ADACEL

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

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

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

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

Dosis:

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

Bentuk farmasi:

INJEKSI

Unit dalam paket:

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

Diproduksi oleh:

SANOFI PASTEUR Limited - Canada

Tanggal Otorisasi:

2022-03-18

Karakteristik produk

---.---.---
SP/550535
Belakang
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 0.33mg)
1.5 mg
2-phenoxyethanol
0.6% (v/v)
Residual formaldehyde
≤ 5 µg
Residual glutaraldehyde
< 50 µg
ADACEL
®
appears as a sterile, uniform, cloudy, white suspension.
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. In accordance with local recommendations, Adacel may be
considered as an
alternative for the fifth dose of tetanus, diphtheria and acellular
pertussis vaccine
(DTaP) in children 4 through 6 years of age, concomitantly
administered with inactivat-
ed Poliomyelitis Vaccine (IPV) at separate sites 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 diphtheriae_ or _Clostridium tetani_ infections.
PEDIATRICS
ADACEL
® IS NOT INDICATED FOR IMMUNIZATION OF CHILDREN BELOW THE AGE OF 4
YEARS.
TETANUS PROPHYLAXIS IN WOUND MANAGEMENT
The need for active immunization with a tetanus toxoid-containing
preparation such
as Td adsorbed vaccine or Adacel, with or without passive immunization
with tetanus
Immune Globulin, depends on both the condition on the wound and the
patie