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PRIORIX-TETRA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN) / LIVE ATTENUATED MUMPS VIRUS [RT 4385 STRAIN] / LIVE ATTENUATED RUBELLA (WISTAR RA 27/3 STRAIN) / LIVE ATTENUATED VARICELLA VIRUS OKA STRAIN / LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN) / LIVE ATTENUATED MUMP

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Package leaflet: Information for the user
Priorix-Tetra , powder and solvent for solution for injection in pre-filled syringe
Measles, mumps, rubella and varicella vaccine (live)
Read all of this leaflet carefully before your child receives 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 your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See Section 4.
What is in this leaflet
1.
What Priorix-Tetra is and what it is used for
2.
What you need to know before your child receives Priorix-Tetra
3.
How to use Priorix-Tetra
4.
Possible side effects
5.
How to store Priorix-Tetra
6.
Contents of the pack and other information

1.

What Priorix-tetra is and what it is used for

Priorix-Tetra is a vaccine for use in children from 11 months up to and including 12 years of
age to protect them against illnesses caused by measles, mumps, rubella and varicella
(chickenpox) viruses. In some circumstances, Priorix-Tetra can also be given to children as
from 9 months of age.
How Priorix-Tetra works
When a person is vaccinated with Priorix-Tetra, the immune system (the body's natural
defence system) will make antibodies to protect the person from being infected by measles,
mumps, rubella and varicella (chickenpox) viruses.
Although Priorix-Tetra contains live viruses, they are too weak to cause measles, mumps,
rubella, or varicella (chickenpox) in healthy people.
As with all vaccines, Priorix-Tetra may not fully protect all people who are vaccinated.

2.

What you need to know before your child receives Priorix-Tetra

Priorix-Tetra should not be given





if your child is 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;
if your child has previously had an allergic reaction to any vaccine against measles,
mumps, rubella and/or varicella;
if your child is 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;
if your child has a severe infection with 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;





if your child has any illness (such as Human Immunodeficiency Virus (HIV) or
Acquired Immunodeficiency Syndrome (AIDS)) or takes any medicine that weakens
the immune system. Whether your child receives the vaccine will depend upon the
level of your immune defences.
If your child is pregnant. In addition, pregnancy should be avoided for 1 month
following vaccination.

Warnings and precautions
Talk to your doctor or pharmacist before your child received Priorix-Tetra if:





your child has a personal or family history of convulsions (fits) including febrile
convulsions. In this case your child must be closely monitored after vaccination as
fever may occur in particular 5 to 12 days after vaccination (see also section 4);
your child has ever had a severe allergic reaction to egg protein;
your child has had a side effect after vaccination against measles, mumps or rubella
that involved easy bruising or bleeding for longer than usual (see also section 4);
your child has weakened immune system (e.g. such as HIV infection). Your child
should be closely monitored as the responses to the vaccines may not be sufficient to
ensure a protection against the illness (see section 2).

Once vaccinated, your child may develop a chickenpox-like rash (see also section 4) and
should avoid contact with the following individuals:
individuals with a lowered resistance to diseases,
pregnant women who either have not had chickenpox or have not been vaccinated
against chickenpox.
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.
Other medicines and Priorix-Tetra
Tell your doctor if your child is taking or has recently taken any other medicines or have
recently received any other vaccine.
Your doctor may delay vaccination for at least 3 months if your child has 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-Tetra.
The use of salicylates (a substance present in many medicines used to lower fever and relieve
pain) should be avoided for 6 weeks following vaccination with Priorix-Tetra.
Priorix-Tetra can be given at the same time as diphtheria, tetanus, acellular pertussis
(whooping cough), Haemophilus influenzae type b, inactivated polio (infantile paralysis) and
hepatitis B vaccines. The injections should be given at separate injection sites.
Pregnancy and breast-feeding
Priorix-Tetra should not be administered to pregnant women.
If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a
baby, ask your doctor or pharmacist for advice before the vaccination is given. Also, it is

important that your child does not become pregnant within one month after having the
vaccine. During this time your child should use an effective method of birth control to avoid
pregnancy.
Priorix-Tetra contains sorbitol.
If you have been told by your doctor that your child has an intolerance to some sugars,
contact your doctor before your child receives this vaccine.

3.

How Priorix-Tetra is given

Priorix-Tetra is injected under the skin in the upper arm or in the outer thigh.
Priorix-Tetra is intended for children from 11 months up to and including 12 years of age.
The appropriate time and number of injections that will be given to your child 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.
The following side effects may happen with this vaccine:


Very common (these may occur with more than 1 in 10 doses of vaccine):
pain and redness at the injection site
fever of 38 C or higher*



Common (these may occur with up to 1 in 10 doses of vaccine):
swelling at the injection site
fever higher than 39.5 C*
irritability
rash (spots and/or blisters)



Uncommon (these may occur with up to 1 in 100 doses of vaccine):
unusual crying, nervousness, inability to sleep
generally feeling unwell, lethargy, fatigue
swollen parotid glands
diarrhoea, vomiting
loss of appetite
upper respiratory tract infection
rhinitis
swollen lymph glands



Rare (these may occur with up to 1 in 1,000 doses of vaccine):
infection of the middle ear
febrile convulsions
cough
bronchitis

* Higher rates of fever were observed after administration of the first dose of Priorix-Tetra
when compared to measles-mumps-rubella and varicella vaccines administered separately at
the same visit.
Additional side effects have been reported on a few occasion during routine use of
GlaxoSmithKline Biologicals measles, mumps, rubella or varicella vaccines:











joint pain and inflammation
allergic reactions. Rashes that may be itchy or blistering, swelling of the eyes and face,
difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of
consciousness. Such reactions may occur before leaving the doctor s surgery. However,
if you get any of these symptoms you should contact a doctor urgently.
Kawasaki syndrome (major signs of the illness are for instance: fever, skin rash,
swollen lymph glands, inflammation and rash of the mucous membranes of the mouth
and throat)
inflammation of the meninges, brain, spinal cord and peripheral nerves, stroke,
Guillain-Barr syndrome (ascending paralysis up to respiratory paralysis), unsteadiness
when walking
punctual or small spotted bleeding or bruising more easily than normal due to a drop in
platelets
erythema exsudativum 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)
Herpes zoster (shingles)
Mumps like symptoms
Transient, painful swelling of the testicles

Reporting of side effects
If your child gets any of the 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.

5.

How to store Priorix-Tetra

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. The expiry date
refers to the last day of that month.
Store and transport refrigerated (2 C - 8 C).
Do not freeze.
Store in the original packaging in order to protect from light.
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator
(2 C 8 C). If it is not used within 24 hours, it should be discarded.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines your child no longer uses. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Priorix-Tetra contains
-

The active substances are: measles, mumps, rubella and varicella live attenuated
viruses.

-

The other ingredients are:
Powder: amino acids, lactose anhydrous, mannitol, sorbitol, medium 199.
Solvent: water for injections.

What Priorix-Tetra looks like and contents of the pack
Priorix-Tetra is presented as a powder and solvent for solution for injection (powder in a vial
for 1 dose and solvent in a pre-filled syringe (0.5 ml)) with or without separate needles in the
following pack sizes:
with 2 separate needles: pack sizes of 1 or 10.
without needles: pack sizes of 1, 10, 20 or 50.
Priorix-Tetra 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
SmithKline Beecham plc
Trading as:
GlaxoSmithKline UK
Stockley Park West,
Uxbridge,
Middlesex UB11 1BT
Manufacturer
GlaxoSmithKline Biologicals s.a.,
Rue de l' Institut 89,
B-1330 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-Tetra
Reference Number
10592/0297
This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in February 2013
Priorix-Tetra is a registered trademark of the GlaxoSmithKline group of companies.
[2013] GlaxoSmithKline group of companies. All rights reserved.

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-Tetra should under no circumstances be administered intravascularly or intradermally.
In the absence of compatibility studies, the medicinal product must not be mixed with other
medicinal products.
The reconstituted (dissolved) vaccine should be inspected visually for any foreign particulate
matter and/or abnormal physical appearance before administration. In the event of either
being observed, the vaccine should be discarded.
The vaccine is 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-Tetra might be slightly different
(without screw thread) than the syringe described in the drawing. In that case, the needle
should be attached without screwing.

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

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

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.
The colour of the reconstituted vaccine may vary from clear peach to fuchsia pink due to
minor variations of its pH. This is normal and does not impair the performance of the vaccine.
In the event of other variation being observed, discard the vaccine.
A new needle should be used to administer the vaccine.
Withdraw the entire contents of the vial.
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator
(2 C 8 C). If it is not used within 24 hours, it should be discarded.
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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