Stamaril

Package leaflet: Information for the user

STAMARIL, powder and solvent for suspension for injection in a pre-filled syringe
Yellow fever vaccine, live

Read all of this leaflet carefully before the vaccine is administered, as 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 a specific individual. Do not pass it on to others.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What STAMARIL vaccine is and what it is used for
2. Important information before vaccination with STAMARIL
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 STAMARIL vaccine is and what it is used for

STAMARIL is a vaccine that provides protection against a serious infectious disease called yellow fever.
Yellow fever occurs in certain parts of the world and is transmitted to humans through bites of infected mosquitoes.

The STAMARIL vaccine is given to individuals who:

• are travelling through or residing in areas where yellow fever occurs,
• are travelling to any country where an international certificate of vaccination is required upon entry (this may depend on countries previously visited during the same trip),
• may be exposed to infectious material, for example, laboratory personnel.

To obtain an official yellow fever vaccination certificate, vaccination must be performed at an authorized vaccination centre by qualified and trained medical personnel, so that an International Certificate of Vaccination can be issued. Such certification becomes valid 10 days after administration of the first dose of the vaccine. In certain cases, when a booster dose is required, the vaccination certificate (see Section 3) becomes valid immediately after vaccination.

2. Important information before receiving the STAMARIL vaccine

It is important to inform your doctor or nurse if any of the following apply
to the adult or child. If anything is unclear, please ask your doctor or
nurse to explain.

When not to use STAMARIL vaccine

• If the adult or child has a known allergy to:
• the active substance, or
• any of the components of the STAMARIL vaccine (listed in Section 6), or
• eggs or chicken proteins.
• If the adult or child has previously experienced a severe allergic reaction after a prior dose of any yellow fever vaccine.
• If the child is under 6 months of age.
• If the adult or child has a weakened or suppressed immune system for any reason, such as illness or treatment (e.g. high-dose steroids or any other medicines affecting the immune system, or chemotherapy). If you are unsure whether a medicine may affect the immune system of the adult or child, discuss this with a healthcare professional before vaccination.
• If the adult or child has a weakened immune system due to HIV infection. Your doctor will advise, based on blood test results, whether the STAMARIL vaccine can be given to the adult or child.
• If the adult or child has symptomatic HIV infection.
• If the adult or child has previously had thymus gland disease or surgical removal of the thymus gland for any reason.
• If the adult or child has an infection with high or moderate fever or an acute illness. Vaccination should be postponed until recovery.

Warnings and precautions
Before receiving the STAMARIL vaccine, it is important that a trained healthcare
professional performs a risk assessment to determine whether the patient should receive
the vaccine.

• Adults aged 60 years and older, or infants under 9 months of age, as these individuals are at increased risk of certain rare but serious reactions following vaccination (including severe reactions affecting the brain and nerves, and organs of the body; see Section 4). The vaccine should only be given to these individuals if the risk of exposure to yellow fever virus is clearly present in the countries they plan to visit.
• Infants aged between 6 and 9 months. STAMARIL may be given to children aged between 6 and 9 months only in exceptional circumstances and in accordance with current official recommendations.
• Asymptomatic HIV infection. Your doctor will advise, based on laboratory test results, whether the STAMARIL vaccine can be administered.
• Adults and children with bleeding disorders (such as haemophilia or low platelet count) or taking any medications that impair normal blood clotting. In such cases, the STAMARIL vaccine may be administered provided it is injected subcutaneously rather than intramuscularly (see Section 3).
• Allergic reaction to latex. The tip caps of the pre-filled syringes contain a derivative of natural rubber latex, which may cause an allergic reaction.

As with all vaccines, STAMARIL may not fully protect all vaccinated individuals.
Fainting may occur after, or even before, any vaccination. Please inform your
doctor or nurse if the adult or child has previously fainted during injections.

STAMARIL and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
If the patient has recently received treatment or medicines that may have weakened the immune system,
vaccination should be postponed until laboratory tests confirm that the immune system has returned to normal. Your doctor will advise on the appropriate timing for vaccination.
STAMARIL may be administered at the same time as measles vaccine or typhoid vaccines (containing Vi capsular polysaccharide) and/or hepatitis A vaccine.
Administration of the STAMARIL vaccine may cause false positive blood test results for diseases such as dengue fever or Japanese encephalitis. If the adult or child is scheduled for such tests in the future, inform the doctor about this vaccination.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before vaccination.
The STAMARIL vaccine should not be given unless unavoidable. In addition,
it is recommended that women avoid becoming pregnant for one month after receiving the STAMARIL vaccine.
Your doctor or pharmacist may advise whether vaccination is necessary during pregnancy or breastfeeding. If vaccination is required, it is recommended to interrupt breastfeeding for at least 2 weeks after receiving the STAMARIL vaccine. If vaccination is given during pregnancy or breastfeeding, consult your doctor, pharmacist, or nurse.

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

3. How to use the STAMARIL vaccine

Dosage
The STAMARIL vaccine is administered to adults and children from the age of 6 months as a single dose of 0.5 ml.
The first dose should be given at least 10 days before protection against yellow fever virus is required, since it takes approximately 10 days after vaccination for immunity to develop and provide effective protection against yellow fever virus.
Protection provided by this dose is expected to last for at least 10 years and may persist for life.
In certain circumstances, a single booster dose (0.5 ml) may be required:

• if an adult or child has shown an inadequate immune response after the first dose and remains at risk of yellow fever virus infection,
• or according to official recommendations.

How STAMARIL is administered
The STAMARIL vaccine is administered by injection by a qualified and trained healthcare professional. It is usually given subcutaneously, but may also be administered intramuscularly.
It must not be injected into a blood vessel.
If more STAMARIL vaccine has been administered than recommended
Higher than recommended doses have been used in some cases.
In these cases, any adverse reactions reported were consistent with those described in section 4.
If you have any doubts regarding the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this vaccine can cause adverse reactions, although not everyone will experience them.

Severe adverse reactions

The following severe adverse reactions have been reported occasionally:

Allergic reactions

• skin 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 have sometimes resulted in death.
Symptoms may include:

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

Serious organ-related reaction
This may occur within 10 days after vaccination and may result in death. The reaction may resemble yellow fever virus infection. It usually begins with a feeling of fatigue, fever, headache, muscle pain and sometimes low blood pressure. Later, it may progress to severe muscle and liver disease, decreased numbers of certain types of blood cells leading to unusual bruising or bleeding and increased risk of infections, and loss of normal kidney and lung function.

If ANY of the above symptoms occur after vaccination, seek immediate medical attention and inform the doctor about the recent administration of the STAMARIL vaccine.

Other adverse reactions

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)
• Vom游戏副本

5. How to store the STAMARIL vaccine

• Keep out of the sight and reach of children.
• Do not use this vaccine after the expiry date stated on the carton under Expiry date (EXP). The expiry date refers to the last day of the stated month.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the vial of powder and the ampoule-syringe of solvent in the carton to protect from light.
• Use immediately after reconstitution.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 17D-204 (live, attenuated)………not less than 1000 IU propagated in specific pathogen-free chicken embryos
• Other components 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 needle). Pack size: 1.
After reconstitution, the suspension is beige to pinkish-beige, more or less opalescent.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised for sale in 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, the Netherlands, the United Kingdom, Iceland, Norway.

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

The following information is intended for healthcare professionals only:
Reconstitution instructions:
Prior to use, the beige to orange-beige powder is mixed with the clear, colourless sodium chloride solvent provided in the syringe, to prepare a beige to pinkish-beige suspension, more or less opalescent.
For syringes without an attached needle only: after removing the syringe cap, firmly attach a needle to the tip of the syringe and secure by turning a quarter turn (90°).
Reconstitute the vaccine by adding the solvent from the pre-filled syringe to the vial. Shake the vial vigorously and withdraw the resulting suspension into the same syringe after complete dissolution, for injection.
Avoid contact with disinfectants, as they may inactivate the virus.
Use immediately after reconstitution.
Before administration, shake the reconstituted vaccine vigorously.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
See also Section 3. How to use STAMARIL vaccine.