TWINRIX JUNIOR (combined hepatitis A & hepatitis B vaccine) 0.5 mL injection pre-filled syringe thiomersal & preservative free

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hepatitis B surface antigen recombinant, Quantity: 20 microgram/mL; Hepatitis a virus antigen, Quantity: 720 ELISA unit/mL

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Hepatitis a virus antigen,Hepatitis B surface antigen recombinant

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: aluminium hydroxide hydrate; aluminium phosphate; polysorbate 20; water for injections; neomycin sulfate; monobasic sodium phosphate; trometamol; sodium chloride; dibasic sodium phosphate heptahydrate; formaldehyde solution; 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

Administration route:

Intramuscular

Units in package:

0.5mL x 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Twinrix (720/20) is indicated for active immunisation against hepatitis A and hepatitis B virus infection in adults and children from 1 year of age. Twinrix Junior (360/10) is indicated for use in children aged 1 to 15 years. Twinrix (720/20) is indicated for active immunisation against hepatitis A and hepatitis B virus infection in adults and children from 1 year of age. Twinrix Junior (360/10) is indicated for use in children aged 1 to 15 years.

Product summary:

Visual Identification: fine white deposit with a clear colourless supernatant. The precipitate is easily resuspended when shaken. Once shaken the vaccine is slightly opaque.; 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

Authorization status:

Registered

Authorization date:

2007-10-18

Patient Information leaflet

1
TWINRIX (720/20) AND TWINRIX
JUNIOR (360/10)
_Combined hepatitis A and hepatitis B vaccine _
CONSUMER MEDICINE INFORMATION LEAFLET
In this leaflet, TWINRIX refers
to both TWINRIX (720/20) and
TWINRIX JUNIOR (360/10).
WHAT IS IN THIS LEAFLET
This leaflet answers some of
the common questions about
TWINRIX vaccine. 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
possible risks of you or your
child having TWINRIX against
the expected benefits.
IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING TWINRIX
TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS
VACCINE. You may need to
read it again.
WHAT TWINRIX IS USED
FOR
TWINRIX is a combination
vaccine used to prevent
hepatitis A and hepatitis B
infection. The vaccine works
by causing the body to
produce its own protection
(antibodies) against these
diseases.
Hepatitis A and hepatitis B are
infectious diseases, which
cause the liver to become
inflamed (swollen). These
diseases are caused by
viruses - hepatitis A and hepatitis
B viruses.
_Hepatitis A _
Symptoms of hepatitis A
usually begin 3 to 6 weeks
after coming into contact with
the virus. These consist of
nausea (feeling sick), fever,
aches and pains. After a few
days the skin and/or the whites
of the eyes may become
yellowish (jaundice). The
severity and type of symptoms
can vary. Hepatitis A is often
milder in young children. Most
people recover completely but
the illness is usually severe
enough to keep adults off work
for about a month.
The hepatitis A virus can be
passed from person to person
in food and drink, or by
swimming in water
contaminated by sewage.
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.
Vaccination is recommended
for travellers to all developing
countries, including people in
the armed forces.
Hepatitis A occurs in Australia,
but is not co

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TWINRIX (720/20) AND TWINRIX JUNIOR (360/10) (COMBINED
HEPATITIS A AND HEPATITIS B VACCINE) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Combined hepatitis A and hepatitis B vaccine_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TWINRIX is a non-infectious combination vaccine containing hepatitis A
virus antigen and
hepatitis B surface antigen (rys).
Each 1 mL dose of TWINRIX contains 720 ELISA units of hepatitis A
virus antigen and 20
micrograms of hepatitis B surface antigen (rys). The viral antigens
are adsorbed on 0.45 mg
aluminium in the form of aluminium phosphate and aluminium hydroxide
hydrate and
suspended in a solution containing 9 mg of sodium chloride.
Each 0.5 mL dose of TWINRIX Junior contains 360 ELISA units of
hepatitis A virus antigen
and 10 micrograms of hepatitis B surface antigen (rys). The viral
antigens are adsorbed on
0.225 mg aluminium in the form of aluminium phosphate and aluminium
hydroxide hydrate
and suspended in a solution containing 4.5 mg of sodium chloride.
TWINRIX is formulated using the HM 175 strain of hepatitis A grown in
human cell culture
(MRC5), and inactivated with formaldehyde. The hepatitis B surface
antigen (rys)
component is produced by culturing genetically-engineered
_Saccharomyces cerevisiae_ yeast
cells (Baker’s yeast), which carry the relevant gene of an adw
subtype, of the surface
antigen of the hepatitis B virus. Both the hepatitis A virus antigen
and hepatitis B surface
antigen (rys) are purified by several physico-chemical steps, and
formulated as separate
antigen suspensions adsorbed onto aluminium salts. TWINRIX is produced
by pooling bulk
preparations of the purified antigens. The bulk hepatitis A virus
antigen and hepatitis B
surface antigen (rys) preparations are identical to those used in the
manufacture of the
currently licensed monovalent hepatitis A (Havrix) and hepatitis B
(Engerix-B) vaccines.
Standardised fermentation and purification procedures ensure batch to
batch consistency.
The vaccines are free of associa