Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about VIVAXIMŽ
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you having VIVAXIMŽ against the benefits they expect it will have for you.
If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.
Keep this leaflet. You may need to read it again.
What VIVAXIMŽ is used for
VIVAXIMŽ is a vaccine used to help prevent Typhoid fever and Hepatitis A disease in adults over the age of 16 years who are at risk of these diseases.
How it works
VIVAXIMŽ works by causing your body to produce its own protection against typhoid fever and hepatitis A infection. It does this by making substances called antibodies in the blood, which fight the typhoid bacteria and hepatitis A viruses. If a vaccinated person comes into contact with the typhoid or hepatitis A organisms, the body is usually ready to destroy them.
Your body usually takes two weeks after vaccination to develop protection against typhoid fever and hepatitis A infection.
Initial protection is provided by one dose of VIVAXIMŽ. For long-term protection against hepatitis A virus a booster vaccination with an inactivated hepatitis A vaccine will be required 6 to 36 months after vaccination with VIVAXIMŽ . The body does not develop long-term protection against typhoid fever and repeat vaccinations are required to maintain protection.
Most people will produce enough antibodies against typhoid fever and hepatitis A infection. However, as with all vaccines, 100% protection cannot be guaranteed.
The vaccine will not give you Typhoid fever or hepatitis A infection.
The chance of a severe reaction from VIVAXIMŽ is very small, but the risks from not being vaccinated against Typhoid fever or Hepatitis A infection may be very serious.
Before you are given VIVAXIMŽ
When you must not be given it
You have had a severe reaction to a previous injection of this vaccine.
Do not have VIVAXIMŽ if you have an allergy to:
VIVAXIMŽ or any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include:
Shortness of breath, wheezing or difficulty breathing
Swelling of the face, lips, tongue or other parts of the body
Skin rash, itching or hives
Do not have VIVAXIMŽ if you have, a fever or acute illness. Minor infections are not a reason to delay vaccination.
Do not have VIVAXIMŽ if you have had a severe reaction to a previous injection of this vaccine.
Do not have VIVAXIMŽ if you are pregnant or intend to become pregnant. VIVAXIMŽ is not recommended for use during pregnancy.
Do not give VIVAXIMŽ to an adult or child under 16 years. The safety and effectiveness of VIVAXIMŽ in adults and children under 16 years have not yet been established.
Do not have VIVAXIMŽ after the expiry date printed on the pack.1
Do not have VIVAXIMŽ if the packaging is torn or shows signs of tampering.
Talk to your doctor or pharmacist if you are not sure whether you should have VIVAXIMŽ.
Before you are given it
Tell your doctor if you have reacted to previous vaccination with any of the following:
Life-threatening allergic reaction
Swelling of the throat
Fainting or collapse
Shock-like state or being unresponsive for a long period of time
Fits or convulsions
High temperature (greater than 40°C)
Severe skin reaction at the injection site, including severe bruising
Tell your doctor if you have an infection or high temperature. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
Lowered immunity due to diseases such as some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
Lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy)
Leukaemia or any other cancers of the blood, bone marrow or lymph system
If you have lowered immunity then the vaccine may not work as well as it would in healthy individuals.
Tell your doctor if you have allergies to:
Any other medicines
Any other substances, such as foods, preservatives or dyes
Tell your doctor if you are pregnant or intend to become pregnant. VIVAXIMŽ is not recommended for use during pregnancy. If there is a need to consider VIVAXIMŽ during your pregnancy, your doctor will discuss with you the benefits and risks of having it.
Tell your doctor if you are breast-feeding. Your doctor will discuss the possible risks and benefits of having VIVAXIMŽ during breastfeeding.
Taking other medicines
As VIVAXIM does not contain any live bacteria or viruses, it can generally be given at the same time as other inactivated vaccines, but at a different injection site.
Other medicines should be taken as usual after the vaccination.
VIVAXIMŽ can be given at the same time as yellow fever vaccine at different injection sites.
How VIVAXIMŽ is given
VIVAXIMŽ is given as a slow injection into your upper arm muscle by a doctor or nurse.
VIVAXIMŽ should not be injected directly into the veins or into the buttocks.
How much is given
The dose is one millilitre of the mixed vaccine.
When it is given
VIVAXIMŽ should be given 14 days before you are exposed to risk of both typhoid fever and hepatitis A. For long term protection you should obtain a booster dose of AVAXIM (hepatitis A vaccine) 6-36 months after your dose of VIVAXIMŽ. You should be revaccinated against Typhoid fever, every 3 years.
After having VIVAXIMŽ
Things you must do
Keep an updated record of your vaccinations.
Attend any other appointments made by your doctor or nurse.
Report any side effects to your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well after having VIVAXIMŽ VIVAXIMŽ may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
Local reaction around the injection site such as redness, pain, swelling or hardness
Generally feeling unwell
Soreness, aching muscles, muscle tenderness or weakness (not caused by exercise)
Nausea or diarrhoea
These are the more common side effects of VIVAXIMŽ. Mostly these are mild and short-lived.
Less common side effects include itchiness of the skin, dizziness and a rash. Very rarely some patients experience vomiting, abdominal pain and increased liver enzyme.
Tell your doctor immediately if you notice any of the following:
Abscess at the injection site
Unusual bleeding, bruising or purple spots on the skin
Skin rash, itchy spots or red lumps on the skin
Painful, swollen joints
Swelling of the glands in the neck, armpit or groin
Itchiness, hives or rash over the body
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body
Pinkish, itchy swellings on the skin, also called hives or nettle rash, shortness of breath, wheezing or trouble breathing
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
VIVAXIMŽ is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store VIVAXIMŽ:
Keep it where children cannot reach it.
Keep VIVAXIMŽ in the original pack until it is time for it to be given.
Keep it in the refrigerator, between 2°C and 8°C. Do not freeze VIVAXIMŽ.
Freezing destroys the vaccine.
What it looks like
VIVAXIMŽ is a combination vaccine contained in a dual chamber syringe. One chamber contains the hepatitis A vaccine, which appears as a white suspension, the other the typhoid vaccine, which appears as a clear liquid. The two vaccine components become mixed together when the plunger is depressed.
0.025 mg Purified Salmonella typhi (Ty 2 Strain) Vi Polysaccharide.
160 ELISA units hepatitis A virus antigen.
Sodium phosphate - dibasic dihydrate
Sodium phosphate - monobasic
Water for injections
Medium 199 (Hanks)
Bovine Serum Albumin
The hepatitis A virus that this vaccine contains was grown in a cell line derived from human embryonic lung in the 1960s.
The manufacture of this product includes exposure to bovine derived 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.
SANOFI PASTEUR SA
1541 Avenue Marcel Merieux
69280 Marcy L'Etoile
SANOFI PASTEUR SA
Parc Industriel d'Incarville
27100 Val de Reuil
SANOFI PASTEUR PTY.LTD
ABN 79 085 258 797
Talavera Corporate Centre - Building D
12-24 Talavera Road
Tel: 1800 829 468
Merck Sharp & Dohme (New Zealand) Limited
PO Box 99851
Tel: 0800 500 673
Aust R number
Aust R 82745
Version: 26 September 2006