Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tremfya

Document Subject

Generated Narrative: MedicinalProductDefinition mp0efb4276dbc7ad1d850b741a6d2cdac5

identifier: http://ema.europa.eu/identifier/EU/1/17/1234/001 1 pre-filled syringe

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tremfya 100 mg solution for injection in pre-filled syringe

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: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0efb4276dbc7ad1d850b741a6d2cdac5

identifier: http://ema.europa.eu/identifier/EU/1/17/1234/001 1 pre-filled syringe

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tremfya

Attesters

What is in this leaflet

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

Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody. This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis and psoriatic arthritis. Plaque psoriasis Tremfya is used to treat adults with moderate to severe plaque psoriasis , an inflammatory condition affecting the skin and nails. Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning. Psoriatic arthritis Tremfya is used to treat a condition called psoriatic arthritis , an inflammatory disease of the joints, often accompanied by plaque psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Tremfya to reduce the signs and symptoms of the disease. Tremfya can be used alone or with another medicine named methotrexate. Using Tremfya in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to do normal daily activities.

Do not use Tremfya

if you are allergic to guselkumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using Tremfya.

if you have an active infection, including active tuberculosis. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tremfya:

if you are being treated for an infection;

if you have an infection that does not go away or that keeps coming back;

if you have tuberculosis or have been in close contact with someone with tuberculosis;

if you think you have an infection or have symptoms of an infection (see below under Look out for infections and allergic reactions );

if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya. If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya. As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Tremfya and when using it. Increases in liver enzymes may occur more frequently in patients receiving Tremfya every 4 weeks than in patients receiving Tremfya every 8 weeks (see How to use Tremfya in section 3). Look out for infections and allergic reactions Tremfya can potentially cause serious side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Tremfya. Signs of infections may include fever or flu like symptoms; muscle aches; cough; shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis. Serious allergic reactions, which can include the following symptoms, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing and hives, have occurred with Tremfya (see Serious side effects in section 4). Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection. Children and adolescents Tremfya is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group. Other medicines and Tremfya Tell your doctor or pharmacist:

if you are using, have recently used or might use any other medicines.

if you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Tremfya. Pregnancy and breast-feeding

Tremfya should not be used in pregnancy as the effects of this medicine 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 Tremfya and for at least 12 weeks after the last Tremfya dose. Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you will breast-feed or use Tremfya. Driving and using machines Tremfya is unlikely to influence your ability to drive and use machines.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much Tremfya is given and for how long Your doctor will decide for how long you need to use Tremfya. Plaque psoriasis

The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks. Psoriatic arthritis

The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). This may be given by your doctor or nurse.

After the first dose, you will receive the next dose 4 weeks later, and then every 8 weeks. For some patients, after the first dose, Tremfya may be given every 4 weeks. Your doctor will decide how often you may receive Tremfya. At the start, your doctor or nurse will inject Tremfya. However, you may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse. For detailed instructions on how to use Tremfya, carefully read the Instructions for use leaflet before use, which is included in the carton. If you use more Tremfya than you should If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor. If you forget to use Tremfya If you have forgotten to inject a dose of Tremfya, inform your doctor. If you stop using Tremfya You should not stop using Tremfya without speaking to your doctor first. If you stop treatment, your symptoms may come back. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor or seek medical help immediately if you get any of the following side effects: Possible serious allergic reaction (may affect up to 1 in 100 people) - the signs may include:

difficulty breathing or swallowing

swelling of the face, lips, tongue or throat

severe itching of the skin, with a red rash or raised bumps Other side effects The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately. Very common (may affect more than 1 in 10 people)

respiratory tract infections Common (may affect up to 1 in 10 people)

headache

joint pain (arthralgia)

diarrhoea

redness, irritation or pain at the injection site

increased level of liver enzymes in the blood Uncommon (may affect up to 1 in 100 people)

allergic reaction

skin rash

decreased number of a type of white blood cell called neutrophils

herpes simplex infections

fungal infection of the skin, for instance between the toes (e.g., athlete s foot)

stomach flu (gastroenteritis)

hives Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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. Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after EXP . The expiry date refers to the last day of that month. Keep the pre-filled syringe in the outer carton in order to protect from light. Store in a refrigerator (2 C 8 C). Do not freeze. Do not shake. Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles. Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes. This medicine is for single use only. 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 Tremfya contains

The active substance is guselkumab. Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.

The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injections. What Tremfya looks like and contents of the pack Tremfya is a clear, colourless to light yellow solution for injection (injection). It is available in packs containing one pre-filled syringe and in multipacks comprising 2 cartons, each containing 1 pre-filled syringe. Not all pack sizes may be marketed. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Biologics B.V. Einsteinweg 2333CB 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 45 94 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: +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: +353 1 800 709 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

: +357 22 207 Sverige Janssen-Cilag AB Tel: +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 This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: