, do not choose areas of skin with signs of psoriasis.
• If someone assists you during the injection, they can also choose the upper arms as the injection site.

*The gray areas are the recommended injection sites.
Figure 2
Prepare the injection site

• Wash your hands very well with soap and warm water.
• Rub the skin where you plan to give the injection with an antiseptic wipe.
• Do not touch this area again before giving the injection.

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

• The protective cap of the needle must notbe removed until you are ready to inject the dose
• Take the prefilled syringe, hold the syringe by its body with one hand
• Remove the protective cap from the needle and discard it. Do not touch the plunger while performing this operation.

Figure 3

• If you should notice an air bubble in the prefilled syringe or a drop of liquid on the needle tip, this is normal. They should not be removed.
• Do not touch the needle, nor allow the needle to touch any surface
• Do not use the prefilled syringe if it is drawn without the protective cap of the needle in place. If this should happen, contact your doctor or pharmacist
• Inject the contents immediately after removing the protective cap from the needle.

4. Inject the dose:

• Hold the pre-filled syringe in one hand between your middle finger and index finger and place your thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin portion holding it between your thumb and index finger. Do not squeeze too hard
• Do not pull back the plunger under any circumstances
• With one quick movement, insert the needle into the skin until it is as far as it will go (see Figure 4)

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely between the needle protection wings (see Figure 5)

NEEDLE
PROTECTION
WINGS

Figure 5

• Push the plunger to the end of its travel and continue to hold the plunger head pressed down, while withdrawing 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 upwards and the needle to be completely covered by the protection wings, 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 can 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 can cover the injection site with a small bandage 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 syringes. Dispose of the sharps container in accordance with local regulations.
• Antiseptic swabs and other devices can be disposed of in the trash.

Figure 8

ABSIMKY 90 mg injectable solution in pre-filled syringe

ustekinumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.
This leaflet is written for people who are taking this medicine. If you are the parent or
the person caring for a child to whom ABSIMKY needs to be administered, read
these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• 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 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 ABSIMKY is and what it is used for
• 2. What you need to know before you use ABSIMKY
• 3. How to use ABSIMKY
• 4. Possible side effects
• 5. How to store ABSIMKY
• 6. Contents of the pack and other information

1. What is ABSIMKY and what is it used for

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

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

• plaque psoriasis (in adults and children starting from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
ABSIMKY will reduce inflammation and other signs of the disease.
ABSIMKY is used in adults with moderate to severe plaque psoriasis, who cannot use
cyclosporine, methotrexate or phototherapy, or in whom these treatments do not work.
ABSIMKY is used in children and adolescents starting 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 worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis. If you have active psoriatic arthritis you will first be treated with other medicines. If you should
not respond adequately to these medicines, you may take ABSIMKY 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 disease of the intestine. If you have Crohn’s disease you will
be treated first with other medicines. If you do not respond well enough or are intolerant to these
medicines, you may be given ABSIMKY to reduce the signs and symptoms of the disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you suffer from ulcerative colitis, you will be treated
first with other medicines. If you do not respond well enough or are intolerant to these medicines,
you may be given ABSIMKY to reduce the signs and symptoms of your disease.

2. What you need to know before using ABSIMKY

Do not use ABSIMKY

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

If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using ABSIMKY.

Warnings and precautions
Talk to your doctor or pharmacist before using ABSIMKY. Your doctor will check your health status before each treatment. Make sure to tell your doctor about any illnesses you have before each treatment. Also, tell 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 giving you ABSIMKY. If your doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

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

Contact your doctor before using ABSIMKY

• If you have ever had an allergic reaction to ABSIMKY. Ask your doctor if you are not sure.
• If you have ever had any type of cancer- because immunosuppressants like ABSIMKY partially weaken the immune system. This can increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicinal productderived from a biological source and usually administered by injection)- the risk of cancer may be higher.
• If you have or have had a recent infection.
• If you have ever had any new or changed skin lesionwithin 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 can also partially reduce the activity of the immune system. The simultaneous use of these therapies with ABSIMKY has not been studied. However, it is possible that 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 ABSIMKY can have an effect on them.
• If you are 65 years of age or older- you may have a greater likelihood of contracting infections.

If you are not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before undergoing treatment with ABSIMKY.
During treatment with ustekinumab, some patients have developed reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly check your risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of your body, facial drooping, or speech or vision abnormalities.

Children and adolescents
ABSIMKY is not recommended for the treatment of children with psoriasis under the age of 6 years, or for the treatment of children under the age of 18 years with psoriatic arthritis, Crohn's disease or ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and ABSIMKY
Tell 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 about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using ABSIMKY.
• if you received ABSIMKY during pregnancy, inform your child's pediatrician about the ABSIMKY treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received ABSIMKY during pregnancy, live vaccines are not recommended for your child in the first twelve months after birth, unless your child's pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• No increased risk of birth defects has been observed in newborns exposed to ABSIMKY in the womb. However, there is limited experience with ABSIMKY in pregnant women. Therefore, it is preferable to avoid the use of ABSIMKY during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during the use of ABSIMKY and for at least 15 weeks after stopping treatment with ABSIMKY.
• Ustekinumab can reach the unborn child through the placenta. If you have received ABSIMKY during pregnancy, your child may have an increased risk of contracting an infection.
• If you received ABSIMKY during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received ABSIMKY during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first twelve months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab may be excreted in small amounts in breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use ABSIMKY. You cannot do both.

Driving and using machines
ABSIMKY does not impair or negligibly impairs the ability to drive vehicles and operate machines.

ABSIMKY contains polysorbate
ABSIMKY contains 0.05 mg of polysorbate 80 in each unit volume, equivalent to 0.04 mg per 90 mg dose.
Polysorbate can cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use ABSIMKY

ABSIMKY is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which ABSIMKY is indicated.
Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor. Discuss with your doctor when you will need to undergo the injections and subsequent check-up visits.

How much ABSIMKY is administered
The doctor will decide how much ABSIMKY you need and for how long.

Adults starting from 18 years of age
Psoriasis and psoriatic arthritis

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

Crohn's disease or ulcerative colitis

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

Children and adolescents starting from 6 years of age
Psoriasis

• The doctor will calculate the correct dose, including the amount (volume) of ABSIMKY that must be injected to ensure the administration of the correct dose. The correct dose will depend on the child's body weight at the time of each dose.
• There is no ABSIMKY formulation for children with a body weight less than 60 kg, therefore if the body weight is less than 60 kg, other medicines containing ustekinumab must be used.
• If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of ABSIMKY.
• If the weight exceeds 100 kg, the recommended dose is 90 mg of ABSIMKY.
• After the initial dose, you will need to receive the next dose after 4 weeks, and subsequently every 12 weeks.

How ABSIMKY is administered

• ABSIMKY is administered by a subcutaneous injection (“by the subcutaneous route”). At the beginning of treatment, medical or nursing staff may inject ABSIMKY for you.
• However, you and your doctor can decide whether you can inject ABSIMKY yourself. In this case, you will be taught how to inject ABSIMKY yourself.
• For instructions on how to inject ABSIMKY, see “Instructions for Use” at

Inform your doctor if you have any questions about the injection to be performed yourself.

If you use more ABSIMKY than you should
If you have used or received too much ABSIMKY, 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 ABSIMKY
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for
the missed dose.

If you stop using ABSIMKY
It is not dangerous to stop using ABSIMKY. However, if you stop treatment, the
symptoms may reappear.
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 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 urgent medical attention if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ABSIMKY (affecting up to 1 in 1,000 patients). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or lightheadedness o 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 pulmonary inflammation have been reported in patients receiving ustekinumab. Tell 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 ABSIMKY again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal and 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 subcutaneous tissue (‘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).

ABSIMKY may decrease your ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur primarily 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 attentive to signs of infection while using ABSIMKY. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warm, red, and painful skin, or a painful blistering rash
• burning when urinating
• diarrhea
• blurred vision or loss of vision
• headache, stiff neck, sensitivity to light, nausea, or confusion

Tell 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 that can have serious complications. See your doctor if you have any type of infection that persists or keeps recurring. Your doctor may decide to stop ABSIMKY until the infection resolves. Also, tell your doctor if you have any cuts or open wounds that may 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, you should tell your doctor immediately.
Other side effects
Common side effects(affecting up to 1 in 10 patients)

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

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

• Dental infection
• 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 (shedding of the skin)
• Acne

Rare side effects(affecting 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 can lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 ABSIMKY

• Keep this medicine out of the sight and reach of children.
• 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.
• If necessary, individual pre-filled syringes of ABSIMKY can also be stored at room temperature up to 30°C for a single period of a maximum of 30 days, in the outer packaging in order to protect them from light. Record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date on which it should be discarded in the spaces provided 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 is earlier.
• Do not shake the pre-filled syringes of ABSIMKY. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date that is stated on the label and the carton after “Exp”. The expiry date refers to the last day of that month.
• If the liquid has a change in colour, is cloudy or if you see foreign particles floating (see section 6 “Description of ABSIMKY 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.

ABSIMKY is for single use. The unused product remaining in 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. FURTHER INFORMATION

What ABSIMKY 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 hydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of ABSIMKY and contents of the pack
ABSIMKY is a solution 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 ustekinumab 90 mg 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,
Netherlands
For further information on 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.
Τηλ: +30 210 74 88 821
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu /.

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

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

Figure 1 shows the appearance of the pre-filled syringe
SPRING OF THE
SAFETY
DEVICE

NEEDLE
PROTECTION
WINGS
PROTECTIVE
CAP
NEEDLE BODY
LABEL
PLUNGER HEAD
PLUNGER
ACTIVATION
CLIP OF THE
NEEDLE PROTECTION
Figure 1

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

Prepare for the use of the pre-filled syringes.

• Remove the pre-filled syringe or pre-filled syringes from the refrigerator. Leave the pre-filled syringe out of its packaging for about half an hour. This will allow the liquid to reach a comfortable temperature for injection (room temperature). Do not remove the needle protective cap while waiting to reach room temperature.
• Hold the pre-filled syringe by its body with the covered needle pointing upwards.
• Do not hold by the plunger head, the plunger, the needle shield or the needle protective cap.
• Do not pull back the plunger under any circumstances.
• Do not remove the needle cap from the pre-filled syringe until necessary.
• Do not touch the activation clip of the protection to prevent premature covering of the needle with the needle shield.

Check the pre-filled syringe to ensure that:

• the number of pre-filled syringes and the dose are correct or if your dose is 90 mg you will take one 90 mg pre-filled syringe of ABSIMKY
• 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 from colorless to slightly yellow and from clear to slightly opalescent

• the liquid in the pre-filled syringe does not have an altered or cloudy color and that it does not contain foreign particles
• the solution in the pre-filled syringe is not frozen

Take everything you need and place it on a clean surface. There should be antiseptic wipes, a
cotton ball or gauze and a sharps container.

2. Choose the injection site and prepare it

Choose a site for the injection (see Figure 2).

• ABSIMKY is administered by injection under the skin (subcutaneously).
• A good place for the injection is the upper thigh or around the abdomen (belly) at least 5 cm away from the navel.
• If possible, do not choose areas of skin with signs of psoriasis.
• If someone assists you during the injection, they can also choose the upper arms as the injection site.

*The grey areas are the recommended sites for the injection.
Figure 2
Prepare the injection site

• Wash your hands very well with soap and warm water.
• Rub the skin where you plan to give the injection with an antiseptic wipe.
• Do not touch this area again before giving the injection.

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

• The protective cap of the needle must notbe removed until you are ready to inject the dose.
• Take the pre-filled syringe, hold the syringe by its body with one hand.
• Remove the protective cap from the needle and discard it. Do not touch the plunger while performing this operation.

Figure 3

• If you should notice an air bubble in the pre-filled syringe or a drop of liquid on the needle tip, this is normal. They should not be removed.
• Do not touch the needle and avoid allowing the needle to touch any surface
• Do not use the pre-filled syringe if it is pulled out without the protective cap of the needle in place. If this should happen, contact your doctor or pharmacist.
• Inject the contents immediately after removing the protective cap from the needle.

4. Inject the dose

• Hold the pre-filled syringe in one hand between your middle and index fingers and place your thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin area between your thumb and index finger. Do not pinch too forcefully.
• Do not pull back on the plunger in any way.
• With one quick motion, insert the needle into the skin until it is as far as it will go (see Figure 4).

Figure 4

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

NEEDLE
GUARD
WINGS

Figure 5

• Push the plunger all the way to the end of its travel and continue to hold the plunger head pressed while you withdraw the needle and gently release the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty syringe to rise upwards and the needle to be completely covered by the guard wings, 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 can 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 can cover the injection site with a small bandage 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 the safety of others, never reuse the syringe. Dispose of the sharps container in accordance with local regulations.
• Antiseptic swabs and other devices can be disposed of in the trash.

Figure 8