Active ingredient
- yellow fever vaccine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL06745/0087 .
Stamaril
PACKAGE LEAFLET: INFORMATION FOR THE USER
STAMARIL, powder and solvent for suspension for injection in pre-filled syringe
Yellow fever vaccine (Live)
Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.
What is in 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 provides protection against a serious infectious disease called yellow fever.
Yellow fever occurs in certain areas of the world and is spread to man through the bites of infected mosquitoes.
STAMARIL is given to people who:
To obtain a valid vaccination certificate against yellow fever, it is necessary to be vaccinated in an approved vaccination centre so that an International Certificate of Vaccination can be issued. This certificate is valid from 10 days after the first dose of vaccine. When a booster is needed, the certificate (see Section 3) is valid immediately after the injection.
2. What you need to know before you or your child use STAMARIL
It is important to tell the doctor or nurse if any of the points below apply to you or your child. If there is anything you do not understand, ask the doctor or nurse to explain.
Do not use STAMARIL if you or your child:
Warning and precautions
Talk to your doctor, pharmacist or nurse before using STAMARIL.
As with all vaccines, STAMARIL may not fully protect all persons who are vaccinated.
Fainting can occur following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted with a previous injection.
Other medicines and STAMARIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you have recently had any treatment or medicine which may have weakened your immune system, the vaccination must be delayed until your laboratory results show that your immune system has recovered. Your doctor will advise you when it is safe for you to be vaccinated.
STAMARIL can be given at the same time as measles vaccine or vaccines against typhoid fever (those containing the Vi capsular polysaccharide) and/or hepatitis A.
Vaccination with STAMARIL may lead to false positive results of blood tests for dengue or Japanese encephalitis. If you or your child have in the future such tests prescribed, please inform your doctor about this vaccination.
Pregnancy, breast-feeding
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being vaccinated.
You should not receive STAMARIL unless this cannot be avoided. Your doctor or pharmacist can advise you on whether it is essential that you are vaccinated while pregnant or breastfeeding.
STAMARIL contains sodium, potassium and sorbitol
This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”, and less than 1 mmol potassium (39 mg) per dose that is to say essentially “potassium free”.
This medicine contains approximately 8 mg of sorbitol per dose.
3. How to use STAMARIL
Dosage
STAMARIL is given as a single, 0.5 millilitre dose to adults and children from 6 months of age.
The first dose should be given at least 10 days before protection from yellow fever is needed. This is because it takes 10 days for the first dose of vaccine to work and provide good protection against the yellow fever virus. The protection provided by this dose is expected to last at least 10 years and may be life-long.
A booster with one dose (0.5 millilitre) may be needed:
How STAMARIL is given
STAMARIL is given as an injection by a doctor or nurse. It is usually injected just underneath the skin but it can be given 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 than the recommended dose was used.
In these cases, when side effects were reported, the information was in line with what is described in Section 4.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
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 sometimes been reported:
Allergic reactions:
Reactions affecting the brain and nerves:
These may occur within one month of the vaccination and have sometimes been fatal.
Symptoms include:
Serious reaction affecting vital organs:
This may occur within 10 days of the vaccination and may have a fatal outcome. The reaction can resemble an infection with the yellow fever virus. It generally begins with feeling tired, fever, headache, muscle pain and sometimes low blood pressure. It may then go on to a severe muscle and liver disorder, drops in number of some types of blood cells resulting in unusual bruising or bleeding and increased risk of infections, and loss of normal functioning of the kidneys and lungs.
If you experience ANY of the above symptoms contact your doctor IMMEDIATELY
Other side effects
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Additional side effects in children
Very common (may affect more than 1 in 10 people)
These side effects usually occurred within the 3 days following vaccination and lasted usually not more than 3 days. Most of these side effects were of mild intensity.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In Ireland
You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.
In the UK
You can also report side effects directly via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
By reporting side effects you can help provide more information on the safety of this vaccine.
5. How to store STAMARIL
6. Contents of the pack and other information
What STAMARIL contains
After reconstitution, for one dose (0.5 ml):
What STAMARIL looks like and contents of the pack
STAMARIL is presented 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, 10, 20.
After reconstitution the suspension is beige to pink beige, more or less opalescent.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Distributed by:
United Kingdom:
Ireland:
This medicinal product is authorised in the Member States of the EEA under the following name:
STAMARIL: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hrvatska, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Poland, Portugal, Romania, Slovakia, Spain, Sweden, The Netherlands, United Kingdom, Iceland, Norway.
This leaflet was last revised in 05/2020
Other sources of information
Detailed information on this medicine is available on the website of: Medicines and Healthcare Products Regulatory Agency (MHRA) or The Health Products Regulatory Authority (HPRA).
410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 471 8627
+44 (0)845 023 0441
+44 (0)800 035 2525