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BOOSTRIX-IPV SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): DIPHTHERIA TOXOID / INACTIVATED POLIOVIRUS TYPE 1 / INACTIVATED POLIOVIRUS TYPE 2 / INACTIVATED POLIOVIRUS TYPE 3 / PERTACTIN 69KDA / PERTUSSIS FILAMENTOUS HAEMAGGLUTININ / PERTUSSIS TOXOID / TETANUS TOXOID / DIPHTHERIA TOXOID / INACTIVATED POLIOVIRUS TYPE 1 / INAC

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GSK-BEL-Wavre-BEWAV-St.Amand
United Kingdom-GBR
Polioboostrix
N/A
BIO_DRW202

N/A
N/A
1

Boostrix-IPV, Suspension for injection in
pre-filled syringe
Diphtheria, tetanus, pertussis (acellular component) and
poliomyelitis (inactivated) 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.
- 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.
What is in this leaflet:
1. What Boostrix-IPV is and what it is used for
2. What you need to know before you or your child receive
Boostrix-IPV
3. How Boostrix-IPV is given
4. Possible side effects
5. How to store Boostrix-IPV
6. Contents of the pack and other information

1. What Boostrix-IPV is and what it is used for

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

Boostrix-IPV is a vaccine used as a booster dose in children from
3 years onwards, teenagers and adults to prevent four diseases:
diphtheria, tetanus (lockjaw), pertussis (whooping cough) and
poliomyelitis (polio). The vaccine works by causing the body to
produce its own protection (antibodies) against these diseases.
· Diphtheria: 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.
· Tetanus (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.
· Pertussis (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.
· Poliomyelitis (Polio): Poliomyelitis, sometimes called simply
“polio” is a viral infection that can have variable effects. Often
it causes only a mild illness but in some people it causes
permanent damage or even death. In its severest form, polio
infection causes paralysis of the muscles (muscles cannot
move), including those muscles needed for breathing and
walking. The limbs affected by the disease may be painfully
deformed.
None of the ingredients in the vaccine can cause diphtheria,
tetanus, whooping cough or poliomyelitis.

2. 
What you need to know before you or your
child receive Boostrix IPV
Boostrix-IPV should not be given:
· if you or your child have previously had any allergic
reaction to Boostrix-IPV, or any of the other ingredients
of this vaccine (listed in section 6) or to neomycin or
polymyxin (antibiotics). 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,
pertussis (whooping cough) or poliomyelitis 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 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.
· 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.

Warnings and precautions
Talk to your doctor or pharmacist before you or your child
are given Boostrix IPV:
· if after previously having Boostrix-IPV or another vaccine
against pertussis (whooping cough) disease, you or your
child had any problems, especially:
- 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-IPV 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-IPV may not completely protect all
people who are vaccinated.
Other medicines and Boostrix-IPV
Tell your doctor or pharmacist if you or your child is/are taking,
have recently taken or might take any other medicines, or
have/has recently received any other vaccine.
Boostrix-IPV can be given at the same time as some other
vaccines. A different injection site will be used for each type of
vaccine.
Boostrix-IPV 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-IPV during pregnancy.
It is not known if Boostrix-IPV passes into breast milk. Your
doctor will discuss with you the possible risks and benefits of
having Boostrix -IPV 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-IPV is unlikely to produce an effect on the ability to
drive and use machines.
Boostrix-IPV contains neomycin and polymyxin
This vaccine contains neomycin and polymyxin (antibiotics).
Please tell your doctor if you or your child have had an allergic
reaction to these ingredients.

3. How Boostrix-IPV is given
·
·
·
·

Boostrix-IPV will be given as an injection into the muscle.
The vaccine should never be given into blood vessels.
You or your child will receive a single injection of Boostrix-IPV.
Your doctor will verify if you or your child have previously
received vaccines against diphtheria, tetanus, pertussis and/or
polio.
· Boostrix-IPV 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.
· Your 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). 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.
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.

The following information is intended for healthcare professionals only:
Prior to vaccination, the vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being
observed, discard the vaccine.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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MINIATURE PHARMA CODE N°

DEVCOMP-0004708

MINIATURE PHARMA CODE N°

3

DEVCOMP-0004708

Package leaflet: Information for the user

3
DEVCOMP-0004708
GSK-BEL-Wavre-BEWAV-St.Amand
United Kingdom-GBR
Polioboostrix
N/A
BIO_DRW202

N/A
N/A
1
K

0

0

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.0pt
Leading: 10.0pt
Horizontal Scale: 100%
Smallest text size: 9.0pt
Microtext:No

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

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
· Sleepiness
Common (these may occur with up to 1 in 10 doses of the vaccine):
· Fever equal to or greater than 37.5°C (including fever
greater than 39°C)
· Bleeding, itching and hard lump at the injection site
· Large swelling of the vaccinated limb
· Loss of appetite
· Irritability
· Headache
Uncommon (these may occur with up to 1 in 100 doses of
the vaccine):
· Diarrhoea, nausea, vomiting
· Stomach pain
· Swollen glands in the neck, armpit or groin
(lymphadenopathy)
· Sleeping problems
· Apathy
· Dry throat
· Tiredness
Co-administration with measles-mumps-rubella (MMR) or
measles-mumps-rubella-varicella (MMRV) vaccines in children
aged 3-6 years
In studies where Boostrix-IPV was given at the same time as a
MMR or MMRV vaccine; skin rash and upper respiratory tract
infection (including runny nose and sore throat) were commonly
reported. Fever, irritability, fatigue, loss of appetite and
gastrointestinal disorders (including diarrhoea and vomiting)
were reported more frequently (very common) than in studies
where Boostrix Polio was given alone.
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
· Tiredness
· Headache
Common (these may occur with up to 1 in 10 doses of the vaccine):
· Fever equal to or greater than 37.5°C
· Bruising, itching, hard lump, warmth and/or numbness at the
injection site
· Stomach pain, nausea, vomiting
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
· Fever greater than 39°C
· Large swelling of the vaccinated limb
· Chills
· Pain
· Dizziness
· Joint pain, muscle ache
· Itching
· Oral herpes
· Swollen glands in the neck, armpit or groin
(lymphadenopathy)
· Decreased appetite
· Tingling or numbness of the hands or feet (paraesthesia)
· Sleepiness
· Asthma
The following side effects occurred during routine use of
Boostrix-IPV and are not specific for any age group:
· Collapse or periods of unconsciousness or lack of awareness
· Swelling of the face, lips, mouth, tongue or throat which may
cause difficulty in swallowing or breathing (angioedema)
· Seizures or fits (with or without fever)
· Hives (urticaria)
· Unusual weakness (asthenia)
Additionally, the following side effects have been reported
during clinical trials with Boostrix (GlaxoSmithKline Biologicals’
booster vaccine against diphtheria, tetanus and pertussis):
Side effects that occurred in children from the age of 4 to 8 years
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
· Disturbances in attention
· Discharge with itching of the eyes and crusty eyelids
(conjunctivitis)
· Pain
Side effects that occurred 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):
· Generally feeling unwell
Common (these may occur with up to 1 in 10 doses of the
vaccine):
· Hard lump or abscess at the injection site
Uncommon (these may occur with up to 1 in 100 doses of
the vaccine):
· Upper respiratory tract infection
· Sore throat and discomfort when swallowing
(pharyngitis)
· Fainting (syncope)
· Cough
· Diarrhoea
· Excessive sweating (hyperhidrosis)
· Skin rash
· Joint stiffness, joint and muscle stiffness
· Flu-like symptoms, such as fever, sore throat, runny nose,
cough and chills

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).
Reporting of side effects
If you or your child get any side effects, talk to your doctor
or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Boostrix-IPV
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 protect the
environment.

6. Contents of the pack and other information
What Boostrix-IPV 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
Inactivated poliovirus
type 1 (Mahoney strain)²
40 D-antigen unit
type 2 (MEF-1 strain)²
8 D-antigen unit
type 3 (Saukett strain)²
32 D-antigen unit
1adsorbed on aluminium hydroxide, hydrated (Al(OH) )
3
0.3 milligrams Al3+
and aluminium phosphate (AlPO4)
0.2 milligrams Al3+
²propagated in VERO cells
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: Medium 199 (as stabilizer including
amino acids, mineral salts and vitamins), sodium chloride and
water for injections.
What Boostrix-IPV looks like and contents of the pack
Suspension for injection in pre-filled syringe.
Boostrix -IPV is a white, slightly milky liquid presented in a
pre-filled syringe (0.5 ml).
Boostrix-IPV is available in packs of 1 and 10 with or without
needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
SmithKline Beecham Ltd, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals S.A.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
This medicinal product is authorised in the Member States of the
EEA under the following names:
Boostrix Polio: België/Belgique/Belgien, България, Česká
republika, Danmark, Deutschland, Ελλάδα, España, Ísland, Latvija,
Lietuva, Luxembourg/Luxemburg, Magyarország,
Nederland, Norge, Österreich, Polska, Portugal, Slovenija,
Slovenská republika, Suomi/Finland, Sverige
Boostrix Tetra: France
IPV-Boostrix: Ireland, Malta
Polio Boostrix: Italia
Boostrix-IPV: România, United Kingdom
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Boostrix-IPV
Reference number
10592/0214
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in November 2016
Boostrix is a registered trade mark of the GSK group of companies.
©2016 GSK group of companies. All rights reserved.

DEVCOMP-0004708

Page 2 of 2

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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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