Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tezspire

Document Subject

Generated Narrative: MedicinalProductDefinition mpf6cd137002e2af601eb2a1335966e882

identifier: http://ema.europa.eu/identifier/EU/1/22/1677/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tezspire 210 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-f6cd137002e2af601eb2a1335966e882

identifier: http://ema.europa.eu/identifier/EU/1/22/1677/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tezspire

Attesters

What is in this leaflet

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

What Tezspire is and how it works Tezspire contains the active substance tezepelumab, which is a monoclonal antibody. Antibodies are proteins that recognise and bind to a specific target substance in the body, which in the case of tezepelumab is a protein called thymic stromal lymphopoietin (TSLP). TSLP plays a key role in causing the inflammation in your airways that leads to the signs and symptoms of asthma. By blocking the action of TSLP, this medicine helps to reduce inflammation and asthma symptoms. What Tezspire is used for Tezspire is used with other asthma medicines to treat severe asthma in adults and adolescents (12 years of age and older) when the disease is not controlled with their current asthma medicines. How Tezspire can help Tezspire may reduce the number of asthma attacks you experience, improve your breathing and reduce your asthma symptoms.

Do not use Tezspire

if you are allergic to tezepelumab or any of the other ingredients of this medicine (listed in section 6). If this applies to you, or if you are not sure, check with your doctor, pharmacist or nurse. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tezspire.

Tezspire is not a rescue medicine. Do not use it to treat a sudden asthma attack.

If your asthma is not getting any better, or it gets worse during treatment with this medicine, talk to a doctor or nurse.

Look out for signs of allergic reactions. Medicines like Tezspire can potentially cause serious allergic reactions in some people. The signs of these reactions may vary, but can include swelling of your face, tongue or mouth, breathing problems, fast heartbeat, fainting, dizziness, feeling lightheaded, hives and rash. If you notice any of these signs, speak to a doctor or nurse immediately. Talk to your doctor about how to recognise early signs of allergy, and how to manage reactions if they occur.

Look out for any signs of a possible serious infection while you are taking Tezspire such as:

fever, flu-like symptoms, night sweats;

cough which will not go away;

warm, red and painful skin, or a painful skin rash with blisters. If you notice any of these signs, speak to a doctor or nurse immediately. If you already have a serious infection, talk to your doctor before taking Tezspire.

Look out for any symptoms of a heart problem, such as:

chest pain;

shortness of breath;

a general feeling of discomfort, illness, or lack of well-being;

feeling lightheaded or faint. If you notice any of these symptoms, speak to a doctor or nurse immediately.

If you have a parasitic infection or if you live in (or travel to) an area where parasitic infections are common, talk to your doctor. Tezspire may weaken your body s ability to fight certain types of parasitic infections. Children Do not give this medicine to children under 12 years of age because the safety and benefits of this medicine are not known in children in this age group. Other medicines for asthma

Do not suddenly stop taking your other asthma medicines when you start Tezspire. This is especially important if you take steroids (also called corticosteroids). These medicines must be stopped gradually, under the supervision of your doctor and based on your response to Tezspire. Other medicines and Tezspire Tell your doctor or pharmacist:

if you are taking, have recently taken or might use any other medicines.

if you have recently had or are due to have a vaccination. Pregnancy and breast-feeding 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.

Do not use Tezspire during pregnancy unless your doctor advises it. It is not known if Tezspire can harm your unborn baby.

Tezspire may pass into breast milk. If you are breast-feeding or plan to breast-feed, talk to your doctor. Driving and using machines Tezspire is unlikely to affect your ability to drive and use machines. Tezspire contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 210 mg dose, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure. Adults and adolescents aged 12 years and over:

The recommended dose is 210 mg (1 injection) every 4 weeks. Tezspire is given as an injection under the skin (subcutaneously). Your doctor or nurse will decide if you can inject yourself or if your caregiver can do that for you. If so, you or your caregiver will receive training on the right way to prepare and inject Tezspire. Before injecting Tezspire yourself, carefully read the Instructions for Use for Tezspire pre-filled syringe. Do this each time you get another injection. There may be new information. Do not share Tezspire pre-filled syringes or use a syringe more than one time. If you forget to use Tezspire

If you have forgotten to inject a dose, inject a dose as soon as possible. Then have your next injection on your next scheduled injection day.

If you did not notice that you missed a dose until it is time for your next dose, simply inject the next dose as scheduled. Do not inject a double dose to make up for a forgotten dose.

If you are not sure when to inject Tezspire, ask your doctor, pharmacist or nurse. If you stop using Tezspire

Do not stop using Tezspire without speaking first to your doctor, pharmacist or nurse. Interrupting or stopping the treatment with Tezspire may cause your asthma symptoms and attacks to 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 allergic reactions Seek medical attention immediately if you think you may be having an allergic reaction. Such reactions may happen within hours or days after the injection. Not known (the frequency cannot be estimated from the available data)

allergic reactions, including serious allergic reaction (anaphylaxis) symptoms usually include:* swelling of your face, tongue, or mouth* breathing problems, fast heartbeat* fainting, dizziness, feeling lightheaded Other side effects Common (these may affect up to 1 in 10 people)

sore throat

rash

joint pain

injection site reaction (such as redness, swelling, and pain) 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 after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C).

Keep the pre-filled syringe in the outer carton in order to protect from light.

Tezspire may be kept at room temperature (20 C to 25 C) in the outer carton for a maximum of 30 days. Once Tezspire has reached room temperature, do not put it back in the refrigerator. Tezspire that has been stored at room temperature for more than 30 days should be safely disposed of.

Do not shake, freeze or expose to heat.

Do not use this medicine if it has been dropped or damaged, or if the security seal on the carton has been broken. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tezspire contains

The active substance is tezepelumab.

The other ingredients are acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injections. What Tezspire looks like and contents of the pack Tezspire is a clear to opalescent, colourless to light yellow solution. Tezspire is available in a pack containing 1 single-use pre-filled syringe or in a multipack containing 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may be marketed. Marketing Authorisation Holder AstraZeneca AB SE 151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Slovenija AstraZeneca UK Limited Tel: +353 1609 7Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: