Infanrix IPV

What Infanrix-IPV is and what it is used for

Infanrix-IPV is a vaccine used as a booster dose to protect your child against 4 diseases:

• Diphtheria – a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems and even death.
• Tetanus – tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine.
• Whooping cough (pertussis) – a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a ‘whooping’ sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
• Polio – a viral infection. Polio is often only a mild illness. However, sometimes it can be very serious and cause permanent damage or even death. Polio can make the muscles unable to move (paralysis of the muscles). This includes the muscles that are needed for breathing and walking. The arms or legs affected by the disease may be painfully twisted (deformed).

Infanrix-IPV is for children from 16 months to 13 years of age inclusive. It is not intended for people over 14 years of age.

How the vaccine works

Infanrix-IPV helps your child’s body make its own protection (antibodies). This will protect your child against these diseases.

The vaccine cannot cause the diseases that it protects your child from.

Before your child receives Infanrix-IPV

Infanrix-IPV should not be given if:

• your child is allergic (hypersensitive) to:
• any of the ingredients in Infanrix-IPV (listed in Section 6)
• neomycin or polymyxin (types of antibiotics)
• formaldehyde. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue
• if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough or polio
• if your child experienced problems of the nervous system (encephalopathy) within 7 days after previous vaccination with a vaccine against whooping cough
• if your child has a severe infection with a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your doctor first.

Infanrix-IPV should not be given if any of the above apply to your child. If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix-IPV.

Take special care with Infanrix-IPV:

Check with your doctor or pharmacist before your child is given this vaccine if:

• after previously having Infanrix-IPV or another vaccine against whooping cough, your child had any problems, especially:
  • 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
  • fits with or without a high temperature within 3 days of vaccination
• your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy. After control of the disease the vaccine should be administered.
• your child has a bleeding problem or bruises easily
• your child has a tendency to fits due to a fever or if there is a history in the family of this
• your child has problems with their immune system (including HIV infection). Your child may still be given Infanrix-IPV. However, the protection against the infections may not be as high.

If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before your child is given Infanrix-IPV.

Using other medicines, treatments or vaccines

Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription, or has recently received any other vaccine. In particular, tell your doctor or pharmacist if your child is using any of the following:

medicines or other treatments (such as radiotherapy) that affect their immune system. Your child may still be given Infanrix-IPV. However, Infanrix-IPV may not work as well. If possible the vaccine should be given after this treatment has finished other vaccines. Infanrix-IPV can be given at the same time as other vaccines. A different place for the injection will be used for each vaccine.

Pregnancy and breast-feeding

It is unlikely that Infanrix-IPV would be given to people who are pregnant or breast-feeding. This is because it is only intended to be used in children from 16 months to 13 years of age inclusive. The use of this vaccine is not recommended during pregnancy or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It is unlikely that Infanrix-IPV would be given to people who drive or use tools or machines. This is because it is only intended to be used in children from 16 months to 13 years of age inclusive. Your child may feel sleepy after having this vaccination. This will temporarily affect your ability to drive or use tools or machines.

Important information about some of the ingredients of Infanrix-IPV

This vaccine contains neomycin, polymyxin (antibiotics) and formaldehyde. Your child should not be given Infanrix-IPV if they are allergic to any of these ingredients.

How Infanrix-IPV is given

When the vaccine will be given

Your doctor or nurse will tell you when your child should have this vaccine. It depends on official recommendations.

How the vaccine is given

Your child will receive a single injection of Infanrix-IPV.

Infanrix-IPV is always injected into a muscle.

This will usually be in the shoulder muscle. However, in young children it can be given in the thigh.

The vaccine should never be given into a vein.

Possible side effects

Like all medicines, Infanrix-IPV can cause side effects, although not everybody gets them. The following side effects may happen with this vaccine:

Allergic reactions

If your child has an allergic reaction, see your doctor straight away. The signs may include:

1. skin rashes that may be itchy or blistering
2. swelling of the eyes and face
3. difficulty in breathing or swallowing,
4. a sudden drop in blood pressure
5. loss of consciousness.

These signs usually start very soon after the injection has been given. Take your child to see a doctor straight away if they happen after leaving the clinic. Allergic reactions are very rare (less than 1 in 10,000 doses of the vaccine).

See your doctor straight away if your child has any of the following serious side effects:

1. collapse
2. loss of consciousness
3. lack of awareness
4. fits.

See your doctor straight away if you notice any of the above. These side effects have happened with other vaccines against whooping cough. They usually occur within 2 to 3 days after vaccination.

Other side effects include:

Very common (these may occur with more than 1 in 10 doses of the vaccine)

• feeling sleepy
• headache
• loss of appetite
• high temperature of 38°C or higher
• pain, redness and swelling at the injection site
• unusual crying
• feeling irritable or restless

Common (these may occur with up to 1 in 10 doses of the vaccine)

• diarrhoea
• nausea, vomiting (feeling or being sick)
• high temperature of 39.5°C or higher
• generally feeling unwell
• hard lump at the injection site
• feeling weak.

Uncommon (these may occur with up to 1 in 100 doses of the vaccine) skin allergies or rash.

Rare (these may occur with up to 1 in 1,000 doses of the vaccine)

• swollen glands in the neck, armpit and groin (lymphadenopathy)
• coughing or chest infection (bronchitis)
• itching
• lumpy rash (hives).

Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)

• bleeding or bruising more easily than normal (thrombocytopenia)
• temporarily stopping breathing (apnoea)
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioneurotic oedema)
• blisters at the injection site.

Booster doses of Infanrix-IPV may increase the risk of reactions at the injection site. Some of these affect the entire arm or leg that has been injected. These reactions usually begin within 48 hours of the injection and go away after 4 days.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Infanrix-IPV

Keep out of the reach and sight of children.

Store in a refrigerator (2°C to 8°C).

Store in the original package in order to protect from light.

Do not freeze. Freezing destroys the vaccine.

Do not use Infanrix-IPV after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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.

Further information

What Infanrix-IPV contains

–   I ne active suDstances are: Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigensPertussis toxoid1 Filamentous Haemagglutinin1 Pertactin1 Poliovirus (inactivated)2 type 1 (Mahoney strain) type 2 (MEF-1 strain) type 3 (Saukett strain) adsorbed on aluminium hyclroxicle,hydrated propagated in VERO cells

not less than 30IU not less than 40 IU25 micrograms 25 micrograms 8 micrograms 40 D-antigen unit 8 D-antigen unit 32 D-antigen unit 0.5 milligrams AI3+

Aluminium hydroxide is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine. The other ingredients are: sodium chloride, Medium 199 (containing principally amino acids, mineral salts, vitamins), water for injections.

What Infanrix-IPV looks like and contents of the pack

Infanrix-IPV is a suspension for injection in pre-filled syringe (0.5 ml).

The suspension is white, and slightly milky.

Packs either contain 1,10 or 20 pre-filled syringes with or without needles.

Not all pack sizes may be marketed.