HAVRIX 1440 Hepatitis A vaccine inactivated 1440 ELISA units/1mL injection syringe

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Hepatitis a virus antigen, Quantity: 1440 ELISA unit

Dostupno od:

GlaxoSmithKline Australia Pty Ltd

INN (International ime):

Hepatitis a virus antigen

Farmaceutski oblik:

Injection, suspension

Sastav:

Excipient Ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine

Administracija rute:

Intramuscular

Jedinice u paketu:

1 x 1mL syringe

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

HAVRIX is indicated for active immunisation against hepatitis A virus (HAV) infection in susceptible subjects at risk of exposure to HAV. HAVRIX JUNIOR is indicated in subjects aged 2 to 15 years and HAVRIX 1440 is indicated in subjects aged 16 years and older. In areas of low prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in the following subjects: Travellers : Persons travelling to areas of intermediate or high endemicity for hepatitis A. These areas include Africa, Asia, India, the Pacific Islands, the Mediterranean basin, the Middle East, Central and South America. Armed Forces : Armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of HAV infection. Persons for whom hepatitis A is an occupational hazard or for whom there is an increased risk of transmission. These include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts of the intellectually disabled; staff and residents of residential facilities for the intellectually disabled; health workers and teachers in remote Aboriginal and Torres Strait Islander communities; nursing staff and other healthcare workers in contact with patients in paediatric wards, infectious diseases wards, emergency rooms and intensive care units sewerage workers ; food handlers, since food hygiene procedures and food processing methods are not always adequate to protect from contamination from food handlers. Homosexual men : Increased incidence of hepatitis A infection among homosexual males suggests that the disease may be sexually transmitted in this group. Contacts of infected persons : Since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts is recommended. The use of vaccine in outbreak control has been shown to be more effective than the use of immunoglobulin. Specific population groups known to have a higher incidence of hepatitis A: eg. Australian aboriginals, recognised community-wide HAV epidemics. Individuals with chronic liver disease and recipients of liver transplants, as hepatitis A infections is likely to be more severe in these groups. Many injecting drug users will have pre-existing liver disease from hepatitis B or hepatitis C infection. Recipients of blood products, such as Factor VIII eg. haemophiliacs. HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E or other pathogens known to infect the liver.

Proizvod sažetak:

Visual Identification: A turbid liquid with a slow settling white deposit; 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

Status autorizacije:

Licence status A

Datum autorizacije:

2008-04-22

Uputa o lijeku

1
HAVRIX 1440 AND HAVRIXJUNIOR
_Inactivated Hepatitis A Virus Vaccine _
CONSUMER MEDICINE INFORMATION LEAFLET
In this leaflet, HAVRIX refers to
the use of both HAVRIX 1440
for adults, and HAVRIX Junior
for children.
WHAT IS IN THIS LEAFLET
This leaflet answers some of
the common questions about
HAVRIX 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 or your
child having HAVRIX against
the expected benefits.
IF YOU HAVE ANY CONCERNS
ABOUT HAVRIX TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
VACCINE. You may need to
read it again.
WHAT IS HAVRIX USED FOR
HAVRIX is a vaccine used to
prevent hepatitis A infection.
The vaccine works by causing
the body to produce its own
protection (antibodies) against
this disease.
Hepatitis A is an infectious
disease, which can affect the
liver. This disease is caused by
the hepatitis A virus.
The hepatitis A virus can be
passed from person to person in
food and drink, or by swimming in
water contaminated by sewage.
Symptoms of hepatitis A begin 3 to
6 weeks after coming into contact
with the virus. These consist of
nausea (feeling sick), fever and
aches and pains. After a few days
the whites of eyes and skin may
become yellowish (jaundice). The
severity and type of symptoms can
vary. Young children may not
develop jaundice. Most people
recover completely but the illness
is usually severe enough to keep
people off work for about a month.
Hepatitis A is very common in
many parts of the world, and the
risk of infection is greatest in those
areas where hygiene and
sanitation are poor. Such areas
include Asia, India, Africa, Central
and South America, the Pacific
Islands, the Middle East, and the
Mediterranean basin. HAVRIX is
recommended for all travellers to
these areas, including people in
the armed forces.
Hepatitis A occurs in Australia, but
is not common. Some groups of
pe

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION
HAVRIX 1440 AND HAVRIX JUNIOR (INACTIVATED HEPATITIS A VIRUS
VACCINE) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Inactivated Hepatitis A virus vaccine_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HAVRIX, hepatitis A vaccine, is a sterile suspension containing
formaldehyde - inactivated
hepatitis A virus (HM 175 hepatitis A virus strain) adsorbed onto
aluminium hydroxide
hydrate.
The virus is propagated in MRC5 human diploid cells. Before viral
extraction, the cells are
extensively washed to remove culture medium constituents. A virus
suspension is then
obtained by lysis of the cells followed by purification using
ultrafiltration techniques and gel
chromatography. The virus is then inactivated with formalin. Residual
formaldehyde in the
vaccine should be not more than 0.01%.
One dose (1.0 ml) of HAVRIX 1440 Adult contains:
Hepatitis A virus (inactivated)
1,2
1440 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide hydrate
Total: 0.50 milligrams Al
3+
One dose (0.5 ml) of HAVRIX 720 Junior contains:
Hepatitis A virus (inactivated)
1,2
720 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide hydrate
Total : 0.25 milligrams Al
3+
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.
HAVRIX meets the World Health Organization requirements for biological
substances.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
2
3
PHARMACEUTICAL FORM
Suspension for injection.
Turbid liquid suspension. Upon storage, a fine white deposit with a
clear colourless
supernatant can be observed.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HAVRIX is indicated for active immunisation against hepatitis A virus
(HAV) infection in
susceptible subjects at risk of exposure to HAV. H