INFANRIX-IPV + HIB

Ország: Indonézia

Nyelv: indonéz

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

Aktív összetevők:

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

Beszerezhető a:

GLAXO WELLCOME INDONESIA - Indonesia

INN (nemzetközi neve):

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

Adagolás:

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

Gyógyszerészeti forma:

SERBUK DAN SUSPENSI INJEKSI

db csomag:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML (INFANRIX-IPV) + 1 VIAL @ 0,5 M...

Gyártó:

GlaxoSmithKline Biologicals SA - Belgium

Engedély dátuma:

2022-01-03

Termékjellemzők

ERS_leaINFIPVHIBinj_ MA Transfer SBP to GWI (Project
Rinjani)_circ1_10Nov21
Page 1 of 7
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 immunization 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
immunized 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.
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 subseque