InfoCons Consumer Protection informs you – KAVIGALE – Package Leaflet

Before anything else

Read all of this leaflet carefully before the medicine is given 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, pharmacist 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.

ℹ️ 1. What KAVIGALE is and what it is used for

KAVIGALE is a medicine called a monoclonal antibody . It contains the active substance sipavibart.

KAVIGALE is used to help prevent COVID -19 (pre-exposure prophylaxis). It is used in adults and adolescents aged from 12 years and weighing at least 40 kg who are at increased risk of infection because they have a weakened immune system caused by a medical condition or by treatments .

The active substance in K AVIGALE (sipavibart) is designed to recognise and attach to a specific protein of the SARS -CoV -2 virus that causes COVID -19. This prevents the virus from entering into your cells and from spreading between cells. This may help your body to resist the infection.

⚠️ 2. What you need to know before you are given KAVIGALE

You must not be given this medicine

• if you are allergic to sipavibart or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you are given KAVIGALE

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

This medicine may cause an allergic reaction, which may be severe or life -threatening. If you notice any signs or symptoms of an allergic reaction , get medical help immediately . Signs and symptoms of an allergic reaction include :

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin, with a red rash or raised bumps.

KAVIGALE may cause a reaction to the infusion (drip) . This could happen immediately or within a few hours of the infusion. Symptoms may include:

• feeling sick (nausea)
• joint pain
• headache
• fever and chills
• upset stomach
• pain
• feeling lightheaded or faint
• red, warm face
• coughing
• chest discomfort
• dizziness
• shortness of breath .

Talk to a doctor or nurse if you notice any of these symptoms.

You may still get COVID -19 after you receive K AVIGALE . The SARS -CoV -2 virus that causes COVID -19 change s over time and KAVIGALE may not protect you against every circulating variant of the virus . COVID -19 affects different people in different ways , but the most common symptoms include:

• fever
• chills
• sore throat
• cough
• tiredness
• new loss of taste or smell.

The most serious symptoms of COVID -19 include:

• difficulty breathing or shortness of breath
• loss of speech or mobility
• confusion
• chest pain.

Talk to a doctor right away if you get symptoms of COVID -19.

Children and adolescents

KAVIGALE should not be given to children under 12 years of age and children 12 years of age and older weighing less than 40 kg. It has not been studied in these population s.

Other medicines and KAVIGALE

It is not known if this medicine affects other medicines, or if it is affected by them. Tell your doctor , pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast -feeding Tell your doctor or nurse if you are pregnant, think you m ay be pregnant or are planning to have a baby .

This medicine has not been studied in pregnant women . It is not known if it can affect the unborn child . Your doctor will only give t his medicine if the potential benefits of treatment to the mother outweigh the potential risks to the unborn child.

Tell your doctor or nurse if you are breast -feeding. It is not yet known whether this medicine passes into human breast milk, and what the effects might be on the baby. Your doctor will help you decide whether you can breast -feed or not.

Driving and using machines

It is unlikely that KAVIGALE will affect your ability to drive or use machines.

KAVIGALE contains polysorbate 80

This medicine contains 0.8 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How KAVIGALE is given

The recommended dose is 300 milligrams (mg).

KAVIGALE is given by your doctor or nurse as an injection into the muscle of your thigh or as an infusion into your vein. Depending on how you are given the infusion , the procedure lasts from 6 to about 20 minutes .

Your doctor or nurse will decide how long you will be monitored for side effects after you are given the medicine.

❗ 4. Possible side effects

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

Patients receiving medicines similar to KAVIGALE have experienced serious allergic reactions. If you experience symptoms of a serious allergic reaction, immediately contact a doctor or go to the emergency centre . Signs and symptoms of an allergic reaction include :

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin, with a red rash or raised bumps.

Other side effects

Common (may affect up to 1 in 10 people)

• Injection site reactions ( reactions near where the injection in the muscle was given , such as pain, bruising, redness, bleeding, swelling, blood under the skin, itching, numbness and tingling, rash, discolouration , warm feeling on the skin , discomfort, and inflammation ).
• Allergic reaction (hypersensitivity) including itching, skin redness, hives, rash , feeling lightheaded or faint .
• Infusion site reactions (reactions near where the infusion in the vein was given, such as bruising, pain, itching, redness , and swelling).
• Reactions related to the infusion (reactions that affect the body, such as feeling sick, joint pain, headache , and fever) .

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.

🌡️ 5. How to store KAVIGALE

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 – 8°C).
• Do not freeze.
• Do not shake.
• Keep the vial in the outer carton in order to protect from light.

Prepared syringes or prepared infusion bags should be used immediately. If necessary, store the prepared syringes or prepared infusion bags for no more than:

• 24 hours at 2 °C to 8°C, and
• 4 hours at room temperature up to 25°C.

📦 6. Contents of the pack and other information

What KAVIGALE contains

• The active substance is sipavibart . Each vial contains 300 mg sipavibart in 2 ml of solution.

The other ingredients are histidine, histidine mono hydrochloride, arginine hydrochloride, polysorbate 80 (E 433) and water for injections.

What KAVIGALE looks like and contents of the pack

KAVIGALE is a clear to opalescent, colourless to slightly yellow solution for injection/infusion (injection/infusion), provided in a clear glass vial with a light green cap.

Each carton contains 1 vial.

Marketing Authorisation Holder

AstraZeneca AB SE-151 85 Södertälje Sweden

Manufacturer

AstraZeneca AB Gärtunavägen SE-152 57 Södertälje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 България АстраЗенека България ЕООД Тел.: +359 24455000 Luxembourg/Luxemburg AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11 Česká republika AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111 Magyarország AstraZeneca Kft.

Tel.: +36 1 883 6500 Danmark AstraZeneca A/S Tlf.: +45 43 66 64 62 Malta Associated Drug Co. Ltd Tel: +356 2277 8000 Deutschland AstraZeneca GmbH Tel: +49 40 809034100 Nederland AstraZeneca BV Tel: +31 85 808 9900 Eesti AstraZeneca Tel: +372 6549 600 Norge AstraZeneca AS Tlf: +47 21 00 64 00 Ελλάδα AstraZeneca A.E.

Τηλ: +30 210 6871500 Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 España AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00 Polska AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00 France AstraZeneca Tél: +33 1 41 29 40 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00 Hrvatska AstraZeneca d.o.o.

Tel: +385 1 4628 000 România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Vistor Sími: +354 535 7000 Slovenská republika AstraZeneca AB, o.z.

Tel: +421 2 5737 7777 Italia AstraZeneca S.p.A.

Tel: +39 02 00704500 Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 Κύπρος Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305 Sverige AstraZeneca AB Tel: +46 8 553 26 000 Latvija SIA AstraZeneca Latvija Tel: +371 67377100

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . ———————————————————————————————————————– The f ollowing information is intended for healthcare professionals only:

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

KAVIGALE is supplied as a single -dose vial. KAVIGALE may be administered via an intramuscular injection or via an intravenous infusion using an infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection or a syringe pump. The solution for injection/infusion should be prepared and administered by a healthcare professional, using aseptic technique as follows:

Preparation of the solution before administration 1. Remove the vial from refrigerated storage.

2. Visually i nspect the vial for particulate matter and discolouration. The solution is clear to opalescent, colourless to slightly yellow. Discard the vial if the solution is cloudy, discoloured, or visible particles are observed. Do not shake the vial.

For storage conditions of the prepared syringe or prepared infusion bag, see Summary of Product Characteristics (SmPC) section 6.3.

Intramuscular injection 1. Withdraw 2 ml from the vial into a syringe.

2. Administer the intramuscular injection in the anterolateral aspect of the thigh.

Intravenous infusion – infusion bag or syringe pump Preparation of solution 1. Withdraw 2 ml from the vial and prepare an admixture for infusion by transferring into a 50 ml or 100 ml infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection , or administer using a syringe pump (see below) .

2. Do not freeze or shake the solution.

Administration – infusion bag 1. Do not co -administer other medicinal products through the same infusion line.

2. Administer the infusion solution intravenously via infusion pump or gravity over approximately 20 minutes through an intravenous line containing a sterile, low protein -binding 0.2 or 0.22 micron in -line filter.

3. Once the infusion is complete, flush the tubing with sufficient sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection to ensure delivery of the required dose.

Administration – syringe pump 1. Administer 2 ml (300 mg) as an undiluted intravenous infusion using a syringe pump over at least 6 minutes.

2. After the entire contents of the syringe have been administered, flush the administration set with a sufficient volume of sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection to ensure that the full dose has been administered.

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information KAVIGALE (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1900).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.