PNEUMOVAX® 23
Pneumococcal Vaccine
Single Dose Vial
What is in this leaflet
This leaflet answers some common questions about PNEUMOVAX 23. It does not
contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has weighed
the risks of you being given PNEUMOVAX 23 against the benefits they expect it
will have for you.
If you have any concerns about being given this vaccine, ask your doctor or
pharmacist.
Keep this leaflet. You may need to read it again.
What PNEUMOVAX 23 is used for
PNEUMOVAX 23 is a vaccine used to help prevent infections caused by certain
types of germs or bacteria called pneumococcus. PNEUMOVAX 23 helps protect
against the most common types of pneumococcal bacteria.
It is given to children 2 years of age and older, teenagers and adults who:
- have no spleen or a spleen that does not function properly
- have long-term diseases and are at increased risk of pneumococcal
infection, or where pneumococcal infection may be more severe - are living in communities or institutions where pneumococcal infections
are spreading very quickly and who are at increased risk of being infected.
It is also recommended as a routine vaccination for people aged 50 years
and older.
Pneumococcal infection is an important cause of death worldwide. Protection
against pneumococcal infection is important because the germs or bacteria can
cause serious diseases such as:
- meningitis, an infection of the brain and/or spinal cord
- pneumonia, an infection of the lungs
- otitis media, an infection of the middle ear
- bacteraemia, an infection in the blood.
Groups of people who are at increased risk of pneumococcal disease include
those who have poor immune systems, such as people with organ transplants,
certain cancers and HIV/AIDS. Other people who are at risk of pneumococcal
disease include those with no spleen, those with long-term problems of the
heart, lung, kidney or liver, diabetes mellitus, alcoholics and people aged 50
years and older.
Infection from pneumococcal bacteria usually occurs when you come into
contact with an infected person. The infection may be spread when an infected
person coughs or sneezes near another person. Apart from certain diseases,
other situations that may increase the risk of infection include:
- being around groups of other children (e.g. Day care)
- living in the same household as someone who is infected.
How it works
PNEUMOVAX 23 works by causing your body to produce its own protection
against pneumococcal infection. It does this by making disease-fighting
substances called antibodies to fight the bacteria. The vaccine itself cannot
cause the infection. If a vaccinated person comes into contact with live
bacteria, the body is usually ready and produces antibodies to destroy it.
However, as with all vaccines, 100% protection against pneumococcal disease
cannot be guaranteed.
The chance of a severe reaction from PNEUMOVAX 23 is very small, but the
risks from not being vaccinated are very serious.
PNEUMOVAX 23 only protects against infections caused by the most common
types of pneumococcal bacteria, not against the less common types of
pneumococcal bacteria or other germs.
Before you are given PNEUMOVAX 23
When you or your child must not be given it
Do not have PNEUMOVAX 23 if:
- you have an allergy to PNEUMOVAX 23 or any of the ingredients listed at
the end of this leaflet - the expiry date on the pack has passed
If the vaccine is used after the expiry date has passed, it may not work.
If you are not sure whether you or your child should be given PNEUMOVAX 23,
talk to your doctor.
Do not give PNEUMOVAX 23 to children under 2 years of age. The safety and
effectiveness of PNEUMOVAX 23 in children below the age of 2 years have not
been established.
Before you or your child are given it
Tell your doctor if:
- you are pregnant or intend to become pregnant
It is not known whether the vaccine is harmful to an unborn baby when given
to a pregnant woman. Your doctor will give you PNEUMOVAX 23 only if it is
clearly needed - you are breast-feeding
It is not known whether PNEUMOVAX 23 passes into breast milk. Your doctor
will discuss the possible risks and benefits of you being given PNEUMOVAX 23
while breast-feeding - you have any medical conditions, especially the following:
- heart or lung problems
- idiopathic thrombocytopaenic purpura (ITP), a disease which causes
unusual bleeding or bruising under the skin - blood problems
- you have an infection or a high temperature
Your doctor may decide to delay your injection of PNEUMOVAX 23. - you are currently being treated or have recently been treated with
radiotherapy
Your doctor may decide to delay your injection of PNEUMOVAX 23. - you have been vaccinated with a pneumococcal vaccine before
Revaccination in people who have previously received PNEUMOVAX 23 within the
last four years is not recommended as it can cause more severe adverse
effects. - you have any allergies to any other medicines or vaccines, or any other
substances, such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before
you or your child are given an injection of PNEUMOVAX 23.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that
you buy without a prescription from your pharmacy, supermarket or health food
shop.
PNEUMOVAX 23 may not work as well as it should if you or your child are
taking or receiving medicines that decrease the immune system, such as
corticosteroids (e.g. prednisone), cyclosporin, or chemotherapy.
Your doctor will advise you if you are taking or receiving any of these or
other medicines that decrease the immune system. Your doctor will decide
whether or not to give the vaccine.
How PNEUMOVAX 23 is given
How much is given
Your doctor will decide on the dose of PNEUMOVAX 23 that you or your child
will be given.
The usual dose of PNEUMOVAX 23 is 0.5 mL. The dose of the vaccine is the
same for everyone.
Usually only one injection is needed to help protect against pneumococcal
disease. However, if you are at increased risk of serious pneumococcal
infection, you may need to have a second injection. Your doctor will decide if
and when you need a second injection of PNEUMOVAX 23.
How it is given
PNEUMOVAX 23 is given as an injection by a doctor or trained nurse, either
into a muscle, such as your upper arm or mid-thigh, or under the skin.
Adverse Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
during or after having had an injection of PNEUMOVAX 23.
PNEUMOVAX 23 helps protect most people from pneumococcal infections, but it
may have unwanted adverse effects in a few people. All medicines and vaccines
can have adverse effects. Sometimes they are serious, most of the time they
are not. You may need medical treatment if you get some of the adverse
effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you or your child has any of the following and they
are troublesome or ongoing:
- soreness, redness, warmth, swelling or hard lump where you had the
injection - swelling of hands, ankles or feet
- fever
- headache
- nausea
- vomiting
- unusual tiredness or weakness
- chills
- generally feeling unwell
- pain and decreased ability to move the limb where you had the injection
These are usually mild adverse effects of PNEUMOVAX 23.
Tell your doctor immediately if you or your child notice any of the
following:
- aching muscles, muscle tenderness or weakness, not caused by exercise
- painful or swollen joints
- tingling or numbness of the hands or feet
- swollen and painful lymph glands
These may be serious adverse effects. You may need urgent medical attention.
These adverse effects are rare.
Allergic Reaction:
As with all vaccines given by injection, there is a very small risk of a
serious allergic reaction. Tell your doctor immediately or go to accident and
emergency at your nearest hospital if you or your child notice any of the
following:
- skin rash, itching
- pinkish, itchy swellings on the skin, also called hives or nettle rash
- swelling of the face, lips, tongue or other parts of the body
- shortness of breath, wheezing or trouble breathing
These may be serious adverse effects. If you have them, you may have had a
serious allergic reaction to PNEUMOVAX 23. You may need urgent medical
attention or hospitalisation. Most of these adverse effects occur within the
first few hours of vaccination.
Other adverse effects not listed above may also occur in some patients.
Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible adverse effects. You may not
experience any of them.
Storage
PNEUMOVAX 23 is usually stored in the doctor's surgery or clinic, or at the
pharmacy. However if you need to store PNEUMOVAX 23:
Keep it where children cannot reach it.
Keep it in the refrigerator, but not in the door compartment.
Do not put PNEUMOVAX 23 in the freezer, as freezing destroys the vaccine.
Keep the injection in the original pack until it is time for it to be
given.
Product description
What it looks like
PNEUMOVAX 23 comes in glass vials.
Ingredients
Active ingredient:
The active ingredient of PNEUMOVAX 23 is a mixture of inactive parts from
23 of the most common types of pneumococcal bacteria. Each 0.5 mL of vaccine
contains 25 micrograms of each polysaccharide type.
Inactive ingredients:
phenol
sodium chloride solution
PNEUMOVAX 23 is made without any human blood or blood products. It does not
contain any infectious material.