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Menomune

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Menomune. It does not contain all the information that is known about Menomune. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Menomune vaccine is used for

Menomune vaccine is used to help prevent meningitis or infections caused by the meningococcal bacteria groups A, C, Y and W-135. Menomune vaccine is used to help prevent meningitis in people likely to be infected with the meningococcal bacteria. These include:
travellers to countries where there is a risk of contracting meningitis
people living in an area where an outbreak or epidemic of meningitis has occurred
people in close contact with someone who has meningitis
people at high-risk of contracting meningitis such as those who have their spleen removed or those whose spleen does not work properly

How Menomune vaccine works

Menomune vaccine works by causing your body to produce its own protection against infections caused by meningococcal bacteria groups A, C, Y and W-135. It does this by making substances called antibodies in the blood which fight meningococcal bacteria. If a vaccinated person comes into contact with meningococcal bacteria groups A, C, Y and W-135, the body is usually ready to destroy it. Your body usually takes several weeks after vaccination to develop protection against the meningococcal bacteria. Protection requires one dose. Most people will produce enough antibodies against meningococcal bacteria groups A, C, Y and W-135. However, as with all vaccines, 100% protection cannot be guaranteed.
Menomune vaccine will not protect you against bacteria other than meningococci groups A, C, Y and W-135. The vaccine will not give you meningitis. The chance of a severe reaction from Menomune vaccine is very small, but the risks from not being vaccinated against meningitis may be very serious.

Before you are given Menomune vaccine

When you must not be given Menomune vaccine

Do not receive Menomune vaccine if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Menomune vaccine (including latex, which is used in the vial stopper) listed in the FURTHER INFORMATION section.
Tell your doctor if you have an illness. Your doctor may decide to delay vaccination until the illness has passed.
Menomune vaccine is not recommended for use in children younger than 2 years of age.
If you are not sure whether you should have Menomune vaccine, talk to your doctor or pharmacist.

Take special care with Menomune vaccine

Tell your doctor if you have, or have had, any medical conditions, especially the following:
lowered immunity due to diseases such as malaria, HIV/AIDS or cancer
leukaemia or any other cancers of the blood or lymph system
your spleen is removed or your spleen does not work properly
Tell your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of having Menomune vaccine during pregnancy.
Tell your doctor if you are breastfeeding.
Your doctor will discuss the possible risks and benefits of having Menomune vaccine during breastfeeding.

Taking other medicines

Medicines that may reduce your immune response: such as corticosteroids (for example prednisone), medicines used to treat cancer (chemotherapy), radiotherapy or other medicines affecting the immune system. Tell your doctor if you have been treated with such medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Having other vaccines

Your doctor will advise you if Menomune vaccine is to be given with another vaccine.

How Menomune vaccine is given

Menomune vaccine is given as a single injection, usually into your upper arm by a doctor or nurse.
Menomune vaccine should not be injected directly into the veins, muscle or skin.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after receiving Menomune vaccine.
Menomune vaccine 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 tenderness and redness of the skin
loss of appetite, nausea, diarrhoea, vomiting
headache
tiredness (fatigue), unusual weakness (asthenia)
generally feeling unwell (malaise)
joint pain (arthralgia)
high temperature (more than 38°C), chills
irritability, drowsiness
These are the more common side effects of Menomune vaccine. Mostly, these are mild and short-lived.
Other side effects that have been reported include:
dizziness
sore, aching muscles (myalgia)
fainting
tingling or numbness of the hands or feet (paraesthesia)
If any of the following happen, tell your doctor immediately or go to Accident and Emergency department at your nearest hospital:
sudden severe allergic reactions, for which symptoms may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
headache and high temperature associated with hallucinations, confusion, paralysis of part or all of the body, disturbances of behaviour, speech and eye movements, stiff neck and sensitivity to light
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are 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.

After using Menomune vaccine

Storage

Menomune vaccine is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Menomune vaccine:
Keep it where children cannot reach it.
Keep Menomune vaccine 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 Menomune vaccine. Freezing destroys the vaccine.
Do not use Menomune vaccine after the expiry date printed on the pack.
Do not use Menomune vaccine if the packaging is torn or shows signs of tampering.

Product description

What Menomune vaccine looks like

Each pack of Menomune vaccine contains one vial of vaccine powder and one vial of liquid. Your doctor will inject the liquid into the vial to make the liquid for your injection. The resulting liquid is a clear colourless liquid.

What Menomune vaccine contains

Active ingredients:
50 micrograms of polysaccharide from each of the group A, C, Y and W-135 meningococcal bacteria
Other ingredients:
Sodium chloride solution
Lactose
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.

Name and Address of Australian Sponsor

sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Tel: 1800 829 468

Name and Address of New Zealand Sponsor

sanofi-aventis new zealand limited
Level 8, James & Wells Tower
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 727 838

Aust R number

AUST R 80091

Date of preparation

02 May 2013