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ENGERIX®-B Consumer Medicine

  • hives, itching

(especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions

  • unusual tiredness or

weakness that is sudden and severe.

Allergy to ENGERIX-B is rare. Any such severe reactions will usually occur within the first few hours of vaccination.

Other rare events that have been reported with ENGERIX-B include:

  • blood disorders or low

blood pressure

  • changes in liver

function tests

  • Guillain-Barre

Syndrome (an inflammatory illness affecting nerves, resulting in weakness of muscles)

  • Disease of the brain

including infection and swelling

  • Convulsions

Other side effects not listed above, can also occur during or soon after a dose of ENGERIX-B. Check with your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

STORAGE

ENGERIX-B is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But if you need to store ENGERIX-B always:

  • Keep ENGERIX-B in the

refrigerator stored between

Issue 4

Information

+2C and +8C. THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.

  • Keep the vaccine out of the

reach of children.

Keep ENGERIX-B in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over ENGERIX-B that has expired or has not been used.

PRODUCT DESCRIPTION

WHAT IT LOOKS LIKE ENGERIX-B comes in glass vials as a white, slightly milky liquid. Two different vaccine dosages are available:

  • 20 microgram in 1mL of liquid

  • 10 microgram in 0.5mL of

liquid

INGREDIENTS: The active ingredient of ENGERIX-B is the surface protein of the hepatitis B virus, derived from genetically engineered yeast cells. The vaccine is not infectious, and will not give you the hepatitis B virus.

Inactive ingredients in the vaccine are: aluminium hydroxide, sodium phosphate, sodium chloride (salt), sodium acid phosphate, polysorbate 20 and water. A very small amount of thiomersal may also be present.

ENGERIX-B is made without any human blood or blood products, or any other substances of human origin.

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

4(4)

encephalopathy) has resulted from the administration of any vaccine product.

FURTHER INFORMATION

ENGERIX-B is only available if prescribed by a doctor.

ENGERIX-B comes in the following packs:

20 microgram/1mL - Monodose vials in packs of 1 and 10 (AUST R 73477)

10 microgram/0.5mL - Monodose vials in packs of 1 and 10 (AUST R 73478)

MANUFACTURER

GlaxoSmithKline Biologicals s.a. rue de l’Institut 89 B-1330 Rixensart, Belgium.

DISTRIBUTED BY:

GlaxoSmithKline Australia Pty Ltd 1061 Mountain Highway Boronia 3155 VIC

Leaflet prepared: 9 May 2005

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