The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 06745/0121 .
Suspension for injection in pre-filled syringe
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
1. What REPEVAX is and what it is used for
2. What you need to know before REPEVAX is given to you or your child
3. How and when REPEVAX is given
4. Possible side effects
5. How to store REPEVAX
6. Contents of the pack and other information
REPEVAX (Tdap-IPV) 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, adolescents and adults following a complete primary course of vaccination.
Use of REPEVAX during pregnancy allows protection to be passed on to the child in the womb to protect her/him from whooping cough during the first few months of life.
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.
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.
Tell your doctor or nurse before vaccination if you or your child has:
Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you or your child fainted in connection with a previous injection.
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.
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 nurse if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby. Your doctor will help you decide if you should receive REPEVAX during pregnancy.
It has not been studied if the vaccine affects the ability to drive or use machines. The vaccine has no or negligible influence on the ability to drive and use machines.
REPEVAX contains 1.01 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.
Your doctor will determine if REPEVAX is suitable for you or your child, depending on:
Your doctor will decide how long you have to wait between vaccinations.
If you are pregnant, the doctor will help you decide if you should receive REPEVAX during pregnancy.
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.
All age groups for whom REPEVAX is indicated will receive one injection (half a millilitre).
In case you or your child experience an injury which requires preventative action for tetanus disease, your doctor may decide to give REPEVAX with or without tetanus immunoglobulin.
REPEVAX can be used for repeat vaccination. Your doctor will give you advice on repeat vaccination.
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.
Like all medicines, REPEVAX can cause side effects, although not everybody gets them.
If any of these symptoms occur after leaving the place where you or your child received the injection, you must consult a doctor IMMEDIATELY.
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. Serious allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.
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 (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
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 (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
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, abdominal pain.
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 Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
The active substances in each dose (0.5 mL) of vaccine are:
Diphtheria Toxoid not less than 2 International Units (2 Lf)
Tetanus Toxoid not less than 20 International Units (5 Lf)
Pertussis Toxoid 2.5 micrograms
Filamentous Haemagglutinin 5 micrograms
Pertactin 3 micrograms
Fimbriae Types 2 and 3 5 micrograms
Inactivated Poliomyelitis Virus (produced in Vero cells):
Type 1 (Mahoney) 40 D antigen units
Type 2 (MEF1) 8 D antigen units
Type 3 (Saukett) 32 D antigen units
Adsorbed on aluminium phosphate 1.5 mg (0.33 mg Al3+)
Aluminium phosphate is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine. The other ingredients are: phenoxyethanol, ethanol, polysorbate 80, water for injections
REPEVAX is presented as a suspension for injection in pre-filled syringes (0.5 mL):
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:
The manufacturer responsible for batch release is:
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, Sweden, United Kingdom: REPEVAX
Belgium, Italy, Luxembourg, Netherlands, Spain: TRIAXIS POLIO
Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia: ADACEL POLIO
This leaflet was last revised in 03/2021.