Indications & Uses
Hepatitis B Immuneglobulin is used to stop hepatitis B virus infection from coming back after a liver transplant, when the liver failure was caused by that virus. It also gives antibodies against the virus quickly, so hepatitis B can be prevented in these cases. The first is accidental exposure in non-immunised people, meaning people who have not been vaccinated against the hepatitis B virus, including those whose vaccination is incomplete or whose status is unknown. The second is haemodialysed patients, that is patients with severe renal failure who need their blood cleaned by an artificial kidney, and here the medicine is used until vaccination has become effective. The third is the newborn of a mother who carries the hepatitis B virus. The last is people who showed no immune response after vaccination (the vaccination did not become effective) and who need continuous protection because they stay at risk of catching the virus.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Hepatitis B Immuneglobulin is used to prevent hepatitis B virus infection from coming back after a liver transplant for liver failure caused by the virus. In adults, the suggested dose is 2000 IU IM every 15 days after the transplant, leaving out the first week. For long-term treatment, the dose should be adjusted so the serum level of HBsAg antibodies stays above 100 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients. Adequate virostatic agents should also be considered where appropriate, as a standard part of preventing hepatitis B reinfection.
In children, UMAN BIG has no relevant use for preventing the virus from coming back after liver transplantation for hepatitis B induced liver failure.
For preventing hepatitis B in other situations, the doses depend on who is being protected. After accidental exposure in people who are not immunised, give at least 500 IU (International Units), depending on how intense the exposure was. Give it as soon as possible after exposure, preferably within 24 to 72 hours. For haemodialysed patients, the dose is 8 to 12 IU/kg with a maximum of 500 IU, given every 2 months until the vaccination has become effective. For a newborn whose mother carries the hepatitis B virus, give 30 to 100 IU/kg at birth or as soon as possible after birth. The immunoglobulin may need to be repeated until the vaccination has become effective.
In all of these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be given on the same day as the human hepatitis B immunoglobulin, but at a different injection site.
If a person has not shown an immune response after vaccination (no measurable hepatitis B antibodies) and continuous prevention is still necessary, the doctor may consider giving 500 IU to adults and 8 IU/kg to children every 2 months.
Side Effects
Hypersensitivity, anaphylactic shock, headache, tachycardia, hypotension, vomiting, erythema, itching and malaise.
Cautions & Contraindications
Warnings & Precautions
The person giving you Hepatitis B Immuneglobulin must make sure it is not injected into a blood vessel. If it is, it could cause an acute (or severe) crisis of the circulatory system, known as shock. If you are a carrier of HBsAg, there is no benefit in giving you Hepatitis B Immuneglobulin. Serious allergic reactions are rare. Rarely, human anti-hepatitis B immunoglobulins can cause a sudden fall in blood pressure with breathing difficulty, fainting, sometimes fever and skin reactions (an anaphylactic reaction). This can happen even if you have tolerated earlier treatment with immunoglobulins. If your doctor or the person giving you the product suspects an allergic or anaphylactic reaction, they must stop the administration immediately. In case of shock, your doctor should follow the standard medical treatment for shock. The product contains 3.9 mg sodium per ml. If you are on a low salt diet, this must be taken into account, depending on the total amount of product you need to receive. 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: careful selection of blood and plasma donors, so that those at risk of carrying infections are excluded; testing of the donations to make sure there are no infective agents and/or viruses; and steps during the manufacturing process that can inactivate or remove viruses. Even with these measures, the possibility of passing on infection cannot be totally excluded when medicines prepared from human blood or plasma are given. This also applies to any unknown or emerging infectious agents or other types of infections. The measures are considered effective against viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and hepatitis A virus (HAV). They may be of limited value against viruses such as parvovirus B19. Immunoglobulins have not been linked with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections, which are contained in the product, are protective. Every time you receive a dose of Hepatitis B Immuneglobulin, it is strongly recommended that the name and batch number of the product are recorded, so that a record of the batches used is kept.
Contraindications
Don't use Hepatitis b immune globulin if you are allergic (hypersensitive) to human immunoglobulins or to any of the other ingredients in it. Take a person with a deficiency of immunoglobulin A (IgA). Their blood may develop antibodies against immunoglobulin A. Hepatitis b immune globulin contains a small quantity of IgA, so 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.
Pregnancy & Breastfeeding
Pregnancy: The safety of Hepatitis B Immuneglobulin in human pregnancy has not been established in controlled clinical trials, so it should only be given with caution to pregnant women and breast-feeding mothers. Still, clinical experience with immunoglobulins suggests that no harmful effects are expected on the course of pregnancy, on the fetus or on the neonate.
Breastfeeding: Immunoglobulins pass into the milk and may help transfer protective antibodies to the neonate.
Fertility: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are expected.
Driving and using machines: No effects on the ability to drive and use machines have been observed.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep Hepatitis B Immuneglobulin in a refrigerator at 2-8°C. Leave it in its outer carton so the light can't reach it. Always keep it out of the reach and sight of children.
Common questions about IMMUNOHBs 180 IU/ml
What is IMMUNOHBs 180 IU/ml Injection?
IMMUNOHBs 180 IU/ml Injection is a medicine that contains Hepatitis B Immuneglobulin. It is made by ZAS Corporation. It belongs to the Vaccines group of medicines.
What is IMMUNOHBs used for?
Hepatitis B Immuneglobulin is used to stop hepatitis B virus infection from coming back after a liver transplant, when the liver failure was caused by that virus. It also gives antibodies against the virus quickly, so hepatitis B can be prevented in these cases.
What are the side effects of IMMUNOHBs?
Hypersensitivity, anaphylactic shock, headache, tachycardia, hypotension, vomiting, erythema, itching and malaise.
Can I take IMMUNOHBs during pregnancy or while breastfeeding?
Pregnancy: The safety of Hepatitis B Immuneglobulin in human pregnancy has not been established in controlled clinical trials, so it should only be given with caution to pregnant women and breast-feeding mothers. Still, clinical experience with immunoglobulins suggests that no harmful effects are expected on the course of pregnancy, on the fetus or on the neonate. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store IMMUNOHBs?
Keep Hepatitis B Immuneglobulin in a refrigerator at 2-8°C. Leave it in its outer carton so the light can't reach it.
Do I need a prescription for IMMUNOHBs?
IMMUNOHBs is a prescription (Rx) medicine. Take it as your doctor advises.