Prospect: Information for the User

STAMARIL, powder and solvent for injectable suspension in pre-filled syringe

Vaccine (live) against yellow fever

Read this prospect carefully before you/your child are vaccinated because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your healthcare professional.
• This vaccine has been prescribed only for you or your child andmust not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consultyour healthcare professional and tell them that you received the yellow fever vaccine, even if it is for adverse effects that do not appear in this prospect. See section 4.

1.What is Stamaril and for what it is used

2.What you need to know before you or your child start using Stamaril

3.How to use Stamaril

4.Possible adverse effects

5Storage of Stamaril

6.Contents of the package and additional information

Stamaril is a vaccine that provides protection against a serious infectious disease called yellow fever.

Yellow fever occurs in certain areas of the world and is transmitted to humans through bites from infected mosquitoes.

Stamaril is administered to people who:

• travel, pass through, or live in an area where yellow fever exists.
• travel to any country that requires an International Certificate of Vaccination to enter (this may depend on previously visited countries during the same trip),
• may handle infected materials such as laboratory workers.

To obtain a valid vaccination certificate against yellow fever, it is necessary to be vaccinated at an authorized vaccination center by a qualified and trained healthcare professional, so that an International Certificate of Vaccination can be issued. This certificate is valid for 10 years, starting 10 days after the first dose of vaccine. In some circumstances, when a booster dose is required, the certificate (see section 3) is valid immediately after the injection.

It is essential to consult your healthcare professional if any of the following points apply to you or your child. If you do not understand something, ask your healthcare professional to explain it to you.

Do not use Stamaril if you or your child:

• are allergic to:
• the active substance, or
• any other component of this vaccine (listed in section 6), or
• eggs or chicken proteins.
• have had a severe allergic reaction after a previous dose of any yellow fever vaccine,
• are less than 6 months old,
• have a weakened or impaired immune system due to any reason, such as illness or medical treatment (for example, high doses of steroids or any other medication that affects the immune system or chemotherapy). If you are unsure if the medication can affect your immune system or that of your child, speak with your healthcare professional before administering the vaccine,
• have a weakened immune system due to HIV infection. Your healthcare professional will advise you if you or your child can still receive Stamaril based on the results of your blood tests,
• are infected with HIV and have active symptoms due to the infection
• have a history of problems with the thymus gland or that of your child or have had the thymus gland removed for any reason,
• have an acute illness with high or moderate fever. Vaccination will be delayed until you or your child have recovered.

Warnings and precautions

Before using Stamaril, it is essential to complete a risk assessment with a qualified healthcare professional to determine if you should receive the vaccine.

• If you are over 60 years old or if your child is less than 9 months old due to an increased risk of certain types of severe but rare reactions to the vaccine (including severe reactions affecting the brain and nerves, and vital organs, see section 4). You will only receive the vaccine if the risk of infection with the virus is well established in the countries where you will be staying,
• If your child is between 6 and 9 months old. Stamaril can be administered to children between 6 and 9 months old only in special situations and based on current official recommendations,
• If you or your child is infected with the HIV virus but does not have active symptoms due to the infection. Your healthcare professional will advise you if you can still receive Stamaril based on the results of your laboratory tests and specialist advice,
• If you or your child has any bleeding disorder (such as hemophilia or low platelet count) or is using any medication that prevents normal blood clotting. You can still receive Stamaril as long as it is injected under the skin and not into the muscle (see section 3).
• If you have had any allergic reaction to latex, it may cause severe allergic reactions because it contains a natural latex rubber derivative (latex rubber) in the pre-filled syringe tip.

Like all vaccines, Stamaril may not protect all people who are vaccinated.

After any injection with a needle, or even before, dizziness may occur. Therefore, inform your healthcare professional if you or your child have experienced dizziness with any previous injection.

Use of Stamaril with other medications

Inform your healthcare professional if you are using, have used recently, or may need to use any other medication.

If you have recently received any treatment or medication that may have weakened your immune system, vaccination should be delayed until your laboratory results show that your immune system has recovered. Your doctor will tell you when it is safe for you to be vaccinated.

Stamaril can be administered at the same time as the measles vaccine or vaccines against typhoid fever (those containing the capsular polysaccharide of typhoid fever Vi) and/or against hepatitis A.

Vaccination with Stamaril may lead to false-positive results in blood tests for dengue or Japanese encephalitis. If you or your child are prescribed these types of tests in the future, please inform your doctor about this vaccination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your healthcare professional before using this medication.

You should not receive Stamaril during pregnancy or breastfeeding unless it cannot be avoided. Additionally, it is recommended that you do not become pregnant within one month of receiving STAMARIL. Your healthcare professional will tell you if you need to be vaccinated. If you need to be vaccinated, it is recommended that you interrupt breastfeeding for at least 2 weeks after receiving STAMARIL. If you receive the vaccine during pregnancy or breastfeeding, consult your healthcare professional.

STAMARIL contains sodium, potassium, and sorbitol

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is considered essentially "sodium-free",and less than 1 mmol of potassium (39 mg) per dose,which is considered essentially "potassium-free".

This medication contains approximately 8 mg of sorbitol per dose.

Dose

Stamaril is administered as a single dose of 0.5 milliliters to adults and children aged 6 months and above.

The first dose must be administered at least 10 days before the need for protection against yellow fever. This is because the first dose of the vaccine takes 10 days to take effect and provide good protection against the yellow fever virus. It is expected that the protection provided by this dose will last at least 10 years and may last a lifetime.

In some circumstances, a booster dose with a single dose (0.5 milliliters) may be necessary:

• if you or your child have had an insufficient response to the first dose and you or your child continue to be at risk of contracting the yellow fever virus infection,
• or as per official recommendations.

How Stamaril is administered

Stamaril is administered as an injection by a qualified and trained healthcare professional. It is usually injected under the skin, but it may be injected into a muscle.

It must not be injected into a blood vessel.

If you or your child use more Stamaril than prescribed

In some cases, more doses than recommended were used.

In these cases, when adverse effects were reported, they were in line with those described in section 4.

If you have any other questions about the use of this vaccine, consult your healthcare professional.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

Severe side effects

The following severe side effects have been reported at some time:

Allergic reactions:

-Rash, itching, or hives on the skin

-Swelling of the face, lips, tongue, or other parts of the body

-Difficulty swallowing or breathing

-Loss of consciousness

Reactions affecting the brain and nerves:

These may occur within a month of vaccination and have sometimes been fatal.

The symptoms may include:

-High fever with headache and confusion

-Excessive fatigue

-Stiff neck

-Brain and nerve tissue inflammation

-Seizures

-Loss of movement or sensation in part or all of the body (e.g. Guillain-Barré syndrome)

-Changes in personality

Severe reactions affecting vital organs:

These may appear within 10 days of vaccination and may be fatal. The reaction may resemble yellow fever virus infection. It usually starts with a feeling of fatigue, fever, headache, muscle pain, and sometimes low blood pressure. It may then continue with severe muscle and liver disorders, a decrease in some types of blood cells leading to bruising or bleeding, and an increased risk of infections, and loss of normal kidney and lung function.

If you experience ANY of the above symptoms after vaccination, seek medical attention IMMEDIATELY mentioning that you have recently received STAMARIL.

Other side effects

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

• Headache.
• Mild or moderate fatigue or weakness (asthenia)
• Pain or discomfort at the injection site
• Muscle pain
• Fever (in children)
• Vomiting (in children)

Common (may affect up to 1 in 10 people)

• Fever (in adults)
• Vomiting (in adults)
• Joint pain
• Feeling unwell (nausea)
• Reactions at the injection site: redness, hematomas, swelling, or the appearance of a hard lump

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Stomach pain
• A pimple (papule) at the injection site

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

• Diarrhea
• Runny, congested, or itchy nose (rhinitis)

Frequency not known (cannot be estimated from available data)

• Swollen lymph nodes (lymphadenopathy)
• Numbness or tingling (paresthesia)
• Flu-like illness

Other side effects in children

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

• Irritability, crying
• Loss of appetite
• Somnolence

These side effects usually occurred within 3 days of vaccination and generally did not last more than 3 days. Most of these side effects were of mild intensity.

Reporting side effects

If you experienceany type of side effect, consult your healthcare professional, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this vaccine out of sight and reach of children.
• Do not use this vaccine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Storein the refrigerator (between2°Cand8°C). Do not freeze.
• Store the vial of powder and the syringe of diluent in the outer packaging to protect it from light.
• Use immediately after reconstitution.
• Medicines should not be disposed of through drains or inthe trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of Stamaril

After reconstitution, a dose of 0.5 ml contains:

• The active principle is:

Yellow fever virus 1 (live, attenuated) strain 17D-204………... not less than 1,000 IU

1 propagated in pathogen-free chicken embryos

• The other components are:

Lactose, sorbitol, L-Histidine chloride, L-Alanine, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, calcium chloride, magnesium sulfate, and water for injection preparations.

Appearance of the product and contents of the package

Stamaril is presented as a powder and solvent for injectable suspension (powder in a vial (0.5 ml dose) + solvent in a preloaded syringe (0.5 ml dose) with or without needle). Package of 1.

After reconstitution, the suspension is beige to pinkish-beige, more or less opalescent.

Only some package sizes may be marketed.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing

Sanofi Winthrop Industrie

1541 avenue Marcel Mérieux

69280 Marcy l'Etoile

France

or

Sanofi Winthrop Industrie

Voie de l'Institut – Parc Industriel d'Incarville

B.P 101

27100 Val de Reuil

France

Phone: +34 93 485 94 00

This medicinal product is authorized in the member states of the European Economic Area with the following names:

STAMARIL: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Croatia, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Netherlands, United Kingdom, Iceland, Norway.

Last review date of this leaflet: 12/2020

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals :

Instructions for reconstitution:

Before use, the beige to light orange powder is mixed with the colorless and transparent sodium chloride solvent provided in a syringe to obtain a beige to pinkish-beige suspension, which is more or less opalescent.

Only for syringes without fixed needle: after removing the cap from the end of the syringe, the needle must be firmly attached to the end of the syringe and secured by rotating a quarter of a turn (90°).

The vaccine is reconstituted by adding the solvent provided in the preloaded syringe to the vial. The vial is shaken and, after complete dissolution, the suspension obtained is removed with the same syringe for injection.

Contact with disinfectants should be avoided as they may inactivate the virus.

Use immediately after reconstitution.

Before administration, the reconstituted vaccine must be shaken vigorously.

Any unused or waste medicinal product must be disposed of in accordance with local regulations.

See also section 3. C How to use Stamaril