TWINRIX VACCINE

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

HEPATITIS A VIRUS ANTIGEN (INACTIVATED); HEPATITIS B SURFACE ANTIGEN (r-DNA)

から入手可能:

GLAXOSMITHKLINE PTE LTD

ATCコード:

J07BC20

投薬量:

720 elisa units/ml

医薬品形態:

INJECTION

構図:

HEPATITIS A VIRUS ANTIGEN (INACTIVATED) 720 elisa units/ml; HEPATITIS B SURFACE ANTIGEN (r-DNA) 20 mcg/ml

投与経路:

INTRAMUSCULAR

処方タイプ:

Prescription Only

製:

GSK Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG (Primary Packager)

認証ステータス:

ACTIVE

承認日:

1999-05-18

情報リーフレット

1

TWINRIX™ 
INACTIVATED HEPATITIS A AND RDNA HEPATITIS B VACCINE (ADSORBED) 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Suspension for injection. 
One dose (1.0ml) 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 vial or glass prefilled syringe  

PHARMACEUTICAL FORM 
Suspension for injection. 

CLINICAL PARTICULARS 
INDICATIONS 
TWINRIX™ is indicated for use in non immune adults and
children aged from 1 year upwards, 
who are at risk of both hepatitis A and hepatitis B infection. 
DOSAGE AND ADMINISTRATION 
DOSAGE 
A dose of 1.0 ml TWINRIX™ is recommended for adults and
children aged from 1 year 
upwards. 
_Primary vaccination schedule_
x 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. 
x Children of 1 to 15 years of age 
2
The standard primary course of vaccination
with TWINRIX™ consists of two doses, the first is 
administered a

製品の特徴

_ _
1
TWINRIX
INACTIVATED HEPATITIS A AND RDNA HEPATITIS B VACCINE (ADSORBED)
SUSPENSION FOR INJECTION
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
pre-filled syringe.
CLINICAL INFORMATION
INDICATIONS
TWINRIX is indicated for use in non-immune adults and children aged
from 1 year upwards,
who are at risk of both hepatitis A and hepatitis B infection.
DOSAGE AND ADMINISTRATION
_Dosage _
A dose of 1.0 ml TWINRIX is recommended for adults and children aged
from 1 year upwards.
_ _
_Primary vaccination schedule _

_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 months 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 and adolescents of 1 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 first
dose. Protection against hepatitis B infections may not be obtained
until after the second
dose. Therefore, TWINRIX should be used only when there is a
relati