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BOOSTRIX SUSPENSION FOR INJECTION IN PFS

Active substance(s): DIPHTHERIA TOXOID ADSORBED / PERTACTIN 69KDA / PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED / PERTUSSIS TOXOID / TETANUS TOXOID ABSORBED / DIPHTHERIA TOXOID ADSORBED / PERTACTIN 69KDA / PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED / PERTUSSIS TOXOID / TETANUS TO

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GSK-BEL-Wavre-BEWAV-St.Amand
Ireland-IRL
Boostrix

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Package leaflet: Information for the user

Boostrix®, Suspension for
injection in pre-filled syringe
Diphtheria, tetanus, and pertussis (acellular, component)
vaccine (adsorbed, reduced antigen(s) content)
Read all of this leaflet carefully before you or your
child start receiving this vaccine because it contains
important information for you.

N/A

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This vaccine has been prescribed for you or your
child only. Do not pass it on to others.
- If you or your child get any side effects, talk to your
doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

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What is in this leaflet
1. What Boostrix is and what it is used for
2. What you need to know before you or your child receive
Boostrix
3. How Boostrix is given
4. Possible side effects
5. How to store Boostrix
6. Contents of the pack and other information
1. What Boostrix is and what it is used for

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Boostrix is a vaccine used as a booster dose in children
from 4 years onwards, teenagers and adults to prevent
three diseases: diphtheria, tetanus (lockjaw) and pertussis
(whooping cough). The vaccine works by causing the body
to produce its own protection (antibodies) against these
diseases.
• D
 iphtheria: Diphtheria mainly affects the airways and
sometimes the skin. Generally the airways become
inflamed (swollen) causing severe breathing difficulties
and sometimes suffocation. The bacteria also release
a toxin (poison), which can cause nerve damage, heart
problems, and even death.
• T
 etanus (Lockjaw): Tetanus bacteria enter the body
through cuts, scratches or wounds in the skin. Wounds
that are especially prone to infection are burns, fractures,
deep wounds or wounds contaminated with soil, dust,
horse manure/dung or wood splinters. The bacteria release
a toxin (poison), which can cause muscle stiffness, painful
muscle spasms, fits and even death. The muscle spasms can
be strong enough to cause bone fractures of the spine.

10.0pt
11.0pt
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10.0pt
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• P
 ertussis (Whooping cough): Pertussis is a highly
infectious illness. The disease affects the airways causing
severe spells of coughing that may interfere with
normal breathing. The coughing is often accompanied
by a “whooping” sound, hence the common name
“whooping cough”. The cough may last for 1-2 months
or longer. Pertussis can also cause ear infections,
bronchitis which may last a long time, pneumonia, fits,
brain damage and even death.
None of the ingredients in the vaccine can cause
diphtheria, tetanus or whooping cough.
2. What you need to know before you or your
child receive Boostrix
Boostrix should not be given:

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Additional Information Panel
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Folded dimensions: 210x25mm
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• if you or your child have previously had any allergic
reaction to Boostrix, or any of the other ingredients
contained in this vaccine (listed in section 6). Signs
of an allergic reaction may include itchy skin rash,
shortness of breath and swelling of the face or tongue.
• if you or your child have previously had an allergic
reaction to any vaccine against diphtheria, tetanus
or whooping cough diseases.
• if you or your child experienced problems of the
nervous system (encephalopathy) within 7 days
after previous vaccination with a vaccine against
pertussis (whooping cough) disease.
• if you or your child have a severe infection with a
high temperature (over 38°C). A minor infection
should not be a problem, but talk to your doctor first.
• if you or 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.

Warnings and precautions
Talk to your doctor or pharmacist before you or your
child are given Boostrix:
• if after previously having Boostrix or another
vaccine against pertussis (whooping cough) disease,
you or your child had any problems, especially:

MINIATURE PHARMA CODE N° 1219

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MINIATURE PHARMA CODE N° 1219

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- A high temperature (over 40°C) within 48 hours
of vaccination
- A collapse or shock-like state within 48 hours of
vaccination
- Persistent crying lasting 3 hours or more within
48 hours of vaccination
- Seizures/fits with or without a high temperature
within 3 days of vaccination
• if your child is suffering from an undiagnosed or
progressive disease of the brain or uncontrolled epilepsy.
After control of the disease the vaccine should be
administered.
• if you or your child have a bleeding problem or bruise
easily
• if you or your child have a tendency to seizures/fits due
to a fever, or if there is a family history of this
• if you or your child have long standing immune system
problems due to any reason (including HIV infection).
You or your child may still be given Boostrix but the
protection against infections after having the vaccine
may not be as good as in children or adults with good
immunity to infections.
Fainting can occur (mostly in adolescents) following, or
even before, any needle injection. Therefore tell the
doctor or nurse if you or your child fainted with a previous
injection.
As with all vaccines Boostrix may not completely protect all
people who are vaccinated.
Other medicines and Boostrix
Tell your doctor or pharmacist if you or your child are
taking, have recently taken, or might take any other
medicines or have recently received any other vaccine.
Boostrix may not work as well if you or your child are
taking medicines that reduce the effectiveness of their
immune system to fight infection.
Pregnancy and breastfeeding
Your doctor will discuss with you the possible risks and
benefits of having Boostrix during pregnancy.
It is not known if Boostrix passes into breast milk. Your
doctor will discuss with you the possible risks and benefits
of having Boostrix during breastfeeding.
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before you are given this vaccine.
Driving and using machines
Boostrix is unlikely to produce an effect on the ability to
drive and use machines.
3. How Boostrix is given
• Boostrix will be given as an injection into the muscle.
• The vaccine should never be given into blood vessels.
• Y
 ou or your child will receive a single injection of
Boostrix.
• Y
 our doctor will verify if you or your child have
previously received vaccines against diphtheria,
tetanus and/or pertussis.
• B
 oostrix may be used in case of a suspected infection
with tetanus, although additional provisions,
i.e. elaborate wound dressing and/or application of
Tetanus-anti-Toxin will be taken as well to reduce
the risk of manifestation of the disease.
• Y
 our doctor will give you advice on repeat
vaccination.
4. Possible side effects
Like all medicines, this vaccine can cause side effects,
although not everybody gets them.
As with all injectable vaccines severe allergic reactions
(anaphylactic and anaphylactoid reactions) may occur
very rarely (with up to 1 in 10,000 doses of the vaccine).

The following information is intended for healthcare
professionals only:

matter and/or variation of physical aspect. In the event of
either being observed, discard the vaccine.

Prior to use, the vaccine should be at room temperature,
and well shaken in order to obtain a homogeneous turbid
white suspension. Prior to administration, the vaccine
should be visually inspected for any foreign particulate

Any unused medicinal product or waste material
should be disposed of in accordance with local
requirements.

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These can be recognised by:





Rashes that may be itchy or blistering,
Swelling of the eyes and face,
Difficulty in breathing or swallowing,
A sudden drop in blood pressure and loss of
consciousness.

Ireland-IRL

Such reactions may occur before leaving the doctor’s
surgery. However, if you or your child get any of these
symptoms you should contact a doctor immediately.

Boostrix

Side effects that occurred during clinical trials in
children from the age of 4 to 8 years
Very common (these may occur with more than 1 in
10 doses of the vaccine):
• Pain, redness and swelling at the injection site
• Irritability
• Sleepiness
• Tiredness

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Common (these may occur with up to 1 in 10 doses of the
vaccine):
• Loss of appetite
• Headache
• Fever equal to or greater than 37.5°C (including fever
greater than 39°C)
• Large swelling of the vaccinated limb
• Vomiting and diarrhoea
Uncommon (these may occur with up to 1 in 100 doses of
the vaccine):
• Upper respiratory tract infection
• Disturbances in attention
• Discharge with itching of the eyes and crusty eyelids
(conjunctivitis)
• Skin rash
• Hard lump where the injection was given
• Pain
Side effects that occurred during clinical trials in adults,
teenagers and children from the age of 10 years onwards
Very common (these may occur with more than 1 in
10 doses of the vaccine):
• Pain, redness and swelling at the injection site
• Headache
• Tiredness
• Generally feeling unwell
Common (these may occur with up to 1 in 10 doses of the
vaccine):
• Fever equal to or greater than 37.5°C
• Dizziness
• Nausea
• Hard lump and abscess at the injection site

10.0pt
11.0pt
100%
10.0pt
No

Biologicals
Additional Information Panel
Unfolded dimensions: 210x422mm
Folded dimensions: 210x25mm
2D Pharmacode value: N/A

Reporting of side effects
If you or your child get any side effects, talk to your
doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie. By reporting side effects
you can help provide more information on the safety
of this medicine.
5. How to store Boostrix
Keep this vaccine out of the sight and reach of
children.
Do not use this vaccine after the expiry date which is stated
on the carton and the pre-filled syringe label after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not freeze. Freezing destroys the vaccine.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you or your child no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What Boostrix contains
- The active substances are:
Diphtheria toxoid1
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid1
not less than 20 International Units (IU) (5 Lf)
Bordetella pertussis antigens
Pertussis toxoid1
8 micrograms
Filamentous Haemagglutinin1
8 micrograms
Pertactin1
2.5 micrograms
adsorbed on aluminium hydroxide,
hydrated (Al(OH)3)
and aluminium phosphate (AlPO4)

1

0.3 milligrams Al3+
0.2 milligrams Al3+

Aluminium hydroxide and aluminium phosphate are
included in this vaccine as adjuvants. Adjuvants are
substances included in certain vaccines to accelerate,
improve and/or prolong the protective effects of the
vaccine.
- The other ingredients are: sodium chloride and water for
injections.
What Boostrix looks like and contents of the pack

Uncommon (these may occur with up to 1 in 100 doses
of the vaccine):
• Fever greater than 39°C
• Pain
• Joint and muscle stiffness
• Vomiting
• Diarrhoea
• Joint stiffness, joint pain, muscle ache
• Itching
• Excessive sweating (hyperhidrosis)
• Skin rash
• Swollen glands in the neck, armpit or groin
(lymphadenopathy)
• Sore throat and discomfort when swallowing
(pharyngitis)
• Upper respiratory tract infection
• Cough
• Fainting (syncope)
• Flu-like symptoms, such as fever, sore throat,
runny nose, cough and chills

Suspension for injection in pre-filled syringe.

The following side effects occurred during routine use
of Boostrix and are not specific for any age group:

This leaflet was last revised in November 2016

• S welling of the face, lips, mouth, tongue or
throat which may cause difficulty in swallowing
or breathing (angioedema)
• Collapse or periods of unconsciousness or lack of
awareness
• Seizures or fits (with or without fever)
• Hives (urticaria)
• Unusual weakness (asthenia)

Boostrix is a white, slightly milky liquid presented in a
pre-filled syringe (0.5 ml).
Boostrix is available in packs of 1, 10, 20, 25 or 50 with or
without needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline (Ireland) Ltd.
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
Boostrix is a registered trade mark of the GSK group
of companies.
©2016 GSK group of companies. All rights reserved.

Following administration of vaccines against tetanus
a temporary inflammation of the nerves, causing
pain, weakness and paralysis in the extremities and
often progressing to the chest and face have been
reported very rarely (with up to 1 in 10,000 doses of
the vaccine) (Guillain-Barré Syndrome).

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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