PEDIACEL, suspension for injection in pre-filled syringe.Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Nunua Sasa

Taarifa za kipeperushi (PIL)

27-06-2023

Tabia za bidhaa (SPC)

27-06-2023

Viambatanisho vya kazi:

PERTACTIN, PERTUSSIS TOXOID, POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, FIMBRIAE TYPES, AND, HAEMOPHILUS INFLUENZAE, TYPE B, POLYSACCHARIDE, POLYRIBOSYLRIBITOL PHOSPHATE, TETANUS TOXOID

Inapatikana kutoka:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC kanuni:

J07CA06

INN (Jina la Kimataifa):

PERTACTIN 3 µg PERTUSSIS TOXOID 20 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 20 µg FIMBRIAE TYPES 2 AND 3 5 µg HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) 10 µg TETANUS TOXOID

Dawa fomu:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Tungo:

Dawa ya aina:

POM

Eneo la matibabu:

VACCINES

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2011-04-26

Taarifa za kipeperushi

Page 1 of 7
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 spasms of the muscles,
leading to inability to breathe and
the possibility of suffocation.

Pertussis (often called whooping cough) is a bacterial inf

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Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
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
not less than 30 IU
Tetanus Toxoid
1
not less than 40 IU
Acellular Pertussis Antigens
1
Pertussis Toxoid (PT)
20 micrograms
Filamentous Haemagglutinin (FHA)
20 micrograms
Pertactin (PRN)
3 micrograms
Fimbriae Types 2 and 3 (FIM)
5 micrograms
Poliovirus (Inactivated)
2
Type 1 (Mahoney)
40 D antigen units
3
Type 2 (MEF-1)
8 D antigen units
3
Type 3 (Saukett)
32 D antigen units
3
_Haemophilus influenzae_ Type b Polysaccharide
(Polyribosylribitol Phosphate)
10 micrograms
Conjugated to Tetanus Toxoid (PRP-T)
18-30 micrograms
1
adsorbed on aluminium phosphate
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
Page 2 of 11
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 doses (e.g., 3, 5
months) or 3 doses (e.g.

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