Stamaril

Package leaflet: Information for the user

STAMARIL

powder and solvent for injectable suspension in pre-filled syringe
Yellow fever vaccine (live)
Please 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 questions, ask your healthcare professional.
• This vaccine has been prescribed only for you or your child. Do not give it to others.
• If you experience any side effects, including those not listed in this leaflet, contact your healthcare professional and inform them that you have received the yellow fever vaccine. See Section 4.

Contents of this leaflet:

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

1. What STAMARIL is and what it is used for

STAMARIL is a vaccine that protects you against a serious infectious disease called yellow fever.
Yellow fever occurs in certain areas of the world and is transmitted to humans through the bite of
infected mosquitoes.

• STAMARIL is given to individuals who:
• are travelling to, passing through or living in areas where yellow fever is present;
• are travelling to any country requiring an International Certificate of Vaccination for entry (this may be required depending on previously visited areas);
• may handle infected materials (e.g. laboratory personnel).

To obtain a valid yellow fever vaccination certificate, vaccination must be administered
at an authorized vaccination centre by a qualified and trained healthcare professional authorized to issue an International Certificate of Vaccination. This certificate becomes valid starting from the
tenth day after administration of the first vaccine dose. Under certain circumstances,
when a booster dose is required, the certificate (see Section 3) becomes valid immediately after the injection.

2. What you should know before you or your child use STAMARIL

It is important to inform your healthcare provider if any of the following apply to you or your child. If anything is unclear, please ask your healthcare provider for clarification.

Do not use STAMARIL if you or your child:

• are allergic to:
  • the active substance, or
  • any of the other components of this vaccine (listed in Section 6), or
  • egg or chicken proteins;
• have had a severe allergic reaction after receiving a previous dose of any yellow fever vaccine;
• your child is less than 6 months of age;
• have a weakened or impaired immune system for any reason, such as due to illness or medical treatments (for example, high-dose steroids or any other medicine that affects the immune system, or chemotherapy). If you are unsure whether a medication may affect the immune system of you or your child, discuss this with your healthcare provider before the vaccine is administered;
• have a weakened immune system due to HIV infection. Your healthcare provider will inform you whether you or your child can receive STAMARIL based on blood test results;
• are infected with HIV and have active symptoms due to the infection;
• you or your child have had problems with your thymus gland or if the thymus gland has been removed for any reason;
• have a moderate or severe fever or an acute illness. Vaccination should be postponed until you or your child has recovered.

Warnings and precautions
Before using STAMARIL, it is important that you complete a risk assessment with a qualified healthcare provider to determine whether vaccination is necessary.

• if you are over 60 years of age or if your child is under 9 months of age, because you have an increased risk of developing certain serious but rare vaccine reactions (including severe reactions affecting the brain, nerves, and vital organs; see Section 4). The vaccine will only be administered if there is a clear risk of exposure to the virus in the countries you are travelling to.
• if your child is between 6 and 9 months of age. STAMARIL may be administered to children aged between 6 and 9 months only in specific circumstances and in accordance with official recommendations.
• if you or your child are infected with HIV but do not have active symptoms due to the infection. Your healthcare provider will inform you whether you can receive STAMARIL based on laboratory test results and the advice of a specialist.
• if you or your child have any coagulation disorder (such as haemophilia or low platelet levels) or are taking any medication that interferes with normal blood clotting. You may still receive STAMARIL provided the vaccine is administered subcutaneously and not intramuscularly (see Section 3).
• if you have had allergic reactions to latex. The needle shield of the pre-filled syringe contains a natural rubber latex derivative which may cause an allergic reaction.

As with all vaccines, STAMARIL may not fully protect all individuals who are vaccinated.
Fainting may occur following any needle injection, sometimes even before the injection is given. Therefore, inform your healthcare provider if you or your child have previously fainted after an injection.

Other medicines and STAMARIL
Inform your healthcare provider if you are taking, have recently taken, or might take any other medicines. If you have recently undergone any treatment or taken any medication that may have weakened your immune system, vaccination should be postponed until laboratory results confirm that your immune system has recovered. Your doctor will advise you when it is safe to receive the vaccine.
STAMARIL may be administered at the same time as the measles vaccine or typhoid fever vaccines (those containing Vi capsular polysaccharide) and/or hepatitis A vaccines.
Vaccination with STAMARIL may cause false positive results in blood tests for infections such as dengue or Japanese encephalitis. If you or your child may need to undergo these tests in the future, inform the doctor about this vaccination.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, please consult your healthcare provider before being vaccinated.
You should not receive STAMARIL during pregnancy or breastfeeding unless vaccination cannot be avoided. In addition, it is recommended not to start a pregnancy within one month after receiving STAMARIL. Your healthcare provider will inform you if vaccination is essential. If vaccination is necessary, breastfeeding should be discontinued for at least 2 weeks after receiving STAMARIL.
If you receive the vaccine during pregnancy or breastfeeding, consult your healthcare provider.

STAMARIL contains sodium, potassium and sorbitol
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free", and less than 1 mmol of potassium (39 mg) per dose, i.e., essentially "potassium-free".
This medicine contains approximately 8 mg of sorbitol per dose.

3. HOW TO USE STAMARIL

Dosage
STAMARIL is administered as a single 0.5 mL dose in adults and children from 6 months of age onwards. The first dose should be given at least ten days before potential exposure to yellow fever infection. This is because at least ten days are required for the first dose of vaccine to become effective and provide adequate protection against the yellow fever virus.
The protection provided by this dose is expected to last for at least 10 years and may even be lifelong.
In certain circumstances, a booster dose (0.5 mL) may be necessary:

• if you or your child did not mount an adequate immune response after the first dose and you or your child remain at risk of infection with yellow fever virus, according to official recommendations.

How STAMARIL is administered
STAMARIL is administered by injection by a qualified and trained healthcare professional. The vaccine is usually injected into the layer just beneath the skin (subcutaneously), but may also be given intramuscularly. It must not be injected into a blood vessel.

If you or your child have used more STAMARIL than you should
In some cases, doses higher than those recommended have been used. In such cases, when adverse reactions were reported, they were consistent with those described in Section 4.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody will experience them.
Serious side effects:
The following serious side effects have occasionally been reported:
Allergic reactions

• rash, itching or hives;
• 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 one month after vaccination and may occasionally be fatal.
Symptoms may include:

• high fever with headache and confusion;
• extreme tiredness;
• neck stiffness;
• inflammation of the brain or nervous tissues;
• seizures;
• loss of movement or sensation in part or all of the body (e.g. Guillain-Barré syndrome);
• personality changes.

Serious reactions affecting vital organs
A serious reaction may occur within 10 days after vaccination and may be fatal. The reaction may resemble yellow fever virus infection. It usually begins with fatigue, fever, headache, muscle pain and occasionally low blood pressure. These symptoms may progress to severe liver and muscle disorders, reduced levels of certain blood cells leading to unusual bruising or bleeding, increased risk of infections, and loss of normal kidney and lung function.
If you experience ANY of the above symptoms after vaccination, consult a doctor IMMEDIATELY and mention that you have recently received STAMARIL.
Other side effects
Very common (may affect more than 1 in 10 people)

• Headache;
• Mild to moderate tiredness 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;
• Nausea;
• Injection site reactions: redness, bruising, swelling or development of a hard lump.

Uncommon (may affect up to 1 in 100 people)

• Dizziness;
• Stomach pain;
• Development of a small bump (papule) at the injection site.

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

• Diarrhea;
• Runny nose, nasal congestion or nasal itching (rhinitis).

Not known (frequency cannot be estimated from available data)
Swelling of the glands (lymphadenopathy);

• Numbness or tingling sensation (paresthesia);
• Influenza-like illness.

Additional side effects in children
Very common (may affect more than 1 in 10 children)

• Irritability, crying;
• Loss of appetite;
• Drowsiness.

These side effects generally occur within 3 days after vaccination and usually do not last longer than 3 days. Most of these side effects have been mild in intensity.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your healthcare professional. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store STAMARIL

• Keep out of the sight and reach of children.
• Do not use this vaccine after the expiry date 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.
• Keep the powder vial and the solvent syringe in the outer carton to protect them from light.
• Use immediately after reconstitution.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What STAMARIL contains
After reconstitution, per dose (0.5 mL):

• The active substance is: Yellow fever virus strain 17D-204 (live, attenuated)………………not less than 1000 IU

Cultivated in specific pathogen-free chicken embryos

• The other components 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 injectable preparations.

Description of the appearance of STAMARIL and contents of the pack
STAMARIL is supplied as a powder and solvent for injectable suspension (powder in a vial + solvent in a pre-filled syringe (0.5 mL dose) with a pre-attached needle or with two separate needles). Packs of 1.
After reconstitution, the suspension is beige to pinkish-beige in colour, more or less opalescent.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Representative in Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milano
Manufacturers
Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
(France)
Sanofi AVENTIS Zrt.
1225 Budapest,
Campona u.1. (Harbor Park)
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria STAMARIL
Belgium STAMARIL
Bulgaria STAMARIL
Cyprus STAMARIL
Czech Republic STAMARIL
Denmark STAMARIL
Estonia STAMARIL
Finland STAMARIL
France STAMARIL
Germany STAMARIL
Croatia STAMARIL
Hungary STAMARIL
Ireland STAMARIL
Italy STAMARIL
Latvia STAMARIL
Lithuania STAMARIL
Luxembourg STAMARIL
Malta STAMARIL
Poland STAMARIL
Portugal STAMARIL
Romania STAMARIL
Slovakia STAMARIL
Spain STAMARIL
Sweden STAMARIL
Netherlands STAMARIL
United Kingdom STAMARIL
Iceland STAMARIL
Norway STAMARIL

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for reconstitution.
Prior to use, the beige to orange-beige coloured powder is mixed with the colourless sodium chloride solvent contained in a syringe to obtain a beige to pinkish-beige suspension, which appears more or less opalescent.
For syringes without attached needle only: after removing the syringe cap, a needle must be firmly placed on the end of the syringe and secured by rotating a quarter turn (90°).
The vaccine is reconstituted by adding the solvent provided in the pre-filled syringe to the vial containing the powder. The vial should be shaken, and after complete dissolution, the resulting suspension should be drawn back into the same syringe used for reconstitution and injection.
Contact with disinfectants must be avoided, as they may inactivate the virus.
Use immediately after reconstitution.
Before administration, the reconstituted vaccine must be shaken vigorously.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
See also Section 3. How to use STAMARIL.