Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - stelara

Document Subject

Generated Narrative: MedicinalProductDefinition mp58c54bdf6fab9e6178694c2f025cc813

identifier: http://ema.europa.eu/identifier/EU/1/08/494/005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: STELARA 130 mg concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-58c54bdf6fab9e6178694c2f025cc813

identifier: http://ema.europa.eu/identifier/EU/1/08/494/005

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - stelara

Attesters

What is in this leaflet

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

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

Moderate to severe Crohn s disease - in adults

Moderate to severe ulcerative colitis - in adults Crohn s disease Crohn s disease is an inflammatory 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 Stelara to reduce the signs and symptoms of your disease. Ulcerative colitis Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Stelara to reduce the signs and symptoms of your disease.

Do not use Stelara

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 Stelara. Warnings and precautions Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are before treatment. Make sure you tell your doctor about any illness you have before 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 Stelara. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it. Look out for serious side effects Stelara can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Stelara. See Serious side effects in section 4 for a full list of these side effects. Before you use Stelara tell your doctor:

If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.

If you have ever had any type of cancer this is because immunosuppressants like Stelara 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 or if you have any abnormal skin openings (fistulae).

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 Stelara 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 Stelara 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 Stelara. 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 Stelara. 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 Stelara is not recommended for use in children under 18 years of age with Crohn s disease or ulcerative colitis because it has not been studied in this age group. Other medicines, vaccines and Stelara 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 Stelara.

If you received Stelara while pregnant, tell your baby s doctor about your Stelara 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 Stelara during the pregnancy unless your baby s doctor recommends otherwise. Pregnancy and breast-feeding

It is preferable to avoid the use of Stelara in pregnancy. The effects of Stelara 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 Stelara and for at least 15 weeks after the last Stelara treatment.

Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Stelara can pass across the placenta to the unborn baby. If you received Stelara 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 Stelara 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 Stelara 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 Stelara - do not do both. Driving and using machines Stelara has no or negligible influence on the ability to drive and use machines. Stelara contains sodium Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free . However, before Stelara is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.

Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn s disease or ulcerative colitis. Stelara 130 mg concentrate for solution for infusion will be given to you by your doctor, through a drip in the vein of your arm (intravenous infusion) over at least one hour. Talk to your doctor about when you will have your injections and follow-up appointments. How much Stelara is given Your doctor will decide how much Stelara you need to receive and for how long. Adults aged 18 years or older

The doctor will work out the recommended intravenous infusion dose for you based on your body weight. Your body weight Dose 55 kg 260 mg

55 kg to 85 kg 390 mg 85 kg 520 mg

After the starting intravenous dose, you will have the next dose of 90 mg Stelara by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks therafter. How Stelara is given

The first dose of Stelara for treatment of Crohn s disease or ulcerative colitis is given by a doctor as a drip in the vein of an arm (intravenous infusion). Talk to your doctor if you have any questions about receiving Stelara. If you forget to use Stelara If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment. If you stop using Stelara It is not dangerous to stop using Stelara. 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 Stelara (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 (these may affect up to 1 in 100 people). Infusion-related reactions If you are being treated for Crohn s disease or ulcerative colitis, the first dose of Stelara is given through a drip into a vein (intravenous infusion). Some patients have experienced serious allergic reactions during the infusion. 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 Stelara 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) Stelara 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 Stelara. 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 Stelara 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 side effects (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 side effects (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 side effects (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 side effects (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.

Stelara 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle 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 carton in order to protect from light.

Do not shake the Stelara vials. 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 you can see other foreign particles floating in it (see section 6 What Stelara 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.

If the seal is broken. Stelara is for single use only. Any diluted infusion solution or unused product remaining in the vial and the syringe should be thrown away in accordance with local requirements.

What Stelara contains

The active substance is ustekinumab. Each vial contains130 mg ustekinumab in 26 mL.

The other ingredients are EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for injection. What Stelara looks like and contents of the pack Stelara is a clear, colourless to light yellow concentrate for solution for infusion. It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial. Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Biologics B.V. Einsteinweg 2333 CB Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: 1 800 709 medinfo@its.jnj.com Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

T : +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 medinfo@its.jnj.com This leaflet was last revised in. Detailed information on this medicine is available on the European Medicines Agency web site: