ADACEL

Țară: Indonezia

Limbă: indoneziană

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

Ingredient activ:

DIPHTERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FIMBRIAE TYPES 2 AND 3, PERTACTIN, TETANUS TOXOID, PERTUSSIS TOXOID

Disponibil de la:

AVENTIS PHARMA - Indonesia

INN (nume internaţional):

DIPHTERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FIMBRIAE TYPES 2 AND 3, PERTACTIN, TETANUS TOXOID, PERTUSSIS TOXOID

Dozare:

2 LF /5 MCG /5 MCG /3 Mcg /5 LF /2.5 LF

Forma farmaceutică:

INJEKSI

Unități în pachet:

DUS, 1 VIAL @ 0,5 ML (1 DOSIS)

Produs de:

SANOFI PASTEUR Limited - Canada

Data de autorizare:

2022-03-18

Caracteristicilor produsului

DISETUJUI OLEH BPOM 4 AGUSTUS 2022
ID REG:EREG10002212000297
ADACEL-CCDS V19-v06-Aug22
ADACEL
®
TETANUS TOXOID AND DIPHTHERIA TOXOIDS ADSORBED
COMBINED WITH COMPONENT PERTUSSIS VACCINE
COMPOSITION
Each single dose (0.5 mL) contains:
Tetanus Toxoid
5 Lf
Diphtheria Toxoid
2 Lf
Component Pertussis
Pertussis Toxoid
2.5 µg
Filamentous Haemagglutinin
5 µg
Fimbrial agglutinogens 2 + 3
5 µg
Pertactin
3 µg
Aluminum Phosphate (aluminum 0.33 mg)
1.5 mg
2-phenoxyethanol
0.6% (v/v)
Residual formaldehyde
≤ 5 µg
Residual glutaraldehyde
ADACEL
®
appears as a sterile, uniform, cloudy, white suspension.
< 50 µg
DESCRIPTION
ADACEL
®
[Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis
Vaccine
Adsorbed], is a sterile, uniform, cloudy, white suspension of tetanus
and diphtheria toxoids adsorbed
separately on aluminum phosphate, combined with acellular pertussis
vaccine and suspended in water
for injection. The acellular pertussis vaccine is composed of 5
purified pertussis antigens (PT. FHA,
PRN and FIM).
INDICATIONS
ADACEL
®
is indicated for active booster immunization for the prevention of
tetanus,
diphtheria and pertussis (whooping cough) in person 4 to 6 years of
age and 10 years or older.
ADACEL® is indicated for passive protection against pertussis in
early infancy following maternal
DISETUJUI OLEH BPOM 4 AGUSTUS 2022
ID REG:EREG10002212000297
ADACEL-CCDS V19-v06-Aug22
immunization during pregnancy (see sections DOSAGE AND ADMINISTRATION,
and WARNING
AND PRECAUTION).
ADACEL®
should be used in accordance with official recommendations
In accordance with local recommendations, Adacel may be considered as
an alternative for the fifth
dose of tetanus, diphtheria and acellular pertussis vaccine (DTaP)
(Tdap) in children 4 through 6 years
of age, concomitantly administered with inactivated Poliomyelitis
Vaccine (IPV) at separate site to
complete the vaccination series of this age when indicated.
ADACEL®
is
not
to
be
used
for
the
treatment
of
disease
caused
by
Bordetella
pertussis.
Corynebacterium diphtheri