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PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PNEUMOCOCCAL POLYSACCHARIDE
VACCINE SANOFI PASTEUR MSD
solution for injection in a vial
Pneumococcal Polysaccharide Vaccine
For adults and children 2 years and above.
Read all of this leaflet carefully before you or your child receive this vaccine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This vaccine has been prescribed for you or your child. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours or your child’s.
• If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
What is in this leaflet
1. What PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is and what it is
used for
2. What you need to know before you or your child use PNEUMOCOCCAL POLYSACCHARIDE
VACCINE SANOFI PASTEUR MSD
3. How to use PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
4. Possible side effects
5. How to store PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
6. Contents of the pack and other information
1. What PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
is and what it is used for
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is a pneumococcal vaccine.
Vaccines are used to protect you or your child against infectious diseases. Your doctor has
recommended that you or your child (two years of age and older) have PNEUMOCOCCAL
POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD to help protect against severe infections caused
by bacteria that are called pneumococci.
Pneumococci can cause infections of the lungs (especially pneumonia) and of the coverings over the
brain and spinal cord (meningitis) and in the blood (bacteraemia or septicaemia). PNEUMOCOCCAL
POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD will only be able to protect you or your child against
pneumococcal infections that are due to the types of these bacteria that are included in the vaccine.
However, the 23 pneumococcal types in the vaccine include those that cause almost all (about nine
out of ten) infections caused by pneumococci.
When the vaccine is given to you or your child, the body’s natural defences make antibodies that
help to protect against pneumococcal infections.
Pneumococcal infections occur throughout the world and can occur in anyone at any age, but are
most likely in:
• elderly people.
• people who have lost their spleen or whose spleen is not working.
• people who have low resistance to infections due to longstanding illnesses or infections
(such as heart disease, lung disease, diabetes mellitus, kidney disease, liver disease or HIV
infection).
• people who have low resistance to infections due to treatment that they have had for some
illnesses (such as cancer).
Pneumococcal infections of the coverings of the brain and spinal cord (meningitis) sometimes
occur after injuring and cracking the skull and very rarely after certain medical operations.
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD may not be able to prevent all
of these infections.
Also, pneumococcal infections can occur in the sinuses, ears, and in other parts of the body.
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is not thought likely to protect
you or your child against these more minor kinds of infections.

2. What you need to know before you or your child use PNEUMOCOCCAL
POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is for use only in persons who
are at least two years old. This is because younger children do not reliably respond to the vaccine.
To make sure that PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is suitable
for you or your child, it is important to tell your doctor or nurse if any of the points below apply
to you or your child. If there is anything you do not understand, or if you are not sure, ask your
doctor or nurse to explain. As with other vaccines, PNEUMOCOCCAL POLYSACCHARIDE VACCINE
SANOFI PASTEUR MSD may not fully protect all those who get it.
Do not use PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
if you or your child are allergic (hypersensitive) to pneumococcal polysaccharide vaccine or any of
the ingredients that are listed in section 6.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before vaccination if:
• you or your child has an infection with a high temperature, as vaccination may need to be
delayed until you or your child has recovered.
You should also tell your doctor before vaccination if:
• you or your child has a low resistance to infections because of a course of treatment (such as
drugs or radiation treatment for cancer).
• you or your child has a longstanding illness or an infection that may have lowered resistance
to pneumococcal infections.
In these cases vaccination may need to be delayed and even then it may not protect you as well
as it protects healthy people.
Individuals aged 65 years and older may not tolerate medical interventions as well as younger
individuals. Therefore a higher number and/or greater severity of reactions in some older
individuals cannot be ruled out.
Other medicines and PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI
PASTEUR MSD
Tell your doctor or pharmacist if you or your child are using, have recently used or might use any
other medicines.
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD can be given at the same time
as influenza vaccine as long as different injection sites are used. Most people are able to respond
to both vaccines at the same time so that they can be protected against both infections.
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD should not be given at the same
time as ZOSTAVAX. For more information about these vaccines, talk to your doctor or health care
provider.
If you or your child are already taking antibiotics to prevent pneumococcal infection, these should
not be stopped after vaccination. Also, even after having the vaccine, it is still important that you
see a doctor and get antibiotic treatment quickly if you think that you or your child may have
any type of infection and you or your child have been told that you have a high risk of getting a
pneumococcal infection (for example, if you have no spleen or it is not working properly).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby
or to breast-feed, ask your doctor or pharmacist for advice before taking this vaccine.
Driving and using machines
There is no information to suggest that PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI
PASTEUR MSD will affect your ability to drive or use machines.
3. How to use PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR
MSD
The vaccination should be given by a doctor or nurse who has been trained in the use of vaccines.
The vaccine should be given in a surgery or clinic because there is equipment to deal with any
uncommon severe allergic reaction to the injection.
Always use this vaccine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.

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PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is given as an injection into
a muscle or deep under the skin. Your doctor or nurse will avoid giving you or your child the
injection either into the skin or into a blood vessel.
The vaccine is sometimes given before (usually at least two weeks before) the planned date
for taking out your spleen or for starting special treatments for cancer. If you or your child have
already started or have finished special treatments, the vaccine may be delayed for about
three months.
When the vaccine is given to people who are HIV positive, it is usually given as soon as the test
result is known.
You or your child will receive one dose of the vaccine. A second dose of PNEUMOCOCCAL
POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is not usually given until at least three years
after the first dose. Healthy people do not usually need to have a second dose. However, for
persons at increased risk of serious pneumococcal infection (such as those who have no spleen or
a spleen that does not work properly), further doses of the vaccine may be recommended, usually
between 3 and 5 years after the first dose. A repeat dose is not usually recommended within
3 years of the first dose due to a higher risk of side effects.

• an increase in the value of a blood test that is a measure of inflammation in the body
(C-reactive protein (CRP)),
• patients who have had blood disorders may develop destruction of red blood cells leading to
an inadequate number of red blood cells (haemolytic anaemia),
• an increase in the number of certain types of white blood cells,
• a fit (convulsion) associated with a high temperature.
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
5. How to store PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI
PASTEUR MSD
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 box after EXP. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C -– 8°C). Do not freeze.

Your doctor or nurse will be able to decide if and when you or your child need a further dose of
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD.

Your doctor or nurse will check that the liquid is clear and colourless and that there are no large
particles in it before giving you or your child the vaccine.

If you use more PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR
MSD than you should

Do not throw away any vaccines via wastewater or house hold waste. Ask your pharmacist how to
throw away vaccines you no longer need. These measures will help protect the environment.

There have been no reports of overdose with PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI
PASTEUR MSD. Overdose is very unlikely because the vaccine is provided in single dose vials and is
given by a doctor or nurse.

6. Contents of the pack and other information
What PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD contains

4. Possible side effects

0.5 millilitre dose contains the following:

Like all vaccines and medicines, PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
can cause side effects, although not everybody gets them.
Allergic Reactions
You must seek urgent medical help if you or your child experience any of the
symptoms, listed below, or other serious symptoms after vaccination,
• difficulty in breathing, blue discolouration of the tongue or lips,
• low blood pressure (causing dizziness) and collapse,
• fever, generally feeling unwell with pains or even inflammation and swelling in the joints
and muscle pain,
• swelling of the face, lips, tongue and/or throat and neck,
• swelling of the hands, feet or ankles,
• hives (inflamed wheals on the skin) and rashes.
If serious allergic reactions occur, they often do so very soon after the injection, while still in the
clinic.
Side Effects
The most common reactions (may affect more than 1 in 10 people) reported are soreness, pain,
redness, warmth, swelling and hardening at the injection site, and fever. These reactions tend to
be more common after the second dose of the vaccine than after the first dose.
Other side effects include:
• swelling in the injected limb,
• decreased mobility of the injected limb,
• feeling tired,
• feeling generally unwell,
• uncontrollable shivering,
• feeling sick or being sick,
• enlarged and/or inflamed glands,
• pain, inflammation and swelling of the joints and muscle pains,
• a drop in the number of certain types of particles in the blood called platelets in people who
already have low numbers of these due to another illness called ITP that causes a higher risk
of bleeding and bruising,
• headache, altered skin sensation or pins and needles, decreased limb mobility, numbness
and weakness of the legs and arms (including an illness called Guillain-Barré syndrome),

• Active ingredients - 25 micrograms (a very small amount) of each of 23 types of
polysaccharide from bacteria known as pneumococci. The 23 types of pneumococcal
polysaccharide in the vaccine are types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14,
15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F.
• Other ingredients - phenol, sodium chloride and water for injections.
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD contains less than 1 mmol
sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
What PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD looks
like and contents of the pack
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is a solution for injection in a
vial. It is available in a vial (small glass container) which contains one dose of 0.5 millilitre of the
vaccine, in a single pack or packs of 10 or 20 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The company licensed to sell PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD
is Sanofi Pasteur MSD Limited. Their address is Mallards Reach, Bridge Avenue, Maidenhead,
Berkshire, SL6 1QP, Tel: +44 1 628 785 291.
PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD is made by Merck Sharp and
Dohme B.V., Merck Manufacturing Division, Waarderweg 39, PO Box 581, 2003 PC Haarlem,
Netherlands.
This medicinal product is authorised in the Member States of the EEA under the following names:

Pneumovax 23

Pneumovax
Pneumococcal Polysaccharide Vaccine
Sanofi Pasteur MSD
This leaflet was last revised in 05/2014.

België/Belgique/Belgien; Ελλάδα; España;
Deutschland; Luxembourg/Luxemburg;
Nederland; Österreich; Portugal, Ireland
Danmark; France; Ísland; Italia; Norge;
Suomi/Finland; Sverige
United Kingdom

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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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