Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - veklury

Document Subject

Generated Narrative: MedicinalProductDefinition mp0884c8c34711aaaaa6729d5f920f611f

identifier: http://ema.europa.eu/identifier/EU/1/20/1459/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Veklury 100 mg powder for concentrate for solution for infusion

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-0884c8c34711aaaaa6729d5f920f611f

identifier: http://ema.europa.eu/identifier/EU/1/20/1459/002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - veklury

Attesters

What is in this leaflet

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

The active substance in Veklury is remdesivir. It is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Veklury stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.

Veklury will be given to treat COVID-19 in:

• adults and children (at least 4 weeks old and weighing at least 3 kg) who have pneumonia, and need extra oxygen to help them breathe, but who are not on artificial ventilation (where mechanical means are used to assist or replace spontaneous breathing at start of treatment).
• adults and children (weighing at least 40 kg) who do not need extra oxygen to help them breathe and are at increased risk for progressing to severe COVID-19.

You will not usually be given Veklury:

• if you are allergic to remdesivir, or any of the other ingredients of this medicine (listed in section 6) Talk to your doctor or nurse as soon as possible, if this applies to you. Warnings and precautions Talk to your doctor or nurse before starting on Veklury:
• if you have kidney problems. Your doctor may monitor you if you have kidney problems to ensure your safety.
• If you are immunocompromised. Your doctor may monitor you more closely if your immune system is not working properly to ensure the treatment is working.

Reactions following the infusion Veklury can cause allergic reactions following and during the infusion, including anaphylactic reactions (sudden life-threatening allergic reactions). Allergic reactions have been seen rarely. For anaphylactic reactions frequency cannot be estimated from the available data. Symptoms can include:

• Changes to blood pressure or heart rate

• Low oxygen level in blood

• High temperature

• Shortness of breath, wheezing

• Swelling of the face, lips, tongue or throat (angioedema)

• Rash

• Feeling sick (nausea)

• Being sick (vomiting)

• Sweating

• Shivering

  Tell your doctor or nurse straight away if you notice any of these effects.

Blood tests before and during treatment If you are prescribed Veklury, you may be given blood tests before treatment starts. Patients being treated with Veklury may have blood tests during their treatment as determined by their healthcare professional. These tests are to check for kidney problems.

Children and adolescents Veklury is not to be given to children under 4 weeks old or to children who weigh less than 3 kg. Not enough is known for it to be given to these children.

Other medicines and Veklury Tell your doctor or nurse about any other medicines you are taking, or have recently taken.

Do not take chloroquine or hydroxychloroquine at the same time as Veklury.

Tell your doctor if you are taking any of these medicines

Pregnancy and breast-feeding Tell your doctor or nurse if you are pregnant, or if you might be. There is not enough information to be sure that Veklury is safe for use in first trimester of pregnancy. Veklury should only be given if the potential benefits of treatment outweigh the potential of risks to the mother and the unborn child. Discuss with your doctor the need to use effective contraception during treatment with Veklury.

Tell your doctor or nurse if you are breast-feeding. Veklury passes into human breast milk in very small amounts. Because there is limited experience with use during breast-feeding, you should carefully discuss with your doctor whether to continue or interrupt breast-feeding during treatment with Veklury. Driving and using machines Veklury is not expected to have any effect on your ability to drive.

Veklury contains a cyclodextrin This medicine contains 3 g betadex sulfobutyl ether sodium in each 100 mg dose of Veklury (6 g in the starting dose). This ingredient is a cyclodextrin emulsifier that helps the medicine to disperse in the body.

Veklury contains sodium This medicine contains 212 mg sodium (main component of cooking/table salt) in each 100 mg dose unit. This is equivalent to 10.6 % of the recommended maximum daily dietary intake of sodium for an adult.

Veklury will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) lasting 30 to 120 minutes, once a day. You will be closely monitored during your treatment.

Recommended dose for adults and children

Adults Children (weighing at least 40 kg) Children at least 4 weeks old (weighing at least 3 kg but less than 40 kg) Day 1 (single starting dose)
200 mg 200 mg 5 mg per kg of body weight Day 2 and onwards (once daily) 100 mg 100 mg 2.5 mg per kg of body weight

How long treatment lasts

Adults

Children (weighing at least 40 kg) Children at least 4 weeks old (weighing at least 3 kg but less than 40 kg) Patients who have pneumonia and need extra oxygen Daily for at least 5 days. May be extended up to a total of 10 days. Daily for at least 5 days. May be extended up to a total of 10 days. Daily for up to a total of 10 days. Patients who do not need extra oxygen and are at increased risk for progressing to severe COVID-Daily for 3 days, starting within 7 days of the onset of COVID-symptoms. Daily for 3 days, starting within 7 days of the onset of COVID-symptoms. Not applicable.

See the Instructions for healthcare professionals which gives details on how the Veklury infusion is given.

If you are given more or less Veklury than you should
As Veklury is only given to you by a healthcare professional, it is unlikely that you will be given too much or too little. If you have been given an extra dose, or missed one, tell your nurse or doctor straight away.

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.

Some side effects could be or could become serious:

Rare (these may affect up to 1 in 1000 patients)

• Allergic reactions following and during the infusion. Symptoms can include:
• Changes to blood pressure or heart rate
• Low oxygen level in blood
• High temperature
• Shortness of breath, wheezing
• Swelling of the face, lips, tongue or throat (angioedema)
• Rash
• Feeling sick (nausea)
• Being sick (vomiting)
• Sweating
• Shivering

Not known (frequency cannot be estimated from the available data)

• Anaphylactic reactions, anaphylactic shock (sudden life-threatening allergic reactions) Symptoms are the same as for allergic reactions however the reaction is more severe and requires immediate medical care.
• Sinus bradycardia (heart beats more slowly than normal).
  Tell your doctor or nurse straight away if you notice any of these effects.

Other side effects:

Very common side effects (these may affect more than 1 in 10 patients)

• Blood tests may show an increase in liver enzymes, called transaminases
• Blood tests may show it takes longer for blood to clot

Common side effects (these may affect up to 1 in 10 patients)

• Headache
• Feeling sick (nausea)
• Rash

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.

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

• Before use, this medicinal product does not require any special storage conditions.
• Once reconstituted, Veklury should be diluted immediately.
• Once diluted, Veklury should be used immediately. If necessary, bags of diluted solution can be stored for up to 24 hours below 25 C, or for up to 48 hours in a refrigerator. Do not allow more than 48 hours between dilution and administration.

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 Veklury contains

• The active substance is remdesivir. Each vial contains 100 mg.
• The other ingredients are: betadex sulfobutyl ether sodium, hydrochloric acid and sodium hydroxide.

What Veklury looks like and contents of the pack Veklury 100 mg powder for concentrate for solution for infusion is a white, off-white to yellow powder, to be reconstituted and then diluted into sodium chloride solution prior to administration by intravenous infusion. It is supplied in a single-use clear glass vial.

Veklury is available in cartons containing 1 vial.

Marketing Authorisation Holder and Manufacturer Gilead Sciences Ireland UC Carrigtohill County Cork, T45 DPIreland

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

Belgi /Belgique/Belgien Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 Lietuva Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1
Gilead Sciences Ireland UC .: + 353 (0) 1 686 1Luxembourg/Luxemburg Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 esk republika Gilead Sciences s.r.o. Tel: + 420 910 871 Magyarorsz g Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1Danmark Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1Malta Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0

Nederland Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 Eesti Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Norge Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 210 8930 sterreich Gilead Sciences GesmbH Tel: + 43 1 260 Espa a Gilead Sciences, S.L. Tel: + 34 91 378 98 Polska Gilead Sciences Poland Sp. z o.o. Tel.: + 48 22 262 8France Gilead Sciences T l : + 33 (0) 1 46 09 41 Portugal Gilead Sciences, Lda. Tel: + 351 21 7928Hrvatska Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Rom nia Gilead Sciences (GSR) S.R.L. Tel: + 40 31 631 18 Ireland Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 Slovenija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1 sland Gilead Sciences Sweden AB S mi: + 46 (0) 8 5057 1Slovensk republika Gilead Sciences Slovakia s.r.o. Tel: + 421 232 121 Italia Gilead Sciences S.r.l. Tel: + 39 02 439Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 210 8930 Sverige Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1Latvija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1United Kingdom (Northern Ireland) Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113 This leaflet was last revised in .

Other sources of information

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