injection, suspension

Vaccine against diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), polio (inactivated), and Haemophilus influenzae type b conjugate ( adsorbed )

Read this leaflet carefully before your child receives this vaccine. It contains information that is important for your child.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • If your child has any side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Hexyon is and what it is used for
2. What you need to know before your child receives Hexyon
3. How to use Hexyon
4. Possible side effects
5. How to store Hexyon
6. Contents of the packaging 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, hepatitis B, polio, and serious diseases caused by Haemophilus influenzae type b. Hexyon is given to children from six weeks of age.

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

  • Diphtheria is an infectious disease that usually first affects the throat. In the throat, infection causes a pain and swelling that can lead to suffocation. Bacteria that cause the disease also produce a toxin (poison) that can damage the heart, kidneys and nerves.
  • tetanus ( tetanus ) is usually caused by tetanus bacteria entering the body through a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms which lead to difficulty breathing and the risk of suffocation.
  • whooping cough (pertussis) is a highly contagious disease that affects the respiratory tract. The disease causes severe cough that can cause breathing problems. The cough often has a “peeking” sound. The cough can last for one to two months or longer. Whooping cough can also cause ear infections, respiratory tract infections ( bronchitis ) that can last for a long time, pneumonia , seizures, brain damage and even death.
  • hepatitis B is caused by the hepatitis B virus . It causes the liver to swell (become inflamed). In some people, the virus can remain in the body for a long time and can eventually cause serious liver problems, including liver cancer.
  • polio (poliomyelitis) is caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, usually in the legs. Paralysis of muscles that control breathing and swallowing can cause death.
  • infection with Haemophilus influenzae type b (often called just Hib) are serious bacterial infections that can cause meningitis ( inflammation of the outer membranes of the brain), which can lead to brain damage, deafness, epilepsy or partial blindness. Infection can also cause inflammation and swelling in the throat, which in turn leads to difficulty breathing and swallowing; infection can affect other parts of the body such as the blood, lungs, skin, bone tissue and joints.

Important information about how the vaccine works

  • Hexyon only helps to protect against these diseases if they are caused by the bacteria and viruses for which the vaccine is intended. Your child can get diseases with similar symptoms if they are caused by other bacteria or viruses .
  • The vaccine does not contain any live bacteria or viruses and can not cause any of the infectious diseases that it protects against.
  • This vaccine does not protect against infection caused by other types of Haemophilus influenzae , nor against meningitis caused by other microorganisms .
  • Hexyon does not protect against hepatitis infection caused by other viruses such as hepatitis A, hepatitis C and hepatitis E or other liver pathogens.
  • Because symptoms of hepatitis B take a long time to develop, it is possible that undetected hepatitis B infection may occur at the time of vaccination. The vaccine may not be able to prevent hepatitis B infection in such cases.
  • As with all vaccines, Hexyon may not provide protection in 100% of the children who receive the vaccine.

2. What you need to know before your child receives Hexyon

Do not use Hexyon

To ensure that Hexyon is suitable for your child, it is important to talk to a doctor or nurse if any of the points listed below apply to your child. If there is anything you do not understand, talk to your doctor, pharmacist, or nurse.

Do not use Hexyon if your child:

  • have had respiratory problems or swelling of the face ( anaphylactic reaction ) after administration of Hexyon
  • have had an allergic reaction
    • against the active substances
    • against any of the other ingredients listed in section 6
    • against glutaraldehyde, formaldehyde, neomycin , streptomycin or polymyxin B as these substances are used during the manufacturing process.
    • after previous administration of Hexyon or other vaccines containing diphtheria , tetanus, pertussis, polio, hepatitis B or Hib
  • have had a severe reaction affecting the brain ( encephalopathy ) within 7 days after a previous dose of a pertussis vaccine (acellular or whole cell pertussis)
  • have an uncontrolled disease state or serious illness that affects the brain and nervous system (uncontrolled neurological disorder) or uncontrolled epilepsy .

Warnings and cautions

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

  • have a moderate or high fever or an acute illness (eg fever, sore throat, cough, cold or flu ). Vaccination with Hexyon may need to be postponed until your child feels better.
  • have had any of the following after receiving the pertussis vaccine, as the decision to give additional doses of pertussis vaccine needs to be carefully considered:
    • fever at 40 ° C or above within 48 hours after vaccination due to no other identifiable cause.
    • collapse or shock-like condition with hypotonic-hyporesponsive episode (loss of energy) within 48 hours after vaccination.
    • persistent and inconsolable crying lasting 3 hours or more and occurring within 48 hours after vaccination.
    • seizures with or without fever that occur within 3 days after vaccination.
  • previously had Guillain-Barré syndrome (temporary inflammation of the 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 vaccine). In this case, the decision to give additional vaccines containing tetanus toxoid should be evaluated by a physician.
  • follows a treatment that suppresses the immune system (the body’s natural defenses) or has a disease that causes a weakened immune system. In these cases, the immune response to the vaccine may be reduced. Then it is normally recommended that the vaccination be postponed until the end of the treatment or the disease. Children with long-term problems with the immune system such as HIV – infection ( AIDS ) can still be Hexyon but the protection may not be as good as in children whose immune system is healthy.
  • suffers from an acute or chronic disease, including chronic renal impairment or renal failure (kidneys do not function properly).
  • suffers from an undiagnosed disease of the brain or uncontrolled epilepsy . Your doctor will then assess the potential benefits of vaccination.
  • have a bleeding disorder that causes slight bruising or bleeding for a long time after minor wounds. Your doctor will tell you if your child can get Hexyon.

Fainting can occur after, or even before, the needle stick. Therefore, tell your doctor or nurse if your child has previously fainted in connection with needle sticks.

Other medicines or vaccines and Hexyon

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

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

When Hexyon is given at the same time as other vaccines, the injections will be given in different places.

Hexyon contains phenylalanine, potassium and sodium

Hexyon contains 85 micrograms of phenylalanine per 0.5 ml dose. Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.

Hexyon contains less than 1 mmol (39 mg) potassium and less than 1 mmol (23 mg) sodium per dose, ie essentially ‘potassium free and ‘sodium-free.

3. How to use Hexyon

Hexyon is given to your child by a doctor or nurse who is trained in the use of vaccines and who can handle less common severe allergic reactions to the injection (see section 4. Possible side effects ).

Hexyon is given as an injection into the muscle ( intramuscular route of administration, im) in the upper part of your baby’s leg or upper arm. The vaccine is never given in a blood vessel, in or under the skin.

The recommended dose is as follows:

First vaccination series (primary vaccination)

Your child will receive either two injections given in an interval of two months or three injections given in an interval of one to two months (at least four weeks apart). This vaccine should be used according to the local vaccination program.

Additional injection (booster)

After the first series of injections, your child will receive a booster dose, according to local recommendations, at least 6 months after the last dose of one in the first vaccination series. Your doctor will tell you when this dose should be given.

If you miss a dose of Hexyon

If your child misses a scheduled injection, you must discuss it with your doctor or nurse who will decide when the missed dose should be given.

It is important to follow the instructions from the doctor or nurse so that your child completes the entire vaccination series, otherwise, your child may not have complete protection against the diseases.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Severe allergic reactions ( anaphylactic reaction )

Contact a doctor IMMEDIATELY if any of these symptoms occur after your child has been injected:

  • breathing difficulties
  • bluish discoloration of tongue or lips
  • rash
  • swelling of the face or neck
  • sudden and severe malaise with falling blood pressure causing dizziness and unconsciousness, increased heart rate associated with difficulty breathing.

These signs or symptoms (signs and symptoms of anaphylactic reaction ) usually occur very soon after receiving an injection and while the child is still in the clinic or doctor’s office.

Severe allergic reactions are rare (may affect up to 1 in 1,000 people) after vaccination with this vaccine.

Other side effects are

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

  • Very common side effects (may affect more than 1 in 10 people) are:
    • loss of appetite ( anorexia )
    • crying
    • drowsiness ( somnolence )
    • vomiting
    • pain, redness or swelling at the injection site
    • irritability
    • fever (body temperature 38 ° C or higher).
  • Common side effects (may affect up to 1 in 10 people) are:
    • abnormal crying (persistent crying)
    • diarrhea
    • induration at the injection site ( induration ).
  • Uncommon side effects (may affect up to 1 in 100 people) are:
    • allergic reaction
    • tubercle at the injection site
    • high fever (body temperature 39.6 ° C or higher).
  • Rare side effects (may affect up to 1 in 1,000 people) are:
    • rash
    • major injection site reactions (greater than 5 cm), including extensive swelling of the arm or leg, extending from the injection site over one or more joints. These reactions begin within 24-72 hours after vaccination and may be associated with redness , warmth, tenderness or pain at the injection site and resolve within 3–5 days without the need for treatment.
    • seizures with or without fever.
  • Very rare side effects (may affect up to 1 in 10,000 people) are:
    • episodes when your child goes into a shock-like state or is pale, limp and uncontactable for a period of time (hypotonic reactions or hypotonic-hyporesponsive episodes, HHE).

Any side effects are

Isolated cases of other side effects not listed above have been reported with other vaccines containing diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib and not directly with Hexyon:

  • temporary inflammation of nerves causing pain, paralysis and sensory disturbances ( Guillain-Barré syndrome ) as well as severe pain and reduced mobility of the arm and shoulder (brachial neuritis ) have been reported after administration of vaccine containing tetanus
  • inflammation of several nerves causing sensory disturbances or weakness in the extremities (polyradiculoneuritis), facial paralysis, visual disturbances, sudden blurred vision 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 after administration of a vaccine containing hepatitis B antigen
  • swelling or inflammation of the brain (encephalopathy / encephalitis).
  • in children born very prematurely (at or before the 28th week of pregnancy) longer than normal breathing intervals may occur for 2-3 days after vaccination
  • swelling of one or both feet and lower extremities which may occur together with a bluish discoloration of the skin (cyanosis), redness , small areas of bleeding under the skin (transient purpura) and severe crying after vaccination with vaccine containing Haemophilus influenzae type b. About this reaction occurs usually after the first (primary) injections and occurs within the first hours after vaccination. All symptoms go away completely within 24 hours without the need for treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hexyon

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

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze.

Store in the outer carton. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are per dose (0.5 ml) 1 :
Diphtheria toxoid not less than 20 IU 2
Tetanus toxoid not less than 40 IU 2.3
Bordetella pertussis – antigen is  
Pertussis toxoid 25 micrograms
Filamentous hemagglutinin 25 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
Hepatitis B surface antigen 6 10 micrograms
Haemophilus influenzae type b polysaccharide 12 micrograms
(polyribosyl ribitol phosphate)  
conjugated to tetanus protein 22–36 micrograms

1 Adsorbed on aluminum hydroxide, hydrated (0.6 mg Al 3+ )

2 IU international unit

3 Or equivalent activity determined by an immunogenicity evaluation

4 Cultivated in Vero cells

5 corresponding antigen amounts in the vaccine

6 Cultured in yeast cells Hansenula polymorpha using recombinant DNA technology

Other ingredients 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.

What the medicine looks like and contents of the pack

Hexyon was provided as an injection, suspension in a vial (0.5 ml).

Hexyon is available in a pack containing 10 vials.

The normal appearance of the vaccine after shaking is a whitish and cloudy suspension.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France

Manufacturer:

Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l’Etoile, France

Sanofi Pasteur, Incarville Industrial Park, 27100 Val de Reuil, France

Contact the representative of the marketing authorization holder to find out more about this medicine:

Sanofi AB

Tel: +46 8-634 50 00

Muhammad Nadeem

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