Leaflet: information for the user

Hexyon injectable suspension in pre-filled syringe

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

Read this leaflet carefully before your child is vaccinated as it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If your child experiences any side effects, consult your doctor, pharmacist or nurse even if they are not listed in this leaflet.See section 4.

Hexyon (DtaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.

Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and serious diseases caused byHaemophilus influenzaetype b. Hexyon 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 these different infections:

• Diphtheria is an infectious disease that usually affects the throat first. In the throat, the infection causes pain and swelling that can lead to asphyxiation. The bacteria causing this disease also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus usually occurs when the tetanus bacteria enter 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) is a highly contagious disease that affects the respiratory tract. This causes severe coughing attacks that can lead to respiratory problems. The coughing attacks often have a characteristic "inspiratory sound." The cough can last from one to two months or more. Pertussis can also cause ear infections, chest infections (bronchitis), which can last a long time, lung infections (pneumonia), convulsions, brain damage, and even death.
• Hepatitis B is 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 problems in the liver, including liver cancer.
• Poliomyelitis (also known as polio) is 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 referred to as Hib) are serious bacterial infections that can cause meningitis (inflammation of the membranes surrounding the brain), which can cause brain damage, hearing loss, epilepsy, or partial blindness. The infection can also cause throat inflammation and swelling, leading to difficulty swallowing and breathing. The infection can affect other parts of the body, such as the blood, lungs, skin, bones, and joints.

Important information about the protection provided

• Hexyon will only help prevent these diseases if they are caused by the bacteria or viruses for which the vaccine is intended. Your child could contract diseases with similar symptoms caused by other bacteria or viruses.
• The vaccine does not contain any live bacteria or viruses and cannot cause any of the infectious diseases it protects against.
• This vaccine does not protect against infections caused by other types ofHaemophilus influenzaeor against meningitis caused by other microorganisms.
• Hexyon will not protect against infectious hepatitis caused by other agents such as hepatitis A, hepatitis C, and hepatitis E.
• Since the symptoms of hepatitis B take a long time to develop, it is possible that an undetected hepatitis B infection may be present at the time of vaccination. In such cases, the vaccine may not prevent hepatitis B infection.
• Like any other vaccine, it is possible that Hexyon may not protect 100% of vaccinated children.

To ensure that Hexyon is suitable for your child, it is essential to inform your doctor or nurse if your child has any of the characteristics listed below. If you do not understand anything, consult your doctor, pharmacist, or nurse.

Do not use Hexyon if your child:

• has had a respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexyon.
• has had an allergic reaction

- to the active principles,

- to any of the other components included in section 6,

- to glutaraldehyde, formaldehyde, neomycin, streptomycin, and polymyxin B, as these substances are used during the manufacturing process,
- after previous administration of Hexyon or any other vaccine containing diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib.

• 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

Before vaccination, consult your doctor, pharmacist, or nurse if your child:

• has a moderate or high temperature or an acute illness (fever, sore throat, cough, cold, or flu). It may be possible to postpone the 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°C or higher within 48 hours after vaccination that was not due to another identifiable cause.

- collapse or a state similar to shock with hypotonic-hyporeactive episode (weakness) within 48 hours after vaccination.

- inconsolable crying, persistent for 3 hours or more, produced within 48 hours after vaccination.

- seizures (convulsions) with or without fever, produced within 3 days after vaccination.

• has previously suffered from Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis, and sensory disturbances) or brachial neuritis (severe pain and decreased mobility in arm and shoulder) after administration of a vaccine containing tetanus toxoid (a form of inactivated tetanus toxoid). In this case, your doctor will evaluate the decision to administer any vaccine containing tetanus toxoid.
• is receiving immunosuppressive treatment or has any disease causing immunodeficiency. In these cases, the immune response to the vaccine may be reduced. Therefore, it is recommended to postpone vaccination until the end of treatment or disease. However, children with long-term immunological problems, such as HIV infection (AIDS), may be administered Hexyon, but the protection may not be as good as in children with a healthy immune system.
• has a chronic or acute disease, including chronic renal insufficiency or failure (inability of the kidneys to function correctly).
• has an undiagnosed or uncontrolled cerebral disease or uncontrolled epilepsy. Your doctor will evaluate the potential benefit of vaccination.
• has any blood disorder that causes easy bruising or prolonged bleeding after minor cuts. Your doctor will advise on the suitability of administering Hexyon to your child.

Use of Hexyon with other vaccines or medications

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

Hexyon can be administered at the same time as other vaccines, such as pneumococcal vaccines, vaccines against measles-rubella, varicella vaccines, rotavirus vaccines, or meningococcal vaccines.

When administered at the same time as other vaccines, Hexyon will be administered in different injection sites.

Fainting can occur after, or even before, any injection with a needle. Therefore, inform your doctor or nurse if your child has fainted with a previous injection.

Hexyon contains phenylalanine, potassium, and sodium

Hexyon contains 85 micrograms of phenylalanine in each 0.5 ml dose. Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it correctly.

Hexyon contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "potassium-free" and "sodium-free".

Hexyon 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 section 4 “Possible Side Effects”).

Hexyon is administered by injection into a muscle (intramuscularly, IM) in the upper part of your child's leg or arm. The vaccine should never be administered into a blood vessel or inside or under the skin.

The recommended dose is as follows:

Primary Vaccination Cycle (First Vaccination Cycle)

Your child will receivetwo injections administeredin a two-month intervalorthree injections administered in a one- to two-month interval (at least a four-week interval). This vaccine should be used according to the local vaccination schedule.

Additional Injections (Booster Vaccination)

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

If your child misses a Hexyon dose

Ifby mistake, your child misses a scheduled injection in the vaccination calendar, itisimportant to inform your doctor or nurse, who will decide when to administer the missed dose.

Itisimportant to follow the doctor's or 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 (anaphylactic reaction)

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

• difficulty breathing
• blue discoloration of the tongue or lips
• eruption
• swelling of the face or throat
• sudden and severe discomfort with a drop in blood pressure causing dizziness and loss of consciousness, rapid heart rate associated with respiratory disorders

When these signs and symptoms (signs or symptoms of an anaphylactic reaction)appear, they usually developrapidly after the injection and while the child is still at the clinic or medical consultation.

The possibility of severe allergic reactionsafter receiving this vaccineis rare (may affect up to 1 in 1,000 people).

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:

- loss of appetite (anorexia)

- crying

- drowsiness (somnolence)

- vomiting

- fever (temperature of 38°C or higher)

- irritability

- pain, redness, or swelling at the injection site

• Common side effects (may affect up to 1 in 10 people) are:

- abnormal crying (prolonged crying)

- diarrhea

- hardening at the injection site (induration)

• Rare side effects (may affect up to 1 in 100 people) are:

- allergic reaction

- high fever (temperature of 39.6°C or higher)

- lump (nodule) at the injection site

• Rare side effects (may affect up to 1 in 1,000 people) are:

- eruption

- extensive reactions at the injection site (larger than 5 cm), including extensive swelling of a limb that extends from the injection site to beyond one or both joints. These reactions begin within 24-72 hours after vaccination, may be associated with redness, heat, tenderness, or pain at the injection site, and resolve within 3-5 days without treatment.

- seizures (convulsions) with or without fever.

• Very rare side effects (may affect up to 1 in 10,000 people) are:

- episodes in which your child enters a state similar to shock or is pale, weak, and unresponsive for a period of time (hypotonic reactions or episodes of hypotonia-hyporesponsiveness, EHH).

Potential side effects

Occasionally, other side effects not mentioned earlier have been reported with other vaccines that containdiphtheria,tetanus, pertussis, poliomyelitis, hepatitis Bor Hiband not directly with Hexyon:

• Notified after administration of a vaccine containing tetanus, temporary inflammation of nerves causing pain, paralysis, and sensory disorders (Guillain-Barré syndrome), severe pain, and decreased mobility in the arm and shoulder (brachial neuritis).
• Notified after administration of vaccines containing the hepatitis B antigen, inflammation of nerves causing sensory disorders or weakness in the arms and/or legs (poliradiculoneuritis), facial paralysis, visual disorders, sudden darkening or loss of vision (optic neuritis), inflammatory disease of the brain and spinal cord (central nervous system demyelination, multiple sclerosis).
• Swelling or inflammation of the brain (encephalopathy/encephalitis).
• In children born very prematurely (at 28 weeks of gestation or earlier), longer-than-normal intervals between breaths may occur for 2-3 days after vaccination.
• Swelling of one or both feet and lower extremities. This may be accompanied by blue discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura), and severe crying, after administration of vaccines containingHaemophilus influenzaetype b. If this reaction occurs, it will mainly occur after the first injections and will be observed in the first hours after vaccination. All symptoms will resolve completely within 24 hours without treatment.

Reporting side effects

If your child experiencesany type ofside effect, consult your doctor, pharmacist, or nurse, even if it is a 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 medication.

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

Do not use this medication after the expiration date that appears on the packaging and label after CAD/EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C).

Do not freeze.

Store the packaging in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Hexyon

The active principles by dose (0.5ml)1are:

1Adsorbed on aluminium hydroxide, hydrated (0.6mg Al3+)

2As lower confidence limit (p=0.95) and no less than 30 IU as median value

3As lower confidence limit (p=0.95)

4Or equivalent activity determined by immunogenicity evaluation

5Cultivated in Vero cells

6These antigen amounts are strictly the same as those expressed earlier as 40-8-32 units of antigen D, for virus types 1, 2 and 3 respectively, when measured by another suitable immunochemical method.

7Produced in Hansenula polymorpha yeast cells by recombinant DNA technology

The other components are:

Sodium dihydrogen phosphate, potassium dihydrogen phosphate, trometamol, sucrose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment) and water for injection.

The vaccine may contain traces ofglutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.

Appearance of the product and contents of the pack

Hexyon is supplied as a pre-filled syringe (0.5 ml).

Hexyon is available in packs of 1, 10 or 50 pre-filled syringes without a fixed needle.

Hexyon is available in packs of 1 or 10 pre-filled syringes with 1 separate needle.

Hexyon is available in packs of 1 or 10 pre-filled syringes with 2 separate needles.

Hexyon is available in a multiple pack of 5 packs, each containing 10 pre-filled syringes without a fixed needle.

Hexyonis available in packs of 1 or 10 pre-filled syringes with 1 or 10 safety needles.

Only some pack sizes may be marketed.

After shaking, the normal appearance of the vaccine is a turbid white suspension.

Holder of the marketing authorisation and responsible for manufacturing

Holder of the marketing authorisation

Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Responsible for manufacturing

Sanofi Winthrop Industrie, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, France

Sanofi Winthrop Industrie, Voie de L’Institut - Parc Industriel d'Incarville, BP 101, 27100 Val de Reuil, France

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Date of the last revision of this summary of product characteristics:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

The most recent approved information on this vaccine is available at the following URL:https://hexyon.info.sanofior by scanning the QR code with your smartphone:

[QR code to include]

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This information is intended solely for healthcare professionals:

• Shake the pre-filled syringe to ensure the contents are homogeneous.
• Hexyon should not be mixed with other medicinal products.
• Hexyon should be administered by intramuscular injection. The recommended injection sites are the antero-lateral superior region of the thigh (preferred site) or the deltoid muscle in older children (possibly from 15 months of age).

Do not use intradermal or intravenous routes. Do not administer by intravascular injection: ensure the needle has not penetrated a blood vessel.

• Do not use pre-filled syringes if the box is damaged.

Preparation for administration

The pre-filled syringe with the injection suspension should be visually inspected before administration. If there are any foreign particles, leaks, premature activation of the plunger or defective sealing of the tip, discard the pre-filled syringe.

The syringe is designed for single use and should not be re-used.

Instructions for use of the pre-filled syringe Luer Lock

Image A: Luer Lock syringe withcap on the rigid end

Instructions for use of the safety needle with the Luer Lock syringe

Follow steps 1 and 2 above to prepare the Luer Lock syringe and attach the needle.

Disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.