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PEDIACEL SUSPENSION FOR INJECTION IN VIAL

Active substance(s): DIPHTHERIA TOXOID ADSORBED / HAEMOPHILUS INFLUENZAE TYPE B POLYRIBOSYLRIBITOL PHOSPHATE / HAEMOPHILUS INFLUENZAE TYPE B POLYSACC.-TETANUS TOXOID CONJ. / PERTUSSIS ADSORBED PURIFIED FILAMENTOUS HAEMAGGLUTININ / PERTUSSIS PURIFIED FIMBRIAL AGGLUTINOGENS 2 AND 3

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sanofi pasteur
315 – PEDIACEL®

Annotated Package Leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

PEDIACEL
Suspension for injection in a vial
Diphtheria, tetanus, pertussis, (acellular, component), poliomyelitis (inactivated) and
Haemophilus type b conjugate vaccine (adsorbed)
Read all of this leaflet carefully before your child is vaccinated because it contains important
information for you.


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



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



This medicine has been prescribed only for your child. Do not pass it on to others.



If your child gets any side effects, talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What PEDIACEL is and what it is used for
2. What you need to know before PEDIACEL is given to your child
3. How and when PEDIACEL is given
4. Possible side effects
5. How to store PEDIACEL
6. Contents of the pack and other information
1 What PEDIACEL is and what it is used for
PEDIACEL is a vaccine. Vaccines are used to protect against infectious diseases.
PEDIACEL helps to protect against diphtheria, tetanus, pertussis, poliomyelitis and serious diseases
caused by Haemophilus influenzae type b. PEDIACEL is given to children between the ages of 6
weeks and 4 years of age.
The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria
and viruses that cause these different infections:

Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection
causes pain and swelling which can lead to suffocation. The bacteria that cause the disease also
make a toxin (poison) that can damage the heart, kidneys and nerves.

Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound.
The bacteria make a toxin (poison) that causes spasms of the muscles, leading to inability to
breathe and the possibility of suffocation.

Pertussis (often called whooping cough) is a bacterial infection of the airways that can occur at
any age but mostly affects infants and young children. Increasingly severe coughing spells that
can last for several weeks are a characteristic of the disease. Coughing spells may be followed
by a whooping noise.

Poliomyelitis (often just called polio) is caused by viruses that affect the nerves. It can lead to
paralysis or muscle weakness most commonly of the legs. Paralysis of the muscles that control
breathing and swallowing can be fatal.

Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections
and can cause meningitis (inflammation of the outer covering of the brain), infections of the
blood, inflammation of the tissue under the skin, inflammation of the joints and inflammation of
part of the back of the throat, causing difficulty in swallowing and breathing.

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Important information about the protection provided

Annotated Package Leaflet

PEDIACEL will only help to prevent these diseases if they are caused by the bacteria or viruses
targeted by the vaccine. Your child could get diseases with similar symptoms if they are caused by
other bacteria or viruses.
The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious
diseases against which it protects.
Remember that no vaccine can provide complete, life long protection in all people who are vaccinated.
2 What you need to know before PEDIACEL is given to your child
To make sure that PEDIACEL is suitable for your child, it is important to tell your doctor or nurse if
any of the points below apply to your child. If there is anything you do not understand, ask your
doctor or nurse to explain.
Do not use PEDIACEL if your child

is allergic (hypersensitive) to:
o diphtheria, tetanus, pertussis, poliomyelitis or Hib vaccines
o any of the other ingredients listed in section 6
o any residual component carried over from manufacture (including neomycin, streptomycin,
polymyxin B, glutaraldehyde, formaldehyde, and bovine serum albumin).

has had a severe reaction affecting the brain within one week after a previous dose of any
vaccine protecting against whooping cough.

has a progressive condition or severe illness affecting the brain and nervous system or
uncontrolled epilepsy.

has an acute illness with or without a high temperature at the moment. Vaccination with
PEDIACEL may need to be delayed until your child is better.
Warnings and precautions
Tell your doctor or nurse before vaccination if your child:

has had a vaccine that protects against whooping cough in the past and any of the following
occurred soon afterwards:






-

had a temperature of 40°C or above, not due to another identifiable cause, within 48 hours
of having the vaccine.

-

became floppy, unresponsive or unconscious after the previous vaccination, within 48 hours
of having the vaccine.

-

cried continuously and could not be comforted for more than 3 hours within 48 hours of
having the vaccine.

- had a fit (convulsion) within 3 days of having the vaccine.
is receiving steroids, chemotherapy or radiotherapy or has any other illness that may reduce the
ability to fight infections. If possible, vaccination should be postponed until the end of such
disease or treatment.
Children with long standing problems with their immune system due to any reason (including
HIV infection) may still be given PEDIACEL but the protection against infections after having
the vaccine may not be as good as in children whose immune system is healthy.
has any problems with the blood that cause easy bruising or bleeding for a long time after minor
cuts. Your doctor or nurse will advise you whether your child should have PEDIACEL.
has had Guillain-Barré syndrome (temporary loss of movement and feeling) or brachial neuritis
(loss of movement, pain and numbness of the arm and the shoulder) following a previous
injection with a tetanus containing vaccine. Your doctor or nurse will decide whether to give
PEDIACEL to your child.

In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between
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breaths may occur for 2 - 3 days after vaccination.

Annotated Package Leaflet

A persistent hard lump or nodule may be felt under the skin at the injection site, especially if the
injection was not very deep. An abscess may develop. These abscesses are not usually infected.
Other medicines or vaccines and PEDIACEL
PEDIACEL can be given at the same time as other vaccines such as meningococcal group C vaccine,
hepatitis B vaccine, 7-valent pneumococcal vaccine, measles, mumps and rubella (MMR) vaccine and
varicella vaccine. Your doctor or nurse will give the two injections at different sites and will use
separate syringes and needles for each injection.
Tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines.
Important information about some of the ingredients of PEDIACEL
PEDIACEL may contain trace amounts of formaldehyde, glutaraldehyde and bovine serum albumin as
well as the following antibiotics: neomycin, streptomycin and polymyxin B.
3 How and when PEDIACEL is given
The vaccination should be given by medical or healthcare professionals who are trained in the use of
vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection.
Please refer to Section 4.
Your doctor or nurse will inject PEDIACEL into a muscle in the upper part of your child’s leg (infants
from the age of 6 weeks) or arm (older children up to four years).
Dosage
First Course of Vaccination (Primary Vaccination)
Your child will receive two or three injections of half a millilitre given at least one month apart
according to the local vaccination schedule.
Booster
When indicated by the local vaccination schedule, your child should receive a booster dose at least 6
months after the last dose of the primary vaccination. Your doctor or nurse will tell you when this dose
should be given.
PEDIACEL is not suitable after a child has reached their fourth birthday.
If You Forget One Dose of PEDIACEL
If your child misses a scheduled injection, your doctor will decide when to give the missed dose.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions
If any of these symptoms occur after leaving the place where your child received his/her
injection, you must consult a doctor IMMEDIATELY.
Serious allergic reactions are a very rare possibility (may affect up to 1 user in 10,000 people) after
receiving any vaccine. These reactions may include:


difficulty in breathing



blueness of the tongue or lips



a rash

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swelling of the face or throat



low blood pressure causing dizziness or collapse.

Annotated Package Leaflet

When these signs or symptoms occur they usually develop quickly after the injection is given and
while the child is still in the clinic or doctor’s surgery.
Other side effects
Very common reactions (may affect more than 1 in 10 people) are:


loss of appetite



irritability



abnormal crying



vomiting



less active



fever (temperature 38°C or higher)



pain, redness, swelling

Common reactions (may affect up to 1 in 10 people) are:


diarrhoea



bruising and bleeding at the injection site

Uncommon (may affect up to 1 in 100 people) are:


a fit (convulsion) with or without fever



extensive limb swelling (from the injection site to beyond the joint)

The following additional side effects have been reported during the commercial use of PEDIACEL:


allergic reactions, hives, swollen face



high-pitched crying



a period of floppiness and decreased responsiveness that gets better without treatment and has
no after effects



sleepy or drowsy (somnolence)



paleness



temporary absence of breathing



rash



pain in the vaccinated limb



high fever (temperature 40.5°C or higher)



injection site mass



tiredness or lack of energy (asthenia)



lethargic (listlessness)

rarely skin reactions have been reported that may include rashes (which may be itchy), swelling of the
lower limbs, blueness, redness, severe crying and sometimes a purple spotted rash of the legs that gets
better without treatment.
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
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Annotated Package Leaflet

Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5 How to store PEDIACEL
Keep this medicine out of the sight and reach of children.

Store in a refrigerator between 2°C and 8°C. Do not freeze. Keep the vaccine in the outer carton in
order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton and the label. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
Each 0.5 mL dose of PEDIACEL contains the following:
Active substances
diphtheria toxoid

not less than 30 international units

tetanus toxoid

not less than 40 international units

acellular pertussis antigens
pertussis toxoid

20 micrograms

filamentous haemagglutinin

20 micrograms

pertactin

3 micrograms

fimbriae types 2 and 3

5 micrograms

poliovirus (inactivated)
type 1 (Mahoney)

40 D antigen units

type 2 (MEF-1)

8 D antigen units

type 3 (Saukett)

32 D antigen units

Haemophilus influenzae type b polysaccharide
(polyribosylribitol phosphate)

10 micrograms

conjugated to tetanus toxoid

18-30 micrograms

adsorbed on aluminum phosphate

1.5 milligrams (0.33 milligram aluminum)

Other ingredients
Phenoxyethanol, polysorbate 80 and water for injections.
What PEDIACEL looks like and contents of the pack
PEDIACEL, suspension for injection, is provided in a single dose vial.
Pack size of 1 or 10 vials.
Not all pack sizes may be marketed.
The normal appearance of the vaccine is a cloudy, white to off-white suspension, which may sediment
during storage.

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315 – PEDIACEL®

Annotated Package Leaflet

Marketing Authorisation Holder

Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon
France
Manufacturer
The manufacturer responsible for batch release is
Sanofi Pasteur SA
2, avenue Pont Pasteur
69007 Lyon
France
This medicinal product is authorised in the Member States of the EEA under the following
names:
Member state

Name

The Netherlands and the United Kingdom

PEDIACEL

This leaflet was last revised in

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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