BOOSTRIX™

Combined diphtheria, tetanus, acellular pertussis (dTpa) vaccine

What Is In This Leaflet?

This leaflet answers some of the common questions about BOOSTRIX vaccine.
It does not contain all the available information. It does not take the place
of talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed
the possible risks of your child having BOOSTRIX against the expected
benefits.

If you have any concerns about BOOSTRIX talk to your doctor, nurse or
pharmacist.

Keep this leaflet. You may need to read it again.

What Is BOOSTRIX Used For

BOOSTRIX is a vaccine used for booster vaccination against diphtheria,
tetanus and pertussis (whooping cough). The vaccine is sometimes called dTpa
vaccine.

BOOSTRIX is intended for use in children aged 10 years and older and
adults.

Diphtheria, pertussis and tetanus are three life-threatening diseases
caused by bacterial infection. The vaccine works by causing the body to
produce its own protection (antibodies) against the disease.

Diphtheria

Diphtheria is a bacterium that lives in the airways of humans and can also
affect the skin. Generally, the airways become inflamed (swollen) causing
severe breathing difficulties and sometimes suffocation. The bacteria release
a toxin (poison) which can cause nerve damage, heart problems and death. The
risk of serious complications and death is greater in the very young and
elderly.

Tetanus

Tetanus bacteria enter the body through wounded skin. Wounds that are
especially prone to infection are burn wounds, fractures, deep wounds or
wounds contaminated with soil, dust, horse manure or wood splinters. The
bacteria release toxins, which can cause muscle stiffness, painful spasms,
fits and death. The spasm can be strong enough to cause bone fractures of the
spine.

Pertussis (whooping cough)

Pertussis is highly infectious. It affects the breathing tract causing
severe spells of coughing that may interfere with normal breathing. The
coughing is often accompanied by a "whooping" sound. The cough may last for
1-2 months or longer. Pertussis can also cause inner ear infections, long
lasting bronchitis, pneumonia, fits, brain damage and death. The risk of
severe complications and death is greatest in infants under 6 months of age.

Vaccination is the best way of protecting against these diseases. BOOSTRIX
vaccine cannot give you or your child diphtheria, tetanus or pertussis
infection. The vaccine will not protect against diseases caused by other types
of bacteria or organisms.

Before Receiving BOOSTRIX

BOOSTRIX Must Not Be Given If:

you/your child has had an allergic reaction to INFANRIX®, any ingredient
contained in this vaccine or any other diphtheria, tetanus or pertussis
vaccine. The ingredients are listed at the end of this leaflet. Signs of an
allergic reaction may include itchy skin rash, shortness of breath or
swelling of the face or tongue.
you/your child has had blood clotting problems or problems with the
nervous system following an earlier immunisation against diphtheria and/or
tetanus.
you/your child has a severe infection with a high temperature. A minor
infection such as a cold should not be a problem, but talk to your doctor or
nurse about this before being vaccinated.
you/your child has experienced an inflammation/disease in the brain,
which occurred 7 days following previous vaccination with a pertussis
vaccine. Another type of vaccine should be used for a booster in this case.
you/your child suffer from neurological disorders, including infantile
spasms, uncontrolled epilepsy or progressive encephalopathy (a brain
disease).
the expiry date printed on the pack has passed
the packaging is torn or shows signs of tampering

If you are not sure whether BOOSTRIX should be given, talk to your doctor
or nurse.

Tell your doctor if:

you/your child has any medical conditions, such as:
a bleeding disorder. Sometimes BOOSTRIX may need to be given differently
in people with bleeding problems
an immune deficiency condition (eg. are HIV positive)
brain disease or Central Nervous System (CNS) disease such as epilepsy
or a tendency to febrile convulsions (seizures /fits due to a high fever)
you/your child has allergies to any other medicines or substances, such
as dyes, foods or preservatives.
after having been given INFANRIX or another vaccine containing
diphtheria, tetanus, pertussis, your child had problems such as:
high temperature (over 40.0°C) within 2 days of vaccination
A collapse or shock-like state within 2 days of vaccination
crying lasting 3 hours or more within 2 days of vaccination
convulsions/fits with or without fever within 3 days of vaccination
you/your child is receiving any other medication or vaccines
you/your child has never been given a vaccine for diphtheria, tetanus or
pertussis or have not completed a full course of diphtheria and tetanus
vaccinations
You are pregnant, trying to become pregnant or are breastfeeding

Some vaccines may be affected by other vaccines or medicines. Your doctor,
nurse or pharmacist will be able to tell you what to do if BOOSTRIX is to be
given with another vaccine or medicine.

Giving BOOSTRIX

How BOOSTRIX Is Given

The doctor or nurse will give BOOSTRIX as an injection. If you have any
concerns about how this vaccine is to be given, talk to your doctor, nurse or
pharmacist.

How Much Is Given

The dose of BOOSTRIX is 0.5mL

HOW IS IT GIVEN

BOOSTRIX will be injected into a muscle, normally the upper arm muscle. In
patients with bleeding problems, the dose may need to be given under the skin
(subcutaneously).

The vaccine should never be given intravenously (IV).

WHEN IT WILL BE GIVEN

BOOSTRIX is given in accordance with local medical practice for booster
vaccination, when a booster dose for tetanus, diphtheria or pertussis is
required.

To provide effective protection against diphtheria and tetanus, a booster
vaccine should be given every 10 years.

If A Dose Is Missed

If a scheduled booster dose is missed, talk to your doctor or nurse and
arrange another visit as soon as possible.

While Getting BOOSTRIX

THINGS YOU MUST DO

Keep your and your child's visits with the doctor or clinic. It is
important that the BOOSTRIX dose are given on the correct schedule. This will
ensure your child has the best protection against diphtheria, tetanus and
pertussis (whooping cough).

Side Effects

Tell your doctor, nurse or pharmacist as soon as possible if you/your child
does not feel well during or after having had a dose of BOOSTRIX.

BOOSTRIX helps protect most children and adults from diphtheria, tetanus
and pertussis infection, but it may have unwanted side effects in some
patients. All medicines and vaccines can have side effects. Sometimes they are
serious; most of the time they are not. Some side effects may need medical
treatment. However, the chance of you/your child having a serious side effect
is less than the chance of you/your child having a permanent injury from the
infections.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Most unwanted effects with BOOSTRIX are mild and usually clear up within a
few days. These effects, as with other vaccines, generally occur around the
injection site.

MILD EFFECTS

Tell your doctor if you notice any of the following that are troublesome or
ongoing after vaccination:

redness, swelling, a hard lump, soreness, bruising or itching around the
injection site, or a rash on your skin
feeling generally unwell, fever (between 38°C and 40°C), aches and pains
loss of appetite, or feeling sick (nausea), vomiting, constipation or
diarrhoea
restlessness, irritability, loss of appetite

SERIOUS EFFECTS

As with all vaccines given by injection, there is a very small risk of
serious allergic reaction. Contact your doctor immediately or go to the
Accident and Emergency department of your nearest hospital if any of the
following happens:

swelling of limbs, face, eyes, inside of nose, mouth or throat
shortness of breath, or breathing or swallowing difficulties
hives, itching (especially of the hands or feet), reddening of skin
(especially around the ears), or severe skin reactions
unusual tiredness or weakness that is sudden and severe, muscular aches
and pains
convulsions/fits, collapse or periods of unconsciousness
fever over 40°C

Those are signs of an allergic reaction. Allergy to BOOSTRIX is rare. Any
such severe reactions will usually occur within the first few hours of
vaccination.

Other side effects not listed above can also occur during or soon after a
dose of BOOSTRIX, including as respiratory infections and middle ear
infections. Check with your doctor or nurse if you notice any other
effects.

Be aware, but do not be alarmed by this list of possible side effects.
You/your child may not experience any of them.

STORAGE

BOOSTRIX is usually stored at the doctor's clinic or surgery, or at the
pharmacy. But if you need to store BOOSTRIX always:

Keep BOOSTRIX in the refrigerator stored between +2°C and +8°C. THE PACK
SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
Keep the vaccine out of the reach of children.
Keep BOOSTRIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over BOOSTRIX that has expired
or has not been used.

Product Description

WHAT IT LOOKS LIKE

BOOSTRIX comes in glass vials or prefilled syringes. It is a white,
slightly milky liquid.

INGREDIENTS

The active ingredients of BOOSTRIX are non-infectious substances from
tetanus and diphtheria bacteria, and purified proteins of pertussis bacteria.
The vaccine cannot cause these diseases.

Each 0.5mL dose contains:

2.5Lf U of diphtheria toxoid
5Lf U of tetanus toxoid
8mcg of pertussis toxoid, 8mcg of filamentous haemagglutinin and 2.5mcg
of 69Kd outer membrane protein (pertactin).

Inactive ingredients in the vaccine are: aluminium hydroxide, aluminium
phosphate, 2-phenoxyethanol, sodium chloride, and water.

BOOSTRIX does not contain any infectious material.

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