Pyczchiva: detailed information

Package leaflet: Information for the user

Pyzchiva 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 side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This leaflet has been 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pyzchiva is and what it is used for
What you need to know before using Pyzchiva
How Pyzchiva will be used
Possible side effects
How to store Pyzchiva
Contents of the pack and other information

1. What Pyzchiva is and what it is used for

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

What Pyzchiva is used for
Pyzchiva 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, Pyzchiva may be given to you to reduce the signs and symptoms of your disease.

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below)
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, speak with your doctor or pharmacist before using Pyzchiva.
Warnings and precautions
Talk to your doctor or pharmacist before using Pyzchiva. Your doctor will assess your health status before starting treatment. Make sure to inform your doctor about any medical conditions 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 Pyzchiva. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Pyzchiva can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Pyzchiva. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Pyzchiva, contact your doctor

If you have ever had an allergic reaction to ustekinumab – ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants like ustekinumab 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 concurrent use of these therapies with ustekinumab has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.
If you are currently using or have ever used injections for allergy treatment – it is not known whether ustekinumab may affect these.
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, speak with your doctor or pharmacist before starting treatment with Pyzchiva.
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
Ustekinumab 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 Pyzchiva
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 due to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Pyzchiva.
if you received Pyzchiva during pregnancy, inform your child’s paediatrician about the treatment with Pyzchiva before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Pyzchiva during pregnancy, live vaccines are not recommended for your child during the first twelve months of life, unless otherwise advised by your child’s paediatrician.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
No increased risk of congenital malformations has been observed in newborns exposed to ustekinumab in utero. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab 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 ustekinumab and for at least 15 weeks after stopping treatment with ustekinumab.
Ustekinumab can cross the placenta and reach the unborn child. If you received Pyzchiva during pregnancy, your child may have an increased risk of developing infections.
If you received Pyzchiva during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Pyzchiva 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 ustekinumab. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has negligible effect on the ability to drive or use machinery.
Pyzchiva contains sodium
Pyzchiva contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
However, before Pyzchiva is administered, it is mixed with a solution containing sodium. Speak with your doctor if you are on a low-salt diet.
Pyzchiva contains polysorbate 80 (E433)
This medicine contains 10.4 mg of polysorbate 80 (E433) per vial (30 mL), equivalent to 10.4 mg/26 mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Pyzchiva will be used

Pyzchiva is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn's disease.
Your doctor will administer Pyzchiva 130 mg concentrate for solution for infusion to you via a 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 Pyzchiva is administered
Your doctor will decide how much Pyzchiva you need and for how long.

Adults from 18 years of age

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

Body weight Dose
≤ 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 Pyzchiva as an injection under the skin (subcutaneous injection), followed by subsequent doses every 12 weeks.

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 Pyzchiva as an injection under the skin (subcutaneous injection), followed by subsequent doses every 12 weeks.

How Pyzchiva is administered

The first dose of Pyzchiva for the treatment of Crohn's disease is administered by your doctor through a drip into a vein in your arm (intravenous infusion). Inform your doctor if you have any questions about the use of Pyzchiva.

If you forget to use Pyzchiva
If you forget or miss your scheduled dose appointment, contact your doctor to arrange a new appointment.

If you stop using Pyzchiva
Stopping ustekinumab is not dangerous. However, if you discontinue treatment, your symptoms may return. If you have any doubts about using this medicine, consult 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 ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
o 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 ustekinumab is given via an intravenous infusion (drip). Some patients have experienced severe allergic reactions during the infusion. Rarely, 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 Pyzchiva 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 painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Ustekinumab may reduce your body’s 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 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 aware of the signs of infection while using ustekinumab. 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
visual disturbances 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 can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop ustekinumab 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 skin 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 cause 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)

Blistering skin rash, possibly with redness, itching, and pain (bullous pemphigoid)
Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes accompanied by 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 Pyzchiva

Pyzchiva 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 the outer packaging to protect the medicine from light.
Do not shake the vials of Pyzchiva. 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 the 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 Pyzchiva and contents of the container”).
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 vigorously shaken.
If the seal is broken.

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

6. Package contents and other information

What Pyzchiva contains

The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
The excipients are: histidine, histidine monohydrochloride monohydrate, methionine, disodium edetate, sucrose, polysorbate 80 (E 433), water for injections.

Description of the appearance of Pyzchiva and package contents
Pyzchiva is a clear concentrate for infusion solution, colourless to pale yellow. It is supplied in
a cardboard pack containing 1 or 3 single-dose 30 mL glass vials, and a multiple pack containing 3 cardboard packs, each with one vial. Each vial
contains 130 mg of ustekinumab in 26 mL of concentrate for infusion solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Samsung Bioepis NL. B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037
България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97
Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890
Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf: +45 63 95 10 00 Tel: +35699644126
Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600
Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000
Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00
España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00
France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60
Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111
Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: + 353 27 50077 Tel: +421 2 48 200 600
Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 81280696 Puh/Tel: +358 10 6133 400
Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000
Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

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

The following information is intended for healthcare professionals only.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly recorded.
Dilution instructions.
Pyzchiva concentrate for infusion solution must be diluted, prepared, and administered by a healthcare professional using aseptic technique.

Calculate the dose and number of Pyzchiva vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL vial of Pyzchiva contains 130 mg of ustekinumab.
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 Pyzchiva to be added (discard 26 mL of sodium chloride for each required Pyzchiva vial; for 2 vials, discard 52 mL; for 3 vials, discard 78 mL; for 4 vials, discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% sodium chloride solution for injection may be used.
Withdraw 26 mL of Pyzchiva from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.
Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration, or foreign particles are observed.
Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within 72 hours of dilution in the infusion bag. If necessary, the diluted infusion solution may be stored at 2 °C to 8 °C for up to 1 month and at room temperature up to 30 °C for an additional 72 hours after removal from refrigeration, including the infusion period.
Use a single, sterile, non-pyrogenic, low-protein-binding in-line filter infusion set (pore size 0.2 micrometres).
Each vial is for single use only, and any unused medicinal product must be disposed of in accordance with local regulations.

Storage
The diluted infusion solution should be stored at room temperature up to 30 °C for a maximum of 72 hours, including the infusion period. If necessary, the diluted infusion solution may be stored at 2 °C to 8 °C for up to 1 month and at room temperature up to 30 °C for an additional 72 hours after removal from refrigeration, including the infusion period. Do not freeze.

Package leaflet: Information for the user

Pyzchiva 45 mg solution for injection

ustekinumab
This medicinal product is subject to additional monitoring. This will allow any new safety information to be rapidly identified. 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 all of 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 a parent or caregiver of a child receiving Pyzchiva, please read this information carefully.

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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pyzchiva is and what it is used for
What you need to know before using Pyzchiva
How to use Pyzchiva
Possible side effects
How to store Pyzchiva
Contents of the pack and other information

1. What Pyzchiva is and what it is used for

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

What Pyzchiva is used for
Pyzchiva 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.

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 Pyzchiva 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, Pyzchiva may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
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 Pyzchiva.
Warnings and precautions
Talk to your doctor or pharmacist before using Pyzchiva. Your doctor will check your health status
before each treatment. Make sure to inform your doctor about any medical conditions you have before
each treatment. Also, 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 Pyzchiva. If your doctor believes you are at risk of tuberculosis, you may be given
medicines to treat tuberculosis.
Be aware of serious side effects
Pyzchiva can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Pyzchiva. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Pyzchiva, contact your doctor

If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants like ustekinumab 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 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 partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been

studied. However, it could potentially increase the likelihood of conditions related to immune system weakening.

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

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) should not be administered while you are using Pyzchiva.
if you received Pyzchiva during pregnancy, inform the paediatrician of your child about the Pyzchiva treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Pyzchiva 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 ustekinumab in utero, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab 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 ustekinumab and for at least 15 weeks after stopping treatment with ustekinumab.
Pyzchiva can cross the placenta and reach the unborn child. If you received Pyzchiva during pregnancy, your baby may have an increased risk of developing an infection.
If you received Pyzchiva during pregnancy, it is important to inform your paediatrician and other healthcare providers before your child receives any vaccine. If you received Pyzchiva 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 child’s 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 ustekinumab. You cannot do both.
Driving and using machines
Ustekinumab does not affect, or has a negligible effect on, the ability to drive vehicles or operate
machinery.
Pyzchiva contains polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E433) per vial (2 mL), equivalent to 0.02 mg/0.5 mL.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Pyzchiva

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

Adults from 18 years of age
Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Pyzchiva. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
Four weeks after the initial dose, you will receive the next dose, followed by administration 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 Pyzchiva is administered by your doctor as an intravenous infusion (IV infusion) into a vein in the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Pyzchiva, followed by subcutaneous injections (under the skin) every 12 weeks.
In some patients, after the first subcutaneous injection, the 90 mg dose of Pyzchiva may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

Your doctor will calculate the correct dose, including the amount (volume) of Pyzchiva 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.
If body weight is below 60 kg, the recommended dose is 0.75 mg of Pyzchiva per kg of body weight.
If body weight is between 60 and 100 kg, the recommended dose is 45 mg of Pyzchiva.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Pyzchiva.
Four weeks after the initial dose, the next dose should be administered, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

During treatment, the first dose of approximately 6 mg/kg of Pyzchiva is administered by your doctor as an intravenous infusion (IV infusion) into a vein in the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Pyzchiva, followed by subcutaneous injections (under the skin) every 12 weeks.
In some patients, after the first subcutaneous injection, the 90 mg dose of Pyzchiva may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

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

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

If you forget to use Pyzchiva
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 Pyzchiva
Stopping ustekinumab is not dangerous. However, if you stop treatment, symptoms may return. If you have any questions about using this medicine, consult 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 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 ustekinumab (affect up to 1 in 1,000 patients). Signs include:
o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or swelling of the face, lips, mouth or throat.
Common signs of an allergic reaction include rash and hives (affect up to 1 in 100 patients).

Allergic lung reactions and lung inflammation have been reported rarely 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 no longer use Pyzchiva.

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 (affect 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 painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Ustekinumab may reduce your body's 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 occur mainly 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 the signs of infection while using ustekinumab. 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

Other side effects

Common side effects (may affect up to 1 in 10 people)

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 (may affect up to 1 in 100 people)

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

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 cause a rash with small red or purple bumps, fever or joint pain (vasculitis)

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

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 get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Pyzchiva

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 Pyzchiva vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

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

Pyzchiva 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 required. This will help protect the environment.

6. Package contents and other information

What Pyzchiva contains

The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
The other components are: histidine, monohydrochloride monohydrate histidine, polysorbate 80 (E 433), sucrose, water for injections.

Description of the appearance of Pyzchiva and contents of the pack
Pyzchiva is a clear solution for injection, colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing one single dose in a 2 mL glass vial. Each vial contains 45 mg of ustekinumab in 0.5 mL of solution for injection.

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

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Deutschland
Hexal AG
Tel: +49 8024 908 0

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

France
Sandoz SAS
Tél: +33 1 49 64 48 00

Hrvatska
Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111

Ireland
Rowex Ltd.
Tel: +353 27 50077

Italia
Sandoz S.p.A.
Tel: +39 02 81280696

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Slovenija
Sandoz d.o.o.
Tel: +386 1 580 29 02

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 200 600

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

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

More detailed information on this medicinal product is available on the European Medicines Agency website: https://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 whether you can self-inject Pyzchiva. In this case, you will be taught how to self-inject Pyzchiva. Inform your doctor if you have any questions about self-injection.

Do not mix Pyzchiva with other injectable liquids.
Do not shake Pyzchiva vials. Vigorous shaking may damage the medicine. Do not use the medicine if it has been vigorously shaken.

1. Check the number of vials and prepare materials

Take out the vial or vials from the refrigerator. Leave the vial outside the refrigerator for about
half an hour. This will allow the liquid to reach a comfortable temperature for injection
(room temperature).
Check that:

the number of vials and the dose are correct; if your dose is 45 mg or less, you will take one 45 mg vial of Pyzchiva; if your dose is 90 mg, you will take two 45 mg vials of Pyzchiva and will need to perform two injections. Choose two different injection sites for these injections (e.g., one injection on the right thigh and the other on the left thigh), and carry out the injections one after the other. Use a new needle and a new syringe for each injection.
the medicine is the correct one
the medicine has not expired
the vial is not damaged and the cap is intact
the solution in the vial is clear or slightly opalescent (pearl-like appearance) and colourless or pale yellow
the liquid does not have a changed or cloudy colour and does not contain foreign particles
it has not been frozen.

Children with paediatric psoriasis and a body weight below 60 kg require a dose lower than 45 mg.
Ensure the appropriate amount (volume) to be withdrawn from the vial and the type of syringe needed for dosing. If you do not know the amount of medicine or the type of syringe to use, contact your doctor for further instructions.
Gather all necessary supplies and place them on a clean surface. You will need a syringe, needle,
antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).

Technical drawing of a syringe with needle, a glass vial, a square adhesive bandage, two cotton swabs, and a biohazard waste container

Figure 1

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

Pyzchiva is administered by subcutaneous injection (under the skin).
A suitable site for the injection is the upper thigh or around the abdomen (abdominal area), at least 5 cm away from the navel.
If possible, avoid areas of skin showing signs of psoriasis.
If someone is assisting you with the injection, the upper arms may also be used as an injection site.

Figure 2
Preparing the injection site

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

3. Prepare the dose:

Remove the cap from the top of the vial (see Figure 3).

Two hands holding a glass vial while a finger presses on the top of the cap to open or manipulate it

Figure 3

Do not remove the stopper.
Clean the stopper with an antiseptic swab.
Place the vial on a flat surface.
Take the syringe and remove the protective needle cap.
Do not touch the needle, and do not let the needle touch anything.
Insert the needle through the rubber stopper.
Turn the vial and syringe upside down.
Pull back the plunger of the syringe to draw up the amount of liquid prescribed by your doctor.
It is important that the needle remains immersed in the liquid at all times, to prevent air bubbles from entering the syringe (see Figure 4).

Figure 4

Remove the needle from the vial.
Hold the syringe with the needle pointing upwards to check for any air bubbles.
If there are air bubbles, gently tap the side of the syringe until the air bubbles rise to the top (see Figure 5).

Line drawing of two hands gripping a syringe with needle pointing toward the

Figure 5

Then push the plunger to expel all air (but not the liquid).
Do not place the syringe down and avoid letting the needle touch anything.

4. Inject the dose

Gently pinch a clean area of skin between your thumb and index finger. Do not squeeze too tightly.
Insert the needle into the pinched skin.
Push the plunger with your thumb until all the liquid is injected. Press slowly and steadily, keeping the skin gently pinched.
When the plunger reaches the end of the syringe, remove the needle and release the skin.

5. After the injection

Press an antiseptic swab on the injection site for a few seconds after the injection.
There may be a small amount of blood or fluid at the injection site. This is normal.
You may press a cotton ball or gauze pad 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 needed.

6. Disposal

Used syringes and needles must be placed in a puncture-resistant container, such as a
sharps disposal container. For your safety and the safety of others, never reuse needles or syringes.
Dispose of the sharps container according to local regulations.
Empty vials, antiseptic swabs, and other devices may be discarded in regular waste.

Package leaflet: Information for the user

Pyzchiva 45 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow 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 as it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are a parent or caregiver of a child who needs to be given Pyzchiva, please read these instructions carefully.

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 give it to other people, even if their symptoms are the same as yours, because it could 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

What Pyzchiva is and what it is used for
What you need to know before using Pyzchiva
How to use Pyzchiva
Possible side effects
How to store Pyzchiva
Contents of the pack and other information

1. What Pyzchiva is and what it is used for

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

What Pyzchiva is used for
Pyzchiva 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.

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, Pyzchiva may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
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 Pyzchiva.
Warnings and precautions
Talk to your doctor or pharmacist before using Pyzchiva. 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. Also, 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 Pyzchiva. If your doctor believes you are at risk of tuberculosis, you may be given
medicines to treat it.
Be aware of serious side effects
Pyzchiva can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Pyzchiva. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Pyzchiva, contact your doctor

If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants like ustekinumab 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 have or have recently had an infection.
If you have ever had any new or changing 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 partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been

studied. However, it could increase the likelihood of conditions related to a weakened immune system.

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

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) must not be given while you are using Pyzchiva.
if you received Pyzchiva during pregnancy, inform your child’s paediatrician about the Pyzchiva treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Pyzchiva 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, ask your doctor for advice before taking this medicine.
In newborns exposed to ustekinumab in utero, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab 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 ustekinumab and for at least 15 weeks after stopping treatment with ustekinumab.
Pyzchiva can cross the placenta and reach the unborn child. If you received Pyzchiva during pregnancy, your baby may have an increased risk of developing an infection.
If you received Pyzchiva during pregnancy, it is important to inform your paediatrician and other healthcare providers before your child receives any vaccine. If you received Pyzchiva 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 ustekinumab. You cannot do both.
Driving and using machines
Ustekinumab does not affect, or has a negligible effect on, the ability to drive vehicles or operate
machinery.
Pyzchiva contains polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E433) per pre-filled syringe (1 mL), equivalent to
0.02 mg/0.5 mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known
allergies.

3. How to use Pyzchiva

How much Pyzchiva is administered

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

Adults from 18 years of age
Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Pyzchiva. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
Four weeks after the initial dose, you will receive the next dose, followed by administration 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 Pyzchiva is administered by your doctor as an intravenous infusion (an infusion into a vein in the arm). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Pyzchiva, followed by subcutaneous injection (under the skin) every 12 weeks.
In some patients, after the first subcutaneous injection, the 90 mg dose of Pyzchiva may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

Your doctor will calculate the correct dose, including the amount (volume) of Pyzchiva 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 dose.
A 45 mg vial is available for children who require a dose lower than the full 45 mg dose.
If body weight is below 60 kg, the recommended dose is 0.75 mg of Pyzchiva per kg of body weight.
If body weight is between 60 and 100 kg, the recommended dose is 45 mg of Pyzchiva.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Pyzchiva.
Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

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

How Pyzchiva is administered
Pyzchiva is administered by subcutaneous injection (“subcutaneously”). At the beginning of
treatment, medical or nursing staff may administer Pyzchiva to you.

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

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

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 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 ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of 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).

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, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use
Pyzchiva 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 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).

Ustekinumab may reduce the ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including those causing tuberculosis) or parasites, including infections occurring mainly 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 ustekinumab. 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
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 ustekinumab 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, you must 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 associated with joint pain).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Pyzchiva

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 Pyzchiva may also be stored at room temperature up to 30 °C for a single period of up to 35 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 in the space provided on the outer packaging. At any time before the end of this period, the product may be returned to the refrigerator once and stored until the original expiry date. Discard the syringe if not used within 35 days of removal from refrigerated storage or by the original expiry date, whichever comes first.
Do not shake the pre-filled syringes of Pyzchiva. 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 the month.
If the liquid has changed colour, appears cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Pyzchiva and contents of the pack”).
If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
If the product has been shaken vigorously.

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

6. Package contents and other information

What Pyzchiva contains

The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
The other components are: histidine, monohydrate histidine hydrochloride, polysorbate 80 (E 433), sucrose, water for injections.

Description of the appearance of Pyzchiva and contents of the pack
Pyzchiva is a clear solution for injection, colourless to pale yellow. The solution may contain a few small translucent or white protein particles. 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 45 mg of ustekinumab in 0.5 mL of solution for injection.

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

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

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d. filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf: +45 63 95 10 00 Tel: +35699644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 81280696 Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

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

Do not mix Pyzchiva with other injectable liquids.
Do not shake the pre-filled syringes of Pyzchiva, 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.

Technical diagram of a syringe with labels indicating protective cap, needle, viewing window, barrel, flange, plunger, and plunger head

Figure 1

1. Check the number of prefilled syringes and prepare materials

Prepare for the use of prefilled syringes.

Remove the prefilled syringe or prefilled syringes from the refrigerator. Leave the prefilled syringe outside the carton for about half an hour. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not heat the prefilled syringe in any other way (for example, do not heat in a microwave oven or with warm water). 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 rod, plunger, needle guard wings, 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.

Inspect the prefilled syringe to ensure that:

the number of prefilled syringes and the dose are correct; if your dose is 45 mg, you will use one 45 mg Pyzchiva prefilled syringe; if your dose is 90 mg, you will use two 45 mg Pyzchiva prefilled syringes and will need to administer two injections. Choose two different injection sites for these injections (for example, one injection in the right thigh and the other in 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 clear and colorless to pale yellow
the liquid in the prefilled syringe does not have a changed or cloudy appearance and does not contain foreign particles
the solution in the prefilled syringe has not been frozen

Gather all necessary supplies and place them on a clean surface. These 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).

Pyzchiva is administered by injection under the skin (subcutaneously).
A suitable place for the injection is the upper 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 with 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 injection site on the skin with an antiseptic swab.
Do not touch this area again before giving the injection.
Do not vent or blow on the cleaned area.

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 body of the syringe with one hand.
Remove and discard the needle protective cap. Do not touch the plunger during this procedure.

Two hands moving a syringe back and forth toward a cap with black arrows indicating horizontal motion

Figure 3

If you notice an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle, this is normal. Do not remove them.
Do not touch the needle and avoid contact between the needle and 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 top of the plunger head. Use the other hand to gently pinch the cleaned area of skin between the thumb and index finger. Do not pinch too tightly.
Under no circumstances should you pull back on the plunger.
With one quick, swift motion, insert the needle into the skin as far as possible (see Figure 4).

A hand holds a syringe to inject medication while the

Figure 4

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

Two hands holding and manipulating a transparent medical device with internal components and a grooved structure for the

Figure 5

Continue pushing the plunger until it reaches the end of its travel. Keep pressing on the plunger head while removing the needle and gently releasing the skin (see Figure 6).

A hand holds an injection device with a needle penetrating a skin surface following the direction of a black arrow

Figure 6

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

A hand holds a syringe-shaped medical device with a black arrow indicating movement toward the

Figure 7

5. After the injection

Press an antiseptic swab on the injection site for a few seconds after the injection.
There may be a small amount of blood or fluid 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 disposal 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.

A hand holds a syringe above a biohazard waste container with the biohazard symbol for safe disposal

Figure 8

Package leaflet: Information for the user

Pyzchiva 90 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow 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 who are taking this medicine. If you are a parent or caregiver of a child who needs to be given Pyzchiva, please read these instructions carefully.

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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pyzchiva is and what it is used for
What you need to know before using Pyzchiva
How to use Pyzchiva
Possible side effects
How to store Pyzchiva
Contents of the pack and other information

1. What Pyzchiva is and what it is used for

What Pyzchiva is
Pyzchiva contains the active substance "ustekinumab", a monoclonal antibody. Monoclonal
antibodies are proteins that recognise and bind to specific proteins in the body.
Pyzchiva belongs to a group of medicines called "immunosuppressants". These medicines partially
reduce the activity of the immune system.
What Pyzchiva is used for
Pyzchiva 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 causing inflammation of the skin and nails.
Pyzchiva will reduce inflammation and other signs of the disease.
Pyzchiva is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or in whom these treatments are ineffective.
Pyzchiva 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 worked.
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 Pyzchiva to:

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

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
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 Pyzchiva.
Warnings and precautions
Talk to your doctor or pharmacist before using Pyzchiva. Your doctor will check your health status
before each treatment. Before each treatment, make sure to inform your doctor about any medical
conditions you have. Also, 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
you start using Pyzchiva. If your doctor believes you are at risk of tuberculosis, they may prescribe
medicines to treat it.
Be aware of serious side effects
Pyzchiva can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Pyzchiva. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Pyzchiva, contact your doctor

If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants like ustekinumab 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 partially reduce immune system activity. The combined use of these therapies with ustekinumab has not been studied. However, it could potentially increase the risk of conditions related to a weakened immune system.
If you are using or have ever used allergy injections – it is not known whether ustekinumab may affect them.
If you are aged 65 years or older – you may have a higher risk of developing infections.

if you are taking, have recently taken, or might take any other medicines
if you have recently been vaccinated or are due to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using Pyzchiva.
if you received Pyzchiva during pregnancy, inform your child’s paediatrician about the Pyzchiva treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Pyzchiva during pregnancy, live vaccines are not recommended for your child during the first twelve months of life, 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 ustekinumab in utero, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab 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 ustekinumab and for at least 15 weeks after stopping treatment with ustekinumab.
Pyzchiva can cross the placenta and reach the unborn child. If you received Pyzchiva during pregnancy, your baby may have an increased risk of developing an infection.
If you received Pyzchiva during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Pyzchiva 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 ustekinumab. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has a negligible effect on the ability to drive or operate machinery.
Pyzchiva contains polysorbate 80 (E433)
This medicine contains 0.04 mg of polysorbate 80 (E433) per pre-filled syringe (1 mL), equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Pyzchiva

Pyzchiva is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Pyzchiva is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor. Discuss with your doctor when you should receive injections and follow-up visits.
How much Pyzchiva is administered
Your doctor will decide how much Pyzchiva you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Pyzchiva. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
4 weeks after the initial dose, you will receive the next dose, followed by administration 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 Pyzchiva is administered by your doctor as an intravenous infusion into the arm (intravenous infusion). 8 weeks after the initial dose, you will receive the next dose of 90 mg of Pyzchiva, followed by subcutaneous injection (subcutaneous route) every 12 weeks.
In some patients, after the first subcutaneous injection, the 90 mg dose of Pyzchiva may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

Your doctor will calculate the correct dose, including the amount (volume) of Pyzchiva 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 dose administration.
A 45 mg vial is available for children who need to receive a dose lower than the full 45 mg dose.
If body weight is less than 60 kg, the recommended dose is 0.75 mg of Pyzchiva per kg of body weight.
If body weight is between 60 and 100 kg, the recommended dose is 45 mg of Pyzchiva.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Pyzchiva.
4 weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

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

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

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

If you use more Pyzchiva than you should
If you have used or received too much Pyzchiva, 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 Pyzchiva
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a
missed dose.
If you stop using Pyzchiva
Stopping ustekinumab is not dangerous. However, if you stop 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 everybody gets them.

Serious side effects

Some patients may experience serious side effects that may require 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 ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of 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).

Rarely, 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 Pyzchiva 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).

Ustekinumab may reduce your body's 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 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 aware of signs of infection while using ustekinumab. 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
visual disturbance or loss of vision
headache, neck stiffness, sensitivity to light, nausea or confusion

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 cause 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system mentioned in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pyzchiva

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 its outer packaging to protect the medicine from light.
If necessary, individual pre-filled syringes of Pyzchiva may also be stored at room temperature up to 30°C for a single period of up to 35 days, while remaining in the outer packaging to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator in the space provided on the outer packaging. At any time before the end of this period, the product may be returned to the refrigerator once and stored until the original expiry date. Discard the syringe if not used within the maximum storage period of 35 days at room temperature or by the original expiry date, whichever comes first.
Do not shake the pre-filled syringes of Pyzchiva. 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 the month.
If the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Pyzchiva 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 shaken vigorously.

6. Package contents and other information

What Pyzchiva contains

The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
The excipients are: histidine, monohydrochloride monohydrate histidine, polysorbate 80 (E 433), sucrose, water for injections.

Description of the appearance of Pyzchiva and contents of the pack
Pyzchiva is a clear solution for injection, colourless to pale yellow. The solution may contain a few small translucent or white protein particles. 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 and Manufacturer
Samsung Bioepis NL. B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Deutschland
Hexal AG
Tel: +49 8024 908 0

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

France
Sandoz SAS
Tél: +33 1 49 64 48 00

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Ireland
Rowex Ltd.
Tel: +353 27 50077

Italia
Sandoz S.p.A.
Tel: +39 02 81280696

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 200 600

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicine must be clearly recorded.

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

Do not mix Pyzchiva with other injectable liquids.
Do not shake the pre-filled syringes of Pyzchiva, 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.

Diagram of a syringe with labels indicating protective cap, needle, viewing window, barrel, flange, plunger, and plunger head

Figure 1

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

Prepare for using the prefilled syringes.

Remove the prefilled syringe or 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 heat the prefilled syringe in any other way (for example, do not use a microwave oven or warm water). 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 rod, plunger, needle safety shield, 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.

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 90 mg prefilled syringe of Pyzchiva
the medicine is the correct one
the medicine has not expired
the prefilled syringe is not damaged
the solution in the prefilled syringe is clear and colourless to slightly yellow
the liquid in the prefilled syringe does not have a changed or cloudy colour and does not contain foreign particles
the solution in the prefilled syringe has not been 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).

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

Figure 2
Preparing the injection site.

Wash your hands thoroughly with soap and warm water.
Clean the injection site on the skin with an antiseptic swab.
Do not touch this area again before administering the injection.
Do not blow or pass air over the cleaned area.

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.

Two hands moving a syringe back and forth with black arrows indicating horizontal motion between a container and the syringe barrel

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 found 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, with the thumb placed on top of the plunger head. Use the other hand to 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).

A hand holds a syringe at an angle while the

Figure 4

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

Two hands holding and maneuvering a transparent medical device with internal components and a grooved structure for the

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).

A hand holds an injection device tilted toward a skin surface with an arrow indicating downward movement

Figure 6

Slowly remove your thumb from the plunger head to allow the empty syringe to move 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 an antiseptic swab on the injection site for a few seconds after the injection.
There may be a small amount of blood or fluid 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 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 discarded in regular waste.

Figure 8

Package leaflet: information for the user

Pyzchiva 45 mg solution for injection in pre-filled pen

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 give it to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pyzchiva is and what it is used for
What you need to know before using Pyzchiva
How to use Pyzchiva
Possible side effects
How to store Pyzchiva
Contents of the pack and other information

1. What Pyzchiva is and what it is used for

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

What Pyzchiva is used for
Pyzchiva, administered using a pre-filled pen, is used to treat the following inflammatory diseases:

plaque psoriasis (in adults)
psoriatic arthritis (in adults)
moderate to severe Crohn’s disease (in adults).

Plaque psoriasis
Plaque psoriasis is a skin disease causing inflammation of the skin and nails. Pyzchiva reduces inflammation and other signs of the disease.
Pyzchiva, administered using a pre-filled pen, is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate or phototherapy, or in whom these treatments are ineffective.

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

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
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 Pyzchiva.
Warnings and precautions
Talk to your doctor or pharmacist before using Pyzchiva. Your doctor will check your health status
before each treatment. Before each treatment, make sure to inform your doctor about any medical
conditions you have. Also, inform your doctor if you have recently been in contact with people who
might have had tuberculosis. Your doctor will examine you and carry out tests for tuberculosis before
you start using Pyzchiva. If your doctor believes you are at risk of tuberculosis, they may prescribe
medication to treat it.
Be aware of serious side effects
Pyzchiva can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Pyzchiva. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Pyzchiva, contact your doctor

If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants like ustekinumab 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 partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.
If you are using or have ever used allergy injections (immunotherapy) – it is not known whether ustekinumab may affect these.
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 Pyzchiva.
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 patients with psoriasis 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 unusual sensations on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
The use of the ustekinumab pre-filled pen is not recommended in children and adolescents under 18 years of age with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children from 6 years of age and adolescents with psoriasis, the pre-filled syringe or vial should be used instead. For children with Crohn’s disease weighing at least 40 kg, the infusion solution, vial, or pre-filled syringe should be used.
The use of ustekinumab is not recommended for the treatment of children and adolescents under 18 years of age with psoriatic arthritis, or for children with Crohn’s disease weighing less than 40 kg, as it has not been studied in these populations.
Other medicines, vaccines and Pyzchiva
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 Pyzchiva.
if you received Pyzchiva during pregnancy, inform the paediatrician of your child about the Pyzchiva treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Pyzchiva during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise advised 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.
A higher risk of congenital malformations has not been observed in newborns exposed to ustekinumab in utero. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab 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 ustekinumab and for at least 15 weeks after stopping treatment with ustekinumab.
Pyzchiva can cross the placenta and reach the unborn child. If you received Pyzchiva during pregnancy, your baby may have an increased risk of developing an infection.
If you received Pyzchiva during pregnancy, it is important that you inform the paediatrician and other healthcare providers before your child receives any vaccine. If you received Pyzchiva 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 advised by your child’s 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 to breastfeed or to use ustekinumab. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has a negligible effect on the ability to drive and use machines.
Pyzchiva contains polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E433) in each pre-filled pen (1 mL), equivalent to 0.02 mg/0.5 mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

1. How to use Pyzchiva

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Pyzchiva. Patients with a body weight greater than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
Four weeks after the initial dose, you will receive the next dose, followed by administration 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 Pyzchiva is administered by your doctor as an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Pyzchiva, followed by subcutaneous injections (subcutaneous route) every 12 weeks.
In some patients, after the first subcutaneous injection, the 90 mg dose of Pyzchiva may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

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

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

If you forget to use Pyzchiva
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 Pyzchiva
Stopping ustekinumab is not dangerous. However, if you discontinue treatment, symptoms may return. If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Some patients may experience serious side effects that may require 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 ustekinumab (affect up to 1 in 1,000 patients). Signs include:
o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or swelling of the face, lips, mouth or throat.
Common signs of an allergic reaction include rash and hives (affect up to 1 in 100 patients).

Allergic lung reactions and lung inflammation have been reported rarely 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 Pyzchiva 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 (affect 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 rash with blisters) is uncommon (affects up to 1 in 100 patients).

Ustekinumab may reduce the ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including those causing tuberculosis) or parasites, including infections that occur mainly 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 ustekinumab. 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
visual disturbance or loss of vision
headache, stiff neck, 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. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop ustekinumab 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 (may affect up to 1 in 10 people)

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 (may affect up to 1 in 100 people)

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

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 cause a rash with small red or purple bumps, fever or joint pain (vasculitis)

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

Formation of skin blisters with possible 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Pyzchiva

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 pen in the outer packaging to protect the medicine from light.
If necessary, individual pre-filled pens of Pyzchiva may also be stored at room temperature up to 30 °C for a single period of up to 35 days, in the original outer packaging to protect the medicine from light. Record the date when the pre-filled pen is first removed from the refrigerator in the designated space on the outer packaging. At any time before the end of this period, the product may be returned to the refrigerator once and stored until the expiry date. Discard the pen if not used after the maximum storage period of 35 days at room temperature or by the original expiry date, whichever comes first.
Do not shake the pre-filled pens of Pyzchiva. 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 the month.
If the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Pyzchiva 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.

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

6. Package contents and other information

What Pyzchiva contains

The active substance is ustekinumab. Each pre-filled pen contains 45 mg of ustekinumab in 0.5 mL.
The other components are histidine, monohydrochloride histidine monohydrate, polysorbate 80, sucrose, water for injections.

Description of the appearance of Pyzchiva and package contents
Pyzchiva is a clear, colourless to slightly yellow injection solution. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled pen. Each pre-filled pen contains a 45 mg dose of ustekinumab in 0.5 mL of injection solution.

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

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

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037