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POLIOMYELITIS VACCINE (INACTIVATED) SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE

Active substance(s): POLIOVIRUS INACTIVATED TYPE 1 MAHONEY STRAIN / POLIOVIRUS INACTIVATED TYPE 2 MEF-1 STRAIN / POLIOVIRUS INACTIVATED TYPE 3 SAUKETT STRAIN / POLIOVIRUS INACTIVATED TYPE 1 MAHONEY STRAIN / POLIOVIRUS INACTIVATED TYPE 2 MEF-1 STRAIN / POLIOVIRUS INACTIVATED TYPE 3

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Package leaflet: Information for the user
Poliomyelitis Vaccine (Inactivated)
suspension for injection in pre-filled syringe

Read all of this leaflet carefully before you or your child is vaccinated because it contains
important information for you.
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Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor, pharmacist or nurse.
This vaccine has been prescribed for you or for your child only. Do not pass it on to others.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.
1.

What Poliomyelitis Vaccine (Inactivated) is and what it is used for
What you need to know before you use Poliomyelitis Vaccine (Inactivated)
How to use Poliomyelitis Vaccine (Inactivated)
Possible side effects
How to store Poliomyelitis Vaccine (Inactivated)
Contents of the pack and other information
What Poliomyelitis Vaccine (Inactivated) is and what it is used for

Poliomyelitis Vaccine (Inactivated) is a vaccine. Vaccines are used to protect you against
infectious diseases. This vaccine helps to protect against polio. When an injection of
Poliomyelitis Vaccine (Inactivated) is given, the body's natural defences will produce protection
against polio infection. Poliomyelitis Vaccine (Inactivated) can be given to infants from 2 months
of age, children and adults.
Polio is an infectious disease that is usually caught by swallowing polio viruses in food or drink.
It can also be caught by eating with unwashed hands if there is virus on them. The viruses spread
to the nervous system and can cause permanent paralysis. The viruses in the vaccine have been
killed so that they cannot cause polio but they can cause your body to make antibodies to protect
against future infections.
2.

What you need to know before you receive Poliomyelitis Vaccine (Inactivated)

Do not receive Poliomyelitis Vaccine (Inactivated):
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if you or your child are allergic (hypersensitive) to the active substance, to any of the
excipients or any residual component carried over from manufacture (streptomycin,
neomycin or polymixin B) which may be present in trace amounts (listed in the section 6)
if you or your child are currently suffering from any acute illness, including febrile illness
with high temperature. Vaccination with Poliomyelitis Vaccine (Inactivated) may need to

be delayed until after recovery from infection. A minor illness without fever such as mild
upper respiratory infection is not usually a reason to defer immunization.
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Warnings and precautions
Talk to your doctor, pharmacist or nurse before vaccination:
– if you or your child have ever had an allergic reaction to a vaccine that contained
inactivated poliomyelitis vaccine along with other active ingredients. Your doctor or
nurse will advise you if Poliomyelitis Vaccine (Inactivated) can still be given.
– if you or your child have problems with the immune system due to any reason (including
HIV infection) so that your immune system is poor. You/your child may still be given
Poliomyelitis Vaccine (Inactivated) but the protection against infections after having the
vaccine may not be as good as in people with normal immune systems. Your doctor or
nurse may advise you to have a blood test some time after vaccination to see if you have
responded well or not.
– if you or your child have any problems with the blood that cause easy bruising or
bleeding for a long time after minor cuts. Your doctor or nurse may still advise that
you/your child should have Poliomyelitis Vaccine (Inactivated) but extra care is needed
because of the risk of bleeding at the injection site. Sometimes your doctor or nurse may
give Poliomyelitis Vaccine (Inactivated) as an injection deep into the skin instead of into
muscle (See section 3) to try to reduce the risk of bleeding.
Like all vaccines, Poliomyelitis Vaccine (Inactivated) cannot completely prevent the infection
that it is meant to protect against and protection may not be lifelong.
Other medicines or vaccines and Poliomyelitis Vaccine (Inactivated)
Poliomyelitis Vaccine (Inactivated) can generally be given at the same time as other vaccines. If
this is necessary, the different vaccines will be injected separately into different injection sites.
In case of medical treatment affecting the body's natural defences please refer to the section
"Warnings and precautions" above.
Tell your doctor or nurse if you or your child is taking, has recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
Tell your doctor or nurse if you or your child is pregnant or breast-feeding, think you or your
child might be pregnant or planning to have a baby.
Poliomyelitis Vaccine (Inactivated) should be given to pregnant women only if clearly needed.
Your doctor or nurse can advise you whether or not vaccination should be delayed.
The effect of vaccination while breastfeeding has not been assessed.
Driving and using machines
Some of the possible side effects mentioned in section 4 of this leaflet (such as dizziness) might
affect your ability to drive or use machines.

Poliomyelitis Vaccine (Inactivated) contains ethanol
Poliomyelitis Vaccine (Inactivated) contains small amounts of ethanol (alcohol), less than 100 mg
per dose.
3.

How to receive Poliomyelitis Vaccine (Inactivated)

The vaccination should be given by medical or healthcare professionals who are trained in the use
of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the
injection.
Poliomyelitis Vaccine (Inactivated) is usually given as an injection into a muscle in the upper part
of the arm or, in infants and very young children, into the upper part of the leg. For persons who
are at risk of severe bleeding after an injection deep into muscle, the vaccine can be injected deep
under the skin. Your doctor or nurse will avoid giving the injection into a blood vessel.
First course of vaccination
If you or your child has never been vaccinated against polio before, three injections of 0.5
millilitre Poliomyelitis Vaccine (Inactivated) are needed. The vaccine can be given from the age
of 2 months onwards. A gap of at least one month should occur between the three doses. Your
doctor or nurse will tell you when to attend for the second and third doses.
Booster Vaccination
Booster doses of Poliomyelitis Vaccine (Inactivated) are needed to make sure that protection
continues. Your doctor or nurse will advise you when booster doses need to be given.
Poliomyelitis Vaccine (Inactivated) can be given to you or your child as a booster injection if you
previously received doses of poliomyelitis vaccine by mouth.
4.

Possible side effects

Like all medicines and vaccines, Poliomyelitis Vaccine (Inactivated) can cause side effects
although not everybody gets them.
Serious allergic reactions are a very rare possibility after receiving any vaccine. These reactions
occur in less than one in ten thousand persons. Symptoms may include difficulty in breathing,
blueness of the tongue or lips, a rash, swelling of the face or throat and low blood pressure. When
these signs or symptoms occur they usually develop very quickly after the injection is given and
while you/your child is still in the clinic or doctor’s surgery. If any of these symptoms occur after
leaving the place where the injection was given, you must consult a doctor IMMEDIATELY.
Other side effects
 Very common side effects (may affect more than one in 10 people):
– Pain at the injection site.
– Fever (high temperature).
 Common side effects (may affect up to one in 10 people):
– Redness at the injection site.
– Dizziness.
– Nausea, vomiting, diarrhoea.

– Joint and muscle pain.
– Headache, sleepiness.
– Irritability and crying.
– Inability to sleep.
– Vertigo.
 Uncommon side effects (may affect up to one in 100 people):
– Lump at the injection site
Side effects that have been reported during marketed use include (frequency cannot be
estimated from the available data):
– Swollen glands.
– Swelling or rash at the injection site lasting 1-2 days.
– Rashes on other parts of the body that can be lumpy or itchy.
– Flu like symptoms, usually just on the day of vaccination.
– Fits with or without a fever.
– Pins and needles within 2 weeks of vaccination that will clear up without treatment.
– Restlessness or sleepiness.


In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal
between breaths may occur for 2-3 days after vaccination.
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
In Ireland
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.
In the UK
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 Poliomyelitis Vaccine (Inactivated)

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 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. The vaccine should not be used if it has been frozen.
Keep the vaccine in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.
6.

Contents of the pack and other information

What Poliomyelitis Vaccine (Inactivated) contains
The active substances in each 0.5 millilitre dose of vaccine are:
Inactivated type 1 polio virus (Mahoney)1 . . . . . .. . . . . . 40 D-antigen2 units3
Inactivated type 2 polio virus (MEF-1)1 . . . . . . . . . . . . . . 8 D-antigen2 units3
Inactivated type 3 polio virus (Saukett)1 . . . . . . . . . . . . . 32 D-antigen2 units3
1

Cultivated on Vero cells
Quantity of antigen in the Final Bulk Product, according to WHO (TRS 673, 1982)
3
Or equivalent nominal amount of poliovirus of each type expressed in European Pharmacopoeia Units of
D-antigen (parallel line method)
2

The other ingredients are:
2-phenoxyethanol, ethanol, formaldehyde, medium 199 without phenol red (complex mixture of
amino acids (including phenylalanine), mineral salts, vitamins and other components (including
glucose), supplemented with polysorbate 80 and diluted in water for injections).
What Poliomyelitis Vaccine (Inactivated) looks like and contents of the pack
Poliomyelitis Vaccine (Inactivated) is a suspension for injection in a pre-filled syringe.
It comes in a 0.5 millilitre prefilled syringe (enough for one dose). It is supplied in packs of 1, 10
or 20 prefilled syringes (doses). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The company licensed to sell Poliomyelitis Vaccine (Inactivated) in the UK and Ireland is Sanofi
Pasteur Europe. Their address is 2 Avenue Pont Pasteur, F-69007 Lyon, France
Poliomyelitis Vaccine (Inactivated) is made by Sanofi Pasteur SA, Campus Mérieux, 1541
avenue Marcel Mérieux, F-69280 Marcy L’Etoile, France.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Ireland, United Kingdom,
Germany

Poliomyelitis Vaccine (Inactivated)
IPV Mérieux

This leaflet was last revised in
______________________________________________________________________
The following information is intended for medical or healthcare professionals only:

The vaccine should be brought to room temperature before use.
The vaccine should not be used if it is cloudy, contains particles or if it has been frozen.
Shake before use.
See also section 3. How to use Poliomyelitis Vaccine (Inactivated)

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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