Engerix-B thiomersal-free vaccine

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Hepatitis B surface antigen recombinant

Tillgänglig från:

GlaxoSmithKline Australia Pty Ltd

Klass:

Medicine Registered

Bipacksedel

1 
ENGERIX
®
-B 
_Hepatitis B Vaccine _
_ _
CONSUMER MEDICINE INFORMATION LEAFLET 

WHAT IS IN THIS LEAFLET 

This leaflet answers some of 
the common questions about 
ENGERIX-B vaccine.  It does 
not contain all the available 
information.  It does not take 
the place of talking to your 
doctor, nurse or pharmacist. 

All medicines and vaccines 
have risks and benefits.  Your 
doctor has weighed the 
possible risks of you having 
ENGERIX-B against the 
expected benefits. 

IF YOU HAVE ANY CONCERNS 
ABOUT RECEIVING ENGERIX-B 
TALK TO YOUR DOCTOR, NURSE 
OR PHARMACIST. 

KEEP THIS LEAFLET WITH THIS 
VACCINE.  You may need to 
read it again. 

WHAT ENGERIX-B IS USED 
FOR 

ENGERIX-B is a vaccine 
used to protect you or your 
child against hepatitis B 
infection.  The vaccine works 
by causing your body to 
produce its own protection 
(antibodies) against this 
disease.  ENGERIX-B can be 
given to adults, adolescents, 
children and infants. 

Hepatitis B is an infectious 
disease, which causes the 
liver to become swollen 
(inflamed). It is caused by a 
virus (hepatitis B virus).  The 
virus is found in body fluids 
such as blood, semen, 
vaginal secretions, or saliva 
of infected people.  You can 
catch the virus if it can enter 
your bloodstream.  Ways this can 
happen are through: 

  injection (e.g. needlestick 
injury, or sharing needles for IV 
drug use) 
 sexual intercourse 
  sores, cuts or tiny wounds 
coming into contact with 
infected fluids (e.g. from a 
human bite, sharing razors or 
toothbrushes, or working with 
human blood or body fluids) 
  an infected mother passing the 
virus onto her baby during or 
shortly after birth. 

Some people infected with 
hepatitis B may not look or feel 
sick.  But others will get 
symptoms, which may not be 
seen for 6 weeks to 6 months 
after infection.  Sometimes people 
will only have mild flu-like 
symptoms, but other people can 
become ve

Produktens egenskaper

 
1 
ENGERIX®-B PRODUCT INFORMATION 
(Hepatitis B surface antigen (rys)) 

NAME OF THE MEDICINE 
ENGERIX-B  
Hepatitis B surface antigen recombinant (yeast) vaccine 

DESCRIPTION 
Suspension for injection. 
10 ΜG DOSE VACCINE 

1 dose (0.5 ml) contains: 

10 micrograms Hepatitis B surface antigen
 1, 2

1
Adsorbed on aluminium hydroxide, hydrated 

Total: 0.25 milligrams Al
3+

2
Produced in yeast cells (Saccharomyces
cerevisiae) by recombinant DNA technology 

20ΜG DOSE VACCINE 

1 dose (1 ml) contains: 

20 micrograms Hepatitis B surface antigen
1, 2

1
Adsorbed on aluminium hydroxide, hydrated 
Total: 0.50 milligrams Al
3+

2
Produced in yeast cells (Saccharomyces
cerevisiae) by recombinant DNA technology 

The  final  vaccines  also  contain  sodium  phosphate 
–  dibasic  dihydrate,  sodium  phosphate  – 
monobasic  dihydrate,  sodium  chloride,  and  water  for  injections  and  traces  of  polysorbate  20.    
ENGERIX-B contains no thiomersal._ _

The  manufacture  of  this  product  includes  exposure  to  bovine  derived  materials.    No  evidence 
exists  that  any  case  of  vCJD  (considered  to  be  the  human  form  of  bovine  spongiform 
encephalopathy) has resulted from the administration of any vaccine product. 

ENGERIX-B  is  highly  purified,  and  meets  the  WHO  requirements  for  recombinant  hepatitis  B 
vaccines.  No substances of human origin are used in
its manufacture. 

2 
PHARMACOLOGY 
ENGERIX-B  induces  the  production  of  specific  humoral  antibodies  (anti-HBs),  which  confer 
immunity against hepatitis B.  A peak anti-HBs antibody concentration of 

10 IU/L correlates with 
long-termprotection against hepatitis B virus
(H