180 IU/ml solution
for injection
Human immune globulin against hepatitis B
What Umanbig is and what it is used for
Umanbig is a solution of human immunoglobulin against hepatitis B. Immunoglobulins are blood proteins and act as antibodies .
Umanbig is used in the following cases:
- to prevent re-infection with hepatitis B after liver transplantation due to liver failure caused by hepatitis B.
- to quickly provide available antibodies against the hepatitis B virus to prevent hepatitis B in the following cases:
- in non-immunized persons (i.e. persons not vaccinated against hepatitis B virus, including persons whose vaccination is incomplete or where information on vaccination is missing) who have been inadvertently exposed to hepatitis B virus
- in hemodialysis patients (i.e. people who have severe renal impairment and who require the blood to be purified artificially), until vaccination has been effective
- in newborn children of mothers who are carriers of the hepatitis B virus
- in people who have not shown an immune response after vaccination (i.e. peoplein whom the vaccination has not been effective), and for whom regular preventive treatment is necessary due to the continuous risk of being infected with hepatitis B.
Human hepatitis B immune globulin contained in Umanbig may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before using Umanbig
Do not use Umanbig
if you are allergic to human immunoglobulins or any of the other ingredients of this medicine (listed in section 6).
If you have a deficiency of immunoglobulin A ( IgA ), you can develop antibodies against immunoglobulin A in the blood. Umanbig contains small amounts of IgA and thus severe allergic reactions can occur. The doctor must therefore consider the benefits of treatment with Umanbig against the possible risk of allergic reactions
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Umanbig.
The person giving Umanbig to you should ensure that the medicine is not given into a blood vessel. This can produc,e ananother healthcare professionalof the circulatory system, known a,s shock .
If you are a carrier of HBsAg, there is no benefit in using this medicine.
Serious allergic reactions are rare.
Human hepatitis B immunoglobulin can rarely cause a drop in blood pressure with respiratory effects, fainting, sometimes with fever and skin reactions ( anaphylactic reaction ). This can occur even if you have not had such a reaction during previous treatment with immunoglobulin.
If the doctor or the person giving the medicine to you suspects an allergic or anaphylactic reaction, the treatment should be stopped immediately. If shock occurs, doctors should follow standard medical treatment for shock.
If you notice any of these symptoms; breathing difficulties, pain in and swelling of the arms or legs, loss of movement or feeling in a body part (so-called focal neurological loss), and chest pain contact a doctor immediately or go to the nearest hospital, because you may have had a blood clot.
This medicine contains 3.9 mg of sodium per ml. This should be taken into account if you have been prescribed a low-salt diet, aand nd are dept on the total dose of a Umanbig.
When medicines are made from human plasma or blood, special measures are taken to prevent infection from being passed on to patients. This includes:
- a careful selection of blood and plasma donors, to ensure that people at risk of being carriers are excluded
- a sampling of donors to ensure that there are no infectious agents and/or viruses
- measures to neutralize or remove viruses during manufacturing.
Despite this, the risk of transmission of infection cannot be completely excluded when medicines made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered effective against enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B virus (HBV), hepatitis C virus ( HCV ), and the non-enveloped hepatitis A virus et (HAV).
The measures may be of limited value against viruses such as parvovirus B19.
Immunoglobulins have not been able to be linked to infection with hepatitis A or parvovirus B19, probably due to the fact that the antibodies in the product have a protective effect.
When given Umanbig, it is strongly recommended that the product name and batch number be recorded to enable the tracking of used product.
Effect on blood samples
If you have to give a blood test after receiving Umanbig, you must tell the nurse or doctor that you have received this medicine. Umanbig can interfere with some tests for antibodies against red blood cells.
Children
No special measures or special supervision are required for children.
Other medicines and Umanbig
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Umanbig must not be mixed with other medicines.
Live attenuated virus vaccines
Umanbig can affect the development of the immune response to vaccines with live atbecauseh as rubella, mumps, measles, and chicken pox. The use of immunoglobulin may affect the effectiveness of these vaccines for at least 3 months. After administration of Umanbigthe , a period of at least 3 months should elapse before vaccination with live attenuated virus is performed.
After vaccination with a live attenuated virus, three to four weeks should elapse before human hepatitis B immunoglobulin is used. If the use of human hepatitis B immunoglobulin is necessary within three to four weeks after vaccination, vaccination should be carried out again three months after the use of human hepatitis B immunoglobulin.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to try to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of this drug for use in pregnant women has not been established in controlled clinical trials and should therefore only be given with caution to pregnant women. Clinical experience with immunoglobulins does not the indicate that any harmful effects during pregnancy, on the fetus or the newborn child can be expected.
Breast-feeding
The safety of Umanbig has not been established in controlled clinical trials and should therefore be given with caution to breastfeeding women. Immunoglobulins pass into breast milk and can help protect the newborn from pathogens that enter the body via mucous membranes.
Fertility
Clinical experience with immunoglobulibreastfeedingat no harmful effect on fertility is expected.
Driving ability and use of machinery
Umanbig has no or negligible effects on the ability to drive and use machines. If you experience side effects during the treatment, you must wait until these subside before driving or operating machinery.
Umanbig contains sodium
This medicinal product contains 3.9 mg and 11.7 mg of sodium (the main ingredient in common/table salt) per 1 ml and 3 m,l vial , respectively. This corresponds to 0.19% and 0.58% respectively of the maximum recommended daily intake of sodium for adults.
How to use Umanbig
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Umanbig should be given as an injection into a muscle ( intramuscular ). The medicine must be adjusted to room or body temperature before use. Remove the outermost protection from the rubber stopper and draw up the solution into a syringe. Change the needle and inject. Once the solution has been drawn up into the syringe, the medicine should be given immediately.
The solution is clear and colorless or light yellow to light brown. Do not use solution that is cloudy or contains particles. If larger volumes (over 2 ml for children or over 5 ml for dults) are required, it is recommended that one dose be divided into several doses and given at different injection sites.
Unused medicines and waste must be disposed of according to current instructions.
Dose
The doctor adapts the dose to you.
The usual dosage is as follows:
To prevent re-infection with hepatitis B after liver transplantation due to liver failure caused by hepatitis B:
Adults
The suggested dosage is 2160 IU intramuscularly every 15 days after transplantation, except for the first week. This dosage should be modified during long-term treatment to ensure an HBsAg antibody level above 100 IU/l in HBV- DNA -negative patients and above 500 IU/l in HBV- DNA -positive patients.
Concomitant use of aa n appropriate antiviral agent (antiviral drug ) should be considered as standard treatment to prevent the re-infection of hepatitis B.
Use in children
For the prevention of reinfection in children with hepatitis B after liver transplantation due to liver failure caused by hepatitis B, no data are available.
To prevent hepatitis B in the following cases:
- Prevention of hepatitis B in non-immunized persons who have been inadvertently exposed to hepatitis B virus: at least 500 IU (international units), depending on the degree of exposure, as soon as possible after the exposure and preferably within 24-72 hours.
- Prevention of hepatitis B in hemodialysis patients:8-12 IU/kg but no more than 500 IU, every two months until the vaccination has become effective
- Prevention of hepatitis B in newborn children of mothers who are carriers of the hepatitis B virus, at birth or as soon as possible after birth:30-100 IU/kg. Repeated treatment with the drug may be required until the vaccination has become effective.
In all these situations vaccination against hepatitis B virus is strongly recommended. The first vaccination dose can be injected on the same day as human immunoglobulin against hepatitis B but at different injection sites.
If you have not shown an immune response (no measurable hepatitis B antibodies ) after vaccination and if regular preventive treatment is necessary, doctors may consider injecting 500 IU (for adults) and 8 IU/kg (for children) every two months.
If you have used too much Umanbig
The consequences of overdose are not known.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, Umanbig can cause side effects, although not everybthe ody gets them.
If you experience any of these side effects, contact your doctor immediately or the nearest hospital:
- Allergic reaction (hypersensitivity), anaphylactic shock (an extreme, often life-threatening allergic reaction ). Symptoms of allergic reaction/anaphylactic shock include itching , skin reactions, swelling of lips, face, tongue, difficulty swallowing, difficulty breathing, fainting.
The following side effects can generally occur after treatment with human immunoglobulins given intramuscularly:
– side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain ( arthralgia ), low blood pressure, and moderate pain in the lower back can sometimes occur ;
-in rare cases, human normal immunoglobulins can cause a sudden drop in blood pressure ( hypotension ) and, in rare cases, a hypersensitivity reaction (anaphylactic shock ), even when the patient has not shown hypersensitivity during previous administration .
– local reactions at the injection site: pain, swelling, redness ( erythema ), induration, heat, rash, itching often occur.
The following sid effects have been reported with the adminand istration of Umanbig during post-marketing use of theand medicine (the frequency cannot be estimated from the available data).
- Headache
- Increased heart rate ( tachycardia )
- Drop in blood pressure ( hypotension )
- Nausea
- Vomiting
- Skin reactions, redness ( erythema ), itching
- Joint pain ( arthralgia )
- Fever
- Feeling of illness
- Overindulge
- At the point of administration; pain, swelling, redness, induration, heat, rash, itching
For information about virus security, see section 2 “What you fore using Umanbig”
Other side effects in children
The frequency, type, and severity of side effects in childrenthe are expected to be the same as in adults
How Umanbig should be stored
Store out of sight and reach of children.
Use before the eand xpiry date which is stated on the carton after the Expiration date. and on the label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 o C-8 o C).
Store in the outer carton. Light sensitive.
Do not freeze.
Do not use Umanbig if the solution is cloudy or contains particles ( see also “Appearance of the medicinal product and package sizes” under section 6 “Other information” ). Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is human immunoglobulin against hepatitis B.
| Umanbig 180 IU/ 1 ml | Umanbig 540 IU/ 3 ml | |
|---|---|---|
| Human protein | 100-180 g/l | 100-180 g/l |
| of which human immunoglobulin G to at least | 90% | 90% |
| antibodies against HBs antigen (anti – HBs) at least | 180 IU/vial(180 IU/ml) | 540 IU/vial(180 IU/ml) |
Distribution of IgG subclasses:
IgG 1 63.7%
IgG 2 31.8%
IgG 3 3.3%
IgG 4 1.2%
The highest content of IgA is 300 micrograms/ml.
Made from human plasma.
Other ingredients are glycine, sodium chloride, and water for injections.
ApInformationd package sizes of the medicine
Umanbig is a solution for injection.
The solution is clear and colorless or light yellow to light brown. During storage, the solution may become slightly cloudy or form small amounts of particles.
Umanbig 180 IU solution for injection: vial with 1 ml containing 180 IU.
Umanbig 540 IU solution for injection: vial with 3 ml containing 540 IU.
Marketing Authorisation Holder
Kedrion SpA – Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca), Italy
Manufacturer
Kedrion SpA – SS 7 bis Km 19.5, S. Antimo (Napoli), Italy
This medicine is authorized in the Member States of the EEA under the following names:
Denmark: Uman Big
Italy: UMAN BIG
Poland: UMAN BIG
Portugal: Uman Big
Germany: UMAN BIG
Hungary: Umanbig 180 IU/ml oldatos injekció
Austria: UMAN BIG 180 IU/ml Injektionslösung