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.

In order to prevent recurrence of hepatitis B virus infection after liver transplantation for liver failure caused by hepatitis B virus:

In adults: The suggested posology is 2000 IU IM every 15 days in the period after the transplantation, excluding the first week. This posology should be modified in the long-term treatment to ensure the maintenance of the serous level of HBsAg antibodies above 100 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients.

The concomitant use of adequate virostatic agents should be considered, if appropriate, as a standard in hepatitis B reinfection prophylaxis.

Pediatric population: There is no relevant use of UMAN BIG in the pediatric population in the indication prevention of hepatitis B virus recurrence after liver transplantation for hepatitis B induced liver failure.

In order to prevent hepatitis B:

Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: at least 500 IU (International Units), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 - 72 hours.

Immunoprophylaxis of hepatitis B in haemodialysed patients:

8-12 IU/kg with a maximum of 500 IU, every 2 months until the vaccination has become effective Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth: 30-100 IU/kg. The hepatitis B immunoglobulin administration may need to be repeated until the vaccination has become effective.

In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites.

If you have not shown an immune response after vaccination (no measurable hepatitis B antibodies), and in case a continuous prevention is necessary, the doctor may consider the administration of 500 IU (to adults) and 8 IU/kg (to children) every 2 months.

Administration

Hepatitis b immune globulin should be administered by intramuscular route. The product should be brought to room or body temperature before use. Remove the central protection from the rubber stopper and draw the solution with an injection syringe. Change the needle and inject. Once the solution is withdrawn from the container into the syringe, the medicinal product must be administered immediately. The liquid preparation is clear and colorless or pale-yellow or light brown. Do not use solutions that are cloudy or have deposits.

If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this in divided doses at different sites. Any unused product or waste material should be disposed of in accordance with local requirements.

If you are allergic (hypersensitive) to human immunoglobulins or to any of the other ingredients of Hepatitis b immune globulin. For example, if you have a deficiency of immunoglobulin A (IgA), you may develop, in the blood, antibodies against the immunoglobulin A. Hepatitis b immune globulin contains small quantity of IgA and therefore severe allergic reactions could occur. The physician must therefore weigh the benefit of treatment with Hepatitis b immune globulin against the potential risk of allergic reactions.

Hypersensitivity, Anaphylactic shock, Headache, Tachycardia, Hypotension, Vomiting, Erythema, Itching, Malaise

Overdose Effects

Consequences of an overdose are not known

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 prod

Pregnancy & Lactation

Pregnancy: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.

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 observeduct are recorded in order to maintain a record of the batches used.