Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - regkirona

Document Subject

Generated Narrative: MedicinalProductDefinition mp7c3f725d5ce5b04f0bcec4815df3bcb5

identifier: http://ema.europa.eu/identifier/EU/1/21/1597/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Regkirona 60 mg/mL 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-7c3f725d5ce5b04f0bcec4815df3bcb5

identifier: http://ema.europa.eu/identifier/EU/1/21/1597/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - regkirona

Attesters

What is in this leaflet

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

The active substance of Regkirona is regdanvimab. It is a monoclonal antibody used for the treatment of COVID-19, a disease caused by a virus called SARS-CoV-2. Regkirona is given to adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. This medicine stops the virus from entering human cells by binding to the spike protein of SARS-CoV-2. When it attaches to the spike protein, the interaction between the virus and the cellular receptor is blocked and the ability of the virus to enter the body s cells is reduced. This can help your body to resist the virus infection, and may help to prevent the disease from getting worse.

Do not use Regkirona:

• if you are allergic to regdanvimab 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

Reactions after receiving the medicine
This medicine can cause allergic reactions or other reactions after the medicine is given to you. See also section 4, Possible side effects . Symptoms can include:

• Fever

• Difficulty breathing

• Shortness of breath, rapid breathing or rapid heartbeat

• Chills

• Feeling tired

• Irregular, rapid or slow heart rate

• Chest discomfort or pain

• Weakness

• Confusion

• Feeling sick (nausea)

• Headache

• Shortness of breath, wheezing

• Low or high blood pressure

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

• Rash including nettle rash

• Itching

• Muscle aches

• Feeling faint

• Dizziness

• Sweating

  Seek urgent medical advice if you get any of these symptoms.

Children and adolescents This medicine is not to be given to children and adolescents under 18 years of age because there are no data to show that this medicine is safe and works in this age group.

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

It is not yet known if this medicine affects other medicines, or if it is affected by them. Your healthcare team will monitor you for signs of medicines affecting each other.

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 Regkirona. Your doctor will advise you whether the benefits of treatment with Regkirona are greater than any likely risks for you and your baby.

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

Driving and using machines Regkirona is not expected to have any effect on your ability to drive or use tools or machines.

This medicine will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) lasting 60 minutes.

The recommended dose is a single dose of 40 mg/kg. This medicine should be given within 7 days of symptom onset.

This medicine can cause infusion reactions after the medicine is given to you. You will be closely monitored during your treatment and for at least 1 hour after infusion is complete.

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.

Tell your doctor or nurse if you notice any of the following side effects:

• Uncommon: may affect up to 1 in 100 people

• Allergic reactions due to an infusion (e.g. fever, difficulty breathing, irregular, rapid or slow heart rate, high blood pressure, rash including nettle rash, itching, feeling faint)

In general, these types of reactions occur within minutes to several hours following completion of the infusion.

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 sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Keep the vial in the outer carton in order to protect from light. Do not freeze.

Do not use this medicine if you notice any particulate matter or discoloration prior to administration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

What Regkirona contains

• The active ingredient is called regdanvimab. The vial contains 960 mg of regdanvimab in 16 mL (60 mg/mL).
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, L-arginine monohydrochloride and water for injections.

What Regkirona looks like and contents of the pack This medicine is a clear to opalescent, colourless to pale yellow liquid solution in a glass vial with a rubber stopper and flip-off aluminium seal supplied as a concentrate for solution for infusion.

Regkirona is available in packs containing 1 vial.

Marketing Authorisation Holder

Celltrion Healthcare Hungary Kft.
1062 Budapest
V ci t 1-3. WestEnd Office Building B torony
Hungary

Manufacturer
NUVISAN GmbH
Wegenerstr. 13,
Neu-Ulm, Bayern, 89GERMANY

NUVISAN FRANCE SARL 2400 route des Colles,
06410 BIOT,
FRANCE

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

Belgi /Belgique/Belgien Celltrion Healthcare Belgium BVBA T l/Tel: + 32 1528 7BEinfo@celltrionhc.com Lietuva Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony

Te .: +36 1 231 0healthcare.hu@celltrionhc.com

Luxembourg/Luxemburg Celltrion Healthcare Belgium BVBA T l/Tel: +32 1528 7BEinfo@celltrionhc.com esk republika Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ma arsko Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Magyarorsz g Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Magyarorsz g Tel.: +36 1 231 0healthcare.hu@celltrionhc.com

Danmark Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungarn Tlf: +36 1 231 0healthcare.hu@celltrionhc.com

Malta Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 0healthcare.hu@celltrionhc.com Deutschland Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungarn Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Nederland Celltrion Healthcare Netherlands B.V. Tel: +31 20 888 7NLinfo@celltrionhc.com Eesti Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungari Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Norge Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungarn Tlf: +36 1 231 0healthcare.hu@celltrionhc.com

. . : +30 210 8009111 sterreich Astro-Pharma GmbH Tel.: +43 1 97 99 office@astropharma.at

Espa a OMFE SA
Carretera Fuencarral-Alcobendas N 6 28Madrid Tel: +34 917408lulopezf@cofares.es Polska Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony W gry Tel.: +36 1 231 0healthcare.hu@celltrionhc.com

France CELLTRION HEALTHCARE FRANCE SAS 14 rue Cambac r s 75008 Paris T l: +33 (0)1 71 25 27 contact_FR@celltrionhc.com Portugal PharmaKERN Portugal Produtos Farmac uticos, Sociedade Unipessoal, Lda. Tel: +351 214 200 Hrvatska Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Rom nia Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungaria Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Ireland Celltrion Healthcare Ireland Ltd. 26, Arrow Building, Old Belgard Road, Tallaght, Dublin D24 ND70, Ireland Tel: +353-1-223-4Slovenija Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 0healthcare.hu@celltrionhc.com

sland Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungverjaland S mi: +36 1 231 0healthcare.hu@celltrionhc.com

Slovensk republika Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ma arsko Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Italia Celltrion Healthcare Italy S.R.L. Tel: +39 0247 927Suomi/Finland Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Unkari Puh/Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 0healthcare.hu@celltrionhc.com
Sverige Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungern Tel: +36 1 231 0healthcare.hu@celltrionhc.com

Latvija Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ung rija Tel: +36 1 231 0healthcare.hu@celltrionhc.com

United Kingdom (Northern Ireland) Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Hungary Tel: +36 1 231 0healthcare.hu@celltrionhc.com

This leaflet was last revised in {MM/YYYY}.

Other sources of information

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