VAQTA hepatitis A vaccine inactivated 25 units/0.5mL injection syringe

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Hepatitis A virus, Quantity: 50 U/mL

Saadav alates:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Rahvusvaheline Nimetus):

Hepatitis a virus antigen

Ravimvorm:

Injection

Koostis:

Excipient Ingredients: borax; aluminium; sodium chloride; water for injections

Manustamisviis:

Intramuscular, Subcutaneous

Ühikuid pakis:

0.5mL

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

VAQTA is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 12 months of age and older. Primary immunisation should be given at least 2 weeks prior to expected exposure to Hepatitis A virus. Individuals who are or will be increased risk of infection include: Travellers to areas of intermediate or high endemicity for hepatitis A. Persons for whom Hepatitis A is an occupational hazard. Employee of child day-care centers. Certain institutional workers (eg. caretakers for the intellectually disabled). Health workers and teachers in remote Aboriginal and Torres Strait Islander communities. Nursing staff and other health care workers in contact with patients in paediatric wards and infectious disease wards. Sewerage workers. Recipients of blood products. Individuals with chronic liver disease and those who have had a liver transplant. Homosexually active males. Human Immunodeficiency Virus (HIV)-infected Adults.

Toote kokkuvõte:

Visual Identification: Slightly opaque white suspension.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Licence status A

Loa andmise kuupäev:

1997-01-08

Infovoldik

VAQTA
®
_Hepatitis A vaccine, Inactivated (hepatitis A virus, inactivated)_
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, occasio

Toote omadused

VAQ-I- 122010S
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
VAQTA
®
HEPATITIS A VACCINE, INACTIVATED (HEPATITIS A VIRUS, INACTIVATED)
1
NAME OF THE MEDICINE
hepatitis A virus, inactivated
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
amorphous
aluminium
hydroxyphosphate
sulfate
adjuvant.
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 50 U dose of VAQTA
contains less than 0.1 µg of non-viral protein, less than 4 x 10
-6
µg of DNA, less than 10
-4
µg
of bovine albumin and less than 0.8 µg 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 0.5 mL dose contains
approximately 25 U of
hepatitis A virus protein as the active ingredient.
ADULT FORMULATION: Each 1 mL dose contains approximately 50 U of
hepatitis A virus protein
as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
VAQTA is a Suspension for Injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VAQTA is indicated for