Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - uzpruvo

Document Subject

Generated Narrative: MedicinalProductDefinition mpd78597bd4a8ec02c40a4fe805d40f1ef

identifier: http://ema.europa.eu/identifier/EU/1/23/1784/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Uzpruvo 45 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d78597bd4a8ec02c40a4fe805d40f1ef

identifier: http://ema.europa.eu/identifier/EU/1/23/1784/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - uzpruvo

Attesters

What is in this leaflet

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

What Uzpruvo is
Uzpruvo contains the active substance ustekinumab , a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Uzpruvo belongs to a group of medicines called immunosuppressants . These medicines work by weakening part of the immune system.
What Uzpruvo is used for
Uzpruvo is used to treat the following inflammatory diseases:

Plaque psoriasis - in adults and children aged 6 years and older

Psoriatic arthritis - in adults

Moderate to severe Crohn s disease - in adults Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Uzpruvo will reduce the inflammation and other signs of the disease.
Uzpruvo is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Uzpruvo is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments did not work.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Uzpruvo to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Slow down the damage to your joints.

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

Do not use Uzpruvo

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

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

Warnings and precautions
Talk to your doctor or pharmacist before using Uzpruvo. Your doctor will check how well you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will examine you and do a test for tuberculosis, before you have Uzpruvo. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects
Uzpruvo can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Uzpruvo. See Serious side effects in section 4 for a full list of these side effects.

Before you use Uzpruvo tell your doctor

• If you ever had an allergic reaction to Uzpruvo. Ask your doctor if you are not sure.
• If you have ever had any type of cancer this is because immunosuppressants like Uzpruvo weaken part of the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) the risk of cancer may be higher.
• If you have or have had a recent infection.
• If you have any new or changing lesions within psoriasis areas or on normal skin.
• If you are having any other treatment for psoriasis and/or psoriatic arthritis such as another immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using these therapies together with Uzpruvo has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system.
• If you are having or have ever had injections to treat allergies it is not known if Uzpruvo may affect these.
• If you are 65 years of age or over you may be more likely to get infections.

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

Some patients have experienced lupus-like reactions including skin lupus or lupus-like syndrome during treatment with ustekinumab. Talk to your doctor right away if you experience a red, raised, scaly rash sometimes with a darker border, in areas of the skin that are exposed to the sun or with joint pains.

Heart attack and strokes Heart attack and strokes have been observed in a study in patients with psoriasis treated with ustekinumab. Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities.

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

Other medicines, vaccines and Uzpruvo
Tell your doctor or pharmacist

• If you are taking, have recently taken or might take any other medicines.
• If you have recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Uzpruvo.
• If you received Uzpruvo while pregnant, tell your baby s doctor about your Uzpruvo treatment before the baby receives any vaccine, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your baby in the first six months after birth if you received Uzpruvo during the pregnancy unless your baby s doctor recommends otherwise.

Pregnancy and breast-feeding

• It is preferable to avoid the use of Uzpruvo in pregnancy. The effects of Uzpruvo in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Uzpruvo and for at least 15 weeks after the last Uzpruvo treatment.
• Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
• Uzpruvo can pass across the placenta to the unborn baby. If you received Uzpruvo during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby s doctors and other health care professionals if you received Uzpruvo during your pregnancy before the baby receives any vaccine. Live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby in the first six months after birth if you received Uzpruvo during the pregnancy unless your baby s doctor recommends otherwise.
• Ustekinumab may pass into breast milk in very small amounts. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use Uzpruvo - do not do both.

Driving and using machines
Uzpruvo has no or negligible influence on the ability to drive and use machines.

Uzpruvo is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Uzpruvo is intended.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Talk to your doctor about when you will have your injections and follow-up appointments.
How much Uzpruvo is given
Your doctor will decide how much Uzpruvo you need to use and for how long.

Adults aged 18 years or older
Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg Uzpruvo. Patients who weigh more than 100 kilograms (kg) may start on a dose of 90 mg instead of 45 mg.
• After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The following doses are usually the same as the starting dose.

Crohn s disease

• Uzpruvo is not available for the first dose through a drip in a vein in your arm (intravenous infusion). Another ustekinumab product will be given as intravenous infusion as first dose.
• Uzpruvo is administered by injection under the skin (subcutaneously). You will receive the first dose of 90 mg Uzpruvo 8 weeks after the intravenous infusion, then every 12 weeks thereafter subcutaneously.
• In some patients, after the first injection under the skin, 90 mg Uzpruvo may be given every 8 weeks. Your doctor will decide when you should receive your next dose.

Children and adolescents aged 6 years or older
Psoriasis

• The doctor will work out the right dose for you, including the amount (volume) of Uzpruvo to be injected to give the right dose. The right dose for you will depend on your body weight at the time each dose is given.
• If you weigh less than 60 kg, there is no dosage form for Uzpruvo for children below 60 kg body weight.
• If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Uzpruvo.
• If you weigh more than 100 kg, the recommended dose is 90 mg Uzpruvo.
• After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

How Uzpruvo is given

• Uzpruvo is given as an injection under the skin ( subcutaneously ). At the start of your treatment, medical or nursing staff may inject Uzpruvo.
• However, you and your doctor may decide that you may inject Uzpruvo yourself. In this case you will get training on how to inject Uzpruvo yourself.
• For instructions on how to inject Uzpruvo, see Instructions for administration at the end of this leaflet.
  Talk to your doctor if you have any questions about giving yourself an injection.

If you use more Uzpruvo than you should
If you have used or been given too much Uzpruvo, talk to a doctor or pharmacist straight away. Always have the outer carton of the medicine with you, even if it is empty.

If you forget to use Uzpruvo
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.

If you stop using Uzpruvo
It is not dangerous to stop using Uzpruvo. However, if you stop, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Some patients may have serious side effects that may need urgent treatment.

Allergic reactions these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs.

• Serious allergic reactions ( anaphylaxis ) are rare in people taking ustekinumab (may affect up to 1 in 1,000 people). Signs include: * difficulty breathing or swallowing * low blood pressure, which can cause dizziness or light-headedness * swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include skin rash and hives (may affect up to 1 in 100 people).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab. Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever.

If you have a serious allergic reaction, your doctor may decide that you should not use Uzpruvo again.

Infections these may need urgent treatment. Tell your doctor straight away if you notice any of the following signs.

• Infections of the nose or throat and common cold are common (may affect up to 1 in 10 people)
• Infections of the chest are uncommon (may affect up to 1 in 100 people)
• Inflammation of tissue under the skin ( cellulitis ) is uncommon (may affect up to 1 in 100 people)
• Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people)

Uzpruvo may make you less able to fight infections. Some infections could become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur in people with a weakened immune system (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eye have been reported in patients receiving treatment with ustekinumab.

You must look out for signs of infection while you are using Uzpruvo. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath; cough which will not go away
• warm, red and painful skin, or a painful skin rash with blisters
• burning when passing water
• diarrhoea
• visual disturbance or vision loss
• headache, neck stiffness, light sensitivity, nausea or confusion.

Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, shingles or opportunistic infections that could have serious complications. Tell your doctor if you have any kind of infection that will not go away or keeps coming back. Your doctor may decide that you should not use Uzpruvo until the infection goes away. Also tell your doctor if you have any open cuts or sores as they might get infected.

Shedding of skin increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. You should tell your doctor straight away if you notice any of these signs.

Other side effects

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

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching ( pruritus )
• Back, muscle or joint pain
• Sore throat
• Redness and pain where the injection is given
• Sinus infection

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

• Tooth infections
• Vaginal yeast infection
• Depression
• Blocked or stuffy nose
• Bleeding, bruising, hardness, swelling and itching where the injection is given
• Feeling weak
• Drooping eyelid and sagging muscles on one side of the face ( facial palsy or Bell s palsy ), which is usually temporary
• A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis)
• Peeling of the skin (skin exfoliation)
• Acne

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

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

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

• Blistering of the skin that may be red, itchy, and painful (Bullous pemphigoid).
• Skin lupus or lupus-like syndrome (red, raised scaly rash on areas of the skin exposed to the sun possibly with joint pains).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 carton in order to protect from light.
• The pre-filled syringe should be allowed to reach room temperature (approximately half an hour).
• If needed, individual Uzpruvo pre-filled syringes may also be stored at room temperature up to 30 C for a maximum single period of up to 30 days in the original carton in order to protect from light. Once removed from the refrigerator, record the discard date in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to 30 C), it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.
• Do not shake the pre-filled syringes. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date which is stated on the label and the carton after EXP . The expiry date refers to the last day of that month.
• If the liquid is discoloured, cloudy or has large particles floating in it (see section 6 What Uzpruvo looks like and contents of the pack ).
• If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).
• If the product has been shaken vigorously.

Uzpruvo is for single use only. Any unused product remaining in the syringe should be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Uzpruvo contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
• The other ingredients are histidine, histidine monohydrochloride, polysorbate 80, sucrose, water for injections.

What Uzpruvo looks like and contents of the pack
Uzpruvo is a clear, colourless to slightly yellow and practically free of visible particles solution for injection. It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL solution for injection.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2 61118 Bad Vilbel
Germany

Manufacturer
Alvotech Hf S mundargata 15-Reykjavik, Iceland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien EG (Eurogenerics) NV T l/Tel: +32 4797Lietuva UAB STADA Baltics
Tel: +370 52603
STADA Bulgaria EOOD Te .: +359 29624Luxembourg/Luxemburg EG (Eurogenerics) NV T l/Tel: +32 4797 esk republika STADA PHARMA CZ s.r.o. Tel: +420 257888Magyarorsz g STADA Hungary Kft Tel.: +36 18009Danmark STADA Nordic ApS Tlf: +45 44859Malta STADA Arzneimittel AG Tel: +49 61016Deutschland STADAPHARM GmbH Tel: +49 61016Nederland Centrafarm B.V. Tel.: +31 765081Eesti UAB STADA Baltics
Tel: +370 52603Norge STADA Nordic ApS Tlf: +45 44859
STADA Arzneimittel AG Tel: +30 2106664 sterreich STADA Arzneimittel GmbH Tel: +43 136785Espa a Laboratorio STADA, S.L. Tel: +34 934738Polska STADA Poland Sp. z.o o. Tel: +48 227377France EG LABO - Laboratoires EuroGenerics T l: +33 146948Portugal Stada, Lda. Tel: +351 211209Hrvatska STADA d.o.o. Tel: +385 13764Rom nia STADA M&D SRL Tel: +40 213160Ireland Clonmel Healthcare Ltd. Tel: +353 526177Slovenija Stada d.o.o. Tel: +386 15896 sland STADA Arzneimittel AG S mi: +49 61016Slovensk republika STADA PHARMA Slovakia, s.r.o. Tel: +421 252621Italia EG SpA Tel: +39 028310Suomi/Finland STADA Nordic ApS, Suomen sivuliike Puh/Tel: +358 207416
STADA Arzneimittel AG : +30 2106664Sverige STADA Nordic ApS Tel: +45 44859Latvija UAB STADA Baltics
Tel: +370 52603United Kingdom (Northern Ireland) STADA Arzneimittel AG Tel: +49 61016This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: