Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Hepatitis B surface antigen recombinant, Quantity: 20 microgram/mL
GlaxoSmithKline Australia Pty Ltd
Hepatitis B surface antigen recombinant
Injection, suspension
Excipient Ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate
Intramuscular, Subcutaneous
1 x 1mL, 10 X 1mL, 25 X 1mL
(S4) Prescription Only Medicine
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.
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
Registered
2006-07-24
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 Read the complete document
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 Read the complete document