REPEVAX SUSPENSION FOR INJECTION IN VIALS

Active substance: TETANUS TOXOID ADSORDED PURIFIED

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Package leaflet: Information for the user
REPEVAX®
Suspension for injection
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine
(adsorbed, reduced antigen(s) content)
Read all of this leaflet carefully before you or your child is vaccinated 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, 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.

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

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

1.

What REPEVAX is and what it is used for

REPEVAX is a vaccine. Vaccines are used to protect against infectious diseases. They work by causing the
body to produce its own protection against the bacteria and viruses that cause the targeted diseases.
This vaccine is used to boost protection against diphtheria, tetanus, pertussis (whooping cough) and
poliomyelitis (polio) in children from the age of three years, teenagers and adults following a complete
primary course of vaccination.
Limitations in the protection provided
REPEVAX will only prevent these diseases if they are caused by the bacteria or viruses targeted by the
vaccine. You or your child could still get similar diseases if they are caused by other bacteria or viruses.
REPEVAX does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases
against which it protects.
Remember that no vaccine can provide complete, life long protection in all people who are vaccinated.
2.

What you need to know before you use REPEVAX

To make sure that REPEVAX 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, ask your
doctor or nurse to explain.

Do not use REPEVAX if you or your child






Has had an allergic reaction:
- to diphtheria, tetanus, pertussis or poliomyelitis vaccines
- to any of the other ingredients (listed in section 6)
- to any residual component carried over from manufacture (formaldehyde, glutaraldehyde,
streptomycin, neomycin, polymyxin B and bovine serum albumin) which may be present in trace
amounts.
has ever had
- a severe reaction affecting the brain within one week after a previous dose of a whooping cough
vaccine
has an acute illness with or without fever. The vaccination should be delayed until you or your child
has recovered. A minor illness without fever is not usually a reason to defer vaccination. Your doctor
will determine if you or your child should receive REPEVAX.

Warnings and precautions
Tell your doctor or nurse before vaccination if you or your child has:
received a booster dose of a vaccine for diphtheria and tetanus within the last 4 weeks. In this case you
or your child should not receive REPEVAX and your doctor will decide on the basis of official
recommendations when you or your child can receive a further injection.
 ever had a Guillain-Barré syndrome (temporary loss of movement and feeling in all or part of the
body) or brachial neuritis (loss of movement, pain and numbness of the arm and the shoulder)
following a previous dose of a tetanus containing vaccine. Your doctor will decide if you or your child
should receive REPEVAX.
 a progressive illness affecting the brain/nerves or uncontrolled fits. Your doctor will first start
treatment and vaccinate when the condition has stabilized.
 a poor or reduced immune system, due to:
- medication (e.g. steroids, chemotherapy or radiotherapy)
- HIV infection or AIDS
- any other illness.
The vaccine may not protect as well as it protects people whose immune system is healthy. If possible,
vaccination should be postponed until the end of such disease or treatment.
 any problems with the blood that causes easy bruising, or bleeding for a long time after minor cuts (for
instance due to a blood disorder such as haemophilia or thrombocytopenia or treatment with blood
thinning medicines).


Other medicines or vaccines and REPEVAX
As REPEVAX does not contain any live bacteria or viruses it can generally be given at the same time as
other vaccines or immunoglobulins, but at a different injection site. Studies have demonstrated that
REPEVAX can be used at the same time as any of the following vaccines: an inactivated influenza
vaccine, a hepatitis B vaccine, and a recombinant Human Papillomavirus vaccine respectively. Injections
of more than one vaccine at the same time will be given in different limbs.
If you or your child is receiving medical treatment affecting your or your child's blood or immune system
(such as blood thinning medicines, steroids, chemotherapy), please refer to the section "Warnings and
precautions" above.
Tell your doctor or pharmacist 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. Your doctor or nurse can advise you whether or not vaccination
should be delayed. The use of REPEVAX is not recommended during pregnancy.
Driving and using machines:
It has not been studied if the vaccine affects the ability to drive or use machines.
3.

How to use REPEVAX

When you or your child will be given the vaccine
Vaccination history
Your doctor will determine if REPEVAX is suitable for you or your child, depending on:
 what vaccines have been given to you or your child in the past
 how many doses of similar vaccines have been given to you or your child in the past
 when the last dose of a similar vaccine was given to you or your child
You or your child must have had the complete primary courses of diphtheria, tetanus and polio vaccines
before having REPEVAX.
It is safe to have REPEVAX if you or your child has not had the complete primary course of whooping
cough vaccines but protection may not be as good as in people who have already had the whooping cough
vaccine.
Your doctor will decide how long you have to wait between vaccinations.
Dosage and method of administration
Who will give you REPEVAX?
REPEVAX should be given by healthcare professionals who have been trained in the use of vaccines and
at a clinic or surgery that is equipped to deal with any rare severe allergic reaction to the vaccine.
Dosage
All age groups for whom REPEVAX is indicated will receive one injection (half a millilitre).
In case you or your child experiences an injury which requires preventative action for tetanus disease, your
doctor may decide to give REPEVAX with or without tetanus immunoglobulin.
Use in children and adolescents
REPEVAX should not be used in children under 3 years of age.
Children from the age of 3 years onwards and adolescents should receive the same dosage as adults.
Method of administration
Your doctor or nurse will give you the vaccine into a muscle in the upper outer part of the arm (deltoid
muscle).
Your doctor or nurse will not give you the vaccine into a blood vessel, into the buttocks or under the skin.
In case of blood clotting disorders they may decide to inject under the skin, although this might result in
more local side effects, including a small lump under the skin.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

Like all medicines, REPEVAX can cause side effects, although not everybody gets them.
Serious allergic reactions
Serious allergic reactions are a very rare possibility after receiving any vaccine. These reactions may
include:
difficulty in breathing
blueness of the tongue or lips
a rash
swelling of the face or throat
low blood pressure causing dizziness or collapse.
When these signs or symptoms occur they usually develop very quickly after the injection is given and
while you or your child is still in the clinic or doctor’s surgery.
If any of these symptoms occur after leaving the place where you or your child received the injection,
you must consult a doctor IMMEDIATELY.
Other side effects
The following side effects were observed during clinical studies carried out in specific age groups.
In children 3 to 6 years of age
Very common (in more than 1 in 10 children): pain, swelling and redness in the area where the vaccine was
injected, tiredness, fever (a temperature at or above 37.5°C), irritability.
Common (in less than 1 in 10, but more than 1 in 100 children): bruising, itching and skin inflammation in
the area where the vaccine was injected, headache, nausea, vomiting, diarrhoea, rashes, aching or swollen
joints.

In adolescents (11 years of age and older) and adults
Teenagers are a little more likely than adults to have side effects. Most side effects occur within the first 3
days after vaccination.
Very common (in more than 1 in 10 people): pain, swelling and redness in the area where the vaccine was
injected, headache, nausea, aching or swollen joints, aching muscles, weakness, and chills.
Common (in less than 1 in 10, but more than 1 in 100 people): vomiting, diarrhoea, fever (a temperature at
or above 38.0°C).
The following additional adverse events have been reported in the various recommended age groups during
the commercial use of REPEVAX. The frequency of these adverse events cannot be precisely calculated,
as it would be based on voluntary reporting in relation to the estimated number of vaccinated persons.
Lymph node disorder, allergic/serious allergic reactions, fits (convulsions), fainting, paralysis of part or all
the body (Guillain-Barré syndrome), facial paralysis, inflammation of the spinal cord, inflammation of the
nerves in the arm (brachial neuritis), temporary loss or alteration of sensation in vaccinated limb,
dizziness, pain in vaccinated limb, extensive limb swelling (frequently associated with redness, and
sometimes with blisters), feeling ill, pale skin, a hard lump (induration) in the area where vaccine was
injected.
If you 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 REPEVAX

Keep out of the sight and reach of children.
REPEVAX must not be used after the expiry date which is stated on the label after "EXP". The expiry date
refers to the last day of that month.
Store in a refrigerator (at 2°C to 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Keep the container in the outer carton in order to protect from light.
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 REPEVAX contains
The active substances in each dose (0.5 mL) of vaccine are:
Diphtheria Toxoid
Tetanus Toxoid
Pertussis Antigens:
Pertussis Toxoid
Filamentous Haemagglutinin
Pertactin
Fimbriae Types 2 and 3

not less than 2 International Units (2 Lf)
not less than 20 International Units (5 Lf)
2.5 micrograms
5 micrograms
3 micrograms
5 micrograms

Inactivated Poliomyelitis Virus (produced in Vero cells):
Type 1
Type 2
Type 3
Adsorbed on aluminium phosphate

40 D antigen units
8 D antigen units
32 D antigen units
1.5 mg (0.33 mg aluminium)

The other ingredients are: phenoxyethanol, polysorbate 80, water for injections
What REPEVAX looks like and contents of the pack
REPEVAX is presented as a suspension for injection in vials (0.5 mL):


pack size of 1 (with or without empty polypropylene syringe and two needles), 5, 10 or 20.

Not all pack sizes may be marketed.
The normal appearance of the vaccine is a uniform cloudy white suspension, which may sediment during
storage. After shaking well it is a uniformly white liquid.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in the UK is:
Sanofi Pasteur MSD Limited
Mallards Reach
Bridge Avenue
Maidenhead
Berkshire
SL6 1QP
The manufacturer responsible for batch release is:
Sanofi Pasteur
2, avenue pont Pasteur
69007 Lyon
France
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Norway, Portugal, United Kingdom:

REPEVAX

Belgium, Luxembourg, Netherlands:

TRIAXIS POLIO

This leaflet was last revised on
06/2012

The following information is intended for healthcare professionals only:
Instructions for use
In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products.
Parenteral products should be inspected visually for extraneous particulate matter and/or discolouration
prior to administration. If these conditions exist, the product should not be administered.

When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal
holding it in place.
Needles should not be recapped.

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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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