Stamaril

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: Information for the user

STAMARIL, powder and solvent for suspension for injection

in a pre-filled syringe

Yellow fever vaccine, live

Please read carefully the contents of this leaflet before using the vaccine because it contains important information for the patient

• Please 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 specifically for you. Do not pass it on to others.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is STAMARIL vaccine and what is it used for
• 2. Important information before using STAMARIL vaccine
• 3. How to use STAMARIL vaccine
• 4. Possible side effects
• 5. How to store STAMARIL vaccine
• 6. Contents of the pack and other information

1. What is STAMARIL vaccine and what is it used for

STAMARIL is a vaccine that provides protection against a severe infectious disease called yellow fever.
Yellow fever occurs in some areas of the world and is transmitted to humans through the bites of
infected mosquitoes.
STAMARIL vaccine is given to people who:

• travel to, pass through or live in an area where yellow fever is found,
• travel to any country where an International Certificate of Vaccination is required for entry (which may depend on the countries visited during the same trip),
• may be handling infectious material, such as laboratory personnel.

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

2. Important information before using STAMARIL vaccine

It is important to inform your doctor or nurse if any of the following apply to you or your child. If you are unsure about anything, ask your doctor or nurse to explain .

When not to use STAMARIL vaccine

• If you or your child have been found to be allergic to:
• the active substance, or
• any of the ingredients of STAMARIL vaccine (listed in Section 6), or
• eggs or chicken proteins.
• If you or your child have had a severe allergic reaction after a previous dose of any yellow fever vaccine.
• If the child is less than 6 months old.
• In case of a weakened or impaired immune system for any reason, such as disease or treatment (e.g. steroids in high doses or any other medicines that affect the immune system or chemotherapy). If in doubt, whether a medicine may affect the immune system, consult a healthcare professional before vaccination.
• In case of a weakened immune system due to HIV infection. The doctor will advise, based on laboratory test results, whether STAMARIL vaccine can be given to you or your child.
• If you or your child have HIV infection with symptoms caused by the infection.
• If you or your child have had thymus disease or thymus removal for any reason.
• In case of infection with high or moderate fever or acute illness. Vaccination should be postponed until recovery.

Warnings and precautions

Before using STAMARIL vaccineit is important that a trained healthcare professional assesses the risk to determine whether you or your child should receive the vaccine.

• People over 60 years of age or infants under 9 months, as these people are more likely to experience certain severe, but rare, reactions to the vaccine (including severe reactions that affect the brain and nerves, and organs of the body, see Section 4). These people will only be given the vaccine if the risk of yellow fever virus infection is widely known in the countries they intend to visit.
• These people will only be given the vaccine if the risk of yellow fever virus infection is widely known in the countries they intend to visit.
• Infants between 6 and 9 months old. STAMARIL may be given to children between 6 and 9 months old only in exceptional circumstances and based on current official recommendations.
• Asymptomatic HIV infection. The doctor will advise, based on laboratory test results, whether STAMARIL vaccine can be given.
• Adults and children with bleeding disorders (such as hemophilia or low platelet count) or taking any medicines that prevent normal blood clotting. In these cases, STAMARIL vaccine may be given provided that it is injected under the skin and not into the muscle (see Section 3).
• Allergic reaction to latex. The syringe caps contain a derivative of natural latex, which may cause an allergic reaction.

As with all vaccines, STAMARIL may not fully protect all vaccinated people.
Fainting can occur after, or even before, any vaccination. You should tell your doctor or nurse if you or your child have fainted during previous injections.

STAMARIL and other medicines

Tell your doctor or pharmacist about all medicines you or your child are taking or have recently taken, as well as any medicines you plan to use.
If you or your child have recently received treatment or medicines that may have weakened the immune system, vaccination must be postponed until laboratory tests show that the immune system has returned to normal. Your doctor will inform you of a safe vaccination schedule.
STAMARIL can be given at the same time as measles vaccine or typhoid vaccine (containing Vi capsular polysaccharide) and/or hepatitis A vaccine.
Administration of STAMARIL vaccine may cause false positive results in blood tests for diseases such as dengue fever or Japanese encephalitis. If you or your child are scheduled to have such tests in the future, you should inform your doctor about this vaccination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before vaccination.
STAMARIL vaccine should not be given unless it is unavoidable. Additionally, it is recommended that you do not become pregnant for one month after receiving STAMARIL vaccine.
Your doctor or pharmacist may advise whether vaccination is necessary during pregnancy or breastfeeding. If vaccination is necessary during pregnancy or breastfeeding, it is recommended to stop breastfeeding for at least 2 weeks after receiving STAMARIL vaccine. If you are vaccinated during pregnancy or breastfeeding, consult your doctor, pharmacist, or nurse.

STAMARIL contains sodium, potassium, and sorbitol

This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the vaccine is considered "sodium-free" and less than 1 mmol (39 mg) of potassium per dose, i.e. the vaccine is considered "potassium-free".
This vaccine contains approximately 8 mg of sorbitol per dose.

3. How to use STAMARIL vaccine

Dosage

STAMARIL vaccine is given to adults and children over 6 months of age as a single dose of 0.5 milliliters.
The first dose should be given at least 10 days before the desired protection against yellow fever virus is needed. This is because 10 days are needed after the first dose of the vaccine for it to take effect and provide good protection against yellow fever virus.
Protection provided by this dose is expected to last for at least 10 years and may last for life.
In some cases, a single booster dose (0.5 milliliters) may be required:

• if you or your child have had an insufficient response to the first dose and are still at risk of yellow fever virus infection,
• or depending on official recommendations.

How STAMARIL is given

STAMARIL vaccine is given by injection by a qualified and trained healthcare professional. It is usually injected under the skin, but it can also be given into the muscle.
It must not be injected into a blood vessel.

If you or your child are given more STAMARIL vaccine than needed

In some cases, a higher dose than recommended has been given.
In these cases, when side effects were reported, they were consistent with those described in Section 4.
If you have any doubts about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

The following severe side effects have been reported:

• 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
May occur within one month of vaccination and sometimes resulted in death.
Symptoms may include:

• high fever with headache and disorientation
• severe fatigue
• stiff neck
• inflammation of the brain and nerves
• seizures
• loss of movement or sensation in part or all of the body (e.g. Guillain-Barré syndrome)
• personality changes

Severe reaction affecting the body's organs
May occur within 10 days of vaccination and may result in death. The reaction may resemble yellow fever virus infection. It usually starts with feelings of fatigue, fever, headache, muscle pain, and sometimes low blood pressure. Later, it may progress to severe disease of the muscles and liver, a decrease in the number of certain types of blood cells leading to unusual bruising or bleeding, and increased risk of infections, as well as loss of normal kidney and lung function.

If you or your child experience ANY of the above symptoms, you should

IMMEDIATELY contact your doctor and inform them about the recently administered STAMARIL vaccine.

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 sick (nausea)
• Reactions at the injection site: redness, bruising, swelling, or formation of a hard lump

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Abdominal pain
• Hard lump (nodule) at the injection site

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

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

Frequency not known (frequency cannot be estimated from the available data)

• Enlarged lymph nodes (lymphadenopathy)
• Numbness or tingling (paresthesia)
• Flu-like symptoms

Additional side effects in children

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

• Irritability, crying
• Loss of appetite
• Sleepiness

These side effects usually occurred within 3 days of vaccination and usually lasted no longer than 3 days. Most of these side effects were mild.

Reporting 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. Side effects can be reported to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store STAMARIL vaccine

• Keep out of the sight and reach of children.
• Do not use this vaccine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Store the vial of powder and the pre-filled syringe with solvent in the carton in order to protect from light.
• Use immediately after reconstitution.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What STAMARIL vaccine contains

After reconstitution, in one dose (0.5 ml):

• The active substance of the vaccine is: yellow fever virus strain 17 D-204 (live, attenuated)………at least 1000 IU grown in chick embryos free from specified pathogens
• The other ingredients of the vaccine are: Lactose, sorbitol, L-Histidine hydrochloride, L-Alanine, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, calcium chloride, magnesium sulfate, and water for injections.

What STAMARIL vaccine looks like and contents of the pack

STAMARIL is available as a powder and solvent for suspension for injection (powder in a vial (0.5 ml dose) + solvent in a pre-filled syringe (0.5 ml dose) with or without a needle. Pack size of 1.
After reconstitution, the suspension is beige to pinkish-beige, more or less opalescent.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France

This medicinal product is authorized in the Member States of the European Economic Area under 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.
Date of revision of the leaflet:January 2025

Further information

Detailed information on this medicine is available on the website http://www.urpl.gov.pl

The following information is intended for healthcare professionals only:

Reconstitution instructions:
Before use, the beige to orange-beige powder is mixed with the clear and colorless sodium chloride solvent provided in the syringe to prepare a beige to pinkish-beige suspension, more or less opalescent.
Only for syringes without a needle: after removing the syringe cap, the needle should be firmly attached to the end of the syringe and secured by turning a quarter turn (90 °).
Reconstitution of the vaccine is done by adding the solvent contained in the pre-filled syringe to the vial. The vial is shaken and the resulting suspension, after complete dissolution, is drawn up into the same syringe for injection.
Avoid contact with disinfectants, as they may inactivate the virus.
Use immediately after reconstitution.
Before administration, the reconstituted vaccine should be shaken vigorously.
Any unused product or waste material should be disposed of in accordance with local requirements.
See also Section 3. How to use STAMARIL vaccine.