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.
What Hepatitis B Immunoglobulin-VF is used for
Hepatitis B Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. 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.
Before you are given Hepatitis B Immunoglobulin-VF
Make sure you tell your doctor of any reasons you know of why you should not be given this medicine.
You must not be given this medicine if you have:
- a history of allergy to human immunoglobulin products (allergic reactions may include skin rash, face swelling, wheezing or breathing difficulties) or previously been told you react to any of the ingredients in Hepatitis B Immunoglobulin-VF (human immunoglobulins or glycine)
- been told you have antibodies to immunoglobulin A (IgA).
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.
Vaccinations: Please inform your doctor if you are planning to have a vaccination. Hepatitis B Immunoglobulin-VF may impair the effect of some virus vaccines such as measles, mumps, rubella and chicken pox for a period of at least 6 weeks, and up to 3 months. After receiving this medicine, a period of 3 months should be allowed before vaccination with some virus vaccines. In the case of measles vaccine, this effect may last for up to 1 year. Therefore, your vaccinating doctor should check the effectiveness of the measles vaccination.
Pregnant or lactating women should discuss use of Hepatitis B Immunoglobulin-VF with their doctor.
About blood products
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.
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.
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.
The consequences of overdosage are not known.
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.
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.
What it looks like
Hepatitis B Immunoglobulin-VF is a clear, colourless, viscous (thick) solution. It is available in glass bottles.
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.
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
Australian Red Cross Lifeblood
Date of revision
Australian Register Numbers
100 IU: AUST R 61213
400 IU: AUST R 61214
Published by MIMS August 2021