BOOSTRIX

Χώρα: Ινδονησία

Γλώσσα: Ινδονησιακά

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

Δραστική ουσία:

DIPHTHERIA AND TETANUS TOXOIDS; FHA; FILAMENTOUS HEMAGGLUTININ; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID

Διαθέσιμο από:

SMITH KLINE BEECHAM PHARMACEUTICAL IND. - Indonesia

INN (Διεθνής Όνομα):

DIPHTHERIA AND TETANUS TOXOIDS; FHA; FILAMENTOUS HEMAGGLUTININ; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID

Φαρμακοτεχνική μορφή:

CAIRAN INJEKSI

Μονάδες σε πακέτο:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Κατασκευάζεται από:

GLAXO SMITHKLINE BIOLOGICALS-Belgium

Ημερομηνία της άδειας:

2018-09-28

Αρχείο Π.Χ.Π.

ID REG: EREG10035112000058
DISETUJUI OLEH BPOM 2 FEBRUARI 2022
ERS_leaBOOinj_Update PI to GDS11 IPI12+GDS12 IPI13_circ6_25Jan22
_Page 1 of 8 _
BOOSTRIX
DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) VACCINE
(ADSORBED, REDUCED
ANTIGEN(S) CONTENT)
SUSPENSION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria toxoid
1
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid
1
not less than 20 International Units (IU) (5 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid
1
8 micrograms
Filamentous haemagglutinin
1
8 micrograms
Pertactin
1
2.5 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
_BOOSTRIX_ is a turbid white suspension. Upon storage, a white deposit
and clear supernatant can be
observed. This is a normal finding.
CLINICAL INFORMATION
INDICATIONS_ _
_BOOSTRIX_ is indicated for booster vaccination against diphtheria,
tetanus and pertussis of individuals
from the age of four years onwards (see _Posology_).
_BOOSTRIX_ is also indicated for passive protection against pertussis
in early infancy following maternal
immunization during pregnancy (see _Posology, Pregnancy _and_
Pharmacodynamics_).
The use of _BOOSTRIX_ should be in accordance with official
recommendations.
DOSAGE AND ADMINISTRATION
Posology
A single 0.5 mL dose of the vaccine is recommended.
_ _
_BOOSTRIX_ can be given in accordance with the current local medical
practices for booster vaccination
with reduced-content combined diphtheria-tetanus vaccine, when a
booster against pertussis is
desired.
_BOOSTRIX_ can be administered to pregnant women between 27 and 36
weeks of pregnancy in
accordance with official recommendations (see _Indications, Pregnancy
_and_ Pharmacodynamics_)_._
_BOOSTRIX_ may also be administered to adolescents and adults with
unknown vaccination status or
incomplete vaccination against diphtheria, tetanus and pertussis as
part of an immunization series
against diphtheria, teta