Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - evusheld

Document Subject

Generated Narrative: MedicinalProductDefinition mp1f675c75ae2647759e12de1b52c8e0f9

identifier: http://ema.europa.eu/identifier/EU/1/22/1651/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: EVUSHELD 150 mg + 150 mg solution for injection

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-1f675c75ae2647759e12de1b52c8e0f9

identifier: http://ema.europa.eu/identifier/EU/1/22/1651/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - evusheld

Attesters

What is in this leaflet

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

EVUSHELD is made up of two active substances: tixagevimab and cilgavimab. These are both medicines called monoclonal antibodies. These antibodies are proteins that attach to a specific protein of SARS-CoV-2, the virus that causes COVID-19. By attaching to this protein, they prevent the virus from entering human cells. EVUSHELD is used for the pre-exposure prophylaxis (prevention) of COVID-19 infection in adults and adolescents aged 12 years and older weighing at least 40 kg. EVUSHELD is used to treat adults and adolescents, aged from 12 years and weighing at least 40 kg, with COVID-19 who:

do not require supplemental oxygen to treat COVID-19, and

are at increased risk for the illness becoming severe based on the evaluation of your doctor.

You must not be given this medicine

if you are allergic to tixagevimab, cilgavimab or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given EVUSHELD

if you have low numbers of blood platelets (which help blood clotting), any blood clotting problems or are taking a medicine to prevent blood clots (an anticoagulant).

if you have ever had a severe allergic reaction or breathing problems after you were given EVUSHELD in the past. Tell a doctor, pharmacist or nurse or get medical help immediately:

if you notice any symptoms of a cardiac event, 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 signs of a severe allergic reaction, 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 EVUSHELD should not be given to children under 12 years of age or weighing less than 40 kg. Other medicines and EVUSHELD Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because it is not yet known if this medicine affects other medicines, or if it is affected by them. Pregnancy and breastfeeding Tell your doctor or nurse if you are pregnant, or if you might be pregnant.

This is because there is not enough information to be sure that this medicine is safe for use in pregnancy.

This medicine will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child. Tell your doctor or nurse if you are breast-feeding.

This is because it is not yet known whether this medicine passes into human breast milk, or what the effects might be on the baby or milk production.

Your doctor will help you decide whether to keep breast-feeding or to start treatment with this medicine. Driving and using machines It is unlikely that EVUSHELD will affect your ability to drive or use machines.

The recommended dose for pre-exposure prophylaxis (prevention) is 300 milligrams (mg), given as two injections:

150 mg of tixagevimab

150 mg of cilgavimab The recommended dose for treatment of mild to moderate COVID-19 is 600 mg, given as two injections:

300 mg of tixagevimab

300 mg of cilgavimab EVUSHELD consists of two separate solutions, one containing tixagevimab and one containing cilgavimab. They will be given to you by your doctor or nurse who will inject each one into a separate muscle, usually one into the muscle of each buttock. The 2 injections will be given one after the other. Your doctor or nurse will decide how long you will be monitored after you are given the medicine. This is in case you have any side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects Common (may affect up to 1 in 10 people)

hypersensitivity reaction (rash or an itchy red rash or raised bumps)

injection site reaction (pain, redness, itching, swelling near where the injection was given) Uncommon (may affect up to 1 in 100 people)

injection related reaction (examples of these include headache, chills and redness, discomfort or soreness near where the injection was given) Rare (may affect up to 1 in 1000 people)

sudden, severe allergic reaction with breathing difficulty, swelling, light headedness, fast heartbeat, sweating and loss of consciousness (anaphylaxis) 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. Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals. Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month. Unopened vials:

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

Do not freeze.

Do not shake.

Store in the original package in order to protect from light. Prepared syringes should be used immediately. If necessary, store the prepared syringes for no more than 4 hours at 2 C to 25 C.

What EVUSHELD contains The active substances are:

tixagevimab 150 mg in 1.5 mL of solution.

cilgavimab 150 mg in 1.5 mL of solution. The other ingredients are histidine, histidine hydrochloride monohydrate, sucrose, polysorbate 80 and water for injections. What EVUSHELD looks like and contents of the pack EVUSHELD contains two clear glass vials of solution for injection:

Tixagevimab solution for injection (dark grey cap) is a clear to opalescent, colourless to slightly yellow solution.

Cilgavimab solution for injection (white cap) is a clear to opalescent, colourless to slightly yellow solution. Each carton contains 2 vials: 1 vial of tixagevimab and 1 vial of cilgavimab. 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. Polska AstraZeneca Pharma Poland Sp. z o.o. Tel: +34 91 301 91 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. 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: