ADACEL suspension for injection in pre-filled syringe

• 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 ADACEL is and what it is used for
2. What you need to know before ADACEL is given to you or your child
3. How and when ADACEL is given
4. Possible side effects
5. How to store ADACEL
6. Contents of the pack and other information

ADACEL will only prevent these diseases if they are caused by the bacteria targeted by the vaccine. You or your child could still get similar diseases if they are caused by other bacteria or viruses.

ADACEL 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, lifelong protection in all people who are vaccinated.

• has had an allergic reaction:
  • to diphtheria, tetanus or pertussis vaccines
  • to any of the other ingredients (listed in section 6)
  • to any residual component carried over from manufacture (formaldehyde, glutaraldehyde) 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 ADACEL.

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 ADACEL and your doctor will decide on the basis of official recommendations when you or your child can receive a further injection.
• had a Guillain-Barré 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 ADACEL.
• 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, pharmacist or nurse before using ADACEL, if you or your child have had any allergic reactions to latex. The tip caps of the prefilled syringes contain a natural rubber latex derivative which may cause an allergic reaction.

Tell your doctor, nurse or pharmacist if you or your child is taking, has recently taken or might take any other medicines.

As ADACEL does not contain any live bacteria, it can generally be given at the same time as other vaccines or immunoglobulins, but at a different injection site. Studies have demonstrated that ADACEL can be used at the same time as any of the following vaccines: a hepatitis B vaccine, a poliovirus vaccine (injected or oral), an inactivated flu 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 you or your child's blood or immune system (such as blood thinning medicines, steroids or 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 ADACEL 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.

Your doctor will determine if ADACEL 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 ADACEL during pregnancy.

Who will give you ADACEL?

ADACEL 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 ADACEL is indicated will receive one injection (half a millilitre).

In case you or your child experience an injury which requires preventive action for tetanus disease, your doctor may decide to give ADACEL with or without tetanus immunoglobulin.

ADACEL 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 aged 4 to 6 years

Very common (may affect more than 1 in 10 people):

• decreased appetite
• headache
• diarrhoea
• tiredness
• pain,
• redness
• swelling in the area where the vaccine was injected.

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

• nausea
• vomiting
• rash
• aching (all over the body) or muscular weakness
• aching or swollen joints
• fever
• chills
• underarm lymph node disorder

In adolescents aged 11 to 17 years

Very common (may affect more than 1 in 10 people):

• headache
• diarrhoea
• nausea
• aching (all over the body) or muscular weakness
• aching or swollen joints
• tiredness/weakness
• feeling unwell
• chills
• pain,
• redness and swelling in the area where the vaccine was injected.

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

• vomiting
• rash
• fever
• underarm lymph node disorder

In adults aged 18 to 64 years

Very common (may affect more than 1 in 10 people):

• headache
• diarrhoea
• aching (all over the body) or muscular weakness
• tiredness/weakness
• feeling unwell
• pain,
• redness and swelling in the area where the vaccine was injected.

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

• nausea
• vomiting
• rash
• aching or swollen joints
• fever
• chills
• underarm lymph node disorder

The following additional adverse events have been reported in the various recommended age groups during the commercial use of ADACEL. 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.

• Allergic / serious allergic reactions (how you can recognize such a reaction, you can find in the beginning of section 4), ‘pins and needles’ or numbness, paralysis of part or all the body (Guillain- Barré syndrome), inflammation of the nerves in the arm (brachial neuritis), loss of function in the nerve that supplies the facial muscles (facial palsy), fits (convulsions), fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular part of the heart (myocarditis), itching, hives, inflammation of a muscle (myositis), extensive limb swelling associated with redness, warmth, tenderness or pain in the area where the vaccine was injected, bruising, abscess or a small lump in the area where the vaccine was injected.

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 the national reporting system (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

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.

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

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, water for injections

ADACEL is presented as a suspension for injection in pre-filled syringe (0.5 mL):

• without needle – pack size of 1 or 10
• 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 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:

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Germany: Covaxis

Belgium, Denmark Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands: Triaxis

Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia, United Kingdom: Adacel