STAMARIL 0,5 ml.

WHAT STAMARIL IS AND WHAT IT IS USED
Stamaril is a vaccine that provides protection against serious infectious disease called yellow fever.
Yellow fever occurs in certain areas of the world and spread in humans by the bite of an infected mosquito.

Stamaril is intended for persons who:
travel pass or live in an area where yellow fever occurs;
are traveling to any country that requires an entry International vaccination certificate (which may depend on whether or not the countries that were visited during the same trip);
handling potentially infectious materials such as laboratory staff.
To obtain a valid certificate of vaccination against yellow fever it is necessary to be vaccinated in an approved vaccination center of the World Health Organization (WHO), so as to issue an International Certificate of Vaccination. This certificate is valid for 10 years from the 10th day after the first dose of vaccine. Certificates issued after booster doses (see item 3) are valid immediately after the injection.

2. BEFORE YOU USE STAMARIL
It is important to tell your doctor or nurse if any of the points below apply to the person who will be vaccinated. If there is anything you do not understand, ask your doctor or nurse to explain.

Do not use Stamaril if you or your child
you are allergic (hypersensitive) to eggs, chicken proteins or to any component of Stamaril;
you have had a serious reaction to a previous vaccination with a vaccine against yellow fever;
you have a weak or weakened immune system for any reason, such as illness or medical treatments (eg corticosteroids or chemotherapy);
have a weakened immune system due to HIV infection. Your doctor will advise you if you can still have 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 your thymus gland removed for any reason;
if you have any illness with fever or acute infection. Vaccination should be delayed until recovery;
you are under 6 months of age.
Take special care with Stamaril if:
you are over 60 years old as you are at increased risk of certain types of severe but rare reactions to the vaccine (including serious reactions that affect the brain and nerves and vital organs, see pt. 4). You will be given the vaccine if the risk of infection with the virus is well established in countries where you reside;
Your child is aged 6 to 9 months. STAMARIL can be given to children aged 6 to 9 months only in special circumstances and in accordance with available official recommendations;
You or your child is infected with HIV virus but do not have obvious symptoms of infection, your doctor will advise you if you can still have Stamaril, based on results of laboratory tests and specialist advice;
have a bleeding disorder (such as haemophilia or low levels of platelets) or are taking medications that prevent normal blood clotting. You could be immunized with Stamaril provided that the vaccine is injected subcutaneously and not intramuscularly (See pt. 3).
Using other medicines
Tell your doctor if you are taking or have recently taken any medicines, including medicines obtained without a prescription.
If you have recently taken any other treatment that weakens the immune system, vaccination against yellow fever should be postponed until the laboratory tests have indicated that your immune system is restored.
Your doctor will advise you when it is safe to be vaccinated.
STAMARIL may be administered at the same time as measles vaccine or vaccines against typhoid (those containing Vi capsular polysaccharide) and / or against Hepatitis A.

Pregnancy and lactation
Tell your doctor or nurse if you are pregnant or suspect that you are pregnant or nursing a child.
You should not apply Stamaril unless the application can not be avoided.
Your doctor or nurse will advise whether you should be vaccinated while pregnant or breastfeeding.

Important information about some of the ingredients of STAMARIL
Stamaril contains small amounts of sorbitol. The vaccine should not be administered to persons with fructose intolerance.

3. HOW TO USE STAMARIL
Stamaril administered by injection by a doctor or nurse. Usually administered by subcutaneous injection, but may be applied in the muscle if these are official recommendations in the area where you live. Should not be injected into a blood vessel.

dosage
Stamaril administered as a single dose of 0,5 ml of adults and children over 6 months of age.
The first dose should be given at least 10 days before needing protection against yellow fever. This is because it takes 10 days for the first dose of vaccine to work and provide good protection against the yellow fever virus. Protection provided by this dose will last 10 years.
Booster dose (0,5 ml) is recommended every 10 years if you still believes that you are at risk of infection with yellow fever (ie if you are still traveling or live in an area where you could catch yellow fever or this can be done through your work).

If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, STAMARIL can cause side effects, although not everybody gets them.

Serious side effects
Have sometimes been reported following serious side effects:
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.
Effects affecting the brain and nerves
Can be observed one month after vaccination and are sometimes fatal.
Symptoms include:
High fever with headache and confusion;
Extreme fatigue;
Stiff neck;
Inflammation of the brain and nerve tissue;
seizures;
Loss of mobility or sensation of the body or part thereof.
Serious reactions affecting vital organs
May occur up to 10 days after vaccination and may have a fatal outcome. The reaction can resemble infection with the yellow fever virus. Usually begins with feeling tired, fever, headache, muscle pain and sometimes low blood pressure. It may then continue with severe muscle and liver, reduction in the number of certain types of blood cells resulting in unusual bruising or bleeding, and increased risk of infection, and loss of normal function of the kidneys and lungs.
If any of the above mentioned symptoms, contact your doctor IMMEDIATELY.

Other side effects
Very common side effects (reported in more than 1 in 10 people) Problems around the injection site (like redness, bruising, pain or discomfort, swelling or appearance of a hard lump) and headache.

Common side effects (reported in less than 1 in 10 people): Feeling or being sick, diarrhea, muscle pains, fever and weakness.

Uncommon side effects (reported in less than 1 in 100 people): Pain in joints and stomach pains.

Other side effects include: Swollen glands.

If you get any side effects and it gets serious, or you notice other effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5. HOW TO STORE STAMARIL
Keep out of the reach of children.
Do not use STAMARIL after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Keep the vial and syringe in the outer carton 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 to protect the environment.

6. FURTHER INFORMATION
What Stamaril
active substance
Virus1 yellow fever 17D-204 strain (live, attenuated) ........................... not less than 1000 LD50 edinitsi2.
1proizveden established in nonpathogenic infected chicken embryos
2standartna unit of the WHO.
Other ingredients are:
Lactose, sorbitol, L-histidine hydrochloride, L-alanine, sodium chloride, potassium chloride, disodium phosphate, potassium phosphate, calcium chloride, magnesium sulphate and water for injection.

Stamaril looks like and contents of the pack
STAMARIL is a powder and solvent for suspension for injection (powder in a vial (0,5 ml dose) + solvent in a prefilled syringe (0,5 ml dose) with or without needle. Pack of 1, 10, 20.
After reconstitution the suspension is beige to pink beige.
Not all pack sizes may be marketed.