Sexual Exposure to an HBsAg-positive Person
in order to prevent recurrence of hepatitis B virus infection after liver transplantation for liver failure caused by hepatitis B virus. In order to give rapidly available antibodies against hepatitis B virus to prevent hepatitis B in the following cases:
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- In case of accidental exposure in non-immunised subjects (that is persons who have not been vaccinated against the hepatitis B virus; including persons whose vaccination is incomplete or status unknown).
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in order to prevent recurrence of hepatitis B virus infection after liver transplantation for liver failure caused by hepatitis B virus. In order to give rapidly available antibodies against hepatitis B virus to prevent hepatitis B in the following cases:
- In case of accidental exposure in non-immunised subjects (that is persons who have not been vaccinated against the hepatitis B virus; including persons whose vaccination is incomplete or status unknown).
- In haemodialysed patients (that is patients with a severe renal failure that need a blood purification by an artificial kidney), until vaccination has become effective
- In the newborn of a hepatitis B virus carrier-mother.
- In subjects who did not show an immune response after vaccination (that is persons in which the vaccination did not become effective) and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B virus.
Breastfeeding: Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Fertility: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Driving and using machines: No effects on ability to drive and use machines have been observed
Who administers Hepatitis b immune globulin to you should ensure that the product is not administered into a blood vessel, this could cause an acute (o severe) crisis of the circulatory system, known as shock?
If you are a carrier of HBsAg, there is no benefit in administering this product. Serious allergic reactions are rare.
Rarely, the human anti-hepatitis B immunoglobulins can induce a sudden fall in blood pressure with disorder of breathing, faints, sometimes fever and skin reactions (anaphylactic reaction). This can happen even if you have tolerated previous treatments with immunoglobulins.
If your doctor or who administers to you the product should suspect an allergic or anaphilactic reaction must stop immediately the administration. In case of shock, your doctor should follow the standard medical treatment for shock.
The product contains 3.9 mg sodium per ml. This must be taken into consideration, depending on the total amount of product that you must assume, if you are on a low salt diet.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
- A careful selection of blood and plasma donors to make sure that those at risk of carrying infections are excluded;
- The testing of the donations to ensure that there are no infective agents and/or viruses;
- The inclusion, during manufacturing process of steps capable of inactivating or removing viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging infectious agents or other types of infections.
The measures taken are considered effective for viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and for hepatitis A virus (HAV).
The measures taken may be of limited value against viruses such as parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
It is strongly recommended that every time you receive a dose of Hepatitis b immune globulin the name and batch number of the product are recorded in order to maintain a record of the batches used.