Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ilumetri

Document Subject

Generated Narrative: MedicinalProductDefinition mp4ef629a7127d0f0a54242fe28701c54c

identifier: http://ema.europa.eu/identifier/EU/1/18/1323/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ilumetri 100 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-4ef629a7127d0f0a54242fe28701c54c

identifier: http://ema.europa.eu/identifier/EU/1/18/1323/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ilumetri

Attesters

What is in this leaflet

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

Ilumetri contains the active substance tildrakizumab. Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of a protein called IL-23, a substance found in the body which is involved in normal inflammatory and immune responses and which is present at increased levels in diseases such as psoriasis.

Ilumetri is used to treat a skin condition called plaque psoriasis, in adults with moderate to severe disease.
Using Ilumetri will benefit you by improvements of skin clearance and reducing your symptoms.

Do not use Ilumetri:

• If you are allergic to tildrakizumab or any of the other ingredients of this medicine (listed in section 6).
• If you have an infection which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs.

Warnings and precautions Talk to your doctor, pharmacist or nurse before using Ilumetri:

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, swelling of the face, lips or throat do not inject more Ilumetri and contact your doctor immediately.
• If you currently have an infection or if you have long-term or repeated infections.
• If you have recently had or plan to have a vaccination.

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

Look out for infections and allergic reactions Ilumetri can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are taking Ilumetri. Stop using Ilumetri and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction (see section 4. Possible side effects).

Children and adolescents Ilumetri is not recommended for use in children and adolescents under 18 years of age. This is because it has not yet been evaluated in this group of patients.

Other medicines and Ilumetri
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. These include vaccines and immunosuppressants (medicines that affect the immune system).

You should not be given certain types of vaccines (live vaccines) while using Ilumetri. No data are available with the concomitant use of Ilumetri and live vaccines.

Pregnancy, breastfeeding and fertility It is preferable to avoid the use of Ilumetri in pregnancy. 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 an effective method of contraception whilst having treatment with Ilumetri and for at least 17 weeks after treatment.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines Ilumetri has no or little effect on the ability to drive and use machines.

Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is for single use only.

The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
If you are a patient with high disease burden or with a body weight above 90 kg, your doctor may decide that a dose of 200 mg is recommended for you.

Your doctor will decide for how long you need to take Ilumetri.

After proper training in subcutaneous injection technique, you may inject Ilumetri yourself if your doctor determines that it is appropriate.

For instructions on how to inject Ilumetri yourself, see Instructions for use at the end of this leaflet.

Talk to your doctor about when you will have your injections and follow-up appointments.

Use in children and adolescents The safety and efficacy of Ilumetri in children and adolescents under 18 years of age has not yet been established and therefore Ilumetri is not recommended for use in children or adolescents.

If you use more Ilumetri than you should If you have administered more Ilumetri than you should or the dose has been administered sooner than according to your doctor s prescription, tell your doctor.

If you forget to use Ilumetri If you have forgotten or missed an Ilumetri injection, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

If you stop using Ilumetri The decision to stop using Ilumetri should be discussed with your doctor. Your symptoms may return upon discontinuation.

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 If you notice any of the following, contact your doctor immediately:

• Swelling of the face, lips or throat
• Breathing difficulties As these may be signs of an allergic reaction.

Other side effects Most of the following side effects are mild. If any of these side effects becomes severe, tell your doctor or pharmacist.

Very common (may affect more than 1 in 10 people)

• Upper respiratory infections

Common (may affect up to 1 in 10 people)

• Gastroenteritis
• Nausea
• Diarrhoea
• Injection site pain
• Back pain
• Headache

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 carton and the label of the pre-filled syringe after EXP. The expiry date refers to the last day of that month.

Keep the product in the original carton in order to protect from light. Do not shake.

Store in a refrigerator (2 C - 8 C). Do not freeze.

After taking a pre-filled syringe from the refrigerator, wait approximately 30 minutes to allow the Ilumetri solution in the syringe to reach room temperature (up to 25 C). Do not warm in any other way.

Do not use if the liquid contains visible particles, is cloudy or is distinctly brown.

Once taken out of the refrigerator, do not store tildrakizumab above 25 C or refrigerate it again. Write down the date of removal from the refrigerator in the space provided on the outer carton and appropriate discard date. Use the syringe within 30 days after taking it out of the refrigerator or by the expiry date whichever occurs first.

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 to protect the environment.

What Ilumetri contains

• The active substance is tildrakizumab. Each pre-filled syringe contains 100 mg of tildrakizumab.
• The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections.

What Ilumetri looks like and contents of the pack
Ilumetri 100 mg solution for injection (injection) in pre-filled syringe is a clear to slightly opalescent and colourless to slightly yellow solution. Ilumetri 100 mg solution for injection (injection) in pre-filled syringe is available in unit packs containing 1 pre-filled syringe and packs comprising 2 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder Almirall, S.A. Ronda General Mitre, 08022 Barcelona, Spain

Manufacturer SUN Pharmaceuticals Industries (Europe) B.V. Polarisavenue 2132JH Hoofddorp, Netherlands

Industrias Farmac uticas Almirall, S.A. Ctra. de Martorell 41-08740 Sant Andreu de la Barca, Barcelona, Spain

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

Belgi /Belgique/Belgien/ Luxembourg/Luxemburg
Almirall N.V. T l/Tel: +32 (0)2 771 86 Italia
Almirall SpA Tel: +39 02 346 / Eesti/ / Espa a/ Hrvatska/ / Latvija/ Lietuva/ Magyarorsz g/ Malta/ Rom nia/ Slovenija
Almirall, S.A. Te ./Tel/ : +34 93 291 30 esk republika / Slovensk republika: Almirall s.r.o Tel: +420 739 686 Nederland
Almirall B.V. Tel: +31 (0)307991Danmark/ Norge/ Sverige
Almirall ApS Tlf/Tel: +45 70 25 75 sterreich
Almirall GmbH Tel: +43 (0)1/595 39 Deutschland
Almirall Hermal GmbH Tel: +49 (0)40 72704-0

Polska
Almirall Sp.z o. o. Tel.: +48 22 330 02 France
Almirall SAS, 1 T l: +33(0)1 46 46 19 Portugal
Almirall - Produtos Farmac uticos, Lda.
Tel: +351 21 415 57 Ireland/United Kingdom (Northern Ireland) Almirall, S.A. Tel: +353 (0) 1431 9Suomi/Finland Orion Pharma Puh/Tel: +358 10 4 sland
Vistor hf. S mi: +354 535 70 This leaflet was last revised in

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