Hepatitis B Immunoglobulin-VF Solution for injection

Hepatitis B Immunoglobulin-VF Solution for injection is a brand of medicine containing the active ingredient immunoglobulin (hepatitis B).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Hepatitis B Immunoglobulin-VF

Human Hepatitis B Immunoglobulin, solution for intramuscular injection


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Hepatitis B Immunoglobulin-VF. It does not contain complete information about Hepatitis B Immunoglobulin-VF. It does not take the place of talking to your doctor.

If you have any concerns about using this medicine, ask your doctor. Follow your doctor’s advice even if it is different from what this leaflet says.

Please read this leaflet carefully and keep it for future reference.

The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated.

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What Hepatitis B Immunoglobulin-VF is used for

Hepatitis B Immunoglobulin-VF is prepared from blood obtained from voluntary donors. Hepatitis B Immunoglobulin-VF contains protein substances called antibodies which can prevent infection from developing in a person who has been exposed to the hepatitis B virus. Hepatitis B Immunoglobulin-VF is used to prevent hepatitis B infection in a person who comes into contact with blood or other material suspected of being infected with hepatitis B, for example, by accidental needle stick injury or sexual exposure. It is also given to babies born to mothers with hepatitis B infection.

Ask your doctor if you have any questions about why Hepatitis B Immunoglobulin-VF has been prescribed for you. Your doctor will have assessed the risks and benefits associated with the use of this medicine for you.

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Before you are given Hepatitis B Immunoglobulin-VF

Hepatitis B Immunoglobulin-VF must not be used if you have a history of allergy to this medicine. Tell your doctor if you have allergies to any other medicines, or if you have ever had an allergic reaction to an injection.

Tell your doctor also if you:

  • have previously been advised that you have immunoglobulin A (IgA) deficiency
  • are taking or using any other medicines. These include medicines bought from pharmacies, supermarkets and health food stores.
  • have tested positive for hepatitis B infection
  • suffer from a blood disorder or blood clotting problem
  • have had any vaccination during the last two weeks
  • have any other medical conditions.

Pregnant or lactating women should discuss use of Hepatitis B Immunoglobulin-VF with their doctor.

About blood products

This product is made from human plasma obtained from voluntary donors. When products are made from human blood and injected into you, it is possible that viruses or other substances could be present in the product and cause an illness. These could be viruses such as hepatitis, human immunodeficiency virus (HIV), or human parvovirus B19 and theoretically the Creutzfeldt-Jakob Disease (CJD) agent. There could also be other infectious agents, some of which may not yet have been discovered.

To reduce the risk of this happening, extra steps are taken when manufacturing this product. Strict controls are applied to the selection of blood donors and donations. The product is specially treated to remove and kill certain viruses. These special treatments are considered effective against viruses known as enveloped viruses such as HIV, hepatitis B virus and hepatitis C virus, and the non-enveloped viruses, such as hepatitis A virus and human parvovirus B19. Additionally, the product contains specific antibodies which can provide some protection against human parvovirus B19. Despite these measures, the risk of viral and other agent’s infectivity cannot be totally eliminated.

Vaccines are available against some of these viruses and your doctor will be able to help you decide whether it is worthwhile having any of those vaccines.

Please discuss the risks and benefits of this product with your doctor.

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How to use Hepatitis B Immunoglobulin-VF

Your doctor will determine the dose(s) of Hepatitis B Immunoglobulin-VF that you are to receive. Your doctor will give you the injection. It will be injected into the muscle. If a large volume of product is required, you may receive more than one injection.

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Side effects

Along with their intended effects, medicines may cause some unwanted effects, which can sometimes be serious. Furthermore, individual patients may react differently to the same dose of the same medicine. This applies to Hepatitis B Immunoglobulin-VF.

Reactions are very uncommon after injection with Hepatitis B Immunoglobulin-VF. However, some pain, redness and stiffness may be apparent at the injection site. This may occur after any large injection into a muscle.

Occasionally mild fever, chills, drowsiness or discomfort may be felt and an itchy rash may develop.

If any of these effects are severe, or if you are worried about any other symptoms after the injection, consult your doctor.

Hepatitis B Immunoglobulin-VF can interfere with some live vaccines (e.g. measles and polio), even up to three months later. Advise your doctor if you are to receive other vaccines within three months of receiving Hepatitis B Immunoglobulin-VF.

Overdose

The consequences of overdosage are not known.

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Storing Hepatitis B Immunoglobulin-VF

Store at 2°C to 8°C (Refrigerate. Do not freeze). Protect from light.

Do not use after the expiry date shown on the label.

Further information

Hepatitis B Immunoglobulin-VF can only be obtained on a doctor’s prescription. This leaflet does not contain the complete information about Hepatitis B Immunoglobulin-VF. If you require further information about Hepatitis B Immunoglobulin-VF and your treatment generally, or if you have any questions or are not sure about something in this leaflet, consult your doctor.

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Product description

What it looks like

Hepatitis B Immunoglobulin-VF is a clear, colourless, viscous (thick) solution. It is available in glass bottles.

Ingredients

Each bottle of Hepatitis B Immunoglobulin-VF is a sterile solution containing 160 mg/mL blood proteins of which at least 98% is immunoglobulins. It also contains 22.5 mg/mL glycine.

Manufacturer

Hepatitis B Immunoglobulin-VF is manufactured in Australia by:
CSL Behring (Australia) Pty Ltd
ABN 48 160 734 761
189-209 Camp Road
Broadmeadows VIC 3047
Australia

Distributor

Australian Red Cross Blood Service

Date of most recent amendment

August 2014

Australian Register Numbers
100 IU: AUST R 61213
400 IU: AUST R 61214

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CMI provided by MIMS Australia, January 2015  

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