ZABDENO INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

Zabdeno injectable suspension

Ebola virus vaccine (Ad26.ZEBOV-GP [recombinant])

This medicine is subject to additional monitoring, which will allow for 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 or your child are vaccinated, 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.
• This vaccine has been prescribed for you or your child, do not pass it on to others.
• If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think the side effects are not serious. See section 4.

Contents of the package leaflet

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

1. What is Zabdeno and what is it used for

What is Zabdeno

Zabdeno is a vaccine used for future protection against Ebola virus disease. It is given to people aged 1 year and older who may come into contact with the Ebola virus.

Zabdeno is given as the first dose of a 2-dose vaccination schedule to protect you against Ebola virus disease caused by Zaire ebolavirus, which is a type of filovirus. This vaccine will not protect you against other types of filoviruses.

Because Zabdeno does not contain the whole Ebola virus, it cannot give you Ebola virus disease.

The 2-dose vaccination schedule consists of:

• a first dose of the Zabdeno vaccine,
• followed about 8 weeks later by a dose of the Mvabea vaccine.

Even after you have received the Zabdeno and Mvabea vaccination schedule, you must still be very carefulnot to come into contact with the Ebola virus. As with all vaccinations, it is possible that the vaccination schedule may not fully protect all people against Ebola virus disease.

The 2-dose vaccination schedule with Zabdeno and Mvabea should be used in accordance with official recommendations.

What is Ebola

• Ebola is a serious disease caused by a virus. People get Ebola from other people or animals that are infected with Ebola or have died from Ebola.
• You can get Ebola through blood and body fluids like urine, feces, saliva, vomit, sweat, breast milk, semen, and vaginal fluids from people who are infected with the Ebola virus.
• You can also get Ebola through objects that have been in contact with the blood or body fluids of a person or animal with Ebola (such as clothing or objects that have come into direct contact).
• Ebola is not spread through the air, water, or food.

Ebola virus disease usually causes high fever - and this can affect the blood's ability to clot, leading to severe bleeding (“severe haemorrhagic fever”). This can lead to severe illness and, in some cases, death.

• The first signs and symptoms can be fever, tiredness, weakness, or dizziness and muscle pain.
• Later, the signs and symptoms can include bleeding under the skin or in organs of the body such as the liver or kidneys and from the mouth, eyes, or ears. Some people experience severe diarrhea or a sudden drop in blood pressure or blood flow to the body's organs (shock), which can cause serious and permanent damage to these organs, severe confusion (delirium), seizures (epileptic fits), kidney failure, and coma.

Talk to your doctor, pharmacist, or nurse before deciding whether you or your child should be given this vaccine.

How the vaccine works

The 2-dose vaccination schedule with Zabdeno and Mvabea stimulates the body's natural defenses (immune system). The vaccine works by making the body produce its own protection (antibodies) against the virus that causes Ebola infection. This will help protect you against Ebola virus disease in the future.

2. What you need to know before you or your child are given Zabdeno

To make sure that the vaccination schedule is suitable for you or your child, it is important that you tell your doctor, pharmacist, or nurse if any of the following apply to you or your child. If there is anything you do not understand, ask your doctor, pharmacist, or nurse to explain.

Do not have this vaccine

• if you or your child have ever had a severe allergic reaction to any of the active substances or any of the other ingredients listed in section 6.

If you are not sure, talk to your doctor, pharmacist, or nurse before you are given the vaccine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Zabdeno if you or your child:

• have ever had a severe allergic reaction after receiving any other injectable vaccine,
• have ever fainted after an injection,
• have a bleeding problem or bruise easily,
• currently have a fever or infection,
• are taking medicines that weaken the immune system, such as high-dose corticosteroids (e.g. prednisone) or chemotherapy (cancer medicines),
• have a weakened immune system - for example, due to HIV infection or a disease that is inherited (‘genetic disorder’).

If any of the above apply to you or your child (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given Zabdeno.

If you are at high risk of coming into contact with the Ebola virus, a booster vaccination with Zabdeno may be recommended for you or your child. Talk to your doctor, pharmacist, or nurse if this applies to you or your child.

If you or your child only receive one of the vaccines, Zabdeno or Mvabea, this may offer less protection against Ebola virus disease than if you receive a schedule with both vaccines.

As with all vaccines, it is possible that the 2-dose vaccination schedule with Zabdeno and Mvabea may not fully protect all people against Ebola virus disease and it is not known for how long you will be protected.

• People who have been given the 2-dose vaccination schedule must still take precautions to avoid coming into contact with the Ebola virus.

Washing your hands properly is the most effective way to prevent the spread of harmful germs like the Ebola virus. This reduces the number of germs on your hands and their spread from person to person.

The following are adequate hand washing methods.

• Use water and soap when hands are dirty with dirt, blood, or other body fluids. You do not need to use antimicrobial soap for hand washing.
• Use an alcohol-based hand disinfectant when hands are not dirty. Do not use alcohol-based hand disinfectants when hands are dirty with dirt, blood, or other body fluids.

While you are in an Ebola-affected area, it is important to avoid the following:

• Contact with blood and body fluids (such as urine, feces, saliva, sweat, vomit, breast milk, semen, and vaginal fluids).
• Items that have been in contact with the blood or body fluids of an infected person (such as clothing, bedding, needles, and medical equipment).
• Funeral or burial rituals that require handling the body of someone who has died from Ebola.
• Contact with bats, monkeys, or apes or with blood, fluids, and raw meat from these animals (bush meat) or meat of unknown origin.
• Contact with the semen of a man who has had Ebola. You should practice safe sex until you know that the virus has cleared from the semen. Talk to your doctor, pharmacist, or nurse about how long you should practice safe sex.

Children under 1 year of age

Zabdeno should not be given to children under 1 year of age.

Other medicines and Zabdeno

Tell your doctor or pharmacist if you or your child are using, have recently used, or might use any other medicines or vaccines.

Pregnancy and breastfeeding

If you or your daughter are pregnant or breastfeeding, talk to your doctor or pharmacist before you are given this vaccine. Do this also if you think you or your daughter might be pregnant or are planning to have a baby.

Driving and using machines

Zabdeno has no known effects on the ability to drive or use machines.

Zabdeno contains sodium

Zabdeno contains less than 1 mmol of sodium (23 mg) per 0.5 ml, which is essentially “sodium-free”.

Zabdeno contains ethanol (alcohol)

This medicine contains 0.002 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine does not produce any noticeable effects.

3. How Zabdeno is given

Your doctor or nurse will inject the vaccine into a muscle (intramuscular injection) in the upper arm or thigh.

Zabdeno must not be injected into a blood vessel.

The 2-dose vaccination schedule consists of:

• a dose of the Zabdeno vaccine,
• followed about 8 weeks later by a dose of the Mvabea vaccine.

Your doctor will tell you the date of the second vaccination.

How much vaccine you or your child will receive

First vaccination

• First vaccination with Zabdeno - vial with red cap (0.5 ml).
• Second vaccination with Mvabea - vial with yellow cap (0.5 ml), given about 8 weeks after the first vaccination with Zabdeno.

Booster vaccination with Zabdeno (an additional dose of Zabdeno to increase or renew the effect of the 2-dose vaccination schedule previously received with Zabdeno and Mvabea)

• A booster vaccination is recommended for you or your child if you are at high risk of coming into contact with the Ebola virus and have completed the 2-dose vaccination schedule more than 4 months ago.
• Ask your doctor if you or your child should receive a booster vaccination.

During and after injection of the vaccine, the doctor will observe you or your child for 15 minutes, or longer if necessary, in case of a severe allergic reaction.

At the end of this leaflet, there are instructions for preparing the vaccine- for healthcare professionals only.

If you or your child accidentally receive an injection of Zabdeno or Mvabea

• If you or your child are accidentally given Mvabea as the first vaccination - you will receive Zabdeno as the second vaccination about 8 weeks later.
• If you or your child are accidentally given Zabdeno as the first and second vaccinations - you will receive Mvabea about 8 weeks after the second vaccination with Zabdeno.
• If you or your child are accidentally given Mvabea as the first and second vaccinations - you will receive Zabdeno about 8 weeks after the second vaccination with Mvabea.
• If you or your child have not been given Mvabea about 8 weeks after vaccination with Zabdeno - talk to your doctor, pharmacist, or nurse about receiving the second vaccination with Mvabea.

If you miss a vaccination appointment for Zabdeno or Mvabea

• If you miss an appointment, inform your doctor and make a new appointment.
• If you forget a scheduled injection, you may not be fully protected against the Ebola virus.
• If you have any other questions about the use of this vaccine, ask your doctor.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects occurred within 7 days of receiving the injection.

The following side effects may occur in adults.

Very common(may affect more than 1 in 10 people)

• pain, warmth, or swelling at the injection site
• feeling very tired
• headache or muscle pain
• joint pain
• chills

Common(may affect up to 1 in 10 people)

• vomiting
• itching at the injection site
• generalized itching
• fever

Uncommon(may affect up to 1 in 100 people)

• feeling dizzy
• redness and hardening of the skin at the injection site

The following side effects may occur in children and adolescents from 1 to 17 years of age.

Very common(may affect more than 1 in 10 people)

• pain at the injection site
• decreased activity
• decreased appetite
• irritability
• feeling very tired

Common(may affect up to 1 in 10 people)

• swelling, itching, or redness at the injection site

• vomiting
• nausea
• joint pain
• muscle pain
• fever

Rare(may affect up to 1 in 1,000 people)

• febrile seizures (fits) in young children

Most of these side effects are mild or moderate and are not long-lasting.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think the side effects are not serious. You can also report side effects directly through 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 Zabdeno

Keep this vaccine out of the sight and reach of children.

Information on storage, expiry date, and use and disposal is described in the section for healthcare professionals at the end of this leaflet.

Your doctor or pharmacist is responsible for storing this vaccine and disposing of any unused product correctly.

6. Container Contents and Additional Information

Zabdeno Composition

A dose (0.5 ml) contains:

• The active ingredient is Adenovirus type 26 encoding the glycoprotein of the Zaire ebolavirus Mayinga variant*, not less than 8.75 log10 infectious units

• Produced in PER.C6 cells and using recombinant DNA technology.

This product contains genetically modified organisms (GMOs).

• The other components (excipients) are disodium edetate, ethanol, histidine hydrochloride monohydrate, polysorbate-80, sodium chloride, sucrose, water for injectable preparations, and sodium hydroxide (for pH adjustment).

Appearance of Zabdeno and Container Contents

Zabdeno is a suspension in a single-dose glass vial (0.5 ml) with a rubber stopper and red cap.

Colorless to slightly yellowish suspension, between transparent and very opalescent.

Zabdeno is presented in a container that contains 20 single-dose vials.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

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

Date of Last Revision of this Leaflet: <{MM/AAAA}> <{month AAAA}>.

This vaccine has been authorized under exceptional circumstances. This authorization means that, for scientific reasons, it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency will review the new information on this vaccine once a year and this leaflet will be updated as necessary.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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

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This information is intended only for healthcare professionals:

• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of Zabdeno. Individuals should be kept under observation by a healthcare professional for at least 15 minutes after vaccination.
• Zabdeno should not be mixed with other medicinal products in the same syringe.
• Zabdeno should not be administered by intravascular injection under any circumstances.
• Vaccination should be performed by intramuscular (IM) injection, preferably in the deltoid region of the arm or in the thigh.
• Syncopes (fainting) may occur after, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to avoid injury from fainting and to manage syncopal reactions.

Administration and Handling Instructions

Zabdeno is a colorless to slightly yellowish suspension, between transparent and very opalescent.

Before administration, a visual inspection of the vaccine should be performed to check for the presence of particles and color changes. The vial should be inspected visually before administration for cracks or anomalies such as signs of tampering. If any of these signs are present, do not administer the vaccine.

Once removed from the freezer and thawed, use immediately or store in the refrigerator at a temperature of 2 °C to 8 °C (see section 6.4). Once removed from the refrigerator for administration, it should be used immediately.

Mix the contents of the vial by gently rotating it for 10 seconds. Do not shake. Use a sterile needle and a sterile syringe to withdraw the entire contents of the vial for administration.

Use a different sterile needle and syringe for each person. It is not necessary to change the needle used to withdraw the vaccine from the vial before injecting it into the individual, unless the needle has been damaged or contaminated. Any remaining contents in the vial should be discarded.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations. Any spills should be disinfected with agents that have virucidal activity against adenovirus.

Storage Information

Do not use this vaccine after the expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

Transport frozen between -25 °C and -15 °C. Once received, the product can be stored as follows:

Store in a freezer between -85 °C and -55 °C in the case of storage by the distributor. The expiration date when stored between -85 °C and -55 °C is printed on the vial and on the outer carton after CAD.

The distributor or the final user may also store the vaccine in a freezer between -25 °C and -15 °C for a single period of up to 20 months. When removed from the freezer at a temperature between -85 °C and -55 °C, the distributor or the final user should note the new expiration date on the outer carton and the vaccine should be used or discarded at the end of the 20 months. This new expiration date should not exceed the original expiration date (CAD). The original expiration date should be made illegible.

The distributor or the final user may also store the vaccine in a refrigerator between 2 °C and 8 °C for a single period of up to 8 months. When the product is transferred to a storage temperature between 2 °C and 8 °C, the distributor or the final user should note the expiration date on the outer carton and the vaccine should be used or discarded at the end of the 8 months. This expiration date should not exceed the original expiration date (CAD) or the new expiration date assigned for storage conditions between -25 °C and -15 °C. The original expiration date and/or the new expiration date assigned for storage between -25 °C and -15 °C should be made illegible.

Once thawed, the vaccine cannot be re-frozen.

The vial should be kept in the original packaging to protect it from light and for the tracking of the expiration date or the disposal date depending on the different storage conditions.