STAMARIL POWDER AND SOLVENT FOR INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

2. What you need to know before you or your child start using Stamaril

It is important to consult your healthcare professional if any of the following points apply to you or your child. If there is anything you do not understand, ask your healthcare professional to explain.

Do notuse 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
• eggs or chicken proteins.
• have had a severe allergic reaction after a previous dose of any yellow fever vaccine,
• are less than 6 months old,
• have a poor or weakened immune system due to any reason, such as due to a disease or due to medical treatments (e.g. high-dose steroids or any other medication that affects the immune system or chemotherapy). If you are not sure if the medication can affect your immune system or that of your child, talk to your healthcare professional before administering the vaccine,
• have a weakened immune system due to HIV infection. Your healthcare professional will advise you if you or your child can still receive 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 gland called the thymus or your child has had the thymus gland removed for any reason,
• have a disease with high or moderate fever or an acute disease. Vaccination will be delayed until you or your child have recovered.

Warnings and precautions

Before using Stamaril, it is important that you complete a risk assessment with a trained healthcare professional to determine if you should receive the vaccine.

• If you are over 60 years old or if your child is under 9 months old because you have an increased risk of certain types of severe reactions, although rare, to the vaccine (including severe reactions that affect 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 child is between 6 and 9 months old. Stamaril may be given to children between 6 and 9 months old only in special situations and based on current official recommendations,
• If you or your child are infected with the HIV virus but do not have active symptoms due to the infection. Your healthcare professional will advise you if you can still receive Stamaril based on the results of your laboratory tests and the advice of the specialist,
• If you or your child have any bleeding disorder (such as hemophilia or low platelet count) or are using any medication that prevents blood from clotting normally. You can still receive Stamaril as long as it is injected under the skin and not into the muscle (see section 3).
• If you have had a severe allergic reaction to latex, you may have severe allergic reactions because it contains a derivative of natural rubber latex (latex) in the stopper at the end of the pre-filled syringe.

As with all vaccines, Stamaril may not completely protect all vaccinated people.

After any injection with a needle, or even before, fainting can occur. Therefore, inform your healthcare professional if you or your child have fainted with any previous injection.

Using Stamaril with other medicines

Tell your healthcare professional if you are using, have recently used or might use any other medicines.

If you have recently received any treatment or medication that may have weakened your immune system, vaccination should be delayed until your laboratory results show that your immune system has recovered. Your doctor will tell you when it is safe for you to be vaccinated.

Stamaril can be given at the same time as the measles vaccine or vaccines against typhoid fever (those that contain the Vi capsular polysaccharide of typhoid fever) and/or against hepatitis A.

Vaccination with Stamaril may result in false-positive results in blood tests for dengue or Japanese encephalitis. If you or your child are prescribed these types of tests in the future, please inform your 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, ask your healthcare professional for advice before using this medicine.

You should not receive Stamaril during pregnancy or breastfeeding unless it is unavoidable. Additionally, it is recommended that you do not become pregnant for at least one month after receiving STAMARIL. Your healthcare professional will tell you if it is essential that you are vaccinated. In case vaccination is necessary, it is recommended to interrupt breastfeeding for at least 2 weeks after receiving STAMARIL. If you receive the vaccine during pregnancy or breastfeeding, consult your healthcare professional.

STAMARIL contains sodium, potassium, and sorbitol

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is considered essentially “sodium-free”, and less than 1 mmol of potassium (39 mg) per dose, so it is considered essentially “potassium-free”.

This medicine contains approximately 8 mg of sorbitol per dose.

3. How to use Stamaril

Dose

Stamaril is given as a single dose of 0.5 milliliters to adults and children from 6 months of age.

The first dose should be given at least 10 days before the need for protection against yellow fever. This is because the first dose of vaccine takes 10 days to work and provide good protection against the yellow fever virus. It is expected that the protection provided by this dose will last at least 10 years and may last a lifetime.

In some circumstances, a booster dose may be needed with a dose (0.5 milliliters):

• or depending on official recommendations.

How Stamaril is given

Stamaril is given as an injection by a qualified and trained healthcare professional. It is usually injected under the skin, but it can be injected into a muscle.

It must not be injected into a blood vessel.

If you or your child use more Stamaril than you should

In some cases, more doses than recommended were used.

In these cases, when side effects were reported, they were in line with those described in section 4.

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

4. Possible side effects

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

Serious side effects

The following serious 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 that affect the brain and nerves:

These can occur within a month of vaccination and have sometimes been fatal.

Symptoms may include:

• High fever with headache and confusion
• Excessive tiredness
• Stiff neck
• Inflammation of the brain and nervous tissue
• Seizures
• Loss of movement or sensation in part or all of the body (e.g. Guillain-Barré syndrome)
• Changes in personality

Severe reactions that affect vital organs:

These can appear within 10 days of vaccination and can be fatal. The reaction may resemble a yellow fever virus infection. It usually starts with a feeling of tiredness, fever, headache, muscle pain, and sometimes low blood pressure. It can then continue with severe muscle and liver disorders, a decrease in the number of some types of blood cells resulting in bruising or bleeding, and an increased risk of infections, and loss of normal function of the kidneys and lungs.

If you experience ANY of the above symptoms after vaccination, seek medical attention IMMEDIATELY and mention that you have recently received STAMARIL.

Other side effects

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

• Headache.
• Tiredness or mild or moderate 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)
• Pain in the joints
• Feeling unwell (nausea)
• Reactions at the injection site: redness, bruising, swelling or the appearance of a lump (hard lump)

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Stomach pain
• A nodule (papule) at the injection site

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

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

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

• Swollen glands (lymphadenopathy)
• Numbness or tingling (paresthesia)
• Flu-like illness

Other 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 generally did not last more than 3 days. Most of these side effects were mild.

Reporting of side effects

If you experience any side effects, talk to your healthcare professional, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Stamaril

• Keep this vaccine 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 is the last day of the month shown.
• Store in a refrigerator (between 2°C and 8°C). Do not freeze.
• Store the powder vial and the solvent syringe in the outer packaging 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. This will help protect the environment.

6. Contents of the pack and other information

Composition of Stamaril

After reconstitution, a 0.5 ml dose contains:

• The active substance is:

Yellow fever virus1 (live, attenuated) strain 17D-204………... at least 1,000 IU

1 propagated 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 injections.

Appearance of the product and pack contents

Stamaril is presented as a powder and solvent for injectable suspension (powder in a vial (0.5 ml dose) + solvent in a pre-filled syringe (0.5 ml dose) with or without a needle). Pack of 1.

After reconstitution, the suspension is beige to pinkish-beige in color, 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

or

Sanofi Winthrop Industrie

Voie de l’Institut – Parc Industriel d’Incarville

B.P 101

27100 Val de Reuil

France

Local Representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicine is authorised 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 last revision of this leaflet: 12/2020

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Instructions for reconstitution:

Before use, the beige to beige-orange powder is mixed with the clear and colorless sodium chloride solvent provided in a syringe to obtain a suspension of beige to pinkish-beige color, which is more or less opalescent.

Only for syringes without a fixed needle: after removing the stopper at the end of the syringe, the needle should be firmly placed on the end of the syringe and secured by a quarter turn (90°).

The vaccine is reconstituted by adding the solvent provided in the pre-filled syringe to the vial. The vial is shaken and, after complete dissolution, the resulting suspension is withdrawn with the same syringe for injection.

Contact with disinfectants should be avoided because they can inactivate the virus.

Use immediately after reconstitution.

Before administration, the reconstituted vaccine should be shaken vigorously.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

See also section 3. How to use Stamaril