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PNEUMOCOCCAL POLYSACCHARIDE VACCINE SANOFI PASTEUR MSD SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 / PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A / PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A / PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F / PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 / PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B / PNEUMO

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD solution for injection in pre-filled syringe
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. See section 4.

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

What Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD is and what it is used for
What you need to know before you or your child use Pneumococcal polysaccharide vaccine
Sanofi Pasteur MSD
How to use Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD
Possible side effects
How to store Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD
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 the vaccine 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). The vaccine 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).

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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. The vaccine 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. The
vaccine 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 the vaccine 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
because it may be better to get these vaccines at least 4 weeks apart.
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).
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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 the vaccine 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.
The vaccine 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 the vaccine 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.
Your doctor or nurse will be able to decide if and when you or your child need a further dose of the
vaccine.
If you use more Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD than you should
There have been no reports of overdose with the vaccine. Overdose is very unlikely because the
vaccine is provided in single dose, pre-filled syringe and is given by a doctor or nurse.

4.

Possible side effects

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,





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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:
Rare (may affect up to 1 in 1,000 people): swelling in the injected limb.
Not known (frequency cannot be estimated from the available data):

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),

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.
Reporting of side effects
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. You can also report side effects directly via the national
reporting system (see details below). By reporting side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

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 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.

4

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.

6.

Contents of the pack and other information

What Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD contains
0.5 millilitre dose contains the following:




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.

The vaccine 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
It is provided as a solution for injection in pre-filled syringe (0.5 ml).
It is available in pack containing 1 or 10 pre-filled syringes without needle.
It is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
It is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Manufacturing Authorisation Holder:
Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Avenue
Maidenhead, Berkshire
SL6 1QP
Manufacturer:
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

België/Belgique/Belgien; Ελλάδα; España;
Deutschland; Luxembourg/Luxemburg;
Nederland; Österreich; Portugal; Ireland

Pneumovax

Italia; Ísland; France; Danmark; Norge;
Suomi/Finland; Sverige
United Kingdom

Pneumococcal polysaccharide vaccine Sanofi
Pasteur MSD

This leaflet was last revised in 09/2016

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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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