HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ; HAEMOPHILUS INFLUENZA TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) CONJUGATED TO 22 - 36 μg TETANUS PROTEIN (PRP-T); HEPATITIS B SURFACE ANTIGEN; PERTUSSIS TOXOID; POLIOVIRIUS (INACTIVATED) TYPE 1 (MAHONEY); POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1); POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT); TETANUS TOXOID

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

J07CA09

Pharmaceutical form:

INJECTION, SUSPENSION

Composition:

DIPHTHERIA TOXOID 30 Lf (>= 20 IU)/0.5 mL; FILAMENTOUS HAEMAGGLUTININ 25 μg/0.5 mL; HAEMOPHILUS INFLUENZA TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) CONJUGATED TO 22 - 36 μg TETANUS PROTEIN (PRP-T) 12 μg/0.5 mL; HEPATITIS B SURFACE ANTIGEN 10 μg/0.5 mL; PERTUSSIS TOXOID 25 μg/0.5 mL; POLIOVIRIUS (INACTIVATED) TYPE 1 (MAHONEY) 40 DU/0.5 mL; POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1) 8 DU/0.5 mL; POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT) 32 DU/0.5 mL; TETANUS TOXOID 10 Lf (>= 40 IU)/0.5 mL

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Sanofi Pasteur Val de Reuil

Authorization status:

ACTIVE

Authorization date:

2015-08-25

Summary of Product characteristics

SG/HEX/0823/SmPC0922
NAME OF THE MEDICINAL PRODUCT
Hexaxim suspension for injection in pre-filled syringe
Diphtheria,
tetanus, pertussis (acellular,
component),
hepatitis
B (rDNA),
poliomyelitis
(inactivated) and
_Haemophilus influenzae _
type b conjugate vaccine (adsorbed).
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose
1
(0.5 ml) contains:
Diphtheria Toxoid
not less than 20 IU
2,4
(30Lf)
Tetanus Toxoid
not less than 40 IU
3,4
(10Lf)
_Bordetella pertussis _
antigens
Pertussis Toxoid
25 micrograms
Filamentous Haemagglutinin
25 micrograms
Poliovirus (Inactivated)
5
Type 1 (Mahoney)
40 D antigen units
6
Type 2 (MEF-1)
8 D antigen units
6
Type 3 (Saukett)
32 D antigen units
6
Hepatitis B surface antigen
7
10 micrograms
_Haemophilus influenzae _
type b polysaccharide
12 micrograms
(Polyribosylribitol Phosphate)
conjugated to Tetanus protein
22-36 micrograms
1
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al
3+
)
2
As lower confidence limit (p= 0.95) and not less than 30 IU as mean
value
3
As lower confidence limit (p=0.95)
4
Or equivalent activity determined by an immunogenicity evaluation
5
Produced on Vero cells
6
Or equivalent antigenic quantity determined by a suitable
immunochemical method
7
Produced in yeast
_Hansenula polymorpha _
cells by recombinant DNA technology
The vaccine may contain traces of glutaraldehyde, formaldehyde,
neomycin, streptomycin and
polymyxin B which are used during the manufacturing process (see
section Contraindications).
Excipient with known effect
Phenylalanine ..................... 85 micrograms
(See section Special warnings and precautions for use)
For the full list of excipients, see section List of excipients.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Hexaxim is a whitish, cloudy suspension.
CLINICAL PARTICULARS
SG/HEX/0823/SmPC0922
THERAPEUTIC INDICATIONS
Hexaxim (DTaP-IPV-HB-Hib) is indicated for primary and booster
vaccination of infants
and toddlers from six weeks to 24 months of age against diphtheria,
tetanus, pertussis, hepatitis
B, poliomy