PEDIACEL Suspension for Injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

DIPHTHERIA TOXOID ADSORBED TETANUS TOXOID ADSORBED PERTUSSIS TOXOID ADSORBED (PT) FILAMENTOUS HAEMAGGLUTININ ADSORBED (FHA) FIMBRIAE TYPES 2 AND 3 ADSORBED (FIM) PERTACTIN ADSORBED (PRN) INACTIVATED POLIOMYELITIS VACCINE TYPE 1 (MAHONEY) INACTIVATED POLIOMYELITIS VACCINE TYPE 2 (MEF-1) INACTIVATED POLIOMYELITIS VACCINE TYPE 3 (SAUKETT) HAEMOPHILUS INFLUENZAE B CONJUGATE VACCINE (PRP-T) CONJUGATED TO TENANUS PROTEIN ALUMINIUM PHOSPHATE (A1)

Beschikbaar vanaf:

Sanofi Pasteur MSD Ltd

INN (Algemene Internationale Benaming):

DIPHTHERIA TOXOID ADSORBED TETANUS TOXOID ADSORBED PERTUSSIS TOXOID ADSORBED (PT) FILAMENTOUS HAEMAGGLUTININ ADSORBED (FHA)

farmaceutische vorm:

Suspension for Injection

Prescription-type:

Product subject to prescription which may not be renewed (A)

Autorisatie-status:

Withdrawn

Autorisatie datum:

2012-10-09

Productkenmerken

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
3 PHARMACEUTICAL FORM
Suspension for Injection in pre-filled syringe
Cloudy, white to off-white suspension
Each 0.5 mL dose contains:
Diphtheria Toxoid
not less than 30 IU
Tetanus Toxoid
not less than 40 IU
Acellular Pertussis Antigens
- Pertussis Toxoid (PT)
20 micrograms
- Filamentous Haemagglutinin (FHA)
20 micrograms
- Pertactin (PRN)
3 micrograms
- Fimbriae Types 2 and 3 (FIM)
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 (PRP-T)
20 micrograms
Adsorbed on aluminium phosphate
1.5 mg
(0.33 mg aluminium)
*
Produced in Vero cells.
†
or equivalent antigenic quantity determined by a suitable
immunochemical method.
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/10/2012_
_CRN 2105846_
_page number: 1_
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_
Primar