INFANRIX HEXA

Χώρα: Ινδονησία

Γλώσσα: Ινδονησιακά

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

Δραστική ουσία:

DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; HEPATITIS B SURFACE ANTIGEN (HBS AG); INACTIVATED POLIO VIRUS TYPE 1; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 3; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID

Διαθέσιμο από:

SMITH KLINE BEECHAM PHARMACEUTICAL IND. - Indonesia

INN (Διεθνής Όνομα):

DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; HEPATITIS B SURFACE ANTIGEN (HBS AG); INACTIVATED POLIO VIRUS TYPE 1; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 3; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID

Φαρμακοτεχνική μορφή:

CAIRAN INJEKSI

Μονάδες σε πακέτο:

DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML + 1 VIAL @ 0,5 ML

Κατασκευάζεται από:

GLAXO SMITHKLINE BIOLOGICALS-Belgium

Ημερομηνία της άδειας:

2018-01-23

Αρχείο Π.Χ.Π.

_Page 1 of 10_
INFANRIX HEXA
™
COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, HEPATITIS B, ENHANCED
INACTIVATED POLIO
VACCINE 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)
Tetanus toxoid
1
not less than 40 International Units (IU)
_Bordetella pertussis_ antigens
Pertussis toxoid
1
25 micrograms
Filamentous Haemagglutinin
1
25 micrograms
Pertactin
1
8 micrograms
Hepatitis B surface antigen
2,3
10 micrograms
Poliovirus (inactivated)
type 1 (Mahoney strain)
4
40 D-antigen unit
type 2 (MEF-1 strain)
4
8 D-antigen unit
type 3 (Saukett strain)
4
32 D-antigen unit
_Haemophilus influenzae_ type b polysaccharide
10 micrograms
(polyribosylribitol phosphate)
3
conjugated to tetanus toxoid as carrier protein
20 - 40 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.5 milligrams Al
3+
2
produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
3
adsorbed on aluminium phosphate (AlPO
4
)
0.32 milligrams Al
3+
4
propagated in VERO cells
The DTPa-HBV-IPV component is presented as a turbid white suspension.
Upon storage, a white
deposit and clear supernatant can be observed.
The Hib component is presented as a white powder.
For excipients, see _List of Excipients_.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
CLINICAL PARTICULARS
INDICATIONS
_INFANRIX HEXA_
_™_
is indicated for primary and booster vaccination of infants against
diphtheria,
tetanus, pertussis, hepatitis B, poliomyelitis and _Haemophilus
influenzae_ type b.
DOSAGE AND ADMINISTRATION
POSOLOGY
The primary vaccination schedule consists of two or three doses (of
0.5 mL) which should be
administered according to official recommendations (see
_Pharmacodynamic Effects_ for schedules
evaluated in clinical trials). _ INFANRIX HEXA_
_™_
can be considered for the booster if the antigen
composition is in accordance with the official recommendations.
PRI