Vaqta

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hepatitis a virus antigen

Available from:

Merck Sharp & Dohme Australia Pty Ltd

Class:

Medicine Listed (Export Only)

Patient Information leaflet

VAQTA
®

_Hepatitis A Vaccine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VAQTA. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the risks of you being given
VAQTA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS VACCINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VAQTA IS USED
FOR
VAQTA is a vaccine used to help
prevent hepatitis A. It can be given to
children 12 months of age and older,
teenagers and adults.
Hepatitis A is an infection of the
liver caused by the hepatitis A virus.
It can be caught by coming into
contact with an infected person who
has poor sanitary habits, eating or
drinking foods prepared by an
infected food handler, or, while
uncommon, by blood transfusion
from an infected donor. Other
circumstances that can increase the
risk of infection include:
•
travelling to areas where hepatitis
A is common
•
living in a community with one or
more recorded outbreaks within
the last five years
•
being around groups of other
children, for example, daycare
centres
•
living in the same house as
someone who is infected
•
having chronic liver disease or
having had a liver transplant
•
sexual contact with someone who
is infected
•
being infected with Human
Immunodeficiency Virus (HIV)
•
working in the healthcare field
•
eating raw shellfish
•
sharing needles for injecting
drugs
•
having a blood disorder requiring
transfusion of blood products.
Symptoms of hepatitis A usually
begin 2 to 8 weeks after coming into
contact with the virus. These include
loss of appetite, feeling sick (nausea),
vomiting, fever, chills, tiredness,
yellowing of the skin and/or eyes and
dark urine. Most people recover
completely from hepatitis A disease.
However, occasionally cases develop
into sever

Summary of Product characteristics

VAQ-I- 122010S

1 

PRODUCT INFORMATION 

VAQTA® 
(Hepatitis A Vaccine, Inactivated) 

DESCRIPTION 

VAQTA® (Hepatitis A Vaccine, Inactivated) is an inactivated whole
virus vaccine derived 
from hepatitis A virus grown in cell culture in human MRC-5
diploid fibroblasts and has been 
shown to induce antibody to hepatitis A virus
protein.  It contains inactivated virus of a strain 
which was originally derived by further serial passage of a
proven attenuated strain.  The 
virus is grown, harvested, purified by a combination
of physical and high performance liquid 
chromatographic techniques, formalin inactivated, and then
adsorbed onto aluminium 
hydroxide.  One millilitre of the vaccine contains
approximately 50 units (U) of hepatitis A 
antigen, which is highly purified and
is formulated without a preservative.  Within the limits of 
current assay variability, the 50U dose of VAQTA contains
less than 0.1  g of non-viral 
protein, less than 4 x 10
-6
  g of DNA, less than 10
-4
  g of bovine albumin and less than 0.8 
g of formaldehyde.  Other process chemical residuals (including neomycin) are
less than 10 
parts per billion (ppb). 

The manufacture of this product includes exposure
to bovine related 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. 

VAQTA is supplied in two formulations: 

PAEDIATRIC/ADOLESCENT FORMULATION:  Each 0.5mL dose contains
approximately 25U of 
hepatitis A virus protein as the active
ingredient and approximately 0.225mg of aluminium 
provided as aluminium hydroxide, 35  g of borax as
a pH stabiliser, in 0.9% sodium chloride. 

ADULT FORMULATION:  Each
1mL dose contains approximately 50U of hepatitis A viru