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Consumer Medicine Information
Product Information (Intended for Healthcare Professional)
INFANRIX® hexa
What INFANRIX hexa is used for?
Before vaccination
What are the side-effects?
The following text appears in the INFANRIX hexa Consumer Medicine Information. This information is intended for patients who have been prescribed INFANRIX hexa. Please view Consumer Medicine Information and see your doctor for more information.
What is INFANRIX hexa used for?
INFANRIX hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Diphtheria, tetanus, pertussis and Hib are all serious lifethreatening diseases caused by bacterial infection. Hepatitis B and poliomyelitis are infectious diseases caused by viral infection.
Diphtheria
Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and death. The risk of serious complications and death is greater in the very young and elderly.
Tetanus (Lockjaw)
Tetanus bacteria enter the body through wounded skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with
soil, dust, horse manure or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and death. The spasms can be strong enough to cause bone fractures of the spine. The death rate is 10% of cases.
Pertussis (Whooping cough)
Pertussis is a highly infectious illness. The disease affects the breathing tract causing severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied by a ‘whooping’ sound. The cough may last for 1-2 months or longer. Pertussis can also cause inner ear infections, long-lasting bronchitis, pneumonia, fits, brain damage and death. The risk of severe complications and death is greatest in infants under 6 months of age. The death rate is 0.5% for infants under 6 months of age.
Hepatitis B
Hepatitis B is caused by the hepatitis B virus. It causes the liver to be become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal
secretions, or saliva of infected people. The virus can enter the bloodstream through:
- an infected mother passing the virus onto her baby during or shortly after birth
- sores, cuts or tiny wounds coming into contact with infected fluids (eg from a human bite, sharing razors or toothbrushes, or working with human blood or body fluids)
- injection (eg needlestick injury, or sharing needles for IV drug use)
- sexual intercourse
Some people infected with hepatitis B may not look or feel sick. But others will get symptoms, which may not be seen for 6 weeks to 6 months after infection. Sometimes people will only have mild flulike symptoms, but other people can become very ill.
They may be extremely tired, and have dark urine, pale faeces, yellowish skin and/or eyes (jaundice), and other symptoms possibly requiring hospitalisation.
Most adults fully recover from the disease. However, some people, particularly children, who may not have had symptoms, can remain infected. They are called hepatitis B virus carriers. Hepatitis B carriers can infect others throughout their lives.
Babies infected with hepatitis B at birth almost always become carriers. Often they do not show symptoms, and seem healthy for many years. However, after 30, 40 or 50 years they can become sick and develop symptoms. For all chronic hepatitis B carriers there is a risk of serious liver disease, such as
cirrhosis (liver scarring) and liver cancer.
There is no specific treatment for hepatitis B.
Poliomyelitis (Polio)
Polio is a viral infection that can have variable effects. Often it causes only a mild illness but in some people it causes permanent injury or death. In its severest form, polio infection causes paralysis of the muscles, including those needed for breathing and walking. Polio infection can leave a person unable to breathe without the help of an iron lung machine, unable to walk without leg braces, or confined to a wheel chair. The limbs affected by the disease may be painfully deformed.
Haemophilus influenzae type b (Hib)
Hib most frequently causes brain inflammation (swelling), which is generally seen in infants under 18 months of age. The death rate is 5-10% of infants in
this age group. In 15-30% of surviving infants there will be some type of serious complication such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness. Hib also causes inflammation of the throat, which is mostly seen in children over 18 months of age. It occasionally causes death by suffocation. Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Vaccination is the best way to protect against these diseases. INFANRIX hexa vaccine cannot give your child diphtheria, tetanus, pertussis, hepatitis B or polio infection. The vaccine will not protect against diseases caused by other types of bacteria, viruses or organisms. If a person is already infected with the hepatitis B virus at the time of vaccination, INFANRIX hexa may not prevent the disease in these people.
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INFANRIX hexa SHOULD NOT BE GIVEN IF:
- your child has had an allergic reaction to INFANRIX hexa, or any ingredient contained in this vaccine. The ingredients in INFANRIX hexa are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
If your child had INFANRIX hexa before and became unwell, tell your doctor, nurse or pharmacist before the next dose is given.
- your child experienced a disease of the brain within 7 days after previous vaccination with a pertussis containing vaccine.
- your child has had an allergic reaction to any other diphtheria, tetanus, hepatitis B, inactivated polio or Haemophilus influenzae type b vaccine (such as ENGERIXB®, H-B-Vax II™, INFANRIX®, Triple Antigen™, Tripacel™ or IPOL™ vaccine, HIBERIX®).
- your child has a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before vaccination.
- the expiry date printed on the pack has passed.
- the packaging is torn or shows signs of tampering.
If you are not sure whether your child should have INFANRIX hexa vaccine, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for your child.
BEFORE INFANRIX hexa IS GIVEN TELL YOUR DOCTOR OR NURSE IF:
- your child has any medical problems such as:
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- brain disease or central nervous system (CNS) disease (ie. epilepsy etc.)
- a bleeding problem or bruises easily
- lowered immunity due to medical treatment or a medical condition
- a tendency to febrile convulsions (seizures/fits due to a fever or high body temperature)
- a family history of seizures/fits
- a family history of Sudden Infant Death Syndrome (SIDS)
- allergy to the antibiotics: neomycin and polymyxin.
- after having INFANRIX hexa or another pertussiscontaining vaccine (such as INFANRIX® or Tripacel) your child had any problems, especially:
- a high temperature (over 40.0C) within 2 days of vaccination
- a collapse or shock-like state within 2 days of vaccination
- crying lasting 3 hours or more within 2 days of vaccination
- convulsions (seizures/fits) with or without a fever within 3 days of vaccination
- your child has allergies to any other medicines or substances, such as dyes, foods or preservatives
- your child has received another vaccine recently, or is having any prescription or OTC (overthe- counter) medicines. In particular, mention if your child is being given medicines which suppress the immune system, such as high-dose steroids
Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if INFANRIX hexa is to be given
with another vaccine or medicine.
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What are the side-effects?
Tell your doctor or nurse as soon as possible if your child does not feel or look well during or after having had a dose of INFANRIX hexa vaccine.
INFANRIX hexa helps protect most children from diphtheria, tetanus, pertussis, hepatitis B, poliovirus infection and b, but it may have unwanted side effects in a few children. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment. The chance of your child having a serious side effect is very much less than the chance of your child having a permanent injury from the natural infections.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Most unwanted effects with INFANRIX hexa are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. Side effects are more likely to occur with booster dosing.
MILD EFFECTS
- Tell your doctor if your child has any of the following that are troublesome or ongoing:
- pain, redness, swelling, a hard lump, bruising or itching around the injection site
- fever between 38C and 39.5C
- unusual crying (for more than 1 hour), vomiting, diarrhoea, runny nose or loss of appetite
- sleepiness, nervousness, irritability restlessness, fussiness or difficulty sleeping
- skin rash, bruising, or purple or red-brown spots visible through the skin (purpura)
MORE SERIOUS EFFECTS
- Tell your doctor immediately if you notice any of the following:
- fever greater than 39.5C
- crying for 3 hours or morecollapse, or periods of unconsciousness or lack of awareness
- seizures (convulsions) or fits
- your child has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).
- Contact your doctor immediately or take your child to the casualty department of your nearest hospital if any of the following happens:
- swelling of limbs, face, eyes, inside of nose, mouth or throatshortness of breath, breathing or swallowing difficulties
- hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
- unusual tiredness or weakness that is sudden and severe
These are signs of an allergic reaction. As with all vaccines given by injection there is a very small risk of such reactions. Allergy to INFANRIX hexa vaccine is rare. Any such severe reactions will usually occur within the first few hours of vaccination.
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Other events reported after INFANRIX vaccination, but not be necessarily related to the vaccine include:
- respiratory infections or bronchitis
Other side effects not listed above, can also occur during or soon after a dose of INFANRIX hexa. Check with your doctor or nurse if your child has any other effects.
Do not be alarmed by this list of possible side effects. Your child may not experience any of them.
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Key Products in the Paediatric range are:
Did you Know?
Epidemics of whooping cough occur every 3 to 4 years in Australia. Many cases of whooping cough are in adults and adolescents. The symptoms of whooping cough are usually milder in adults than they are in children. The symptoms in adults include cough, vomiting and sleep disruption. Complication of whooping cough can occur in adults and include urinary incontinence, pneumonia, fractured ribs and weight loss with some adults requiring hospitalisation. Young babies are at risk from catching whooping cough from a close family member. Whooping cough can be very serious and even deadly in babies and young children.
Until vaccines against Haemophilus influenzae type b (Hib) became available, 10 -15 babies died each year in Australia from this disease, and 20-40% of the survivors were left with permanent neurological damage.
Diphtheria, although rare in Australia, has a 10% mortality rate.
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