PENTAVAC 0 %v/v Powder for suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PURIFIED DIPHTHERIA TOXOID PH. EUR., PURIFIED TETANUS TOXOID, ADSORBED PURIFIED PERTUSSIS TOXOID, ADSORBED PURIFIED FILAMENTOUS HAEMAGGLUTININ, INACTIVATED POLIOMYELITIS VIRUS PH. EUR, INACTIVATED TYPE 1 POLIOVIRUS, INACTIVATED TYPE 2 POLIOVIRUS, INACTIVATED TYPE 3 POLIOVIRUS, HAEMOPHILUS INFLUENZAE TYPE B, CONJUGATE WITH TETANUS PROTEIN

Available from:

Sanofi Pasteur MSD Ltd

ATC code:

J07CA06

INN (International Name):

PURIFIED DIPHTHERIA TOXOID PH. EUR., PURIFIED TETANUS TOXOID, ADSORBED PURIFIED PERTUSSIS TOXOID, ADSORBED PURIFIED FILAMENTOUS

Dosage:

0 %v/v

Pharmaceutical form:

Powder for suspension for injection

Prescription type:

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

Therapeutic area:

Bacterial and viral vaccines, combined

Authorization status:

Authorised

Authorization date:

2001-03-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentavac
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and _Haemophilus influenzae _type b
conjugate vaccine (adsorbed).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of reconstituted vaccine contains:
Purified diphtheria toxoid
1
....................................................... not less than 30 I.U. #
Purified tetanus toxoid
1
........................................................... not less than 40 I.U.*
Purified pertussis toxoid (PTxd)
1
............................................ 25 µg 
Purified filamentous haemagglutinin (FHA)
1
............................ 25 µg 
Inactivated type 1 poliovirus
2
................................................. D antigen**: 40 units
Inactivated type 2 poliovirus
2
................................................. D antigen**: 8 units
Inactivated type 3 poliovirus
2
................................................. D antigen**: 32 units
_Haemophilus influenzae _type b polysaccharide..................... 10 µg 
conjugated to tetanus protein
# As mean value
* As lower confidence limit (p = 0.95).
** Quantity of antigen in the final bulk product.
1
adsorbed on aluminium hydroxide (expressed as Al
3+
) 0.30 mg
2
produced on Vero cells
Pentavac solution for injection is obtained by reconstitution of the powder of conjugate _Haemophilus influenzae _type b
vaccine (vial) with the suspension of combined diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis
vaccine, adsorbed (pre-filled syringe).
The vaccine may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and suspension for injection.
Pentavac is composed of a sterile and whitish