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1. What Infanrix-IPV+Hib is and what it is used for

The Infanrix-IPV portion of the Infanrix-IPV+Hib vaccine is presented as half a millilitre of a slightly milky liquid in a prefilled syringe. The Hib portion of the vaccine is presented as a powder in a separate vial. Just before injection, the liquid Infanrix-IPV and the powder Hib portions are mixed together in the syringe.

Infanrix-IPV+Hib is available in packs containing a syringe and a vial to make a single dose of half a millilitre after mixing.

Infanrix-IPV+Hib is a vaccine that can be given to children to prevent five infectious diseases. These are diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliomyelitis (polio) and Haemophilus influenzae serotype b (Hib) infections. See section 6 for more information on these diseases. The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these diseases. This vaccine cannot cause any of the five diseases against which it protects.

Vaccination is the best way to protect against these diseases. Remember, however, that no vaccine can provide complete, life-long protection in all people vaccinated. Also, Infanrix-IPV+Hib can only protect against Haemophilus influenzae infections due to the type b organism (Hib infections). It cannot protect against infections due to other types of this bacterium or prevent infections due to other bacteria that cause similar types of disease (see section 6).

2. Before your child receives Infanrix-IPV+Hib

Infanrix-IPV+Hib must not be given to your child if the answer to any of the following questions is “YES”. If you are not sure of anything, ask your doctor or nurse before Infanrix-IPV+Hib is given to your child.

• Has your child previously had any allergic reaction to any vaccine against diphtheria, tetanus or pertussis (whooping cough), Haemophilus influenzae serotype b or polio, or to any other ingredient contained in this vaccine? The active substances and other ingredients in Infanrix-IPV+Hib are listed at the beginning of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• Has your child ever had an allergic reaction to neomycin, polymyxin B or polysorbate 80?
• Has your child experienced problems with the brain or nerves within 7 days after previous vaccination with a vaccine against pertussis (whooping cough)?
• Does your child have a severe infection with a high temperature? It is usual to wait until the child is better before giving the vaccine. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse first.

Also, please note that this vaccine is not suitable for children who are more than three years old.

If the answer to any of the following questions is “YES”, Infanrix-IPV+Hib may or may not be suitable for your child. Your doctor or nurse will advise you.

• After previously having Infanrix-IPV+Hib or another vaccine containing a pertussis (whooping cough) component, did your child have any of the following:-
  • A high temperature (over 40°C) within 48 hours of vaccination?
  • A collapse or shock-like state within 48 hours of vaccination?
  • Persistent crying lasting 3 hours or more within 48 hours of vaccination?
  • Seizures/fits with or without a high temperature within 3 days of vaccination?
• Does your child have a bleeding problem or bruise easily?
• Is your child taking any other medicine or is he or she having treatment that may affect the immune system? Also, does your child have HIV infection or any other illness that can reduce his or her immunity to infections? Your child can still be given Infanrix-IPV+Hib if your doctor or nurse advises it but your child may not develop such good immunity to the five infections as other children.

3. How Infanrix-IPV+Hib is given

Each dose of Infanrix-IPV+Hib is a single injection of half a millilitre (0.5 ml). The nurse or doctor will give Infanrix-IPV+Hib as an injection into the muscle (usually the thigh muscle in infants) and will make sure that the vaccine is not given into a blood vessel.

The vaccine is not given before age 2 months and there should be a gap of at least four weeks between injections. It is usual for infants to receive three doses of vaccine against these five infectious disease at approximately 2, 3 and 4 months of age. Your doctor or nurse will advise when your child should attend for these injections. If you miss an appointment, it is very important that you contact the surgery or clinic and make a new appointment for your child to have the missed dose or doses as soon as possible.

After receiving this course of injections, your child will need to receive a booster dose vaccine against Hib. Again, your doctor or nurse will advise when your child should return to receive this booster vaccination.

4. Possible side effects

Like all vaccines, Infanrix-IPV+Hib may have some side effects.

Some children can have a severe allergic reaction to a vaccine. Very severe reactions are seen in less than 1 in 10,000 people who are vaccinated. Your child may be asked to stay in the surgery or vaccination area for a short time after vaccination to check that he or she does not have an immediate allergic reaction. Tell the doctor or nurse immediately if your child develops a rash (which may be raised and lumpy), tightness of the throat, swelling of the face or neck or shortness of breath. Other possible symptoms of a severe allergic reaction include a drop in blood pressure and unconsciousness.

It is very important that your child has immediate medical treatment for any severe allergic reaction. If the symptoms start after you have left the clinic, you should go to the nearest accident and emergency department.

In clinical studies that involved giving three doses of vaccine to infants within the first year of life, side effects that occurred after vaccination with Infanrix-IPV+Hib were:-

Very common (in more than 1 in 10 children vaccinated)

• Pain, redness or swelling at the site of the injection
• Fever
• Unusual crying
• Loss of appetite
• Restlessness.

Common (in less than 1 in 10 but more than 1 in 100 children vaccinated)

• Lumpy hardness at the injection site
• Jitteriness
• Diarrhoea
• Being sick
• Sleepiness.

Uncommon (in less than 1 in 100 but more than 1 in 1000 children vaccinated)

• Inability to sleep or unusual sleeping patterns
• Very high fever (more than 39.5 °C).

Rare, (in less than 1 in 1000 but more that 1 in 10,000 children vaccinated)

• Constipation
• Wind
• Ear infections with earache
• Runny nose and sore throat
• Chest infection
• Rash.

Very rare (in less than 1 in 10,000 children vaccinated) and during routine use of clinical studies, the following have occured:

• Severe allergic reactions with shock (see above)
• Collapse or periods of unconsciousness or lack of awareness
• Convulsions (fits)

In clinical trials in older children, all of the above effects were seen. In addition, uncommonly children developed rashes due to bleeding under the skin, swelling of the injected limb, sometimes involving the joint and rarely develop lumpy or itchy rashes, swelling of the glands or general sleepiness. Limb swelling reactions returned to normal over a period of roughly four days.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. Storing Infanrix-IPV+Hib

Your doctor or nurse should make sure that Infranrix-IPV+Hib is stored between 2°C and 8°C (in a refrigerator) before it is given to your child and that it is not frozen. Freezing the vaccine will stop it working properly.

Your doctor or nurse should make sure that Infanrix-IPV+Hib is always kept out of the reach and sight of children.

There is an expiry date on the pack. The doctor or nurse will check that this date has not been passed. The date for last use corresponds to the last day of the month mentioned.

6. Further information on Diphtheria, Tetanus, Whooping cough, Polio and Hib diseases

• Diphtheria: Diphtheria infection usually occurs through the airways and less often through the skin. A tough membrane can form in the throat and the airways can 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 even death.
• Tetanus (lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are especially likely to be infected with tetanus bacteria are burns, broken bones that break through the skin, deep wounds or any wound, even if minor that gets contaminated with soil, dust animal manure/dung or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even suffocation and death.
• Pertussis (whooping cough): Pertussis is a highly infectious illness and can affect people of all ages although it is most common in very young children (under two years). The disease affects the airways causing severe spells of coughing that may interfere with normal breathing. In small children who get the infection, coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”. The cough may last for 1-2 months or longer. Pertussis can also cause ear infections, permanent damage to the airways, pneumonia, fits, brain damage and even death
• Poliomyelitis (polio): Poliomyelitis, sometimes called simply “polio” is a viral infection that can have variable effects. In its severest form, polio infection causes paralysis of the muscles (muscles cannot move), including those muscles needed for breathing and walking and can be fatal. The limbs affected by the disease may be permanently deformed.
• Haemophilus influenzae serotype b (Hib): Hib infection most frequently causes meningitis (inflammation of the coverings of the brain and spinal cord). Even after recovery from Hib meningitis there can be complications such as mental retardation, spastic paralysis, deafness or epilepsy. Hib infection can also cause a life-threatening inflammation of the throat with severe swelling that can cause suffocation. Less commonly, the bacteria can infect other parts of the body, particularly the lungs (causing pneumonia) and the bones and joints.