Pediacel vaccine suspension for injection 0.5ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Human poliovirus type 3 inactivated; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Diphtheria toxoid; Haemophilus influenzae type b polysaccharide protein conjugate

Available from:

sanofi pasteur MSD Ltd

ATC code:

J07CA06

INN (International Name):

Human poliovirus type 3 inactivated; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Diphtheria toxoid; Haemophilus influenzae type b polysaccharide protein conjugate

Pharmaceutical form:

Suspension for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 14040000; GTIN: 5015973553014

Patient Information leaflet

SANOFI PASTEUR
PACKAGE LEAFLET
315 – PEDIACEL
®
PACKAGE LEAFLET
SANOFI PASTEUR
PACKAGE LEAFLET
315 – PEDIACEL
®
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEDIACEL
®
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
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 spasm

Summary of Product characteristics

OBJECT 1
PEDIACEL SYRINGE
Summary of Product Characteristics Updated 04-Jan-2018 | Sanofi
Pasteur
1. Name of the medicinal product
PEDIACEL, suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis
(inactivated) and Haemophilus type b
conjugate vaccine (adsorbed)
2. Qualitative and quantitative composition
Each 0.5 mL dose contains:
Diphtheria Toxoid
1
Tetanus Toxoid
1
not less than 30 IU
not less than 40 IU
Acellular Pertussis Antigens
1
Pertussis Toxoid (PT)
Filamentous Haemagglutinin (FHA)
Pertactin (PRN)
Fimbriae Types 2 and 3 (FIM)
20 micrograms
20 micrograms
3 micrograms
5 micrograms
Poliovirus (Inactivated)
2
Type 1 (Mahoney)
Type 2 (MEF-1)
Type 3 (Saukett)
40 D antigen units
3
8 D antigen units
3
32 D antigen units
3
_Haemophilus influenzae_ Type b Polysaccharide
(Polyribosylribitol Phosphate)
Conjugated to Tetanus Toxoid (PRP-T)
1
adsorbed on aluminium phosphate
10 micrograms
18-30 micrograms
1.5 mg
(0.33 mg aluminium)
2
Produced in Vero cells.
3
or equivalent antigenic quantity determined by a suitable
immunochemical method.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection in pre-filled syringe
PEDIACEL is a uniform, cloudy, white to off-white suspension.
4. Clinical particulars
4.1 Therapeutic indications
PEDIACEL is indicated for primary and booster vaccination against
diphtheria, tetanus, pertussis,
poliomyelitis and invasive _Haemophilus influenzae_ type b disease in
infants and children from the age of
6 weeks up to the fourth birthday. PEDIACEL should be used in
accordance with applicable official
recommendations.
4.2 Posology and method of administration
Posology
_Paediatric population_
Primary Vaccination
The primary vaccination series consists of 2 or 3 doses of 0.5 mL and
may be commenced from 6 weeks
of age according to applicable official recommendations. There should
be an interval of at least one
month between doses.
Booster Vaccination
After primary series vaccination with either 2 do