• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for your child only. Do not pass it on to others.
• If 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 Vaxelis is and what it is used for
2. What you need to know before Vaxelis is given to your child
3. How to use Vaxelis
4. Possible side effects
5. How to store Vaxelis
6. Contents of the pack and other information

• Vaxelis will only help to prevent these diseases caused by the bacteria and viruses targeted by the vaccine. Vaxelis does not protect your child against diseases caused by other bacteria and viruses that may cause similar symptoms.
• The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.
• As with any vaccine, Vaxelis may not protect 100% of children who receive the vaccine.

• has had shortness of breath or swelling of the face (anaphylactic reaction) after administration of a previous dose of Vaxelis.
• is allergic (hypersensitive)
  • to Vaxelis vaccine or any diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines,
  • to any ingredients listed in section 6,
  • to glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B (antibiotics) and bovine serum albumin, as these substances are used during the manufacturing process.
• has suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
• has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy.

Talk to your doctor, pharmacist or nurse before vaccination if your child:

• has a moderate to severe acute disease, with or without fever (e.g. sore throat, cough, cold or flu). Vaccination with Vaxelis may need to be delayed until your child is better.
• has had any of the following events after receiving a vaccine against pertussis (whooping cough), as the decision to give further doses of pertussis containing vaccine will need to be carefully considered:
  • had a fever of 40.5°C or above within 48 hours not due to another identifiable cause.
  • became floppy, unresponsive or unconscious after the previous vaccination, within 48 hours of vaccination.
  • cried continuously and could not be comforted for more than 3 hours within 48 hours of vaccination.
  • had a fit (convulsions) with or without fever, within 3 days of vaccination.
• previously had Guillain-Barré syndrome (temporary loss of feeling and movement) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin). Your doctor will decide whether to give Vaxelis to your child.
• is receiving a treatment (such as steroids, chemotherapy or radiotherapy) or has a disease that suppresses or weakens the body’s ability to fight infections. It is recommended to postpone vaccination until the end of such treatment or disease. However, children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Vaxelis but the protection may not be as good as in children with a healthy immune system.
• suffers from any undiagnosed illness of the brain or epilepsy which is not controlled. Your doctor or nurse will assess the potential benefit offered by vaccination, once the condition is stabilised.
• suffers from fits during a fever, or there is family history of fits occurring during a fever.
• has any problems with bleeding for a long time after minor cuts, or bruises easily. Your doctor will advise you whether your child should receive Vaxelis.
• was born very prematurely (at or before 28 weeks of gestation). In these infants, longer gaps than normal between breaths may occur for 2 to 3 days after vaccination.

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

Vaxelis can be given at the same time as other vaccines such as pneumococcal vaccines, measles- mumps-rubella-varicella (MMRV) vaccines, rotavirus vaccines or meningococcal C vaccines.

Your doctor or nurse will give these injections at different sites and will use different syringes and needles for each injection.

It is expected that Vaxelis will have no or negligible influence on the ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.

It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections. If not, your child may not be fully protected against the diseases.

If any of these symptoms occur after leaving the place where your child received his/her 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 quickly after the injection is given and while the child is still in the clinic or doctor’s surgery.

Serious allergic reactions are very rare (may affect up to 1 in 10,000 people) and can occur after receiving any vaccine.

If your child experiences any of the following side effects, please tell your doctor, nurse or pharmacist.

• Very common side effects (may affect more than 1 in 10 people) are:
  • decreased appetite
  • irritability
  • crying
  • vomiting
  • sleepiness or drowsiness
  • fever (temperature 38°C or higher)
  • pain, redness, swelling at the injection site
• Common side effects (may affect up to 1 in 10 people) are:
  • diarrhoea
  • hard mass, lump (nodule) at the injection site
  • bruising at the injection site
• Uncommon side effects (may affect up to 1 in 100 people) are:
  • rash
  • warmth, rash at the injection site
  • increased appetite
  • stomach pain
  • excessive sweating
  • cough
  • nasal congestion and runny nose
  • paleness
  • sleep disorders including inability to get adequate sleep
  • restlessness
  • swollen glands in the neck, armpit or groin
  • feeling tired
  • floppiness
• Rare side effects (may affect up to 1 in 1,000 people) are:
  • allergic reaction, serious allergic reaction (anaphylactic reaction)
• Side effects with frequency not known (frequency cannot be estimated from the available data) are:
  • fits (convulsions) with or without fever
  • floppiness and unresponsive or unconscious and/or paleness or bluish skin

Other side effects not listed above have been reported with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines:

• extensive swelling of the vaccinated limb
• episodes of shock-like state or paleness, floppy and unresponsive

If your child gets 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 https://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The active substances per dose (0.5 mL):

Diphtheria Toxoid¹ not less than 20 IU ⁶

Tetanus Toxoid ¹ not less than 40 IU ⁶

Bordetella pertussis antigens ¹

Pertussis Toxoid (PT) 20 micrograms

Filamentous Haemagglutinin (FHA) 20 micrograms

Pertactin (PRN) 3 micrograms

Fimbriae Types 2 and 3 (FIM) 5 micrograms

Hepatitis B surface antigen ^2,3 10 micrograms

Poliovirus (Inactivated) ⁴

Type 1 (Mahoney) 40 D antigen units ⁵

Type 2 (MEF-1) 8 D antigen units ⁵

Type 3 (Saukett) 32 D antigen units ⁵

Haemophilus influenzae type b polysaccharide

(Polyribosylribitol Phosphate) 3 micrograms

Conjugated to meningococcal protein ² 50 micrograms

¹ adsorbed on aluminium phosphate (0.17 mg Al ³⁺)

² adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al ³⁺)

³ produced in yeast ( Saccharomyces cerevisiae) by recombinant DNA technology

⁴ produced in Vero cells

⁵ or equivalent antigenic quantity determined by a suitable immunochemical method

⁶ or equivalent activity determined by an immunogenicity evaluation.

Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants. Adjuvants are included to improve the immune response of vaccines.

The other ingredients are:

Sodium phosphate, water for injections

The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin.

The normal appearance of the vaccine is a uniform, cloudy, white to off-white suspension, which may settle down during storage.

Vaxelis is provided as a suspension for injection in pre-filled syringe.

Pack size of 1 or 10 pre-filled syringes, without attached needle, with 1 separate needle or with 2 separate needles.

Multipack of 5 packs of 10 pre-filled syringes with no needle.

Not all pack sizes may be marketed.

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