Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about receiving this vaccine,
speak to your doctor or pharmacist.
1. Why am I or my child receiving Stamaril?
Stamaril contains the active ingredient attenuated (weakened) yellow fever virus.
Stamaril is a vaccine that provides protection against the serious infectious disease,
yellow fever. Yellow fever occurs in certain areas of the world and is spread to people
through the bites of infected mosquitoes.
2. What should I know before my child or I receive Stamaril?
Do not use if you or your child have ever had a severe allergic reaction to Stamaril
or a similar vaccine, the active ingredient, eggs, chicken proteins, or any of the
ingredients listed at the end of the CMI. Talk to your doctor if you or your child have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I or my child is taking other medicines?
Some medicines may interfere with Stamaril and affect how it works.
4. How is Stamaril given?
Stamaril is given as a 0.5mL injection, usually under the skin but can be given into
a muscle by a doctor or nurse.
The injection should be given at least 10 days before being at risk of infection with
yellow fever.
5. What should I know while being given Stamaril?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are receiving Stamaril.
Tell your doctor or nurse if you are pregnant, think you might be pregnant, or are
breastfeeding. You should not receive Stamaril if you are pregnant or breastfeeding.
If you need to receive Stamaril but are breastfeeding, you will need to stop breastfeeding
for at least two weeks after receiving Stamaril.
Tell your doctor or nurse if you are feeling unwell after receiving Stamaril.
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Looking after your medicine
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Stamaril is usually stored in the doctor’s surgery or clinic, or at the pharmacy.
However, if you need to store Stamaril:
Keep Stamaril in the original pack until it is time for it to be given.
Keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Stamaril. Protect
from light.
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6. Are there any side effects?
The most common side effects of Stamaril are injection site redness, pain or discomfort,
unusual weakness, muscle tenderness or weakness not caused by exercise, headaches,
fever, crying and irritability in children, painful joints, rash, feeling sick, vomiting
or stomach pain.
Active ingredient: yellow fever virus (live, attenuated)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about receiving Stamaril. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being given Stamaril.
Where to find information in this leaflet:
1. Why am I or my child receiving Stamaril?
Stamaril contains the active ingredient attenuated (weakened) yellow fever virus. 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 people through
the bites of infected mosquitoes.
Stamaril is given to people who:
1) are travelling to, passing through or living in an area where yellow fever is present
or may be present.
2) are travelling to any country that requires an International Certificate of Vaccination
for entry, this may depend on the countries previously visited during the same trip.
3) may handle infectious materials such as laboratory workers.
To obtain a vaccination certificate against yellow fever it is necessary to be vaccinated
in an approved vaccination centre by a qualified and trained health care professional
so that an International Certificate of Vaccination can be issued. This certificate
is valid from the 10th day after the vaccination.
2. What should I know before my child or I receive Stamaril?
Warnings
Stamaril must not be given to:
women who are pregnant or breast-feeding,
children under 6 months of age.
Stamaril should not be given if you or your child:
have ever had a severe allergic reaction to the active ingredient, eggs, chicken proteins
or any other ingredient of Stamaril,
have experienced a severe allergic reaction after an injection of a yellow fever vaccine,
have an illness with a fever or acute infection. The vaccination will be postponed
until you have recovered,
have a poor or weakened immune system for any reason, such as illness or medical treatments
(for example corticosteroids or chemotherapy),
have a weakened immune system due to HIV infection. Your doctor will tell you if you
can still receive Stamaril based on your blood tests,
are infected with HIV and have active symptoms due to the infection,
have a history of problems with thymus gland or has had thymus gland removed for any
reason.
Always check the ingredients to make sure you can be given this vaccine.
Check with your doctor if:
you are taking any medicines for any other condition,
you are over 60 years old as you have an increased risk of certain types of severe
but rare reactions to vaccines (including serious reactions that affect the brain
and nerves, as well as vital organs). You will only be given the vaccine if the risk
of infection with the virus is well established in countries where you are going to
stay,
your child is aged 6 to 9 months. Stamaril may be given to children aged between 6
and 9 months only in special situations and on the basis of current official recommendations,
you are infected with the HIV but do not present with any HIV infection related symptoms,
your doctor will specify whether Stamaril can be given based on your blood tests,
your child is infected with the HIV (AIDS). The doctor may need to perform specific
exams and seek advice from a specialist before telling you whether your child may
receive Stamaril,
you have bleeding disorders (such as haemophilia or a low level of platelets) or are
taking medicines that reduce blood circulation. You can still receive Stamaril provided
that it is injected under the skin and not into a muscle,
you or your child have rare hereditary problems of fructose intolerance. Stamaril
contains a small amount of sorbitol and should not be given to people who have fructose
intolerance.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor or nurse if you are pregnant, think you might be pregnant or are
breastfeeding. You should not receive Stamaril unless this cannot be avoided.
If Stamaril is needed, you will need to stop breastfeeding for at least 2 weeks after
receiving Stamaril.
Your doctor or nurse can advise you on whether it is essential that you receive Stamaril
while pregnant or breastfeeding.
3. What if I or my child is taking other medicines?
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
If you have recently been receiving any treatment which may have weakened your immune
system (such as chemotherapy or high doses of corticosteroids), vaccination against
yellow fever should be postponed 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 vaccines against typhoid (those containing
the Vi capsular polysaccharide).
In adults, Stamaril can be given at the same time as IMOJEV (live attenuated vaccine
against Japanese encephalitis).
Your doctor will advise you if Stamaril can be given with another vaccine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
Stamaril.
4. How is Stamaril given?
How much is given
Stamaril is given as a single 0.5mL dose by your doctor or nurse.
Stamaril is given as an injection, usually under the skin, but it can be given into
a muscle. It must not be injected into a blood vessel.
When Stamaril is given
The injection should be given at least 10 days before being at risk of infection with
yellow fever, because it takes 10 days for the vaccine to work and provide good protection
against the yellow fever virus.
The protection will last at least 10 years and may be a life-long protection. Some
people may need to be re-vaccinated if they continue to be at risk for yellow fever
virus infection.
If you are given too much Stamaril
Overdose is most unlikely because your doctor or nurse gives the injections. If you
have any concerns, ask your doctor.
5. What should I know while being given Stamaril?
Call your doctor straight away if you:
Do not feel well after receiving Stamaril
Remind any doctor, dentist or pharmacist you visit that you have received Stamaril.
Looking after your medicine
Stamaril is usually stored in the doctor’s surgery or clinic, or at the pharmacy.
However, if you need to store Stamaril:
Keep Stamaril in the original pack until it is time for it to be given.
Keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Stamaril. Protect
from light.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this vaccine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this vaccine after the expiry date.
6. Are there any side effects?
All vaccines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This vaccine is only available with a doctor's prescription.
What Stamaril contains
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Active ingredient
(main ingredient)
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Yellow fever virus (produced in specified pathogen-free chick embryos), 17D strain
(live, attenuated): not less than 1000 IU
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Other ingredients
(inactive ingredients)
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Histidine hydrochloride, alanine, sodium chloride, potassium chloride, sodium phosphate
dihydrate, monobasic potassium phosphate, calcium chloride dihydrate, magnesium sulfate
heptahydrate and water for injections.
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Potential allergens
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Sorbitol
Lactose monohydrate
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Do not receive this vaccine if you are allergic to any of these ingredients.
The manufacture of this vaccine 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 Stamaril looks like
Stamaril is a beige to orange beige homogenous powder, which after reconstitution
with sodium chloride solution (a clear and colourless solution) forms a beige to pinked
beige suspension, which is more or less opalescent.
AUST R 58571
Who distributes Stamaril
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in July 2024.
sta-ccdsv11-cmiv5-09nov23