Hexyon injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hexyon injectable suspension in pre-filled syringe

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

Read all of this leaflet carefully before your child is vaccinated because it contains important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If your child experiences any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Hexyon is and what it is used for

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

Hexyon helps protect against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and serious diseases caused by Haemophilus influenzae type b. Hexyon is administered to infants from six weeks of age.

The vaccine works by stimulating the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections:

• Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection causes pain and swelling that can lead to suffocation. The bacterium causing this disease also produces a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus usually occurs when the tetanus bacterium enters a deep wound. The bacterium produces a toxin (poison) that causes muscle spasms, leading to difficulty breathing and potential suffocation.
• Pertussis (commonly known as whooping cough) is a highly contagious disease affecting the respiratory tract. It causes severe coughing fits that can lead to breathing problems. Coughing fits are often accompanied by a characteristic "whooping" sound during inhalation. The cough may last one to two months or longer. Pertussis can also cause ear infections, chest infections (bronchitis) that may persist for a long time, lung infections (pneumonia), seizures, brain damage, and even death.
• Hepatitis B is caused by the hepatitis B virus. It causes the liver to swell (inflammation). In some people, the virus may remain in the body for a long time and may eventually cause serious liver problems, including liver cancer.
• Poliomyelitis (commonly known as polio) is caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, most frequently in the legs. Paralysis of the muscles controlling breathing and swallowing can be fatal.
• Infections caused by Haemophilus influenzae type b (often referred to simply as Hib) are serious bacterial infections and can lead to meningitis (inflammation of the membranes surrounding the brain), which may result in brain damage, deafness, epilepsy, or partial blindness. The infection can also cause inflammation and swelling of the throat, leading to difficulty swallowing and breathing. The infection may 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 specific bacteria or viruses the vaccine is designed to target. Your child may still contract illnesses 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 of Haemophilus influenzae or against meningitis caused by other microorganisms.
• Hexyon does not protect against infectious hepatitis caused by other agents such as hepatitis A, hepatitis C, and hepatitis E.
• Since symptoms of hepatitis B take a long time to develop, it is possible that an undiagnosed hepatitis B infection may already be present at the time of vaccination. In such cases, the vaccine may not prevent hepatitis B infection.
• As with any vaccine, Hexyon may not protect 100% of vaccinated children.

2. What you need to know before your child is given Hexyon

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

Do not use Hexyon if your child:

• has had a breathing disorder or facial swelling (anaphylactic reaction) after receiving Hexyon.

• has had an allergic reaction

• to the active substances,

• to any of the other components listed in section 6,

• to glutaraldehyde, formaldehyde, neomycin, streptomycin, or 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 experienced a serious reaction affecting the brain (encephalopathy) within 7 days after receiving a previous dose of a pertussis-containing vaccine (acellular or whole-cell).

• has an uncontrolled or serious illness 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 fever or an acute illness (fever, sore throat, cough, cold, or flu). Vaccination with Hexyon may need to be postponed until your child feels better.

• has previously experienced any of the following adverse events after receiving a pertussis-containing vaccine, the decision to administer further doses of pertussis-containing vaccines should be carefully evaluated:

• fever of 40 °C or higher within 48 hours after vaccination not due to an identifiable cause.

• collapse or shock-like state with hypotonic–hyporesponsive episode within 48 hours after vaccination.

• persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours after vaccination.

• seizures (with or without fever) occurring within 3 days after vaccination.

• has previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis, and sensory disturbances) or brachial neuritis (severe pain and reduced mobility in the arm and shoulder) after receiving a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin). In this case, your doctor will evaluate whether to administer any vaccine containing tetanus toxoid.

• is receiving treatment that suppresses the immune system (the body's natural defenses) or has any condition causing immunodeficiency. In such cases, the immune response to the vaccine may be reduced. Therefore, vaccination is recommended to be delayed until the end of treatment or illness. However, children with long-term immune system problems such as HIV infection (AIDS) may still receive Hexyon, although the protection may not be as effective as in children with a healthy immune system.

• has any acute or chronic illness, including chronic kidney disease or kidney failure (inability of the kidneys to function properly).

• has any undiagnosed brain disorder or uncontrolled epilepsy. Your doctor will assess the potential benefit of vaccination.

• has any blood disorder causing easy bruising or prolonged bleeding after minor cuts. Your doctor will advise whether Hexyon should be given.

Use of Hexyon with other vaccines or medicines

Inform your doctor or nurse if your child is taking, has recently taken, or might need to take any other medicines or vaccines.

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

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

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

Hexyon contains phenylalanine, potassium, and sodium

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

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

3. How to use Hexyon

Hexyon will be administered to your child by a doctor or nurse properly trained in the use of vaccines and equipped to respond to any rare severe allergic reactions that may occur after the injection (see section 4 "Possible side effects").

Hexyon is given by injection into a muscle (intramuscular route, IM) in the upper leg or arm of your child. The vaccine must never be administered into a blood vessel or within or under the skin.

The recommended dose is as follows:

Primary vaccination cycle (primary vaccination)

Your child will receive two injections given two months apart or three injections administered at intervals of one to two months (at least four weeks apart). This vaccine should be used in accordance with the local vaccination schedule.

Additional injections (booster vaccination)

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

If your child does not receive a dose of Hexyon

If your child misses a scheduled injection due to oversight, it is important to inform your doctor or nurse, who will decide when the missed dose should be administered.

It is important to follow the instructions of the doctor or nurse so that your child completes the vaccination cycle. Otherwise, your child may not be fully protected against the diseases.

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

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

Severe allergic reactions (anaphylactic reaction)

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

• difficulty breathing
• bluish discoloration of the tongue or lips
• rash
• swelling of the face or throat
• sudden and severe malaise with a drop in blood pressure causing dizziness and loss of consciousness, rapid heartbeat associated with respiratory disorders

When these signs and symptoms (signs or symptoms of an anaphylactic reaction) occur, they usually develop rapidly after the injection is given and while the child is still at the clinic or medical office.

The likelihood of severe allergic reactions occurring after receiving this vaccine is rare (may affect up to 1 in 1,000 people).

Other adverse effects

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

• Very common adverse 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 adverse effects (may affect up to 1 in 10 people) are:

• abnormal crying (prolonged crying)

• diarrhea

• hardening at the injection site (induration)

• Uncommon adverse 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 adverse effects (may affect up to 1 in 1,000 people) are:

• rash

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

• seizures (convulsions) with or without fever.

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

• episodes in which your child enters a shock-like state or appears pale, limp, and unresponsive for a period of time (hypotonic-hyporesponsive episodes, HHE).

Potential adverse effects

Other adverse effects not mentioned above have occasionally been reported with other vaccines containing diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib, but not directly with Hexyon:

• After administration of a vaccine containing tetanus, temporary inflammation of nerves causing pain, paralysis, and sensory disturbances (Guillain-Barré syndrome), severe pain and reduced mobility in the arm and shoulder (brachial neuritis) have been reported.
• After administration of vaccines containing hepatitis B antigen, inflammation of nerves causing sensory disturbances or weakness in the arms and/or legs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of the brain and spinal cord (demyelination of the central nervous system, multiple sclerosis) have been reported.
• Swelling or inflammation of the brain (encephalopathy/encephalitis).
• In infants born very prematurely (at 28 weeks of gestation or earlier), abnormally long pauses between breaths may occur during the 2–3 days following vaccination.
• Swelling of one or both feet and lower limbs. This may occur along with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura), and severe crying, following administration of vaccines containing Haemophilus influenzae type b. If this reaction occurs, it will occur mainly after the first injections and will be observed within the first hours after vaccination. All symptoms will completely resolve within 24 hours without treatment.

Reporting of adverse effects

If your child experiences any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hexyon

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

Do not use this medicine after the expiry date stated on the container and label after CAD/EXP. The expiry date refers to the last day of the month indicated.

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

Do not freeze.

Keep the container in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hexyon

The active substances per dose (0.5 mL)1 are:

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

2 As lower confidence limit (p=0.95) and not less than 30 IU as mean value

3 As lower confidence limit (p=0.95)

4 Or equivalent activity determined by assessment of immunogenicity

5 Grown in Vero cells

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

7 Produced in yeast cells Hansenula polymorpha by recombinant DNA technology

The other components are:

Disodium hydrogen 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 injections.

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

Appearance of the product and contents of the pack

Hexyon is supplied as an injectable suspension in a pre-filled syringe (0.5 ml).

Hexyon is available in packs of 1, 10 or 50 pre-filled syringes without 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 containing 5 packs, each with 10 pre-filled syringes without fixed needle.

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

Only certain pack sizes may be marketed.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

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 is available upon request to the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

The most up-to-date approved information on this vaccine is available at the following URL: https://hexyon.info.sanofi or by scanning the QR code with your mobile phone (smartphone):

[QR code to be included]

This information is intended for healthcare professionals only:

• Shake the prefilled syringe well to obtain a homogeneous suspension.
• Hexyon must not be mixed with other medicines.
• Hexyon must be administered by intramuscular injection. The recommended injection sites are the upper anterolateral area of the thigh (preferred site) or the deltoid muscle in older children (possibly from 15 months of age).

The intradermal or intravenous routes must not be used. Do not administer intravascularly: ensure that the needle has not penetrated into a blood vessel.

• Do not use prefilled syringes if the carton is damaged.

Preparation for administration

The syringe containing the injection suspension should be inspected visually before administration. If foreign particles, leaks, premature plunger activation, or defective tip cap sealing are observed, discard the prefilled syringe.

The syringe is designed for single use and must not be reused.

Instructions for use of the Luer Lock prefilled syringe

Image A: Luer Lock syringe with cap on the rigid end

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

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

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