Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - skyrizi

Document Subject

Generated Narrative: MedicinalProductDefinition mp2d41c9020db6e6ef74cf6c085116c0ad

identifier: http://ema.europa.eu/identifier/EU/1/19/1361/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Skyrizi 150 mg solution for injection in pre-filled pen

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-2d41c9020db6e6ef74cf6c085116c0ad

identifier: http://ema.europa.eu/identifier/EU/1/19/1361/002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - skyrizi

Attesters

7. Instructions for use

What is in this leaflet

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

Skyrizi contains the active substance risankizumab. Skyrizi is used to treat the following inflammatory diseases:

Plaque psoriasis

Psoriatic arthritis How Skyrizi works This medicine works by stopping a protein in the body called IL-23 , which causes inflammation. Plaque psoriasis Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling. Psoriatic arthritis Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis. Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.

Do not use Skyrizi

if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).

if you have an infection, including active tuberculosis, which your doctor thinks is important. Warnings and precautions Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:

if you currently have an infection or if you have an infection that keeps coming back.

if you have tuberculosis (TB).

if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi. It is important to keep a record of the batch number of your Skyrizi. Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after Lot ) and keep this information in a safe place. Allergic reactions Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:

difficulty breathing or swallowing

swelling of the face, lips, tongue or throat

severe itching of the skin, with a red rash or raised bumps Children and adolescents Skyrizi is not recommended for children and adolescents under 18 years of age. This is because Skyrizi has not been studied in this age group. Other medicines and Skyrizi Tell your doctor, pharmacist or nurse:

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

if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi. If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi. Pregnancy, contraception and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby. If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. Driving and using machines Skyrizi is not likely to affect your driving and use of machines. Skyrizi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per pre-filled pen, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This medicine is given as an injection under your skin (called a subcutaneous injection ).
How much Skyrizi to use Each dose is 150 mg given as a single injection. After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks. You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injection after they have been trained. Read section 7 Instructions for use at the end of this leaflet before injecting Skyrizi yourself. If you use more Skyrizi than you should If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.
If you forget to use Skyrizi If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do. If you stop using Skyrizi Do not stop using Skyrizi without talking 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 Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as:

fever, flu-like symptoms, night sweats

feeling tired or short of breath, cough which will not go away

warm, red and painful skin, or a painful skin rash with blisters Your doctor will decide if you can keep using Skyrizi. Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects Very common: may affect more than 1 in 10 people

upper respiratory infections with symptoms such as sore throat and stuffy nose Common: may affect up to 1 in 10 people

feeling tired

fungal skin infection

injection site reactions (such as redness or pain)

itching

headache

rash Uncommon: may affect up to 1 in 100 people

small raised red bumps on the skin

hives (urticaria) 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 pen label and outer carton after EXP . Store in a refrigerator (2 C - 8 C). Do not freeze. Keep the pre-filled pen in the original carton in order to protect from light. If needed, you may also store the pre-filled pen out of the refrigerator (up to a maximum of 25 C) for up to 24 hours in the original carton to protect from light. Do not use this medicine if the liquid is cloudy or contains flakes or large particles. 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 Skyrizi contains

The active substance is risankizumab. Each pre-filled pen contains 150 mg of risankizumab in 1 mL solution.

The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. What Skyrizi looks like and contents of the pack Skyrizi is a clear and colourless to yellow liquid in a pre-filled pen. The liquid may contain tiny white or clear particles. Each pack contains 1 pre-filled pen. Marketing Authorisation Holder and Manufacturer AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: +370 5 205 3

: +359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel: +420 233 098 Magyarorsz g AbbVie Kft. Tel: +36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30-20-Malta V.J.Salomone Pharma Limited Tel: +356 22983Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (geb hrenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel: +372 623 1Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 91 384 09 Polska AbbVie Sp. z o.o. Tel: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel: +385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. Tel: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd Sverige AbbVie AB : +357 22 34 74 Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: