TWINRIX

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

INACTIVATED HEPATITIS A VIRUS, HEPATITIS B SURFACE ANTIGEN

متاح من:

GLAXO WELLCOME INDONESIA - Indonesia

INN (الاسم الدولي):

INACTIVATED HEPATITIS A VIRUS, HEPATITIS B SURFACE ANTIGEN

جرعة:

720 ELISA UNIT /20 Mcg

الشكل الصيدلاني:

SUSPENSI INJEKSI

الوحدات في الحزمة:

DUS, 1 PREFILLED SYRINGE @ 1 ML (1 DOSIS)

المصنعة من قبل:

GlaxoSmithKline Biologicals SA - Belgium

تاريخ الترخيص:

2021-12-23

خصائص المنتج

FAW_leaTWIinj_one PFS_circ1_10Nov22 – for submission
_Page 1 of 7 _
_ _
TWINRIX
INACTIVATED HEPATITIS A AND RDNA HEPATITIS B VACCINE (ADSORBED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Suspension for injection.
One dose (1.0 mL) contains:
Hepatitis A virus (inactivated)
1,2
720 ELISA Units
Hepatitis B surface antigen
3,4
20 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated
0.05 milligrams Al
3+
3
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
4
Adsorbed on aluminium phosphate
0.4 milligrams Al
3+
_TWINRIX_ is a white, slightly milky liquid presented in a glass
prefilled syringe.
PHARMACEUTICAL FORM
Suspension for injection.
CLINICAL PARTICULARS
INDICATIONS
_TWINRIX_ is indicated for use in non immune adults, adolescents and
children aged from 2-15 years, who
are at risk of both hepatitis A and hepatitis B infection and never
been vaccinated or incomplete
vaccinated course of hepatitis B.
DOSAGE AND ADMINISTRATION
DOSAGE
A dose of 1.0 mL _TWINRIX_ is recommended for adults, adolescents and
children aged from 2-15 years.
_Primary vaccination schedules _
•
_Adults and adolescents of 16 years of age and above_
The standard primary course of vaccination with _ TWINRIX_ consists of
three doses, the first
administered at the elected date, the second one month later and the
third six months after the first
dose.
In exceptional circumstances in adults, when travel is anticipated
within one month or more after
initiating the vaccination course, but where insufficient time is
available to allow the standard 0, 1,
6 month schedule to be completed, a schedule of three intramuscular
injections given at 0, 7 and
21 days may be used. When this schedule is applied, a fourth dose is
recommended 12 months
after the first dose.
•
_Children of 2 to 15 years of age_
The standard primary course of vaccination with _ TWINRIX_ consists of
two doses, the first is
administered at the elected date and the second between six and twelve
months after the f