REPEVAX

• 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 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.

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 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.

• 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 severe febrile illness. 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.

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.
• had a Guillain-Barre syndrome (temporary loss of movement and feeling in all or part of the body) within 6 weeks of 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).

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:

• 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

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.

Dosage

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 any of these symptoms occur after leaving the place where you or your child received the injection, you must consult a doctor IMMEDIATELY.

• 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. 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):

• pain
• swelling and redness in the area where the vaccine was injected
• tiredness
• fever (a temperature at or above 37.5°C)
• diarrhoea.

Common (may affect up to 1 in 10 people):

• bruising
• itching and skin inflammation in the area where the vaccine was injected
• headache
• nausea
• vomiting
• rashes
• aching or swollen joints
• irritability.

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):

• pain
• swelling and redness in the area where the vaccine was injected
• headache
• nausea
• aching or swollen joints
• aching muscles
• weakness
• chills.

Common (may affect up to 1 in 10 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-Barre syndrome), facial paralysis, inflammation of the spinal cord, inflammation of the nerves in the arm (brachia! 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.

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 Antigens:

Pertussis Toxoid 2.5 micrograms

Filamentous Haemagglutinin 5 micrograms

Pertactin 3 micrograms

Fimbriae Types 2 and 3 5 micrograms

Inactivated Poliomyelitis Virus (cultivated on Vero cells):

Type 1 (Mahoney) 29 D antigen units¹

Type 2 (MEF1) 7 D antigen units¹

Type 3 (Saukett) 26 D antigen units¹

Adsorbed on aluminium phosphate 1.5 mg (0.33 mg Al³⁺)

¹ These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method.

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):

• without attached needle - pack size of 1, 10 or 20
• with 1 or 2 separate needles - pack size of 1 or 10

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:

Distributed by:

The manufacturer responsible for batch release is:

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