BOOSTRIX
Combined diphtheria, tetanus, acellular pertussis (dTpa) vaccine
CONSUMER MEDICINE INFORMATION
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 with this vaccine. 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 4 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 (Lockjaw)
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.
The use of BOOSTRIX during pregnancy will help to protect your baby from whooping cough in the first
few months of life before he/she receives the primary immunisation.
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.
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BEFORE RECEIVING BOOSTRIX
BOOSTRIX MUST NOT BE GIVEN IF:
• you/your child has had an allergic reaction to BOOSTRIX or any other ingredients contained in
this 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 had an allergic reaction to any other diphtheria, tetanus, pertussis vaccine
• 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, nurse or pharmacist about this before
being vaccinated.
• you/your child has experienced any inflammation of the brain or problems with the nervous
system within 7 days after previous vaccination with a vaccine against pertussis (whooping
cough) disease
• you/your child experienced a temporary reduction in blood platelets (which increases risk of
bleeding or bruising), or problems with the brain or nerves after previous vaccination with a
vaccine against diphtheria and/or tetanus
• 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, nurse or pharmacist.
BEFORE BOOSTRIX IS GIVEN TELL YOUR DOCTOR, NURSE OR PHARMACIST IF:
• you/your child has a severe infection with a high temperature. In these cases, the vaccination
will be postponed until recovery. A minor infection such as a cold should not be a problem but
talk to your doctor first.
• after having been given BOOSTRIX or another vaccine containing diphtheria, tetanus,
pertussis, your child had problems such as:
o high temperature (40.0°C or more) within 2 days of vaccination
o a collapse or shock-like state within 2 days of vaccination
o crying lasting 3 hours or more within 2 days of vaccination
o convulsions/fits with or without fever within 3 days of vaccination
• you/your child suffered 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.
• you/your child has a bleeding disorder or bruises easily. Sometimes BOOSTRIX may need to
be given differently in people with bleeding problems
• you/your child has an immune deficiency condition (eg. are HIV positive)
• you/your child has a tendency to seizures/fits due to a fever, or if there is a family history of
this
• 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
o your doctor will discuss with you the possible risks and benefits of receiving
BOOSTRIX during pregnancy.
Collapse or periods of unconsciousness or lack of awareness, seizures or fits have occurred in children
given other vaccines containing one or more of the active constituents of BOOSTRIX. They usually occur
within two to three days after vaccination.
Fainting can occur following, or even before, any needle injection, therefore tell the doctor, nurse or
pharmacist if you or your child fainted with a previous injection.
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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.
HOW BOOSTRIX IS GIVEN
The doctor, nurse or pharmacist 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 0.5 mL
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 IS 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, nurse or pharmacist 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.
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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, nurse or pharmacist
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 in order to protect from
light.
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 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.
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Each 0.5 mL dose contains:
• not less than 2 IU of diphtheria toxoid
• not less than 20 IU of tetanus toxoid
• 8 micrograms of pertussis toxoid, 8 micrograms of filamentous haemagglutinin and 2.5
micrograms pertactin.
Inactive ingredients in the vaccine are aluminium hydroxide, aluminium phosphate, formaldehyde,
polysorbate 80, sodium chloride, glycine and water for injections.
BOOSTRIX does not contain any infectious material.
FURTHER INFORMATION
BOOSTRIX is only available if prescribed by a doctor, nurse or pharmacist.
BOOSTRIX comes as a prefilled syringe in packs of 1 or 10.
DISTRIBUTOR
GlaxoSmithKline NZ Ltd
Private Bag 106600
Downtown Auckland
NEW ZEALAND
Ph: (09) 367 2900
Fax: (09) 367 2910
Date of preparation: 25 June 2020
Version 8.0
Trade marks are owned by or licensed to the GSK group of companies.
© 2021 GSK group of companies or its licensor.
