Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xevudy

Document Subject

Generated Narrative: MedicinalProductDefinition mp22dcb829aed4334e1e70ad5ac466fd85

identifier: http://ema.europa.eu/identifier/EU/1/21/1562/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xevudy 500 mg concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-22dcb829aed4334e1e70ad5ac466fd85

identifier: http://ema.europa.eu/identifier/EU/1/21/1562/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - xevudy

Attesters

What is in this leaflet

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

Xevudy contains the active substance sotrovimab. Sotrovimab is a monoclonal antibody, a type of protein designed to recognise a specific target on the SARS-CoV-2 virus, the virus that causes COVID-19. Xevudy is used to treat COVID-19 in adults and adolescents (from 12 years and weighing at least 40 kg). It targets the spike protein that the virus uses to attach to cells, blocking the virus from entering the cell and making new viruses. By preventing the virus from multiplying in the body, Xevudy can help your body overcome the infection and prevent you from getting seriously ill.

You must not receive Xevudy

• if you are allergic to sotrovimab or any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you think this applies to you.

Warnings and precautions

Allergic reactions
Xevudy can cause allergic reactions. See Allergic reactions in Section 4. Infusion-related reactions
Xevudy can cause infusion-related reactions. See Infusion-related reactions in Section 4. Children and adolescents Xevudy should not be given to children or adolescents younger than 12 years old or weighing less than 40 kg.
Other medicines and Xevudy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before receiving Xevudy. Your doctor will advise you whether the benefits of treatment with Xevudy are greater than any likely risks for you and your baby.

It is not known whether the ingredients of Xevudy can pass into breast milk. If you are breast-feeding, you must check with your doctor before you receive Xevudy.

Driving and using machines

Xevudy is not expected to have any effect on your ability to drive or use machines.

The recommended dose for adults and adolescents (aged 12 years and older and weighing at least 40 kg) is:

• 500 mg (one vial)

The medicine will be made up into a solution and given to you by a drip (infusion) into a vein by a doctor or nurse. It takes 30 minutes to give you the full dose of medicine. You will be monitored during and for at least 1 hour after your treatment is given.

The Instructions for healthcare professionals below give details for your doctor, pharmacist or nurse on how the Xevudy infusion is made up and given.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

Allergic reactions to Xevudy are common, affecting up to 1 in 10 people.
Rarely, these allergic reactions may be severe (anaphylaxis), affecting up to 1 in 1,000 people (rare). If you have any of the following symptoms after receiving Xevudy you may be having an allergic reaction and should get medical help immediately:

• skin rash, similar to nettle rash (hives) or redness
• itching
• swelling, sometimes of the face or mouth (angioedema)
• becoming very wheezy, coughing or having difficulty in breathing
• suddenly feeling weak or light-headed (may lead to loss of consciousness or falls).

Infusion-related reactions

Allergic-like reactions when you receive an infusion are common, affecting up to 1 in 10 people. These usually develop within minutes or hours but may develop up to 24 hours after treatment or later. Possible symptoms are presented below. If you get any of the following symptoms after receiving Xevudy, you may be having an infusion-related reaction and should get medical help immediately:

• flushing
• chills
• fever
• difficulty in breathing
• rapid heartbeat
• drop in blood pressure Other side effects

Uncommon (may affect up to 1 in 100 people)

• shortness of breath (dyspnoea).

Reporting of side effects
If you get any side effects, talk to your doctor 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.

The healthcare professionals caring for you are responsible for storing this medicine and disposing of any unused product correctly.

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.

Do not freeze.

Before diluting:

• store in a refrigerator (2 C 8 C).
• store in the original carton in order to protect from light.

Once diluted, this medicine is intended to be used immediately. If after dilution, immediate administration is not possible, the diluted solution may be stored at room temperature (up to 25 C) for up to 6 hours or refrigerated (2 C 8 C) for up to 24 hours from the time of dilution until the end of administration.

What Xevudy contains

• The active substance is sotrovimab. Each vial contains 500 mg of sotrovimab in 8 mL concentrate.
• The other ingredients are histidine, histidine monohydrochloride, sucrose, polysorbate 80, methionine and water for injections.

What Xevudy looks like and contents of the pack

Xevudy is a clear, colourless or yellow to brown liquid supplied in a single-use glass vial with a rubber stopper and flip-off aluminium over-seal. Each carton contains one vial.

Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin Ireland

Manufacturer
GlaxoSmithKline Manufacturing S.p.A. Strada Provinciale Asolana, 90, 43056 San Polo di Torrile, Parma Italy

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

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva GlaxoSmithKline Trading Services Limited Tel: + 370 80000
GlaxoSmithKline Trading Services Limited Te .: + 359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com
Magyarorsz g GlaxoSmithKline Trading Services Limited. Tel: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline Trading Services Limited. Tel: + 356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8produkt.info@gsk.com Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline Trading Services Limited. Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0)1 39 17 84 diam@gsk.com

Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com
Hrvatska GlaxoSmithKline Trading Services Limited Tel: +385 800787Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Rom nia GlaxoSmithKline Trading Services Limited
Tel: + 40800672Slovenija GlaxoSmithKline Trading Services Limited Tel: + 386 80688 sland Vistor hf. S mi: + 354 535 7Slovensk republika GlaxoSmithKline Trading Services Limited Tel: + 421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline Trading Services Limited : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija GlaxoSmithKline Trading Services Limited Tel: + 371 80205United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only. Please refer to the Summary of Product Characteristics for further information.

Treatment should be prepared by a qualified healthcare professional using aseptic technique.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Preparation for dilution

1. Remove one vial of sotrovimab from the refrigerator (2 C to 8 C). Allow the vial to equilibrate to ambient room temperature, protected from light, for approximately 15 minutes.
2. Visually inspect the vial to ensure it is free from particulate matter and that there is no visible damage to the vial. If the vial is identified to be unusable, discard and restart the preparation with a new vial.
3. Gently swirl the vial several times before use without creating air bubbles. Do not shake or vigorously agitate the vial. Dilution instructions
4. Withdraw and discard 8 mL from an infusion bag containing 50 mL or 100 mL of sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose for injection.
5. Withdraw 8 mL from the vial of sotrovimab.
6. Inject the 8 mL of sotrovimab into the infusion bag via the septum.
7. Discard any unused portion left in the vial. The vial is single-use only and should only be used for one patient.
8. Prior to the infusion, gently rock the infusion bag back and forth 3 to 5 times. Do not invert the infusion bag. Avoid forming air bubbles. The diluted solution of sotrovimab is intended to be used immediately. If after dilution, immediate administration is not possible, the diluted solution may be stored at room temperature (up to 25 C) for up to 6 hours or refrigerated (2 C to 8 C) up to 24 hours from the time of dilution until the end of administration.

Administration instructions

1. Attach an infusion set to the infusion bag using standard bore tubing. The intravenous dosing solution is recommended to be administered with a 0.2- m in-line filter.
2. Prime the infusion set.
3. Administer as an IV infusion for 30 minutes at room temperature.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.