INFANRIX-IPV™

Combined diphtheria, tetanus, acellular pertussis (DTPa) and poliomyelitis
vaccine

What Is In This Leaflet

This leaflet answers some of the common questions about INFANRIX-IPV vaccine.
It does not contain all the available information. It does not take the place of
talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed
the possible risks of your child having INFANRIX-IPV against the expected
benefits.

If you have any concerns about INFANRIX-IPV talk to your doctor, nurse or
pharmacist.

Keep this leaflet with this vaccine. You may need to read it again.

What  INFANRIX-IPV Is Used For

INFANRIX-IPV is a vaccine used to immunise against diphtheria, tetanus,
pertussis (whooping cough) and poliomyelitis.

INFANRIX-IPV is not intended for use in adults.

Diphtheria, pertussis, tetanus and poliomyelitis are life-threatening
diseases caused by bacterial and viral infections. The vaccine works by causing
the body to produce its own protection (antibodies) against these diseases.

Diphtheria

Diphtheria is a bacterium that lives in the airways of humans and can also
affect the skin. Generally, the airways become inflamed (swollen) causing severe
breathing difficulties and sometimes suffocation. The bacteria 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

Tetanus bacteria enter the body through wounded skin. Wounds that are
especially prone to infection are burn wounds, fractures, deep wounds or wounds
contaminated with soil, dust, horse manure or wood splinters. The bacteria
release toxins, which can cause muscle stiffness, painful spasms, fits and
death. The spasm can be strong enough to cause bone fractures of the spine.

Pertussis (whooping cough)

Pertussis is highly infectious. It 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.

Poliomyelitis

There are various types of poliovirus (types I, II and III) that cause
poliomyelitis. The virus infects the bowel, and from there can attack the
nervous system causing meningitis or paralysis.Infection may be without symptoms
or with only minor bowel upset. When infection spreads to the nervous system, it
can cause paralysis. Incubation for poliomyelitis is commonly 7 to 14 days in
severe cases and ranges from 3 to 35 days. Infection is spread by mouth and
faeces.

Vaccination is the best way of protecting against these diseases.
INFANRIX-IPV vaccine cannot give a child diphtheria, tetanus, pertussis
infection or poliomyelitis. The vaccine will not protect against diseases caused
by other types of bacteria or organisms.

Before Receiving INFANRIX-IPV

INFANRIX-IPV must not be given if:

• your child has had an allergic reaction to INFANRIX-IPV, or any ingredient
  contained in this vaccine. The ingredients 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.
• your child has had an allergic reaction to any other diphtheria, tetanus,
  pertussis and poliomyelitis containing vaccine.
• the expiry date printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

If you are not sure whether INFANRIX-IPV should be given, talk to your
doctor or nurse.

Tell your doctor if:

• your child has any medical conditions, such as:
  • a bleeding disorder. Sometimes INFANRIX-IPV may need to be given
    differently in people with bleeding problems
  • an immune deficiency condition (eg. are HIV positive)
  • brain disease or Central Nervous System (CNS) disease such as epilepsy
    or a tendency to febrile convulsions (seizures /fits due to a high fever).
• your child has allergies to any other medicines or substances, such as
  dyes, foods or preservatives.
  
  
  

• 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 being vaccinated.
  
  
  
• after having been given INFANRIX-IPV or another vaccine containing
  diphtheria, tetanus, pertussis, your child had problems such as:
  • high temperature (over 40.5°C) 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/fits with or without fever within 3 days of vaccination.
• your child is receiving any other medication or vaccines.

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-IPV is to be
given with another vaccine or medicine.

Giving INFANRIX-IPV

How INFANRIX-IPV is given

The doctor or nurse will give INFANRIX-IPV as an injection. If you have any
concerns about how this vaccine is to be given, talk to your doctor, nurse or
pharmacist.

How much is given

The dose of INFANRIX-IPV is 0.5ml

How it is given

INFANRIX-IPV will be injected into the thigh muscle in children over 12
months of age, and into the upper leg muscle/thigh muscle in infants under 12
months of age. For infants and children with bleeding problems, the dose may
need to be given under the skin (subcutaneously).

The vaccine should never be given intravenously.

When it will be given

INFANRIX-IPV is given as a total of three doses in the first year of life
from the age of 2 months. Each dose is given on a separate visit with at least 1
month break between doses. In order to maintain protection, a booster dose is
recommended.

It is important to return at the recommended times for follow up doses.

If a dose is missed

If a scheduled dose is missed, talk to your doctor or nurse and arrange
another visit as soon as possible.

While Getting INFANRIX-IPV

Things you must do

Keep your child's visits with the doctor or clinic. It is important
INFANRIX-IPV doses are given at the correct times. This will ensure the best
effect of the vaccine in protecting your child against diphtheria, tetanus
poliomyelitis and pertussis (whooping cough).

Side Effects

Tell your doctor, nurse or pharmacist as soon as possible if your child does
not feel well during or after having had a dose of INFANRIX-IPV.

INFANRIX-IPV helps protect children from diphtheria, tetanus, pertussis and
poliomyelitis, but it may have unwanted side effects in some 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. However,
the chance of your child having a serious side effect is less than the chance of
your child having a permanent injury from the infections.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Most unwanted effects with INFANRIX-IPV are mild and usually clear up within
a few days. These effects, as with other vaccines, generally occur around the
injection site.

Mild effects

Tell your doctor if you notice any of the following that are troublesome or
ongoing after vaccination:

• redness, swelling, a hard lump, soreness, bruising or itching around the
  injection site, skin rash
• feeling generally unwell, fever (between 38°C and 40°C)
• loss of appetite, or feeling sick (nausea), vomiting, constipation or
  diarrhoea
• restlessness, unusual crying (for more than an hour).

Serious effects

As with all vaccines given by injection there is a very small risk of
serious allergic reaction. Contact your doctor immediately or go to the Accident
and Emergency department of your nearest hospital if any of the following
happens:

• swelling of limbs, face, eyes, inside of nose, mouth or throat
• shortness 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, muscular aches
  and pains
• convulsions/fits, collapse or periods of unconsciousness
• fever over 40°C
• crying for 3 hours or more .

The above are signs of an allergic reaction. Allergy to INFANRIX-IPV is rare.
Any such severe reactions will usually occur within the first few hours of
vaccination.

Other side effects not listed above, can also occur during or soon after a
dose of INFANRIX-IPV such as respiratory infections and middle ear infections.
Check with your doctor or nurse if you notice any other effects.

Do not be alarmed by this list of possible side effects. Your child may not
experience any of them.

Storage

INFANRIX-IPV is usually stored at the doctor's clinic or surgery, or at the
pharmacy. But if you need to store INFANRIX-IPV always:

• Keep INFANRIX-IPV in the refrigerator stored between +2°C and +8°C. THE
  PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
• Keep the vaccine out of the reach of children.
• Keep INFANRIX-IPV in the original pack until it is time for it to be
  given.

Ask your pharmacist what to do with any left over INFANRIX-IPV that has
expired or has not been used.

Product Description

What it looks like

INFANRIX-IPV comes in glass vials or prefilled syringes. It is a white,
slightly milky liquid.

Ingredients

The active ingredients of INFANRIX-IPV are non-infectious substances from
tetanus, diphtheria bacteria, poliomyelitis (3 inactivated polioviruses) and
purified proteins of pertussis bacteria. The vaccine cannot cause these
diseases.

Each 0.5 mL dose contains:

• 30 IU of diphtheria toxoid
• 40 IU of tetanus toxoid
• 25mcg of pertussis toxoid, 25mcg of filamentous haemagglutinin and 8mcg of
  69Kd outer membrane protein (pertactin)
• 40 D antigen units of inactivated poliovirus type 1, 8 D antigen units of
  inactivated poliovirus type 2 and 32 D antigen units of inactivated poliovirus
  type 3.

Inactive ingredients in the vaccine are: aluminium hydroxide,
2-phenoxyethanol, sodium chloride, water, potassium chloride, disodium
phosphate, monopotassium phosphate, polysorbate 80, glycine, formaldehyde, M 199
(as stabilizer), neomycin sulfate and polymyxin sulfate.

INFANRIX-IPV does not contain any infectious material.

Further Information

INFANRIX-IPV is only available if prescribed by a doctor.

The vaccine comes in the following:

INFANRIX-IPV comes as a prefilled syringe in packs of 1 or 10