injection solution 
Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)

Read this leaflet carefully before you are vaccinated. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your healthcare professional.
  • If you get any side effects, talk to your healthcare provider. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Ervebo is and what it is used for 
2. What you need to know before you receive Ervebo 
3. How Ervebo is given 
4. Possible side effects 
5. How to store Ervebo 
6. Contents of the packaging and other information 

1. What Ervebo is and what it is used for

  • Ervebo is a vaccine for adults who are 18 years or older.
  • Ervebo is given to protect you against Ebola, which is caused by the Zaire ebolavirus, which is a type of Ebola virus. This vaccine does not protect you against other types of Ebola virus.
  • Because Ervebo does not contain all of the Ebola viruses, it can not give you Ebola.

Healthcare professionals may recommend that you be given this vaccine in a crisis involving the spread of Ebola.

What is Ebola?

  • Ebola is a serious disease caused by viruses. If you get Ebola, you could die from the disease. Ebola can be transmitted by humans or animals that are infected with Ebola or have died from Ebola.
  • You can get Ebola through blood and body fluids such as urine, feces, saliva, vomit, sweat, breast milk, semen, and vaginal fluids from people infected with the Ebola virus.
  • You can also get Ebola through items that have been in contact with blood or body fluids from a human or animal Ebola (such as clothing or items that have been in direct contact with infection).
  • Ebola is not transmitted through air, water or food.

You will receive information from healthcare professionals and you will then decide together whether you should receive this vaccine.

2. What you need to know before you get Ervebo

You should not get Ervebo:

  • if you are allergic to Ervebo, rice, or any of the other ingredients of this vaccine (listed in section 6).

You should not receive Ervebo if any of the above applies to you. Talk to your healthcare provider if you are unsure.

Warnings and cautions

Everyone who receives this vaccine may not be protected and the time you are protected against Ebola by Ervebo is not known.

Continue to follow the recommendations of your healthcare provider to protect yourself against Ebola infection after receiving this vaccine.

Proper handwashing is the most effective way to prevent the spread of dangerous microorganisms such as the Ebola virus. It reduces the number of microorganisms on your hands and thus reduces their spread from person to person.

Handwash:

Suitable methods for hand washing are described below.

  • Use soap and water when your hands are soiled with dirt, blood, or other body fluids. There is no need to use antimicrobial soap to wash your hands.
  • Use alcohol-based hand sanitizer when hands are not dirty. Do not use alcohol-based hand sanitizer when your hands are soiled with dirt, blood, or other body fluids.

In the area affected by Ebola:

In an area affected by Ebola, it is important to avoid the following:

  • Contact with blood and body fluids (such as urine, feces, saliva, sweat, vomiting, breast milk, semen, and vaginal fluids).
  • Items that may have come in contact with an infected person’s blood or body fluids (such as clothing, bedding, needles, and medical equipment).
  • Funeral or funeral rituals that require the handling of the body of someone who died of Ebola.
  • Contact with bats, monkeys, or with blood, fluids, and raw meat made from these animals (bushmeat) or meat from an unknown source.
  • Contact with semen from a man who has had Ebola. You should practice safe sex until you know that the virus is gone from the sperm.

In case of rash on the skin:

If after the vaccination with Ervebo you get a rash with sore skin, cover it until it heals. Dispose of used patches and dressings, if possible in a closed container, and dispose of them in the dustbin to ensure that people with weakened immune systems or animals do not come into contact with the patches and dressings.

Talk to healthcare professionals before you receive Ervebo if you:

Have had allergic reactions to vaccines or medicines

  • If you have ever had an allergic reaction to a vaccine or medicine, talk to your healthcare provider before receiving this vaccine.

Has a weakened immune system

If your immune system is impaired (meaning your body has a poorer ability to fight disease), you may not be able to get Ervebo. Your immune system may be impaired if:

  • you have HIV – infection or AIDS,
  • you are taking certain medicines that lower the immune system, e.g. immunosuppressive drugs or corticosteroids,
  • you have cancer or problems with the blood that lowers the immune system,
  • Someone in your family has a weakened immune system.

If you think your immune system may be down, ask your healthcare provider before receiving this vaccine. If you receive the vaccine and have a weakened immune system, it may mean that the vaccine does not work as well as in someone with a normal immune system.

Have contact with sensitive people

Tell your healthcare staff if you may be in close contact with or the same household for the next 6 weeks after receiving Ervebo as:

  • infants younger than 1 year,
  • someone who may be pregnant or breastfeeding,
  • someone who has a weakened immune system.

This is because you can pass the virus in the vaccine to them through your body fluids.

Planning to donate blood

  • Do not donate blood for at least 6 weeks after receiving this vaccine.

Has contact with farm animals

  • Make sure that your blood or body fluids do not come into close contact with farm animals for at least 6 weeks after receiving this vaccine. This is because there is a risk that you pass on the virus in the vaccine to the animals.

Have fever

  • If you have a fever, talk to your healthcare provider before receiving Ervebo. The vaccination may need to be postponed until the fever has passed.
  • A mild infection, e.g. a cold, should not be a problem but talk to your healthcare provider before getting Ervebo.

Have a bleeding disorder or have easy bruising

  • Tell your healthcare provider if you have problems with bleeding or you are easily bruised. Ervebo may cause bleeding or bruising at the site where the vaccine is injected.

Test for Ebola after receiving Ervebo

  • You can test positive for the Ebola virus after receiving Ervebo. That does not mean you have Ebola. Tell healthcare professionals that you have received Ervebo. Healthcare professionals may need to take another test.

Children and young people

If you or your child are under 18, talk to your healthcare provider. It is not known if it is safe and works in children and adolescents.

Other medicines and Ervebo

Tell your healthcare provider if you are taking, have recently taken, or might take any other medicines or vaccines.

No studies have examined how other medicines or vaccines and Ervebo may affect each other. The use of Ervebo with other vaccines is not recommended.

If you are planning to receive blood or blood products

You should not be given this vaccine while you are receiving blood or blood products. Ervebo may not have as good an effect if you receive blood or blood products 3 months before or up to 1 month after vaccination.

Pregnancy and breastfeeding

  • If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your healthcare provider before receiving this vaccine. They will help you decide if you should be vaccinated with Ervebo.
  • You should not become pregnant within 2 months of receiving this vaccine. Women who may become pregnant should use an effective method of contraception. It is not known whether Ervebo can harm you or your fetus. It is also not known whether the vaccine can be passed on to your baby via your breast milk.
  • If you can come into close contact with, or in the same household as someone who may be pregnant or breastfeeding for 6 weeks after receiving Ervebo, tell your healthcare provider. This is because you can transmit vaccines to them through your body fluids.

Ervebo contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.

3. How Ervebo is given

Ervebo is provided by health and medical staff. It is given as a single injection (1 ml dose ) in the upper arm or on the outside of the thigh.

If you have any further questions on the use of this vaccine, please contact your healthcare professional.

4. Possible side effects

Like all vaccines, Ervebo can cause side effects, although not everybody gets them.

Serious side effects:

Serious side effects are rare. Seek medical attention immediately if you experience symptoms of an allergic reaction, which may include:

  • wheezing or difficulty breathing,
  • swelling of the face, lips, tongue, or other parts of the body,
  • widespread itching, redness, hot flashes, or itchy lumps on the skin.

Other side effects:

Very common (may affect more than 1 user in 10):

  • Headache,
  • Joint pain,
  • Muscle aches,
  • Fever,
  • Feeling tired,
  • Pain, swelling, or redness at the injection site.

Common (may affect up to 1 in 10 people):

  • Stomach pain,
  • Nausea,
  • Rash,
  • Joint swelling,
  • Overindulge,
  • Heavy sweating.

The number of certain white blood cells may decrease below normal after vaccination, but this decrease has not resulted in disease and the number will return to normal.

Most side effects go away within a few days. Joint pain and joint swelling can sometimes persist for weeks or months. In some people, joint pain and swelling may return after first passing.

Tell your healthcare provider if you get any of the side effects listed above.

Additional side effects in children and adolescents

The vaccine has been studied in a small number of children and adolescents aged 6 to 17 years. In general, side effects in children and adolescents are similar to those in adults.

5. How to store Ervebo

  • 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 vial label and the outer carton after EXP. The expiration date is the last day of the specified month.
  • Store and transport in a frozen state at -80 ° C to -60 ° C.
  • Once the vaccine has been thawed, it should be used immediately. However, after thawing, the vaccine may be stored for up to 14 days at 2 ° C to 8 ° C before use. Discard the vaccine if it has not been used within 14 days. After thawing, the vaccine cannot be re-frozen.
  • When removing from the freezer, the product must be marked with both the date when it was taken out of the freezer and with a new disposal date (instead of the marked expiry date).
  • Keep the vial in the outer carton. Sensitive to light.
  • Do not use the vaccine if you see particles in the liquid.
  • Medicines should not be disposed of via wastewater or household waste. Ask your healthcare provider how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is a live vesicular stomatitis virus. The surface protein of virus et has been replaced by surface protein from Zaireebolavirus (rVSVΔG-ZEBOV-GP).

One dose (1 ml) contains:

Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP 1.2 live, attenuated) ≥72 million pfu 3

Recombinant vesicular stomatitis virus (rVSV) of the Indiana strain on which the VSV envelope glycoprotein (G) has been replaced by surface glycoprotein (GP) from Zaire ebolavirus (ZEBOV) strain Kikwit 1995

2 Produced in Vero cells

3 pfu = plaque-forming units

This product contains genetically modified organisms (GMOs).

This vaccine contains a trace amount of rice protein.

This vaccine contains less than 1 mmol (23 mg) sodium per dose.

The other ingredients are recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, sodium hydroxide.

What the medicine looks like and the contents of the pack

  • Ervebo is a solution for injection.
  • Ervebo is a colorless to pale brownish-yellow liquid.
  • Ervebo is available in packs of 10 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer

Burgwedel Biotech GmbH

In the Long Fields 5

30938 Burgwedel

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & Dohme 
Tel .: +370.5.2780.247 
msd_lietuva@merck.com
BulgariaMark Harp and Dom Bulgaria ЕООД, 
tel .: + 359 2 819 3737 
info-msdbg@merck.com
Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme sro 
Tel .: +420 233 010 111 
dpoc_czechslovak@merck.com
HungaryMSD Pharma Hungary Kft. 
Tel .: + 36.1.888.5300hungary_msd@merck.com
DenmarkMSD Danmark ApSTel: + 45 4482 4000dkmail@merck.com MaltaMerck Sharp & Dohme Cyprus Limited. 
Tel: 8007 4433 (+356 99917558)malta_info@merck.com
GermanyMSD SHARP & DOHME GMBHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel: 0800 9999000(+31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel .: +372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no
GreeceMSD Α.Φ.Β.Ε.Ε.:Ηλ: +30 210 98 97 300dpoc_greece@merck.com AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainMerck Sharp & Dohme de España, SATel: +34 91 321 06 00msd_info@merck.com PolandMSD Polska Sp. z oo 
Tel .: +48.22.549.51.00msdpolska@merck.com
FranceMSD VACCINES 
Phone: +33 (0) 1 80 46 40 40information.medicale@msd.com 
PortugalMerck Sharp & Dohme, LdaTel: +351 21 4465700inform_pt@merck.com
CroatiaMerck Sharp & Dohme doo 
Tel: +385 1 66 11 333croatia_info@merck.com
RomaniaMerck Sharp & Dohme Romania SRLTel: + 4021 529 29 00msdromania@merck.com
IrelandMerck Sharp & Dohme Ireland ( HumanHealth) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, Innovative Customer Service 
Tel: +386.1.520.4201msd.slovenia@merck.com
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicMerck Sharp & Dohme, sr o 
Tel: +421 2 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: +358 (0) 9 804 650info@msd.fi
LatviaSIA Merck Sharp & Dohme Latvia 
Tel: +371.67364.224 
msd_lv@merck.com
United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@merck.com

Muhammad Nadeem

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