Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - adtralza

Document Subject

Generated Narrative: MedicinalProductDefinition mp5e5d8991119f1b6cc9a73ed8524ab6d3

identifier: http://ema.europa.eu/identifier/EU/1/21/1554/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Adtralza 150 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

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5e5d8991119f1b6cc9a73ed8524ab6d3

identifier: http://ema.europa.eu/identifier/EU/1/21/1554/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - adtralza

Attesters

What is in this leaflet

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

Adtralza contains the active substance tralokinumab.

Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays a major role in causing the symptoms of atopic dermatitis.

Adtralza is used to treat adult and adolescent patients 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Adtralza may be used with eczema medicines that you apply to the skin or it may be used on its own.

Using Adtralza for atopic dermatitis can improve your eczema and reduce the related itching and skin pain.

Do not use Adtralza:

• if you are allergic to tralokinumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Adtralza.

Warnings and precautions Talk to your doctor, pharmacist or nurse before using Adtralza.

Allergic reactions Very rarely, medicines can cause allergic (hypersensitivity) reactions and severe allergic reactions called anaphylaxis. You must look out for signs of these reactions (such as breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (because of low blood pressure), hives, itching and skin rash) while you are using Adtralza. Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction. Such signs are listed in the beginning of section 4. Parasitic infection in the intestines Adtralza may reduce your resistance to infections caused by parasites. Any parasitic infection should be treated before you start treatment with Adtralza. Tell your doctor if you have diarrhoea, gas, upset stomach, greasy stools, and dehydration which could be signs of a parasitic infection. If you live in a region where these infections are common or if you are travelling to such a region, tell your doctor.

Eye problems Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.

Children
Do not give this medicine to children below the age of 12 years because the safety and benefits of Adtralza are not yet known in this population.

Other medicines and Adtralza Tell your doctor or pharmacist

• If you are using, have recently used or might use any other medicines.
• If you have recently had a vaccination or are due to have one.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor for advice before using this medicine. The effects of Adtralza in pregnant women are not known; therefore, it is preferable to avoid using it during pregnancy unless your doctor advises you to use it.

If applicable, you and your doctor should decide if you will breast-feed or use Adtralza. You should not do both.

Driving and using machines Adtralza is unlikely to reduce your ability to drive and use machines.

Adtralza contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 150 mg that is to say essentially sodium-free .

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Each pre-filled syringe contains 150 mg of tralokinumab.

How much Adtralza is given and for how long

• Your doctor will decide how much Adtralza you need and for how long.
• The recommended first dose is 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) given every 2 weeks. Based on how well the medicine works, your doctor may decide that you can have a dose every 4 weeks.

Adtralza is given by injection under your skin (subcutaneous injection). You and your doctor or nurse can decide if you can inject Adtralza yourself.

Inject Adtralza yourself only after you have been trained by your doctor or nurse. A caregiver may also give you your Adtralza injection after proper training.

Do not shake the syringe.

Read the Instructions for Use before injecting Adtralza.

If you use more Adtralza than you should If you use more of this medicine than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse.

If you forget to use Adtralza If you miss injecting a dose at the right time, inject Adtralza as soon as possible. Then the next dose should be injected at the regular scheduled time.

If you stop using Adtralza Do not stop using Adtralza without speaking to your doctor first.

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. Adtralza can cause serious side effects, including allergic (hypersensitivity) reactions such as anaphylaxis; the signs may include:

• breathing problems
• swelling of the face, mouth, and tongue
• fainting, dizziness, feeling lightheaded (low blood pressure)
• hives
• itching
• skin rash Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of allergic reaction.

Other side effects

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

• upper respiratory tract infections (i.e. common cold and sore throat)

Common (may affect up to 1 in 10 people)

• eye redness and itching
• eye infection
• injection site reactions (i.e. redness, swelling)

Uncommon (may affect up to 1 in 100 people)

• eye inflammation which may cause eye pain or decreased vision

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

Keep in the original package in order to protect from light.

Store in a refrigerator (2 C to 8 C). Do not freeze. If necessary, Adtralza may be kept at room temperature up to 25 C in the original package for a maximum of 14 days. Do not store above 25 C. Throw away Adtralza if it is not used within 14 days of storage at room temperature.

If you need to permanently remove the carton from the refrigerator, write down the date of removal on the carton, and use Adtralza within 14 days. Adtralza must not be refrigerated again during this period.

Do not use this medicine if you notice that it is cloudy, discoloured or has particles in it. Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

What Adtralza contains

• The active substance is tralokinumab.
• Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution for injection.
• The other ingredients are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polysorbate 80 (E433) and water for injections.

What Adtralza looks like and contents of the pack Adtralza is a clear to opalescent, colourless to pale yellow solution, supplied in a glass pre-filled syringe with a needle guard.

Adtralza is available in unit packs containing 2 pre-filled syringes or in multipacks containing 4 (2 packs of 2) or 12 (6 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

LEO Pharma A/S Industriparken DK-2750 Ballerup Denmark

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

Belgi /Belgique/Belgien LEO Pharma N.V./S.A T l/Tel: +32 3 740 7Lietuva LEO Pharma A/S Tel: +45 44 94 58
LEO Pharma A/S Te .: +45 44 94 58 Luxembourg/Luxemburg LEO Pharma N.V./S.A T l/Tel: +32 3 740 7 esk republika LEO Pharma s.r.o. Tel: +420 734 575 Magyarorsz g LEO Pharma A/S Tel: +45 44 94 58 Danmark LEO Pharma AB Tlf: +45 70 22 49 Malta LEO Pharma A/S Tel: +45 44 94 58 Deutschland LEO Pharma GmbH Tel: +49 6102 2Nederland LEO Pharma B.V. Tel: +31 205104Eesti LEO Pharma A/S Tel: +45 44 94 58 Norge LEO Pharma AS Tlf: +47 22514
LEO Pharmaceutical Hellas S.A. : +30 210 68 34 sterreich LEO Pharma GmbH Tel: +43 1 503 6Espa a Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3Polska LEO Pharma Sp. z o.o. Tel.: +48 22 244 18 France Laboratoires LEO T l: +33 1 3014 4Portugal LEO Farmac uticos Lda.
Tel: +351 21 711 0Hrvatska LEO Pharma A/S Tel: +45 44 94 58 Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8Rom nia LEO Pharma A/S Tel: +45 44 94 58 Slovenija LEO Pharma A/S Tel: +45 44 94 58 sland Vistor hf. S mi: +354 535 7Slovensk republika LEO Pharma s.r.o. Tel: +420 734 575 Italia LEO Pharma S.p.A Tel: +39 06 52625Suomi/Finland LEO Pharma Oy Puh/Tel: +358 20 721 8
The Star Medicines Importers Co. Ltd. : +357 2537 1Sverige LEO Pharma AB Tel: +46 40 3522 Latvija LEO Pharma A/S Tel: +45 44 94 58 United Kingdom (Northern Ireland) LEO Laboratories Ltd Tel: +44 (0) 1844 347This leaflet was last revised in

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