Π Ρ Ο Σ Ο Χ Η εμβόλιο INFANRIX IPV + hib

ΡΙΞΤΕ ΜΙΑ ΜΑΤΙΑ ΣΤΙΣ ΟΔΗΓΕΙΕΣ ΧΡΗΣΕΩΣ

PACKAGE LEAFLET: INFORMATION FOR THE USER

GlaxoSmithKline

Infanrix®-IPV+Hib (as logo) vaccine

Powder and suspension for suspension for injection

Diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and

Haemophilus type b conjugate vaccine (adsorbed)

Read all of this leaflet carefully before your child receives this vaccine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This vaccine has been prescribed for your child. Do not pass it on to others.

• 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.

In this leaflet:

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

2. Before your child receives Infanrix-IPV+Hib

3. How Infanrix-IPV+Hib is given

4. Possible side effects

5. How to store Infanrix-IPV+Hib

6. Further information

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

Infanrix-IPV+Hib is a vaccine used to protect your child against 5 diseases:

• Diphtheria - a serious bacterial infection that mainly affects the airways and

sometimes the skin. The airways become swollen causing serious breathing

problems. 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 disease 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 which may last a long time, lung infections, fits, brain damage and

even death.

• Polio - a viral infection. Polio can make the muscles unable to move (paralysis of

the muscles). This includes the muscles needed for breathing and walking. The

arms or legs affected by the disease may be painfully twisted (deformed).

• Haemophilus influenzae type b (Hib) - can cause brain swelling

(inflammation). This can lead to serious problems such as: mental slowness

(retardation), cerebral palsy, deafness, epilepsy or partial blindness. It can also

cause swelling of the throat. This can cause death by suffocation. Less

commonly, the bacteria can also infect the blood, heart, lungs, bones, joints and

tissues of the eyes and mouth.

Infanrix-IPV+Hib is for children between 2 months and 3 years old. It is not suitable

for children older than 3 years.

How the vaccine works

Infanrix-IPV+Hib helps your child’s body make its own protection (antibodies). This

will protect your child against these diseases.

About the protection from Infanrix-IPV+Hib

• Infanrix-IPV+Hib will only protect against infections caused by the pathogens for

which the vaccine has been developed.

• As with all vaccines, Infanrix-IPV+Hib may not fully protect all children who are

vaccinated.

• Children with a weakened immune system (such as due to HIV infection) may not

get the full benefit from Infanrix-IPV+Hib.

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

2. Before your child receives Infanrix-IPV+Hib

Infanrix-IPV+Hib should not be given

• if your child is allergic (hypersensitive) to Infanrix-IPV+Hib or any other

ingredients in Infanrix-IPV+Hib or neomycin, polymyxin (types of antibiotics) or

Polysorbate 80. The active substances and other ingredients in Infanrix-IPV+Hib

are listed at the end of the leaflet. Signs of an allergic reaction may include itchy

skin, rash, shortness of breath and swelling of the face and tongue.

• if your child experienced problems of the nervous system within 7 days after

previous vaccination with a vaccine against pertussis (whooping cough) disease.

• 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. However, talk to your doctor

first.

Infanrix-IPV+Hib 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+Hib.

Take special care with Infanrix-IPV+Hib:

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

• if after previously having Infanrix-IPV+Hib or another vaccine against

pertussis(whooping cough) disease, 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

- seizures/fits with or without a high temperature within 3 days of having the

vaccine

• 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.

• if your child has a tendency to seizures/fits due to a fever, or if there is a family

history of this

• if your child has a bleeding problem or bruises easily.

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+Hib.

Using other medicines 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 taking any of the following:

• medicines to fight infection that affect the immune system. Infanrix-IPV+Hib may

not work as well if your child is taking these medicines.

Infanrix-IPV+Hib can be given at the same time as other childhood vaccines. A

different place for the injection will be used for each vaccine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Infanrix-IPV+Hib will never be given to people who are pregnant or breast-feeding as

it is only used in children.

Important information about some of the ingredients of Infanrix-IPV+Hib

This vaccine contains neomycin, polymyxin (antibiotics) and Polysorbate 80. Please

tell your doctor if your child has had an allergic reaction to these ingredients.

3. How Infanrix-IPV+Hib is given

How much is given

• The doctor will give the recommended dose of Infanrix-IPV+Hib to your child.

• Usually, your child will receive two or three injections with an interval of 1 month.

It depends on official recommendation. The first injection can be given from the

age of 2 months.

• You will be informed when your child should come back for their next injection.

• If additional injections (boosters) are necessary, the doctor will tell you. These

booster injections will be given at least 6 months after the last injection of the

initial vaccination course.

How the vaccine is given

• Infanrix-IPV+Hib is always injected into a muscle.

• This is usually in the thigh.

• The vaccine should not be given into a blood vessel

If your child misses a dose

• If your child misses a scheduled injection, it is important that you make another

appointment.

• Make sure your child finishes the complete vaccination course. If not your

child may not be fully protected against the diseases.

4. Possible side effects

Like all medicines, Infanrix-IPV+Hib 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:

• face swelling

• low blood pressure

• difficulty breathing

• skin going blue

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

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

side effects:

• collapse

• loss of consciousness

• lack of awareness

• fits

If you notice any of the above, see your doctor straight away. These effects are very

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

Other side effects include:

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

• loss of appetite

• high temperature of 38°C or higher

• swelling, pain and redness at the injection site

• unusual crying

• feeling restless

• feeling irritable

• feeling sleepy.

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

• diarrhoea or being sick (vomiting)

• hard lump at the injection site

• large swelling at the injection site.

Uncommon (these may occur with up to 1 in 100 doses of the vaccine)

• swollen glands in the neck, armpit or groin (lymphadenopathy)

• coughing, chest infection (bronchitis) or runny nose

• upper respiratory tract infection such as a cold, tonsillitis or laryngitis

• rash, lumpy rash (hives)

• tiredness

• swelling of the injected limb and sometimes the nearby joint

• high temperature of 39.5°C or higher.

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

• skin rash

• itching.

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

• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps

than normal between breaths may occur for 2-3 days after vaccination

• temporarily stopping breathing (apnoea)

• swelling of the whole injected limb

• Blisters at the injection site.

Booster doses of Infanrix-IPV+Hib may increase the risk of reactions at the injection

site. These include swelling at the place of injection, swelling of the whole injected

leg or arm and sometimes swelling at the nearby joint. These reactions usually begin

within 2 days 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.

5. How to store Infanrix-IPV+Hib

• Keep out of the reach and sight of children.

• Store in a refrigerator (2°C to 8°C).

• Do not freeze.

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

• Do not use Infanrix-IPV+Hib 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.

6. Further information

What Infanrix-IPV+Hib contains

The active substances are:

Diphtheria toxoid1 not less than 30 IU

Tetanus toxoid1 not less than 40 IU

Bordetella pertussis antigens

Pertussis toxoid1 25 micrograms

Filamentous Haemagglutinin1 25 micrograms

Pertactin1 8 micrograms

Poliovirus (inactivated)

type 1 (Mahoney strain) 2 40 D-antigen unit

type 2 (MEF-1 strain) 2 8 D-antigen unit

type 3 (Saukett strain) 2 32 D-antigen unit

Haemophilus type b polysaccharide

polyribosylribitol phosphate 10 μg

conjugated to tetanus toxoid as carrier protein approximately 30 μg

1adsorbed on aluminium hydroxide, hydrated 0.5 milligrams Al

2propagated in VERO cells

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: lactose, sodium chloride, 2-phenoxyethanol, Medium 199

(containing principally amino acids, mineral salts, vitamins), water for injections.

What Infanrix-IPV+Hib looks like and contents of the pack

• The Infanrix-IPV portion of the Infanrix-IPV+Hib vaccine is a white, slightly milky

suspension presented in a pre-filled syringe (0.5ml).

• The Hib portion of the vaccine is a powder presented in a separate vial.

• Just before injection, the liquid Infanrix-IPV and the powder Hib portions are

mixed together in the pre-filled syringe.

• Infanrix-IPV+Hib is available in packs of 1, 10, 20, 25, 40, 50 and 100.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder is:

SmithKline Beecham plc, trading as:

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

UK

Manufacturer is:

GlaxoSmithKline Biologicals S.A.

Rixensart

Belgium

This medicinal product is authorised in the Member States of the EEA under

the following names:

Infanrix-IPV+Hib : Česká republika, Deutschland, Ελλάδα, Österreich, Portugal,

United Kingdom

INFANRIX-IPV+Hib : Ireland

Infanrix-IPV HIB: Slovenská republika

Infanrix Polio+Hib: Suomi/Finland

This leaflet was last approved in 05/2009