HEXAXIM

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY), INACTIVATED POLIOMYELITIS VIRUS TYPE 2 (MEF STRAIN), INACTIVATED POLIOMYELITIS VIRUS TYPE 3 (SAUKETT STRAIN), HEPATITIS B SUR

Disponible depuis:

AVENTIS PHARMA - Indonesia

DCI (Dénomination commune internationale):

DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY), INACTIVATED POLIOMYELITIS VIRUS TYPE 2 (MEF STRAIN), INACTIVATED POLIOMYELITIS VIRUS TYPE 3 (SAUKETT STRAIN), HEPATITIS B SUR

Dosage:

NLT 20 IU /NLT 40 IU /25 MCG /25 MCG /40 DU /8 DU /32 DU /10 MCG /12 MCG

forme pharmaceutique:

SUSPENSI INJEKSI

Unités en paquet:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML + 2 SEPARATE NEEDLES

Fabriqué par:

SANOFI PASTEUR - France

Date de l'autorisation:

2020-03-18

Résumé des caractéristiques du produit

1
HEXAXIM
SUSPENSION FOR INJECTION
DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B
(RDNA), POLIOMYELITIS
(INACTIVATED) AND
_HAEMOPHILUS INFLUENZAE _
TYPE B CONJUGATE VACCINE (ADSORBED).
COMPOSITION
One dose
1
(0.5 ml) contains:
Diphtheria Toxoid
not less than 20 IU
2
Tetanus Toxoid
not less than 40 IU
2,3
_Bordetella pertussis _antigens
Pertussis Toxoid
25 micrograms
Filamentous Haemagglutinin
25 micrograms
Poliovirus (Inactivated)
4
Type 1 (Mahoney)
Type 2 (MEF-1)
Type 3 (Saukett)
Hepatitis B surface antigen
6
_Haemophilus influenzae _type b
polysaccharide
(Polyribosylribitol Phosphate)
conjugated to Tetanus protein
40 D antigen units
5
8 D antigen units
5
32 D antigen units
5
10 micrograms
12 micrograms
22 -36 micrograms
1
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al
3+
)
2
As lower confidence limit (p= 0.95)
3
Or equivalent activity determined by an immunogenicity evaluation
4
Produced on Vero cells
5
Or equivalent antigenic quantity determined by a suitable
immunochemical method
6
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)
LIST OF EXCIPIENTS:
Disodium hydrogen phosphate, Potassium dihydrogen phosphate,
Trometamol, Saccharose,
Essential
amino
acids
including
L-phenylalanine,
Sodium
hydroxide,
acetic
acid
or
hydrochloric acid (for pH adjustment), Water for injections.
THERAPEUTIC INDICATION
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 _Haemophilus influenzae
_type b (Hib).
The use of this vaccine should be in accordance with official
recommendations.
DISETUJUI OLE