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REGKIRONA 60 mg/mL concentrate for infusion solution

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About the medicine

How to use REGKIRONA 60 mg/mL concentrate for infusion solution

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Patient Information: Summary of Product Characteristics

Regkirona 60 mg/ml concentrate for solution for infusion

regdanvimab

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start receiving this medicine, because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Regkirona and what is it used for

The active substance of Regkirona is regdanvimab, which 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 are at high risk of severe COVID-19 worsening.

This medicine prevents the virus from entering human cells by binding to the spike protein of SARS-CoV-2. When it binds to the spike protein, it blocks the interaction between the virus and the cell receptor, and this reduces the virus's ability to enter the body's cells. In this way, it helps the body to resist the infection and may help prevent the disease from worsening.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Regkirona

You must not be given Regkirona

  • if you are allergic to regdanvimab or any of the other ingredients of this medicine

(listed in section 6).

  • Tell your doctor or nurse as soon as possible if this applies to you.

Warnings and precautions

Reactions after receiving the medicine

This medicine may cause allergic reactions or other reactions after it is given. See also section 4, "Possible side effects". The symptoms may include:

  • Fever
  • Difficulty breathing
  • Shortness of breath, rapid breathing or rapid heartbeat
  • Chills
  • Fatigue
  • Irregular, rapid or slow heartbeat
  • Chest pain or discomfort
  • 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 hives
  • Itching
  • Muscle pain
  • Feeling dizzy
  • Dizziness
  • Sweating
  • Seek medical attention immediatelyif you experience any of these symptoms.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years of age, as there are no data to indicate that this medicine is safe and effective in this age group.

Other medicines and Regkirona

Tell your doctor or nurseif you are taking or have recently taken any other medicines.

It is not known if this medicine affects other medicines or if they may have an effect on it. Your healthcare team will monitor you for possible signs of drug interactions.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnantor plan to become pregnant, consult your doctorbefore receiving Regkirona. Your doctor will advise you if the benefits of treatment with Regkirona outweigh the potential risks to you and your baby.

It is not known if the components of Regkirona are excreted in breast milk. If you are breastfeeding, consult your doctorbefore receiving Regkirona.

Driving and using machines

Regkirona is not expected to have any effect on the ability to drive or use tools or machines.

3. How Regkirona is given

A doctor or nurse will give you this medicine by infusion into a vein (intravenous infusion) over 60 minutes.

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

This medicine may cause infusion reactions after it is given. You will be closely monitored during treatment and for at least 1 hour after the end of the infusion.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

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

  • Uncommon:may affect up to 1 in 100 people
  • Infusion reactions (e.g. fever; difficulty breathing;

slow, rapid or irregular heartbeat, high blood pressure; rash, including hives; itching or feeling faint)

These types of reactions usually occur within a few minutes to several hours after the infusion is completed.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are 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.

5. Storage of Regkirona

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 carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2 °C and 8 °C). Keep the container in the outer carton to protect it from light. Do not freeze.

Do not use this medicine if you notice particles or color changes before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Regkirona

  • The active substance is regdanvimab. The vial contains 960 mg of regdanvimab in 16 ml (60 mg/ml).
  • The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, L-arginine hydrochloride, and water for injectable preparations.

Appearance of the Product and Container Content

This medicine is a transparent to opalescent solution, colorless to pale yellow. It is presented in a glass vial with a rubber stopper and sealed with an aluminum flip-off cap containing concentrate for solution for infusion.

Regkirona is available in packs of 1 vial.

Marketing Authorization Holder

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Manufacturers

NUVISAN GmbH

Wegenerstr. 13,

Neu-Ulm, Bayern, 89231

GERMANY

NUVISAN FRANCE SARL

2400 route des Colles,

06410 BIOT,

FRANCE

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Belgium

Celltrion Healthcare Belgium BVBA

Tel: +32 1528 7418

[email protected]

Lithuania

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B

tower

Hungary

Tel: +36 1 231 0493

[email protected]

Bulgaria

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Bulgaria

Tel: +36 1 231 0493

[email protected]

Luxembourg

Celltrion Healthcare Belgium BVBA

Tel: +32 1528 7418

[email protected]

Czech Republic

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Hungary

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Denmark

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Malta

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Germany

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Netherlands

Celltrion Healthcare Netherlands B.V.

Tel: +31 20 888 7300

[email protected]

Estonia

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Norway

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Greece

ΒΙΑΝΕΞ Α.Ε.

Tel: +30 210 8009111 – 120

Austria

Astro-Pharma GmbH

Tel: +43 1 97 99 860

[email protected]

Spain

OMFE SA

Carretera Fuencarral-Alcobendas Nº 6 28049

Madrid

Tel: +34 917408700

[email protected]

Poland

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

France

CELLTRION HEALTHCARE FRANCE SAS

14 rue Cambacérès 75008 Paris

Tel: +33 (0)1 71 25 27 00

[email protected]

Portugal

PharmaKERN Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Tel: +351 214 200 290

Croatia

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Romania

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Ireland

Celltrion Healthcare Ireland Ltd.

26, Arrow Building, Old Belgard Road, Tallaght,

Dublin D24 ND70, Ireland

Tel: +353-1-223-4026

Slovenia

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Iceland

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Slovakia

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Italy

Celltrion Healthcare Italy S.R.L.

Tel: +39 0247 927040

Finland

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Cyprus

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Sweden

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Latvia

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

United Kingdom (Northern Ireland)

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Tel: +36 1 231 0493

[email protected]

Date of the last revision of this leaflet: {MM/AAAA}.

Other sources of information

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

The leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.

This leaflet is available electronically in all EU/EEA languages if you scan this code.

Square QR code of black and white modules on a white background for access to additional information

URL: http://www.regkirona-eu.com

--------------------------------------------------------------------------------------------------------------------This information is intended only for healthcare professionals.

Consult the Summary of Product Characteristics or Package Leaflet for more information.

Instructions for healthcare professionals

Regkirona 60 mg/ml concentrate for solution for infusion

regdanvimab

Each single-use vial contains 960 mg of regdanvimab in 16 ml.

Regdanvimab should only be administered in environments where healthcare professionals have immediate access to appropriate resuscitation equipment and medications to treat a severe infusion reaction, including anaphylaxis.

Monitor the patient for potential adverse effects during infusion and for at least 1 hour after the end of the infusion.

If signs and symptoms of a hypersensitivity reaction or anaphylaxis with clinical relevance appear, discontinue treatment immediately and start administering the necessary medications and/or supportive treatment.

Dilution of the concentrate with sodium chloride solution for infusion

A qualified healthcare professional will prepare Regkirona solution for infusion using aseptic techniques:

  • Remove the Regkirona vials from the refrigerator and let them stand at room temperature (not exceeding 30 °C) for approximately 20 minutes before preparation. Do not expose to direct heat sources. Do not shake the vials.
  • Regkirona is a transparent to opalescent solution, colorless to pale yellow. Visually inspect the Regkirona vials for particles and color changes before dilution. If any are observed, discard the vials and use new vials for preparation.
  • Calculate the total administration volume of Regkirona. The volume of Regkirona is calculated as follows.

Calculation to determine the total administration volume of Regkirona:

Patient weight (kg) × Regkirona dose (40 mg/kg)

= Regkirona volume (ml)

Vial concentration (60 mg/ml)

Calculation to determine the total number of Regkirona vials needed:

Total administration volume of Regkirona (ml)

= Number of Regkirona vials

Total volume per vial (16 ml/vial)

needed

Table 1:Sample calculations for patients treated with the recommended dose of 40 mg/kg of Regkirona for a weight range of 40 to 120 kg

Weight (kg)

Total dose (mg)

Volume (ml)

Vials (n)

40

1,600

27

2

60

2,400

40

3

80

3,200

53

4

100

4,000

67

5

120

4,800

80

5

Note: If the patient's weight is above 200 kg, 200 kg should be used to calculate the dose. The maximum recommended dose is 8,000 mg.

  • Dilute Regkirona in a bag with sodium chloride 9 mg/ml (0.9%) solution for infusion. The total volume of the medication and sodium chloride should be 250 ml.
  • In a 250 ml bag with sodium chloride, withdraw and discard the necessary volume (equivalent to the calculated volume of Regkirona) of sodium chloride 9 mg/ml (0.9%) from the infusion bag.
  • Withdraw the calculated volume of Regkirona from the vials with a sterile syringe.
  • Transfer Regkirona to the infusion bag.
  • Gently invert the intravenous infusion bag with your hand approximately 10 times to mix. Do not shake.
  • This product does not contain preservatives, so the diluted infusion solution should be administered immediately. After aseptic dilution in a sodium chloride 9 mg/ml (0.9%) solution for infusion, the prepared Regkirona infusion solution in sodium chloride 9 mg/ml (0.9%) solution for infusion is physically and chemically stable for 72 hours at 2-8 °C or for 4 hours at ≤ 30 °C.
  • From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8 °C, unless the dilution has taken place in controlled and validated aseptic conditions. If refrigerated, let the infusion solution stand at room temperature (not exceeding 30 °C) for approximately 20 minutes before administration.

Administration of the infusion

Regkirona solution for infusion will be administered by a qualified healthcare professional.

  • Gather the recommended materials for infusion: intravenous infusion equipment with an in-line filter (a PES [polyethersulfone] filter with a pore size of 1.2 μm or less is recommended). Connect the infusion equipment to the intravenous infusion bag.
  • Connect the infusion equipment to the intravenous infusion bag.
  • Prime the infusion equipment.
  • Administer the intravenous infusion with an infusion pump over 60 minutes.
  • The prepared infusion solution should not be administered simultaneously with another medication.

The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

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General medicine 6 years exp.

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Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Frequently Asked Questions

Is a prescription required for REGKIRONA 60 mg/mL concentrate for infusion solution?
REGKIRONA 60 mg/mL concentrate for infusion solution requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
Who manufactures REGKIRONA 60 mg/mL concentrate for infusion solution?
REGKIRONA 60 mg/mL concentrate for infusion solution is manufactured by Celltrion Healthcare Hungary Kft.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of REGKIRONA 60 mg/mL concentrate for infusion solution online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether REGKIRONA 60 mg/mL concentrate for infusion solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to REGKIRONA 60 mg/mL concentrate for infusion solution?
Other medicines with the same active substance () include GAMMA ANTI-TETANUS GRIFOLS 250 I.U. PRE-FILLED SYRINGE SOLUTION FOR INJECTION, GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe, HEPATECT 50 IU/ml SOLUTION FOR INFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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