Hexaxim Suspension for Injection

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

Diphtheria Toxoid; Filamentous haemagglutin ( FHA ); Haemophilus Influenza Type b Conjugate; Hepatitis B surface antigen purified; Pertussis Toxoid ( PT); poliomyelitis, trivalent, inactivated, whole virus; Tetanus Toxoid

Fáanlegur frá:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Alþjóðlegt nafn):

Diphtheria Toxoid; Filamentous haemagglutin ( FHA ); Haemophilus Influenza Type b Conjugate; Hepatitis B surface antigen purified; Pertussis Toxoid ( PT); poliomyelitis, trivalent, inactivated, whole virus; Tetanus Toxoid

Einingar í pakka:

1units Units; 10units Units; 10vial Vials

Framleitt af:

SANOFI PASTEUR

Upplýsingar fylgiseðill

NOT APPLICABLE

Vara einkenni

MY/HEX/0423/EU SmPC 0922
1. NAME OF THE MEDICINAL PRODUCT
Hexaxim suspension for injection.
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated) and
_Haemophilus influenzae_
type b conjugate vaccine (adsorbed).
2. 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 4.3).
Excipient with known effect
Phenylalanine……………85 micrograms
(See section 4.4)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Suspension for injection.
Hexaxim is a whitish, cloudy suspension.
MY/HEX/0423/EU SmPC 0922
4. CLINICAL PARTICULARS
4.1 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, poliomyelitis and invasive
diseases caused by
_Haemop