INFANRIX-IPV + Hib

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); HAEMOPHILUS INFLUENZA TYPE B CONJUGATE TO; PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA)

Tillgänglig från:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International namn):

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); HAEMOPHILUS INFLUENZA TYPE B CONJUGATE TO; PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA)

Enheter i paketet:

3ml mL; 1ml mL; 3ml mL

Tillverkad av:

GLAXOSMITHKLINE BIOLOGICALS S.A

Bipacksedel

Not Applicable

Produktens egenskaper

1
INFANRIX-IPV+HIB
COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, INACTIVATED POLIO AND
_HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 International Units (IU) (25 Lf)
Tetanus toxoid
1
not less than 40 International Units (IU) (10 Lf)
_Bordetella pertussis_
antigens
Pertussis toxoid (PT)
1
25 micrograms
Filamentous haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Poliovirus (inactivated) (IPV)
type 1 (Mahoney strain)
2
40 D-antigen unit
type 2 (MEF-1 strain)
2
8 D-antigen unit
type 3 (Saukett strain)
2
32 D-antigen unit
_Haemophilus influenzae_
type b polysaccharide
(polyribosylribitol phosphate) (PRP)
10 micrograms
conjugated to tetanus toxoid as carrier protein
approximately 25 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.5 milligrams Al
3+
2
propagated in VERO cells
The Infanrix-IPV component of the vaccine is a turbid white
suspension. Upon storage, a
white deposit and clear supernatant can be observed.
The Hib component of the vaccine is a white powder.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
CLINICAL PARTICULARS
INDICATIONS
_INFANRIX-IPV+HIB_
is indicated for active immunisation in infants from the age of 2
months
against diphtheria, tetanus, pertussis, poliomyelitis and
_Haemophilus influenzae_
type b.
_INFANRIX-IPV+HIB_
is also indicated as a booster dose for children who have previously
been
immunised with diphtheria, tetanus, pertussis (DTP), polio and Hib
antigens.
_INFANRIX-IPV+HIB_
does not protect against diseases caused by other types of
_Haemophilus _
_influenzae _
nor against meningitis caused by other organisms.
2
DOSAGE AND ADMINISTRATION
POSOLOGY
The primary vaccination schedule consists of three doses in the first
6 months of life and can
start from the age of 2 months. An interval of at least 1 month should
be respected between
subsequent doses.
A booster dose is recommended in the second year of li