INFANRIX HEXA

Maa: Indonesia

Kieli: indonesia

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

Aktiivinen ainesosa:

DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN, HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID, HEPATITIS B SURFACE ANTIGEN, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY STRAIN), INA

Saatavilla:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Kansainvälinen yleisnimi):

DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN, HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID, HEPATITIS B SURFACE ANTIGEN, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY STRAIN), INA

Annos:

NOT LESS THAN 30 IU /NOT LESS THAN 40 IU /25 MCG /25 MCG /8 MCG /10 PRP AND ~ 25 T MCG /10 MCG /40

Lääkemuoto:

SERBUK DAN SUSPENSI INJEKSI

Kpl paketissa:

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

Valmistaja:

GlaxoSmithKline Biologicals SA - Belgium

Valtuutus päivämäärä:

2021-12-23

Valmisteyhteenveto

FAW_leaINFHEXinj_ PI update GDS22 IPI17 (One PFS)_circ1_14Nov22 –
for submission
_Page 1 of 10_
INFANRIX HEXA
DIPHTHERIA (D), TETANUS (T), PERTUSSIS (ACELLULAR, COMPONENT) (PA),
HEPATITIS B (RDNA)
(HBV), POLIOMYELITIS (INACTIVATED) (IPV) AND _HAEMOPHILUS INFLUENZAE_
TYPE B VACCINE
(ADSORBED)
POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
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 (PT)
1
25 micrograms
Filamentous Haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Hepatitis B surface antigen (HBs)
2,3
10 micrograms
Poliovirus (inactivated) (IPV)
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, PRP)
3
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
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. This is a normal observation.
The Hib component is presented as a white powder.
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
_INFANRIX HEXA_ is indicated for primary vaccination of infants and
booster vaccination of toddlers against
diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
_Haemophilus influenzae_ type b.
The use of _INFANRIX HEXA_ should be in accordance with official
recommendations.
DOSAGE AND ADMINISTRATION
POSOLOGY
The primary vaccination schedule consists of two or three doses (of
0.5 mL) which sho