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Engerix-B Paediatric TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: hepatitis b vaccine

Brand name

(ARTG)

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

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

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.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, suspension
  • Intramuscular
  • Turbid liquid with a slow settling white deposit and a colourless supernatant. The precipitate is easily resuspended when shaken.

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from Light
  • Do not Freeze
  • Shelf lifetime is 3 Years.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 1 x 0.5mL pack
  • 10 x 0.5mL pack
  • 25 x 0.5mL pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient hepatitis b vaccine

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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