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PRIORIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): LIVE ATTEND MUMPS VIRUS (RIT 4385 DERIVED FROM JERYL LYNN) / LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN) / LIVE ATTENUATED RUBELLA (WISTAR RA 27/3 STRAIN) / LIVE ATTEND MUMPS VIRUS (RIT 4385 DERIVED FROM JERYL LYNN) / LIVE ATTENUATED MEASLES VIRUS (SCHWARZ

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472411
GSK-BEL-Wavre-BEWAV
United Kingdom-GBR

Package leaflet: Information for the user

powder and solvent for solution for injection
in a pre-filled syringe
Measles, Mumps and Rubella vaccine (live)
Read all of this leaflet carefully before you receive 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 only. Do not pass it on to
others.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
This leaflet has been written assuming the person receiving the vaccine is
reading it, but it can be given to adults and children so you may be reading
it for your child.
What is in this leaflet:
1. What Priorix is and what it is used for
2. What you need to know before you receive Priorix
3. How Priorix is given
4. Possible side effects
5. How to store Priorix
6. Contents of the pack and other information

Priorix
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1 What Priorix is and what it is used for
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Priorix is a vaccine for use in children from 9 months up, adolescents and
adults to protect them against illnesses caused by measles, mumps and
rubella viruses.

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How Priorix works
When a person is vaccinated with Priorix, the immune system (the body’s
natural defence system) will make antibodies to protect the person from
being infected by measles, mumps and rubella viruses.
Although Priorix contains live viruses, they are too weak to cause measles,
mumps or rubella in healthy people.
2 What you need to know before you receive Priorix
Priorix should not be given if
• you are allergic against any of the components of this vaccine (listed
in section 6). Signs of an allergic reaction may include itchy skin rash,
shortness of breath and swelling of the face or tongue;
• you are known to be allergic to neomycin (an antibiotic agent). A known
contact dermatitis (skin rash when the skin is in direct contact with
allergens such as neomycin) should not be a problem but talk to your
doctor first;
• you have a severe infection with a high temperature. In these cases, the
vaccination will be postponed until recovery. A minor infection such as a
cold should not be a problem, but talk to your doctor first;
• you have any illness (such as Human Immunodeficiency Virus (HIV) or
Acquired Immunodeficiency Syndrome (AIDS)) or take any medicine
that weakens the immune system. Whether you receive the vaccine will
depend upon the level of your immune defences;
• you are pregnant. In addition, pregnancy should be avoided for 1 month
following vaccination.
Warnings and precautions
Talk to your doctor or pharmacist before you receive Priorix if:
• you have disorders of the central nervous system, a history
of convulsion accompanying high fever or family history of
convulsions. In case of high fever following vaccination please
consult your doctor promptly;
• you have ever had a severe allergic reaction to egg protein;
• you have had a side effect after vaccination against measles,
mumps or rubella that involved easy bruising or bleeding for longer
than usual (see section 4);
• you have weakened immune system (e.g. such as HIV infection).
You should be closely monitored as the responses to the vaccines
may not be sufficient to ensure a protection against the illness
(see section 2 “Priorix should not be given if”).

Fainting can occur (mostly in adolescents) following, or even before,
any needle injection. Therefore tell the doctor or nurse if you fainted
with a previous injection.
If you are vaccinated within 72 hours after contact with someone
with measles, Priorix will to some extent protect you against the
disease.
Children below 12 months of age
Children vaccinated in their first year of life may not be fully
protected. Your doctor will advise if additional doses of vaccine are
needed.
As with all vaccines, Priorix may not fully protect all people who are
vaccinated.
Other medicines and Priorix
Tell your doctor if you are taking, have recently taken or might take any
other medicines (or other vaccines).
Priorix may be given at the same time you receive other recommended
vaccinations such as diphtheria, tetanus, pertussis, Haemophilus influenzae
type b, oral or inactivated polio, hepatitis A and B, meningococcal serogroup
C conjugate vaccines, varicella as well as 10-valent pneumococcal
conjugate vaccine.
The injections should be given at separate injection sites. Your doctor will
advise you.
If not given at the same time, an interval of at least one month is
recommended between administration of Priorix and other live attenuated
vaccines.
Your doctor may delay vaccination for at least 3 months if you have
received a blood transfusion or human antibodies (immunoglobulins).
If a tuberculin test is to be performed, it should be done either any time
before, simultaneously with, or 6 weeks after vaccination with Priorix.
Pregnancy, breast-feeding and fertility
Priorix should not be administered to pregnant women.
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
the vaccination is given. Also, it is important that you do not become
pregnant within one month after having the vaccine. During this time you
should use an effective method of birth control to avoid pregnancy.
In case of inadvertent vaccination of pregnant women with Priorix, this
should not be a reason for termination of pregnancy.
Priorix contains sorbitol.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before receiving this vaccine.
3 How Priorix is given
Priorix is injected under the skin or into the muscle.
Priorix is intended for children from 9 months up, adolescents and adults.
The appropriate time and number of injections that will be given to you
will be determined by your doctor on the basis of appropriate official
recommendations.
The vaccine should never be given into a vein.
4 Possible side effects
Like all medicines, this vaccine can cause side effects, although not
everybody gets them.
Side effects that occurred during clinical trials with Priorix were as follows:
Very common (these may occur with more than 1 in 10 doses of the
vaccine):
• redness at the injection site
• fever of 38°C or higher
Common (these may occur with up to 1 in 10 doses of the vaccine):
• pain and swelling at the injection site
• fever higher than 39.5°C
• rash (spots)
• upper respiratory tract infection

Smallest text size: 9.5pt
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Biologicals
Additional Information Panel
Unfolded dimensions: 210x422mm
Folded dimensions: 210x25mm
2D Pharmacode value: N/A

Measles, Mumps and Rubella vaccine (live)
The following information is intended for healthcare professionals only:
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic
event following the administration of the vaccine.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the
attenuated viruses in the vaccine.
Priorix should under no circumstances be administered intravascularly.
In the absence of compatibility studies, the medicinal product must not be mixed with other medicinal products.
The solvent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to
administration. In the event of either being observed, discard the solvent or reconstituted vaccine.

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Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• infection of the middle ear
• swollen lymph glands (glands in the neck, armpit or groin)
• loss of appetite
• nervousness
• abnormal crying
• inability to sleep (insomnia)
• redness, irritation and watering of the eyes (conjunctivitis)
• bronchitis
• cough
• swollen parotid glands (glands in the cheek)
• diarrhoea
• vomiting
Rare (these may occur with up to 1 in 1,000 doses of the vaccine):
• convulsions accompanying high fever
• allergic reactions
After the marketing of Priorix, the following side effects have been reported
on a few occasions:
• joint and muscle pain
• punctual or small spotted bleeding or bruising more easily than normal
due to a drop in platelets
• sudden life-threatening allergic reaction
• infection or inflammation of the brain, spinal cord and peripheral nerves
resulting in temporary difficulty when walking (unsteadiness) and/or
temporary loss of control of bodily movements, inflammation of some
nerves, possibly with pins and needles or loss of feeling or normal
movement (Guillain-Barré syndrome)
• narrowing or blockage of blood vessels
• erythema multiforme (symptoms are red, often itchy spots, similar to the
rash of measles, which starts on the limbs and sometimes on the face
and the rest of the body)
• measles and mumps like symptoms (including transient, painful swelling
of the testicles and swollen glands in the neck)

Priorix is supplied as a white to slightly pink powder and a clear
colourless solvent (water for injections) for reconstituting the vaccine.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
SmithKline Beecham Limited
Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart, Belgium
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
Priorix
Reference number
10592/0110
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 06/2015
Priorix is a registered trade mark of the GSK group of companies.
© 2015 GSK group of companies. All rights reserved.

Reporting of side effects
If you 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 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 Priorix
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
after EXP.
Store and transport refrigerated (2°C - 8°C)
Do not freeze
Store in the original package in order to protect from light
After reconstitution, the vaccine should be administered promptly. If this
is not possible, it must be stored in the refrigerator (2°C - 8°C) and used
within 8 hours of reconstitution.
Do not throw away any medicines via wastewater or 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 Priorix contains:
• The active substances are: measles, mumps and rubella live attenuated
viruses.
• The other ingredients are:
Powder: amino acids, lactose (anhydrous), mannitol, sorbitol
Solvent: water for injections

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.5pt

What Priorix looks like and contents of the pack
Priorix is presented as a powder and solvent for injection (powder in
a vial for 1 dose and solvent in a pre-filled syringe (0.5 ml)) with or
without needles in the following pack sizes:
- with 1 separate needle: pack sizes of 20 or 40
- with 2 separate needles: pack sizes of 1, 10, 25 or 100
- without needle: pack sizes of 1, 10, 20, 25, 40 or 100

Leading: 11pt
Horizontal Scale: 100%
Smallest text size: 9.5pt
Microtext: No

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

The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
To attach the needle to the syringe, refer to the below drawing. However, the syringe provided with Priorix might be slightly different (without
screw thread) than the syringe described in the drawing.
In that case, the needle should be attached without screwing.
Needle

Syringe
Syringe barrel
1. Holding the syringe
barrel in one hand
(avoid holding the
syringe plunger),
unscrew the syringe
cap by twisting it Syringe plunger
anticlockwise.
Syringe cap

2. To attach the needle
to the syringe,
twist the needle
clockwise into the
syringe until you
feel it lock. (see
picture)

3. Remove
the needle
protector,
which on
occasion can
be a little stiff.

Needle protector

Add the solvent to the powder. After the addition of the solvent to the powder, the mixture should be well shaken until the powder is completely dissolved in
the solvent.
Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.
Withdraw the entire content of the vial and administer it.
A new needle should be used to administer the vaccine.
After reconstitution, the vaccine should be administered promptly. If this is not possible, it must be stored in the refrigerator (2°C - 8°C) and used within 8
hours of reconstitution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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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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