Powder and liquid for injection, suspension in pre-filled syringe.
Yellow fever vaccine, live
What STAMARIL is and what it is used for
STAMARIL is a vaccine that protects against a serious infectious disease called yellow fever.
Yellow fever occurs in certain areas of the world and is spread to humans through the bites of infected mosquitoes.
STAMARIL is intended for people who:
- traveling to, passing through, or living in an area where yellow fever is present,
- traveling to a country where an international vaccination certificate is required for entry (this may depend on the previous route),
- handles potentially infectious materials, e.g. laboratory staff.
To obtain a valid vaccination certificate against yellow fever, the vaccination must be carried out at an approved vaccination center by competent and trained healthcare personnel and an international vaccination certificate issued. This certificate is valid from 10 days after the first dose of a vaccine. In some cases, if a booster dose is needed, the certificate (see section 3 below) becomes valid immediately after injection one.
What you need to know before you or your child use STAMARIL
It is important to tell the healthcare staff if any of the points below apply to you or your child. Ask the healthcare professional to explain if there is something you do not understand.
Do not use STAMARIL if you or your child:
- are allergic to:
- the active substance,
- any of the ingredients in this vaccine (listed in section 6) or
- egg or chicken proteins,
- have had a severe allergic reaction after a previous dose of any yellow fever vaccine,
- is younger than 6 months,
- have a poor or reduced immune system for some reason, such as an illness, or due to medical treatments (for example steroids (“cortisone”) in high doses or other drugs that affect the immune system, or chemotherapy ). If you are unsure whether the medicine may affect your or your child’s immune system, you should consult the health care professional before the vaccine is given,
- have a weakened immune system due to HIV infection. The healthcare professional will tell you whether you or your child can still take Stamaril based on the results of your blood tests,
- is infected with HIV – virus and has active symptoms due to infection,
- have had problems with the thymus gland, or have had the thymus gland removed for any reason,
- have an illness with a high or moderate fever or an acute illness. Vaccination will be postponed until you or your child has recovered.
Warnings and precautions
Before using Stamaril, you must do a risk assessment together with trained healthcare professionals to determine whether you should receive the vaccine.
- If you are over 60 or if your child is less than 9 months old because you are at greater risk of certain types of serious but unusual reactions to the vaccine (including serious 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 baby is aged 6 to 9 months. STAMARIL may only be given to children between 6 and 9 months of age in special situations and based on current official advice.
- If you or your child is infected with HIV but does not have any active symptoms due to infection, the health and medical staff will advise you based on laboratory tests and expert advice if it is possible to vaccinate with STAMARIL.
- If you or your child have a bleeding disorder (such as hemophilia or low platelet count ) or are taking medicine that prevents the blood from clotting. You can still receive STAMARIL if it is injected under the skin and not into the muscle (see section 3).
- If you have had an allergic reaction to latex. The tip cap on the pre-filled syringes contains latex. Can cause serious allergic reactions.
As with all vaccines, STAMARIL may not provide complete protection to all persons vaccinated.
Fainting may occur as a result of, or even before, needle injections. Therefore, tell the healthcare staff or nurse if you or your child have fainted during previous injections.
Other medicines and STAMARIL
Tell your healthcare professional if you are taking, have recently taken, or might take any other medicines.
If you have recently undergone treatment or received medication that may have weakened the immune system, vaccination must be postponed until laboratory results show that your immune system has recovered. The doctor will let you know when you can get vaccinated.
STAMARIL can be given at the same time as the measles vaccine, or vaccines against typhoid fever (those containing Vi capsular polysaccharide) and/or hepatitis A.
Vaccination with STAMARIL may lead to false positive results in blood tests for dengue fever and Japanese encephalitis. If you or your child is prescribed such a test in the future, you must inform the doctor about this vaccination.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult a healthcare professional before using this vaccine.
You should not receive STAMARIL during pregnancy and breastfeeding unless it cannot be avoided. You are also advised not to become pregnant within one month of vaccination with STAMARIL. The healthcare staff can advise you if you must be vaccinated. If the vaccination is necessary, you are advised not to breastfeed for at least 2 weeks after receiving STAMARIL.
If you receive the vaccine during pregnancy or breastfeeding, consult a health care professional.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
STAMARIL contains sodium, potassium, and sorbitol
This product contains less than 1 mmol (23 mg) per dose of sodium and less than 1 mmol (39 mg) of potassium per dose, i.e. is almost “potassium-free” and “sodium-free.”
This product contains approximately 8 mg of sorbitol per dose.
How to use STAMARIL
Dosage
STAMARIL is given in a single dose of 0.5 milliliters to adults and children over 6 months of age.
The first dose must be given at least 10 days before the protection against yellow fever is needed. This is because it takes 10 days for the first dose to take effect and gives you sufficient protection against the yellow fever virus. One dose is expected to protect for at least 10 years and may provide lifelong protection.
In some cases, a booster dose (0.5 milliliters) may be needed:
- if you or your child has not responded well enough to the first dose one and you or your child are still exposed to a risk of yellow fever infection,
- or depending on the official recommendations.
How STAMARIL is given
STAMARIL is given as an injection by qualified and trained healthcare professionals. It is usually injected just under the skin, but can also be given into a muscle.
It must not be injected into a blood vessel.
If you or your child has taken too much STAMARIL
In some cases, a larger dose than recommended has been used.
In these cases, the possible side effects reported were in line with those described in section 4.
If you have further questions about the use of this vaccine, contact your healthcare professional.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Serious side effects are
The following serious side effects have been reported occasionally:
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
- Unconsciousness
Symptoms affecting the brain and nerves
These can occur within a month of vaccination and in some cases have been fatal. These can be:
- High fever with headache and confusion
- Extreme fatigue
- Stiff neck
- Inflammation in brain and nerve tissues
- Seizures
- Loss of movement or loss of sensation in parts or the whole body (for example Guillain-Barré syndrome )
- Personality change
Severe symptoms affecting vital organs
These can occur within 10 days of vaccination and can be fatal. The symptoms can be similar to yellow fever infection. It usually starts with fatigue, fever, headache, muscle pain, and sometimes low blood pressure. It can then turn into a serious muscle and liver disease, reduced number of certain blood cells which leads to unusual bruising or bleeding and increased risk of infection and loss of normal kidney and lung functions.
If you experience ANY of these symptoms after the vaccination, you should IMMEDIATELY contact the healthcare provider and tell them that you have recently received STAMARIL.
Other side effects ar
Very common (may affect more than 1 in 10 users)
- Headache
- Mild to moderate fatigue or weakness ( asthenia )
- Pain or discomfort from the injection site
- Muscle pain
- Fever (in children)
- Vomiting (in children)
Common (may affect up to 1 in 10 users)
- Fever (in adults)
- Vomiting (in adults)
- Joint pain
- Nausea
- Reactions at the injection site: redness, bruising, swelling, or the formation of a hard lump
Uncommon (may affect up to 1 in 100 users)
- Dizziness
- Stomach pain
- A welt (Blume) at the injection site
Rare (may affect up to 1 in 1,000 users)
- Diarrhea
- Runny, blocked, and itchy nose ( rhinitis )
Has been reported (occurring in an unknown number of users)
- Swollen glands ( lymphadenopathy )
- Numbness or tingling ( paresthesia )
- Flu-like symptoms
Additional side effects are in children
Very common (may affect more than 1 in 10 people)
- Fairness, cry
- Loss of appetite
- Drowsiness
These side effects usually appeared within three days of vaccination and usually did not last longer than three days. Most of these side effects were mild.
How STAMARIL should be stored
Keep this vaccine out of the sight and reach of children.
Use before the expiry date which is stated on the label or carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store the vial of powder and the syringe of liquid in the outer carton. Light sensitive.
Use immediately after preparation.
The vaccine should not be thrown down the drain or among the household waste. Ask your pharmacist how to dispose of vaccines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
What STAMARIL contains
After preparation, for one dose (0.5 ml):
- The active substance is
Yellow fever virus 1 17D-204 strain (live, attenuated)….not less than 1,000 IU
1 produced in specified pathogen-free chicken embryos - Other ingredients are Lactose, sorbitol (E420), L-histidine hydrochloride, L-alanine, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, calcium chloride, magnesium sulfate, and water for injections.
Appearance and package sizes of the medicine
STAMARIL is designed as a powder and a liquid for injection, suspension (powder in a vial (0.5 ml dose ) + liquid in a pre-filled syringe (0.5 ml dose ) with or without a needle).
Pack size of 1, 10, or 20.
After preparation, the suspension is a beige to pink-beige, more or less opalescent.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
France
SANOFI-AVENTIS Zrt.
1225 Budapest
Campona u.1. (Harbor Park)
Hungary
Manufacturer:
Sanofi Pasteur
14 Espace Henry Vallée 69007 – Lyon – France
Local representative :
Sanofi AB
Box 30052
104 25 Stockholm
Phone: +46 8-634 50 00
This medicine is approved in the European Economic Area under the name:
STAMARIL: Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Ireland, Iceland, Italy, Croatia, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovakia, Spain, United Kingdom, Czech Republic, Germany, Hungary, Austria.