ENGERIX-B PAEDIATRIC DOSE hepatitis B surface antigen recombinant (yeast) 10 microgram/0.5mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hepatitis B surface antigen recombinant, Quantity: 10 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Hepatitis B surface antigen recombinant

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate; sodium chloride; monobasic sodium phosphate; water for injections

Administration route:

Intramuscular, Subcutaneous

Units in package:

1 x 0.5mL, 10 x 0.5mL, 25 x 0.5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ENGERIX-B is indicated for active immunisation against hepatitis B virus infection. The NH&MRC* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis B. The NH&MRC also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis B virus. Groups identified at increased risk of acquiring HBV infection include: Infants born to carrier (HBsAg-positive) mothers; Individuals for whom post-exposure prophylaxis for hepatitis B is indicated; Household contacts (other than sexual partners) of acute and chronic hepatitis B cases and carriers; susceptible sexual contacts. Risk occurs in susceptible (anti-HBs negative) partners of HBV carriers and patients with acute hepatitis B; Susceptible clients of STD (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; Injecting drug users; Haemodialysis patients, HIV-positive individuals and other immunosuppressed adults; Patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; Individuals with chronic liver disease and / or hepatitis C; Staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; Liver transplant recipients. Such individuals should be vaccinated prior to transplantation if seronegative for hepatitis B, as they may be at increased risk of infection from the transplanted organ; Staff and inmates of long term correctional facilities; Health care workers, dentists, embalmers, tattooists and body-piercers. All staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; Individuals adopting children from overseas. These children should be tested for hepatitis B, and if HBsAg positive, members of the adoptive family should be vaccinated; Others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. Long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. Short-term tourists or business travellers are at very little risk of hepatitis B, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. Although the risk of hepatitis B infection in contact sports is low, immunisation of those involved should not be discouraged. As the risk in Australian schools is very low, vaccination of classroom contacts is seldom indicated. Nevertheless, vaccination of school children and adolescents should be encouraged; As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by vaccination with ENGERIX-B. The vaccine will not protect against infection caused by hepatitis A, hepatitis C and hepatitis E viruses, and other pathogens known to infect the liver.

Product summary:

Visual Identification: Turbid liquid with a slow settling white deposit and a colourless supernatant. The precipitate is easily resuspended when shaken.; 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:

2006-07-24

Patient Information leaflet

1
ENGERIX-B
_Hepatitis B Vaccine _
_ _
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of
the common questions about
ENGERIX-B 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 having
ENGERIX-B against the
expected benefits.
IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING ENGERIX-B
TALK TO YOUR DOCTOR, NURSE
OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
VACCINE. You may need to
read it again.
WHAT ENGERIX-B IS USED
FOR
ENGERIX-B is a vaccine
used to protect you or your
child against hepatitis B
infection. The vaccine works
by causing your body to
produce its own protection
(antibodies) against this
disease. ENGERIX-B can be
given to adults, adolescents,
children and infants.
Hepatitis B is an infectious
disease, which causes the
liver to become swollen
(inflamed). It is caused by a
virus (hepatitis B virus). The
virus is found in body fluids
such as blood, semen,
vaginal secretions, or saliva
of infected people. You can
catch the virus if it can enter
your bloodstream. Ways this can
happen are through:

injection (e.g. needlestick
injury, or sharing needles for IV
drug use)

sexual intercourse

sores, cuts or tiny wounds
coming into contact with
infected fluids (e.g. from a
human bite, sharing razors or
toothbrushes, or working with
human blood or body fluids)

an infected mother passing the
virus onto her baby during or
shortly after birth.
Some people infected with
hepatitis B may not look or feel
sick. But others will get
symptoms, which may not be
seen for 6 weeks to 6 months
after infection. Sometimes people
will only have mild flu-like
symptoms, but other people can
become very ill. They may be
extremely tired, and have dark
urine, pale faeces, yellowish skin
and/or eyes (jaundice), and other
symptoms possibly requiring
hospitalisation.
Most adults fully recover from the
disease. Bu

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ENGERIX-B (HEPATITIS B SURFACE ANTIGEN RECOMBINANT (YEAST))
VACCINE, SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Hepatitis B surface antigen recombinant (yeast)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENGERIX-B PAEDIATRIC DOSE: 10 µg dose vaccine
1 dose (0.5 mL) contains:
Hepatitis B surface antigen
1, 2
10 micrograms
1
Adsorbed on aluminium hydroxide hydrate
Total: 0.25 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
ENGERIX-B: 20 µg dose vaccine
1 dose (1 mL) contains:
Hepatitis B surface antigen
1, 2
20 micrograms
1
Adsorbed on aluminium hydroxide hydrate
Total: 0.50 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
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.
ENGERIX-B is highly purified, and meets the WHO requirements for
recombinant hepatitis B
vaccines. No substances of human origin are used in its manufacture.
3
PHARMACEUTICAL FORM
Suspension for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ENGERIX-B is indicated for active immunisation against hepatitis B
virus infection. The use of
the vaccine should be in accordance with official recommendations.
2
As hepatitis D (caused by the delta agent) does not occur in the
absence of hepatitis B
infection, it can be expected that hepatitis D will also be prevented
by vaccination with
ENGERIX-B. The vaccine will not protect against infection caused by
hepatitis A, hepatitis C
and hepatitis E viruses, and other pathogens known to infect the
liver._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The vaccine can be administered at any age from birth onwards.
Vaccination of individuals
who have antibodies against hepatitis B virus from