Author: Unknown

Patient Information Leaflet
To persons receiving (or parents or guardians
of children receiving) vaccination with YELLOW
FEVER VACCINE, LIVE BP (ARILVAX)

Yellow Fever Vaccine
Live BP
(Arilvax)
17D Strain Live
Freeze-dried (Yel/Vac)

PLEASE READ THIS CAREFULLY before you (or your child) are vaccinated.  This leaflet provides a summary of the information available on the vaccine.  If you have any questions or are not sure about anything, ask your doctor.

The name of this product is ARILVAX^®, or YELLOW FEVER VACCINE, LIVE BP.  It is one of a group of medicines called vaccines, which are used to protect people against infectious diseases.

What is in the vaccine?
Arilvax contains a freeze-dried powder of a live, weakened yellow fever virus (the same type of virus that causes the infectious disease yellow fever except that the weakened virus cannot cause the disease).  The powder is mixed with sterile water before use.

When mixed with the sterile water supplied with the vaccine, each 0.5ml dose of the vaccine contains the equivalent of not less than 1000 units of the weakened strain of the virus.  The vaccine also contains polymyxin B sulphate, neomycin sulphate, sorbitol, gelatin, sodium chloride, disodium hydrogen orthophosphate, potassium chloride, potassium dihydrogen orthophosphate, water and traces of egg derived protein.

The vaccine is supplied as a freeze-dried powder in single-dose or 5-dose containers (in packs of 5 with sterile water).  Sterile water (for dissolving the freeze-dried powder) is supplied in glass containers (with the vaccine).  Your doctor will mix the freeze-dried powder and sterile water together and will withdraw 0.5ml of the mixture into a syringe for your (or your child’s) vaccination.

How does the vaccine work?
When you are vaccinated with Arilvax^® your body produces a response (involving the production of antibodies) against the weakened yellow fever virus.  If you later come into contact with the disease-causing virus, this same response will again be produced to protect you.

The Product Authorisation and Product Licence Holder and Manufacturer are:
Evans Medical Limited, Leatherhead, KT22 7PQ, England.

What is the vaccine used for?
Arilvax^® is used to protect people against yellow fever, a serious infectious disease that causes a high temperature, headache, vomiting, exhaustion and liver problems.  It is given to children aged 9 months and over, adults and elderly who live in or travel to or from areas where the disease is common.

BEFORE YOU RECEIVE YOUR VACCINATION
You and your doctor should check the following details before you (or your child) are given this vaccine.

•	Have you been vaccinated against yellow fever before, and if so, did you feel unwell following vaccination?
•	Do you think you may be allergic/sensitive to any of the ingredients in the vaccine which are listed above in particular EGG (or CHICKEN) PROTEIN, or the antibiotics NEOMYCIN SULPHATE or POLYMYXIN B SULPHATE?
•	Do you feel feverish or do you have any type of infection?
•	Are you receiving any treatment that lowers your resistance to disease, for example, steroids, radiotherapy, or drugs used for treating cancer, or do you have a medical condition that affects your resistance to infection (for instance, are you or your child HlV-positive)?
•	Are you pregnant or breast-feeding?

If the answer to any of these questions is YES, TELL YOUR DOCTOR.  Vaccination may need to be delayed or may not be recommended.

Pregnancy and breast-feeding
It is not normally considered advisable to be vaccinated if you are pregnant or breast-feeding a baby.  If you are pregnant or breast-feeding a baby, your doctor will have considered the possible benefits and risks of vaccination before giving you this vaccine.

Children
Children under 9 months of age should not be given Arilvax^®.

Effects on other medicines or other substances
Tell your doctor if you have recently received any vaccinations (injections) to protect you against other infectious diseases or if you are going to receive any vaccinations soon as these may affect Arilvax^®.

Ability to drive and operate machinery
It is not known whether there are any specific effects of the vaccine on the ability to drive or operate machinery.  However, if you suffer side-effects such as feeling unwell following vaccination it is advisable not to drive or operate machinery until you feel well again.

Warnings
Very occasionally, a person who is extremely sensitive to some substance in the vaccine can suffer a serious allergic reaction following vaccination.  Doctors are aware of this possibility and have emergency treatment available for use if this happens.

How will you be given the vaccine?
The vaccine mixture should be shaken gently to ensure mixing of the freeze-dried powder and sterile water, before each dose is withdrawn from the container into a syringe for your (or your child’s) injection.  The injection needle should not come Into contact with disinfectant or spirit (alcohol) as these my reduce the vaccine’s effectiveness.

Your doctor will inject a single 0.5ml dose of the vaccine under the skin.  Children aged 9 months or over, adults and elderly all receive the same dose of vaccine.

Your doctor will write down the name, dose and lot number of the vaccine, and the date it was given in your (or your child’s) medical records.  However, it may help you to remember what vaccines you have received if you also make note of the name and dose of the vaccines, and the date on which they were given.

How long will you be protected against yellow fever?
One injection of Arilvax^® should protect you against yellow fever for 10 years.  When 10 years or more have passed, another (booster) injection is needed if you require further protection.

Do you need a certificate of vaccination?
It you live in, or are travelling to or from, a country where yellow fever is known to exist, you may be asked to provide written evidence that you have received yellow fever vaccination.  Ask your doctor whether or not you will require a certificate of vaccination.  If you are receiving a first dose of the vaccine, the certificate will be valid for a period of ten years from the tenth day alter vaccination.  If you are receiving a second (booster) dose within 10 years of the first dose, the certificate will be valid at once.

What side effects might you experience?
Severe side-effects following vaccination are extremely rare and may include allergic reactions and encephalitis (this may show as tiredness, fatigue, muscle weakness and paralysis).  Encephalitis has been reported mostly in babies under 9 months of age (therefore it is recommended that babies under 9 months of age are not vaccinated with this vaccine).

Sometimes, a reaction at the injection-site, such as soreness, redness and swelling may occur.  A headache following vaccination has also sometimes been reported.  A few days after vaccination you may develop stiff muscles and a temperature.  If these side-effects are troublesome or last more than a few days, TELL YOUR DOCTOR.

In very rare instances, rash, inflammation of a bursa (a structure associated with a joint), liver problems (a sign of which is yellowing of the skin, called jaundice) and nerve inflammation (symptoms of which may be a pain numbness and tingling) have been reported following vaccination.  If any of these happen, TELL YOUR DOCTOR IMMEDIATELY.

If you (or your child) have any other unwanted effects not mentioned above, TELL YOUR DOCTOR.

Use-by date and storage
The freeze-dried powder should be refrigerated between 2-5°C.  It should be protected from light.  The sterile water for mixing with the vaccine should be stored below 25°C (at room temperature): it should not be frozen.  Once the powder and sterile water have been mixed, the mixture should be kept cool, protected from light and used within 1 hour.  The vaccine should not be used after the “Use-by” date on the label.

Further Information
This leaflet does not contain the complete information about this vaccine.  If you have any questions or are unsure of anything, ask your doctor, who has access to additional information.

This leaflet only applies to the product Arilvax^® or YELLOW FEVER VACCINE, LIVE BP for which it has been prepared.

Package Insert/Patient Information Leaflet produced: July 1995