Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fasenra

Document Subject

Generated Narrative: MedicinalProductDefinition mp7aec1315865776793cc9c31ea9e857c4

identifier: http://ema.europa.eu/identifier/EU/1/17/1252/001 1 pre-filled syringe

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fasenra 30 mg solution for injection in pre-filled syringe

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-7aec1315865776793cc9c31ea9e857c4

identifier: http://ema.europa.eu/identifier/EU/1/17/1252/001 1 pre-filled syringe

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - fasenra

Attesters

What is in this leaflet

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

What Fasenra is Fasenra contains the active substance benralizumab, which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target substance in the body. The target of benralizumab is a protein called interleukin-5 receptor, which is found particularly on a type of white blood cell called an eosinophil. What Fasenra is used for Fasenra is used to treat severe eosinophilic asthma in adults. Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs. Fasenra is used together with other medicines to treat asthma (high doses of corticosteroid inhalers plus other asthma medicines) when the disease is not well controlled by those other medicines alone. How Fasenra works Eosinophils are white blood cells involved in asthma inflammation. By attaching to the eosinophils, Fasenra helps to reduce their numbers and inflammation. What are the benefits of using Fasenra Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms. If you are taking medicines called oral corticosteroids , using Fasenra may also allow you to reduce the daily dose or stop the oral corticosteroids you need to control your asthma.

Do not use Fasenra:

If you are allergic to benralizumab or any of the other ingredients of this medicine (listed in section 6). Check with your doctor, nurse or pharmacist if you think this applies to you. Warnings and precautions Talk to your doctor, nurse or pharmacist before you are given Fasenra:

if you have a parasitic infection or if you live in an area where parasitic infections are common or you are travelling to such a region. This medicine may weaken your ability to fight certain types of parasitic infections.

if you have had an allergic reaction to an injection or medicine in the past (see section 4 for symptoms of an allergic reaction). Also, talk to your doctor, nurse or pharmacist when you are given Fasenra:

if your asthma remains uncontrolled or worsens during treatment with this medicine.

if you have any symptoms of an allergic reaction (see section 4). Allergic reactions have occurred in patients receiving this medicine. Fasenra is not a rescue medicine. Do not use it to treat a sudden asthma attack. Look out for signs of serious allergic reactions Fasenra can potentially cause serious allergic reactions. You must look out for signs of these reactions (such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of your face, tongue or mouth) while you are taking Fasenra. It is important that you talk to your doctor about how to recognise early symptoms of serious allergic reactions and how to manage these reactions if they occur. Other medicines for asthma Do not suddenly stop taking or change the dose of your preventer medicines for your asthma once you have started Fasenra. If your response to the treatment allows it, your doctor may try to reduce the dose of some of these medicines, especially ones called corticosteroids . This should be done gradually and under the direct supervision of your doctor. Children and adolescents Do not give this medicine to children below the age of 18 because the safety and benefits of this medicine are not known in this population. Other medicines and Fasenra Tell your doctor if you are taking, have recently taken or might take any other medicines before using Fasenra. 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 using this medicine. Do not use Fasenra if you are pregnant unless your doctor tells you otherwise. It is not known whether Fasenra could harm your unborn baby. It is not known whether the ingredients of Fasenra can pass into breast milk. If you are breast-feeding or plan to breast-feed, talk to your doctor. Driving and using machines It is unlikely that Fasenra will affect your ability to drive and use machines.

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. The recommended dose is an injection of 30 mg. The first 3 injections are every 4 weeks. After this, injections are 30 mg every 8 weeks. Fasenra is given as an injection just under the skin (subcutaneously). You and your doctor or nurse should decide if you should inject Fasenra yourself. You should not inject Fasenra yourself if you have not received Fasenra previously and if you had previous allergic reaction with Fasenra. You or your caregiver should receive training on the right way to inject Fasenra. Read the Instructions for Use for the pre-filled syringe carefully before using Fasenra. If you forget to use Fasenra If you have forgotten to inject a dose of Fasenra, talk to your doctor, pharmacist or nurse as soon as possible. Stopping treatment with Fasenra Do not stop treatment with Fasenra unless your doctor advises you to. Interrupting or stopping the treatment with Fasenra may cause your asthma symptoms and attacks to come back. If your asthma symptoms get worse while receiving injections of Fasenra, call your doctor. 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):

anaphylaxis symptoms usually include: * swelling of your face, tongue, or mouth * breathing problems* fainting, dizziness, feeling lightheaded (due to a drop in blood pressure) Common (these may affect up to 1 in 10 people):

hypersensitivity reactions (hives, rash) Other side effects Common (these may affect up to 1 in 10 people)

headache

pharyngitis (sore throat)

fever (high temperature)

injection site reaction (for example pain, redness, itching, swelling near where the injection was given) 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. Fasenra is for single use only. Do not use this medicine after the expiry date which is stated on the label and the carton after EXP . The expiry date refers to the last day of that month. Store in the original package in order to protect from light. Store in a refrigerator (2 C to 8 C). The syringe may be kept at room temperature up to 25 C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded, and the discard date should be written on the carton. Do not shake, freeze or expose to heat. 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 Fasenra contains The active substance is benralizumab. One pre-filled syringe of 1 mL solution contains 30 mg benralizumab. The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 and water for injections. What Fasenra looks like and contents of the pack Fasenra is a solution in a clear glass syringe. Its colour may vary from colourless to yellow. It may contain particles.
Fasenra is available in a pack containing 1 pre-filled syringe. Marketing Authorisation Holder AstraZeneca AB SE-151 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW United Kingdom AstraZeneca Nijmegen B.V., Nijmegen Lagelandseweg Nijmegen, 6545CG Netherlands 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 Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +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. Suomi/Finland AstraZeneca Oy Tel: +39 02 00704Puh/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 Detailed information on this medicine is available on the European Medicines Agency web site: