Prospecto: information for the user

Vaxelis pre-filled syringe suspension

Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), inactivated poliomyelitis, and Haemophilus b conjugate (adsorbed) vaccine

Read this prospectus carefully before your child is vaccinated with this medicine as it contains important information for you.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for your child, and it should not be given to other people.
• If your child experiences adverse effects, consult your doctor, pharmacist, or nurse even if they are not listed in this prospectus.See section4.

1.What Vaxelis is and for what it is used

2.What you need to know before Vaxelis is administered to your child

3.How to use Vaxelis

4.Possible adverse effects

5.Storage of Vaxelis

6.Contents of the package and additional information

Vaxelis is a vaccine that helps protect your child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and serious diseases caused byHaemophilus influenzaetype b. Vaxelis is administered to children from six weeks of age.

The vaccine works by causing the body to generate its own protection (antibodies) against the bacteria and viruses that cause the following diseases:

• Diphtheria: a bacterial infection that usually affects the throat first, causing pain and swelling that can lead to asphyxiation. The bacteria also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus: caused by the penetration of the tetanus bacteria into a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms, leading to an inability to breathe and the possibility of asphyxiation.
• Pertussis (also known as whooping cough): a highly contagious disease that affects the respiratory tract. This causes severe coughing attacks that can lead to respiratory problems. The coughing attacks often feature a distinctive "whooping" sound. Pertussis can last from one to two months or more. It can also cause ear infections, bronchitis, which can last a long time, pneumonia, convulsions, brain damage, and even death.
• Hepatitis B: caused by the hepatitis B virus. This causes the liver to become inflamed (inflammation). In some people, the virus can remain in the body for a long time, and eventually can cause serious liver problems, including liver cancer.
• Poliomyelitis (also known as polio): caused by viruses that affect the nerves. It can lead to muscle paralysis or weakness, most often in the legs. Paralysis of the muscles that control breathing and swallowing can be fatal.
• Haemophilus influenzae type b infections (often simply called Hib infections): severe bacterial infections that can cause meningitis (inflammation of the membranes that surround the brain), which can cause brain damage, hearing loss, epilepsy, or partial blindness. The infection can also cause inflammation and swelling of the throat, making it difficult to swallow and breathe, and can affect other parts of the body, such as the blood, lungs, skin, bones, and joints.

Important information about the protection provided

• Vaxelis will only help prevent these diseases if they are caused by the bacteria and viruses for which the vaccine is intended. Vaxelis does not protect your child against diseases caused by other bacteria and viruses that could cause similar symptoms.
• The vaccine does not contain any living bacteria or viruses and cannot cause any of the infectious diseases against which it protects.
• Like any vaccine, Vaxelis may not protect 100% of vaccinated children.

In order to ensure that Vaxelis is suitable for your child, it is essential that you inform your doctor or nurse if your child presents any of the characteristics detailed below. If you do not understand anything, consult your doctor, pharmacist, or nurse.

Do not use Vaxelis if your child:

• has had difficulty breathing or swelling of the face (anaphylactic reaction) after a previous dose of Vaxelis.
• is allergic (hypersensitive)

• to the Vaxelis vaccine or to any other vaccine that contains diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib,
• to any of the other components included in section 6,
• to glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B (antibiotics), andbovine serum albumin,since these substances are used during the manufacturing process,

• has suffered a severe reaction affecting the brain (encephalopathy) within 7 days after administration of a previous dose of a pertussis vaccine (acellular or whole-cell).
• has an uncontrolled disease or severe disease affecting the brain and nervous system (uncontrolled neurological disorder) or uncontrolled epilepsy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before vaccination, if your child:

• has a moderate to severe acute illness, with or without fever (e.g. sore throat, cough, cold, or flu). It may be possible to postpone vaccination until your child feels better.
• has experienced any of the following adverse events after receiving a pertussis vaccine, they should be carefully evaluated to decide whether to administer other doses of vaccine containing the pertussis component:

• fever of 40.5°C or higher within 48hours, not due to another identifiable cause.
• weakness, loss of sensation, or loss of consciousness, after previous vaccination, within 48hours after vaccination.
• continuous crying and could not be comforted for 3hours or more, within 48hours after vaccination.
• attacks (convulsions) with or without fever, within 3days after vaccination.

• has previously experienced Guillain-Barré syndrome (temporary loss of sensation and movement) after administration of a vaccine containing tetanus toxoid (a form of inactivated tetanus toxoid). Your doctor will evaluate the decision to administer Vaxelis to your child.
• is receiving treatment (such as steroids, chemotherapy, or radiation therapy) or has a diseasethat suppressesor weakensthe body's abilityto fight infections.It is recommendedto postponethe vaccinationuntil the end ofsuch treatment ordisease. However, children with long-term problems with their immune system, such as HIV (AIDS), may be given Vaxelis, but the protection may not be as good as in children with a healthy immune system.
• has an undiagnosed brain disease or uncontrolled epilepsy. Your doctor or nurse will evaluate the potential benefit of vaccination once the disease is stabilized.
• has seizures when feverish, or has a family history ofseizuresthat occurwhen feverish.
• has any bleeding disorder, such as prolonged bleeding after minor cuts or easy bruising. Your doctor will advise you on whether to administer Vaxelis to your child.
• was bornveryprematurely(before28 weeksof gestation).In these children, there may be longer than usual pauses between breaths for 2 to 3daysafter vaccination.

Other medications or vaccines and Vaxelis

Inform your doctor or nurse if your child is using, has used recently, or may need to use any other medication or vaccine.

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

Your doctor or nurse will administer these injections in different injection sites andwill usedifferentneedlesand syringesfor each injection.

Driving and operating machinery

It is expected that the influence of Vaxelis on the ability to drive and operate machinery will be negligible or insignificant.

Vaxelis contains sodium

This medicine contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

Vaxelis will be administered to your child by a doctor or nurse who is properly trained in the use of vaccines and equipped to react to any rare severe allergic reaction that may occur after the injection (see section4 “Possible side effects”).

Your doctor or nurse will inject Vaxelis into your child's thigh (in babies from 6weeks of age) or arm (in children over one year old).

The recommended dose is as follows:

Primary vaccination cycle (primary vaccination)

Your child will receivetwo orthree injections administered at least one month apart.Your doctoror nurse will inform you whenyour child should return forthenextinjection according to the local vaccination schedule.

Additional injection (booster vaccination)

After the primary vaccination cycle, your child will receive a booster dose, according to local recommendations, at least 6months after the last dose of the primary vaccination cycle. Your doctor will advise you on when to administer this dose.

If your child did not receive a dose of Vaxelis

If by mistake, your child does not receive a scheduled injection, it isimportant to inform your doctor ornurse, they will decide when to administer the missed dose.

It isimportant to follow the doctor'sor nurse's instructions for your child to complete the vaccination cycle. Otherwise, your child may not be fully protected against diseases.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

Severe allergic reactions

If any of these symptoms occur after leaving the place where your child received the injection, you should consult a doctor IMMEDIATELY:

• difficulty breathing
• blue discoloration of the tongue or lips
• eruption
• swelling of the face or throat
• low blood pressure causing dizziness or collapse.

These signs and symptoms usually develop rapidly after the injection and while the child is still at the clinic or medical consultation.

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

Other side effects

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

• Very common side effects (may affect more than 1 in 10 people) are:
• • decreased appetite
  • irritability
  • crying
  • vomiting
  • drowsiness or somnolence
  • fever (temperature of 38°C or higher)
  • pain, redness, swelling at the injection site
• Common side effects (may affect up to 1 in 10 people) are:
• • diarrhea
  • hard lump, nodule at the injection site
  • redness at the injection site
• Uncommon side effects (may affect up to 1 in 100 people) are:
• • eruption
  • heat, eruption at the injection site
  • increased appetite
  • stomach pain
  • excessive sweating
  • cough
  • nasal congestion and discharge
  • pallor
  • sleep disturbances, includingthe inability to get a good night's sleep
  • restlessness
  • inflammation of the lymph nodes in the neck, armpit or groin
  • sensation of fatigue
  • weakness (hypotonia)
• Rare side effects (may affect up to 1 in 1,000 people) are:

• allergic reaction, severe allergic reaction (anaphylactic reaction)
• extensive swelling of the vaccinated limb

• Side effects with unknown frequency (cannot be estimated from available data) are:

• seizures (convulsions) with or without fever
• weakness and loss of sensation or loss of consciousness and/or pallor or blue skin

Other side effects not mentioned earlier have been reported with other vaccines that contain diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib:

• episodes ofshockor pallor, weaknessand loss of sensation

Reporting of side effects

If your child experiencesany type ofside effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in refrigerator (between 2°C and 8°C). Do not freeze. Store the container in the outer packaging to protect it from light.

Do not use this vaccineafter the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Vaxelis

The active principles per dose (0.5ml) are:

1adsorbed on aluminium phosphate (0.17mg Al3+)

2adsorbed on amorphous aluminium hydroxiphosphate sulphate (0.15mg Al3+)

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

4produced in Vero cells

5or equivalent antigenic amount in the vaccine determined by an appropriate immunochemical method

6or equivalent activity determined by an immunogenicity evaluation.

Aluminium phosphate andamorphous aluminium hydroxiphosphate sulphateare included in the vaccine as adjuvants.The adjuvants are included toimprove the immune response of the vaccines.

The other components are:

Sodium phosphate and water for injections.

The vaccine may contain traces ofglutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B andbovine serum albumin.

Appearance of the product and contents of the pack

The normal appearance of the vaccine is a uniform, turbid white to off-white suspension, which maysedimentduring storage.

Vaxelis is supplied as a pre-filled syringe injection.

Size of pack: 1, 10pre-filled syringes without a fixed needle, with 1separate needle or 2separate needles.

Multi-pack of 5packs, each containing 10pre-filled syringes without a fixed needle.

Only some pack sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden,Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:{month} {year}.

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:https://www.ema.europa.eu.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended for healthcare professionals only:

The pre-filled syringe should be gently agitated to obtain a uniform, white to off-white, opaque suspension.

Visually inspect the suspension before administration to detect any foreign particles and/or physical aspect variations. In case of observing any of these circumstances, discard the pre-filled syringe.

The needle should be firmly attached to the syringe, rotating it by a quarter of a turn.

Vaxelis is only for intramuscular injection.

The recommended injection sites are the antero-lateral area of the thigh or the upper deltoid muscle of the arm if there is sufficient muscle mass. The antero-lateral area of the thigh is the recommended site for infants under one year of age.