BOOSTRIX

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN

متاح من:

GLAXO WELLCOME INDONESIA - Indonesia

INN (الاسم الدولي):

DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN

جرعة:

2.5 LF /5.0 LF /8 MCG /8 MCG /2.5 MCG

الشكل الصيدلاني:

SUSPENSI INJEKSI

الوحدات في الحزمة:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS) + 2 JARUM

المصنعة من قبل:

GlaxoSmithKline Biologicals SA - Belgium

تاريخ الترخيص:

2021-12-31

خصائص المنتج

FAW_leaBOOinj_Update PI to GDS15 IPI16_circ1_2Nov22 - for submission
_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, tetanus and pertussis (see section
_Pharmacodynamics_). Based o