Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ebglyss

Document Subject

Generated Narrative: MedicinalProductDefinition mp3c57f0122132d30c2d609098965d1921

identifier: http://ema.europa.eu/identifier/EU/1/23/1765/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ebglyss 250 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-3c57f0122132d30c2d609098965d1921

identifier: http://ema.europa.eu/identifier/EU/1/23/1765/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ebglyss

Attesters

Instructions for use

What is in this leaflet

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

Ebglyss contains the active substance lebrikizumab.

Ebglyss is used to treat adults and adolescents 12 years and older with a body weight of at least 40 kg with moderate-to-severe atopic dermatitis, also known as atopic eczema, who can be treated with systemic treatments (a medicine given by mouth or injection).

Ebglyss may be used with eczema medicines that you apply to the skin or it may be used on its own.

Lebrikizumab is a monoclonal antibody (a type of protein) that blocks the action of another protein called interleukin-13. Interleukin-13 plays a major role in causing the symptoms of atopic dermatitis. By blocking interleukin-13, Ebglyss can improve your atopic dermatitis and reduce the related itching and skin pain.

Do not use Ebglyss

• if you are allergic to lebrikizumab 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 Ebglyss.

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

Every time you get a new pack of Ebglyss, it is important that you 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

Very rarely, this medicine can cause allergic (hypersensitivity) reactions. These reactions can occur shortly after you take Ebglyss, but also may happen later. If you notice symptoms of an allergic reaction, you should stop using this medicine and contact your doctor or get medical help immediately. Signs of an allergic reaction include:

• breathing problems
• swelling of the face, mouth and tongue
• fainting
• dizziness
• feeling lightheaded (because of low blood pressure)
• hives, itching and skin rash

Eye problems

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

Vaccination

Talk to your doctor regarding your current vaccinations plan. See section Other medicines and Ebglyss .

Children and adolescents This medicine should not be used in children with atopic dermatitis below the age of 12 or adolescents 12 to 17 years of age and weighing less than 40 kg because it has not been tested in this age group.

Other medicines and Ebglyss 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 plan to have one. You should not be given certain types of vaccines (live vaccines) while using Ebglyss.

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

The effects of this medicine in pregnant women are not known. It is better to avoid the use of Ebglyss during pregnancy unless your doctor advises you to use it.

It is not known whether lebrikizumab can pass into breast milk. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you will breast-feed or use Ebglyss. You should not do both.

Driving and using machines Ebglyss is unlikely to influence your ability to drive and use machines.

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

How much Ebglyss is given and for how long Your doctor will decide how much Ebglyss you need and how long you will use it for.

The recommended dose is:

• Two initial injections of 250 mg lebrikizumab each (500 mg in total) at week 0 and week 2. * One injection with 250 mg once every two weeks from week 4 up to week 16. Based on how you respond to the medicine, your doctor may decide to stop giving the medicine or to keep giving you one 250 mg injection every other week up to week 24. * One injection with 250 mg every four weeks from week 16 onwards (maintenance dosing).

Ebglyss is given as an injection under your skin (subcutaneous injection) into the thigh or abdomen, except for 5 cm around the navel. If somebody else gives the injection, it can also be given into the upper arm. You and your doctor or nurse will decide if you can inject Ebglyss yourself.

It is recommended that you change the injection site with each injection. Ebglyss should not be injected into skin that is tender, damaged or has bruises or scars, or in an area of skin that is affected by atopic dermatitis or other skin lesions. For the initial 500 mg dose, administer two 250 mg injections consecutively in different injection sites. It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Ebglyss injection after proper training. In adolescents 12 years of age and older, it is recommended that Ebglyss is administered by or under the supervision of an adult.

The pre-filled syringe must not be shaken.

Read the Instructions for use for the pre-filled syringe carefully before using Ebglyss.

If you use more Ebglyss than you should If you took more Ebglyss than your doctor prescribed or you took the dose before it was scheduled, talk to your doctor, pharmacist or nurse.

If you forget to use Ebglyss If you have forgotten to inject a dose of Ebglyss, talk to your doctor, pharmacist or nurse. If you forgot to inject Ebglyss when you usually have planned to do it, take it as soon as you remember. The next dose should be injected on the regular scheduled day.

If you stop using Ebglyss Do not stop using Ebglyss 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.

Common (may affect up to 1 in 10 people)

• Redness and discomfort in the eye (conjunctivitis)
• Inflammation of the eye due to an allergic reaction (conjunctivitis allergic)
• Eye dryness
• Injection site reactions

Uncommon (may affect up to 1 in 100 people)

• Shingles, a painful, blistering rash in one part of the body (herpes zoster)
• Increase in eosinophils (a type of white blood cell; eosinophilia)
• Inflammation of the cornea (the transparent layer that covers the front of the eye; keratitis)
• Eyelid itching, redness and swelling (blepharitis)

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

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

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

Do not use this medicine if you notice that the solution is cloudy or discoloured or if it contains visible particles. Before use, remove the carton from the refrigerator, take the pre-filled syringe out of the carton and allow to reach room temperature by waiting for 45 minutes. After removal from the refrigerator, Ebglyss must be stored below 30 C and used within 7 days or discarded. Once stored out of refrigeration, do not place back in the refrigerator. The date of removal from the refrigerator may be recorded on the carton.

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 Ebglyss contains

• The active substance is lebrikizumab. Each pre-filled syringe contains 250 mg of lebrikizumab in a 2 mL solution (125 mg/mL).
• The other ingredients are histidine, glacial acetic acid (E260), sucrose, polysorbate 20 (E432) and water for injections.

What Ebglyss looks like and contents of the pack Ebglyss is a clear to opalescent, colourless to slightly yellow to slightly brown sterile solution for injection, free of visible particles. It is supplied as carton packs containing one single-dose, glass, pre- filled syringe or 2 single-dose pre-filled syringes, and as multipacks containing 3 single-dose pre-filled syringes (3 packs of 1), 4 single-dose pre-filled syringes (2 packs of 2), 5 single-dose pre-filled syringes (5 packs of 1) or 6 single-dose pre-filled syringes (3 packs of 2).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Almirall, S.A. Ronda General Mitre, 08022 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 sland Vistor hf. S mi: +354 535 70 / Eesti/ / Espa a/ Hrvatska/ / Latvija/ Lietuva/ Magyarorsz g/ Malta/ Rom nia/ Slovenija Almirall, S.A.
Te ./ Tel/ : +34 93 291 30 Italia Almirall SpA Tel.: +39 02 346 esk republika/Slovensk republika Almirall s.r.o Tel: +420 739 686 Nederland Almirall B.V. Tel: +31 (0) 30 799 11 Danmark/ Norge/ Suomi/Finland/ Sverige Almirall ApS Tlf/ Puh/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 9This leaflet was last revised in .

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