Hepatitis B Immunoglobulin is used to prevent the recurrence of Hepatitis B infection after liver transplantation in patients whose liver failure was caused by the virus. It is also used to provide immediate protection against Hepatitis B in the following situations:

• After accidental exposure in individuals who have not been vaccinated, have incomplete vaccination, or whose vaccination status is unknown.
• In patients undergoing haemodialysis (those with severe kidney failure requiring artificial blood filtration) until the vaccine becomes effective.
• In newborns born to mothers who are carriers of the Hepatitis B virus.
• In individuals who did not develop adequate immunity after vaccination and require ongoing protection due to continuous risk of infection.

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 infection 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.

Hepatitis B immune globulin should not be mixed with any other medicinal products.

Do not use Hepatitis B immune globulin if you are allergic (hypersensitive) to human immunoglobulins or any of its components. For instance, individuals with immunoglobulin A (IgA) deficiency may develop antibodies against IgA present in the blood. Since Hepatitis B immune globulin contains small amounts of IgA, severe allergic reactions may occur. Therefore, the physician must carefully evaluate the benefits of treatment against the potential risks of allergic reactions.

Hypersensitivity, anaphylactic shock, headache, tachycardia, hypotension, vomiting, erythema, itching, malaise.

Pregnancy: The safety of this product during pregnancy has not been confirmed in controlled clinical studies. It should be administered cautiously to pregnant or breastfeeding women. However, clinical experience suggests no harmful effects on pregnancy, the fetus, or the newborn.

Breastfeeding: Immunoglobulins are excreted in breast milk and may help transfer protective antibodies to the newborn.

Fertility: Clinical experience indicates no expected adverse effects on fertility.

Driving and using machines: No effects on the ability to drive or operate machinery have been observed.

The person administering Hepatitis B immune globulin must ensure that it is not injected into a blood vessel, as this may cause a severe circulatory reaction known as shock.

There is no benefit in administering this product to individuals who are carriers of HBsAg. Serious allergic reactions are rare. However, in some cases, anti-hepatitis B immunoglobulin may cause a sudden drop in blood pressure, breathing difficulties, fainting, fever, and skin reactions (anaphylaxis), even in patients who previously tolerated immunoglobulin treatment.

If an allergic or anaphylactic reaction is suspected, administration must be stopped immediately. In case of shock, standard medical treatment should be followed. This product contains 3.9 mg sodium per ml. This should be considered in patients on a low-salt diet, depending on the total dose administered.

Medicines derived from human blood or plasma undergo several safety measures to prevent infection transmission. These include:

• Careful selection of donors to exclude those at risk of infections
• Testing of donated blood and plasma for infectious agents and viruses
• Manufacturing steps designed to inactivate or remove viruses

Despite these precautions, the risk of transmitting infections cannot be completely ruled out. This includes unknown or emerging pathogens. These measures are effective against viruses such as HIV, HBV, HCV, and HAV. However, they may be less effective against viruses like parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, likely because the antibodies present in the product provide protection. It is recommended that the product name and batch number are recorded each time a dose is administered, to ensure traceability.

The effects of overdose are not known.

Vaccines, Anti-sera & Immunoglobulin

Store in a refrigerator at 2–8°C. Keep in the original outer carton to protect from light. Keep out of reach and sight of children.