H-B-VAX II hepatitis B vaccine recombinant preservative-free paediatric 5 microgram/0.5mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hepatitis B surface antigen recombinant, Quantity: 5 microgram

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Hepatitis B surface antigen recombinant

Pharmaceutical form:

Injection, suspension

Composition:

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

Administration route:

Intramuscular

Units in package:

1 x 0.5mL syringe, 10 single use syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For use in the immunisation against infection caused by all known subtypes of hepatitis B virus. INDICATIONS AS AT 17 NOVEMBER 2000: H-B-Vax II is indicated for immunisation against infection caused by all known subtypes of Hepatitis B virus. Adolescent vaccination is not necessary for children who have received a primary course of hepatitis B vaccine. Vaccination is recommended in adults who are at substantial risk of hepatitis B virus infection and have demonstrated or judged to be susceptible. Vaccination of individuals who have antibodies against hepatitis B virus from a previous infection is not necessary.

Product summary:

Visual Identification: Slightly opalescent white liquid; 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:

Licence status A

Authorization date:

2006-08-10

Patient Information leaflet

H-B-VAX
® II
_Hepatitis B Vaccine (recombinant); hepatitis B surface antigen
(recombinant)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about H-B-VAX II. 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
H-B-VAX II 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 WITH THE MEDICINE.
You may need to read it again.
WHAT H-B-VAX II IS
USED FOR
H-B-VAX II is a vaccine used to
help prevent hepatitis B. The vaccine
can be given to newborns, infants,
children, teenagers and adults.
Hepatitis B is an infection of the liver
caused by the hepatitis B virus
(HBV). It can be caught by coming
into contact with an infected person's
blood, semen, vaginal secretions,
saliva or other body fluids. For
example, if these infected fluids enter
your blood stream through a cut in
your skin, you could become
infected. Other situations that could
lead to infection include:
•
being born to a mother who
carries the HBV
•
sexual contact with someone who
is infected
•
living in the same house as
someone who is infected
•
close family contact, for example,
sharing razors or toothbrushes
•
having a job that involves
exposure to human blood or body
fluids, for example, some health
care workers
•
sharing needles for injecting
drugs
•
travelling to areas where hepatitis
B is common
People who have hepatitis B may not
look or feel sick when infected. In
fact, a person could be infected by
the virus six weeks to six months
before symptoms occur. Some people
develop mild, flu-like symptoms.
Others may become very ill and
extremely tired, develop yellowing of
the skin and/or eyes (also called
jaundice), dark urine and other
symptoms that require
hospitalisation.
Most people recover completely from
the HB

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - H-B-VAX
® II HEPATITIS B
VACCINE (RECOMBINANT) HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)
1
NAME OF THE MEDICINE
Hepatitis B surface antigen recombinant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The vaccine against hepatitis B is free of association with human
blood or blood products.
Each 1.0 mL dose of adult formulation vaccine contains 10 µg of
hepatitis B surface antigen
adsorbed onto aluminium (as amorphous aluminium hydroxyphosphate
sulfate – 0.5 mg),
each 0.5 mL dose of the paediatric formulation vaccine contains 5 µg
of hepatitis B surface
antigen adsorbed onto aluminium (as amorphous aluminium
hydroxyphosphate sulfate – 0.25
mg), and each 1.0 mL dose of the dialysis formulation contains 40 µg
of hepatitis B surface
antigen adsorbed onto aluminium (as amorphous aluminium
hydroxyphosphate sulfate – 0.5
mg). The vaccine is of the _adw_ subtype.
All formulations of the vaccine are preservative-free.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Suspension for injection.
After thorough agitation, H-B-VAX II is a slightly opaque, white
suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
H-B-VAX II is indicated for immunisation against infection caused by
all known subtypes of
hepatitis B virus.
Adolescent vaccination is not necessary for children who have received
a primary course of
hepatitis B vaccine.
Vaccination is recommended in adults who are at substantial risk of
hepatitis B virus infection
and have been demonstrated or judged to be susceptible.
Vaccination of individuals who have antibodies against hepatitis B
virus from a previous
infection is not necessary.
Page 2 of 11
4.2
DOSE AND METHOD OF ADMINISTRATION
DO NOT INJECT INTRAVENOUSLY OR INTRADERMALLY.
H-B-VAX II is for intramuscular injection. The deltoid muscle is the
preferred site for
intramuscular injection in adults. Data suggest that injections given
in the buttocks are
frequently given into fatty tissue instead of into muscle. Such
injections h