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INFANRIX-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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Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1

Package Leaflet: Information For the User
Infanrix®IPV, suspension for injection in a pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
Read all of this leaflet carefully before your child starts 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 your child only. Do not pass it on to others.

If your child gets any side effects talk to you doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

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

1.

What Infanrix-IPV is and what it is used for

Infanrix-IPV is a vaccine used as a booster dose to protect your child against 4 diseases:
 Diphtheria - a serious bacterial infection that mainly affects the airways and sometimes the skin. The
airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also
release a poison. This can cause nerve damage, heart problems and even death.
 Tetanus - tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are
more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse
manure or wood splinters in them. The bacteria release a poison. This 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.
 Whooping cough (pertussis) - a highly infectious illness that affects the airways. It causes severe
coughing that may lead to problems with breathing. The coughing often has a ‘whooping’ sound. The
cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest
infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and
even death.
 Polio - a viral infection. Polio is often only a mild illness. However, sometimes it can be very serious and
cause permanent damage or even death. Polio can make the muscles unable to move (paralysis of the
muscles). This includes the muscles that are needed for breathing and walking. The arms or legs affected
by the disease may be painfully twisted (deformed).
Infanrix-IPV is for children from 16 months to 13 years of age inclusive. It is not intended for people over 14
years of age.
How Infanrix-IPV works
 Infanrix-IPV helps your child’s body make its own protection (antibodies). This will protect your child
against these diseases.
 The vaccine cannot cause the diseases that it protects your child from.

Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1

2.

What you need to know before your child receives Infanrix-IPV

Infanrix-IPV should not be given:
 if your child is allergic to:
any of the ingredients of this medicine (listed in Section 6)
- or neomycin, polymyxin (types of antibiotics)
- or formaldehyde.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or
tongue
 If your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough or
polio
 If your child experienced problems of the nervous system (encephalopathy) within 7 days after previous
vaccination with a vaccine against whooping cough
 If your child has a severe infection with a high temperature (over 38°C). A minor infection such as a cold
should not be a problem, but talk to your doctor first.
Infanrix-IPV should not be given if any of the above apply to your child. If you are not sure, talk to your
doctor or pharmacist before your child is given Infanrix-IPV.
Warnings and precautions
Talk to your doctor or pharmacist before your child is given Infanrix-IPV if:
 after previously having Infanrix-IPV or another vaccine against whooping cough, 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
- fits with or without a high temperature within 3 days of vaccination
 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.
 your child has a bleeding problem or bruises easily
 your child has a tendency to fits due to a fever or if there is a history in the family of this
 your child has problems with their immune system (including HIV infection). Your child may still be
given Infanrix-IPV. However, the protection against the infections may not be as high.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the
doctor or nurse if your child fainted with a previous injection.
If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before your
child is given Infanrix-IPV.
Other medicines and Infanrix-IPV
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if your child is using any of the following:
 medicines or other treatments (such as radiotherapy) that affect their immune system. Your child may still
be given Infanrix-IPV. However, Infanrix-IPV may not work as well. If possible the vaccine should be
given after this treatment has finished
 other vaccines. Infanrix-IPV can be given at the same time as other vaccines. A different place for the
injection will be used for each vaccine.

Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1

Pregnancy and breast-feeding
It is unlikely that Infanrix-IPV would be given to people who are pregnant or breast-feeding. This is because
it is only intended to be used in children from 16 months to 13 years of age inclusive.
The use of this vaccine is not recommended during pregnancy or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Infanrix-IPV would be given to people who drive or use tools or machines. This is because
it is only intended to be used in children from 16 months to 13 years of age inclusive.
Your child may feel sleepy after having this vaccination. If this happens, your child should not drive, cycle
or use any tools or machines.
Infanrix-IPV contains neomycin, polymyxin (antibiotics) and formaldehyde
Your child should not be given Infanrix-IPV if they are allergic to any of these ingredients. Please tell your
doctor if your child has had an allergic reaction to these ingredients.

3.

How Infanrix-IPV is given

When the vaccine will be given
 Your doctor or nurse will tell you when your child should have this vaccine. It depends on official
recommendations.
How Infanrix-IPV is given
 Your child will receive a single injection of Infanrix-IPV.
 Infanrix-IPV is always injected into a muscle.
 This will usually be in the shoulder muscle. However, in young children it can be given in the thigh.
 The vaccine should never be given into a vein.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following
side effects may happen with this vaccine:
Allergic reactions
If your child has an allergic reaction, see your doctor straight away. The signs may include:
 skin rashes that may be itchy or blistering
 swelling of the eyes and face
 difficulty in breathing or swallowing
 a sudden drop in blood pressure
 loss of consciousness.
These signs usually start very soon after the injection has been given. Take your child to see a doctor straight
away if they happen after leaving the clinic. Allergic reactions are very rare (less than 1 in 10,000 doses of
the vaccine).
See your doctor straight away if your child has any of the following serious side effects:
 collapse
 loss of consciousness

Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1

 lack of awareness
 fits.
See your doctor straight away if you notice any of the above. These side effects have happened with other
vaccines against whooping cough. They usually occur within 2 to 3 days after vaccination.
Other side effects include:
Very common (these may occur with more than 1 in 10 doses of the vaccine)
 feeling sleepy
 headache
 loss of appetite
 high temperature of 38°C or higher
 pain, redness and swelling at the injection site
 unusual crying
 feeling irritable or restless
Common (these may occur with up to 1 in 10 doses of the vaccine)
 diarrhoea
 nausea, vomiting (feeling or being sick)
 high temperature of 39.5°C or higher
 generally feeling unwell
 hard lump at the injection site
 feeling weak.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
 skin allergies or rash.
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
 swollen glands in the neck, armpit and groin (lymphadenopathy)
 coughing or chest infection (bronchitis)
 itching
 lumpy rash (hives).
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
 bleeding or bruising more easily than normal (thrombocytopenia)
 temporarily stopping breathing (apnoea)
 swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
(angioneurotic oedema)
 blisters at the injection site.
Booster doses of Infanrix-IPV may increase the risk of reactions at the injection site. Some of these affect the
entire arm or leg that has been injected. These reactions usually begin within 48 hours of the injection and go
away after 4 days.
Reporting of side effects
If your child gets 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 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.

Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1

5.

How to store Infanrix-IPV







Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2C to 8C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the
last day of that month.
 Do not throw away any medicines via wastewateror household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Infanrix-IPV contains
-

The active substances are:
Diphtheria toxoid1
Tetanus toxoid1
Bordetella pertussis antigens
Pertussis toxoid1
Filamentous Haemagglutinin1
Pertactin1
Poliovirus (inactivated)2
type 1 (Mahoney strain)
type 2 (MEF-1 strain)
type 3 (Saukett strain)
1
adsorbed on aluminium hydroxide, hydrated
2
propagated in VERO cells

not less than 30 IU
not less than 40 IU
25 micrograms
25 micrograms
8 micrograms
40 D-antigen unit
8 D-antigen unit
32 D-antigen unit
0.5 milligrams Al3+

Aluminium hydroxide is included in this vaccine as an adjuvant. 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, Medium 199 (containing principally amino acids, mineral salts,
vitamins), water for injections.
What Infanrix-IPV looks like and contents of the pack





Infanrix-IPV is a suspension for injection in pre-filled syringe (0.5 ml).
The suspension is white, and slightly milky.
Packs either contain 1, 10 or 20 pre-filled syringes 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., Rixensart, Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
InfanrixTetra: Danmark, Ελλάδα, France

Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1

Infanrix Polio: Česká republika, Eesti, Κύπρος, Latvija, Lietuva, Magyarország, Norge, Slovenská
republika, Suomi/Finland, Sverige
Infanrix-IPV: Polska, Portugal, United Kingdom
IPV Infanrix: Ireland
PolioInfanrix: Italia
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
Infanrix-IPV
Reference number
10592/0209
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in: March 2016
Infanrix is a registered trade mark of the GSK group of companies.
© 2016 GSK group of companies.
Detailed information on this medicine is available on the web site of: the Medicines and Healthcare Products
Regulatory Agency (MHRA)
----------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Upon storage, a white deposit and clear supernatant may be observed. This does not constitute a sign of
deterioration.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
The suspension should be inspected visually for any foreign particulate matter and/or abnormal physical
appearance. In the event of either being observed, discard the vaccine.
A blue, 25mm, 23G needle and an orange, 16mm, 25G needle have been provided for vaccine
administration. The vaccine needs to be injected to the appropriate depth in order for it to be effective.
Choose the most appropriate needle for your patient to ensure the vaccine reaches the muscle.

Reason for MHRA submission: WS1049 Instructions for use of PRTC syringe
Text date: 28/10/2016
MHRA Approval Date: TBC
PIL Issue 7, draft 1



Instructions in case of pre-filled syringe with a luer lock adaptor (PRTC)

Needle

Needle protector

Syringe

Syringe plunger

Syringe barrel
Syringe cap

1.
2.
3.
4.

Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap
by twisting it anticlockwise.
To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock
(see picture).
Remove the needle protector, which on occasion can be a little stiff.
Administer the vaccine.

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

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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