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STAMARIL®
YELLOW FEVER VACCINE (LIVE), STABILISED AUST R 58570
Consumer Medicine Information
This leaflet contains information about STAMARIL®. Please read it carefully and keep it for future reference. The information in this leaflet is only a summary and is not intended to replace advice from your doctor. Please consult your doctor or pharmacist if you have any comments or questions.
WHAT IS STAMARIL®?
STAMARIL® is a vaccine which causes the body to produce immunity against the Yellow Fever virus. It contains a live virus (17D strain) which is similar to the yellow fever virus but does not cause yellow fever. Our bodies, however cannot tell the difference and produce antibodies which are the proteins of the immune system that protect us from yellow fever. These can be found in the blood about 7 to 10 days after injection and last for at least 10 years.
WHAT DOES STAMARIL® CONTAIN?
Each dose contains the 17D strain of yellow fever virus which has been grown in chicken eggs which contain no disease-causing microorganisms. The eggs have specifically been shown to be free of a particular virus - the avian leucosis virus. Each dose contains at least 1000 units of virus. Each dose contains lactose, sorbitol, L-histidine hydrochloride, L-alanine, sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, calcium chloride and magnesium sulfate.
The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
WHAT IS STAMARIL® USED FOR?
STAMARIL® is used for the prevention of yellow fever. Vaccination is recommended for people who live in or travel through infected areas or laboratory workers who handle material which may be infected. Some countries require a valid vaccination certificate for travellers to be allowed entry. The vaccine must be given by an approved vaccination centre to be registered on an international certificate. This certificate is valid from 10 days after the injection for 10 years.
WHO SHOULD NOT HAVE STAMARIL®?
STAMARIL® should not be used in:
- children under 9 months of age,
- people allergic to any part of the vaccine or who have previously had a severe reaction to the vaccine,
- people whose immunity is reduced,
- people who have a fever, people who are pregnant,
- people having cholera or certain typhoid injections on the same day.
BEFORE YOU HAVE YOUR STAMARIL® INJECTION -
YOU SHOULD TELL YOUR DOCTOR IF:
- you may be allergic to any part of the vaccine (eggs),
- you are pregnant,
- you are breastfeeding,
- you have any illness,
- you are taking any medicines and what they are.
SIDE EFFECTS OF STAMARIL®
As with any medicines some side effects may occur.
Reactions at the site of injection are common and include redness, tenderness, pain and swelling. Other common reactions include fever, weakness, muscle aches, and headache. Rarely the glands under the arm can swell. Fever usually happens within one week of the injection and can be simply treated. Rarely, people can get a higher fever with stiffness, tiredness and headache. This happens within 30 days following vaccination. Other reactions that occur rarely are muscle pain, abdominal pain, arthritis and rash.
Very rarely, abnormalities of the central nervous system have been reported after vaccination particularly in children under 12 months but these may not be due to the vaccine. Other very rare side effects include liver upsets, eczema, and generalised swelling and itching.
Other more severe side effects may occur. Always tell your doctor if you have any unpleasant effects after receiving yellow fever vaccine.
Recently, there have been a small number of reports of multi-organ system failure, which may result in death, following vaccination with STAMARIL® and other yellow fever virus vaccine from the same strain. Symptoms are non-specific and include fever, muscle aches, and headache leading quickly to liver, kidney and muscle damage, and internal bleeding. The cause of this reaction is not known. People with a thymus disorder are at a higher risk so you must inform your doctor if you have any history of a thymus disorder including thymoma (tumour of thymus) and prior thymectomy (removal of thymus) before receiving yellow fever vaccination. Because of the seriousness of this reaction and because there have been recent deaths in unvaccinated travellers due to yellow fever, it is most important that your doctor assesses the risks and benefits of yellow fever vaccination for you.
All people who receive yellow fever vaccine should be monitored for any side effects for 10 days after vaccination, particularly those who are aged 60 years and over. It is reported that adults aged 60 years and over are at higher risk of side effects compared with other age groups.
THE DOSE OF STAMARIL®
STAMARIL® comes as a freeze-dried powder which is dissolved in the solution in the accompanying syringe. The solution (0.5 mL) is then given into the muscle or below the skin. The dose is the same for all ages.
OVERDOSAGE
There are no reports of overdosage.
STORAGE
STAMARIL® should be stored between 2°C to 8°C (in the fridge).
It should not be used after the expiry date on the package.
WHERE CAN I GET MORE INFORMATION?
You can get more information from your doctor or pharmacist.
STAMARIL® IS MANUFACTURED BY:
Aventis Pasteur SA
1541, avenue Marcel Mérieux
69280 - Marcy L'Etoile - FRANCE
and
Parc Industriel d'Incarville
BP 101
27100 Val-de-Reuil Cedex - FRANCE
DISTRIBUTOR:
Australia:
Aventis Pasteur Pty Ltd,
ABN 79 085 258 797
Unit 12, Parkview Business Centre
12-14 Columbia Way
Baulkham Hills
NSW 2153
AUSTRALIA
Tel: 1800 829 468
New Zealand:
Merck Sharp & Dohme
(New Zealand) Limited
PO Box 99851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673
Revised October 2005
Item code n° 07721001A
Published by MIMS/myDr April 2006
