50 IU/ml powder and liquid for infusion, solution
Human immunoglobulin against hepatitis B for intravenous use
What Venbig is and what it is used for
Venbig belongs to a group of medicines called immune sera and immunoglobulins. Venbig is a solution of human immunoglobulin against hepatitis B ( proteins that act as antibodies ) for intravenous administration, and it is used in the following cases:
- To prevent reinfection with hepatitis B virus in patients who have undergone liver transplantation for liver failure caused by hepatitis B, in combination with antiviral therapy.
- Prevention to quickly get antibodies against the hepatitis B virus to prevent hepatitis B in the following cases:
- in non-vaccinated persons inadvertently exposed to hepatitis B virus (i.e. persons not vaccinated against hepatitis B virus including persons whose vaccination is incomplete or where information on vaccination is missing)
- in hemodialysis patients (i.e. patients with severe renal impairment and requiring artificial blood purification), until the vaccination has had an effect
- in newborn children of mothers who are carriers of the hepatitis B virus
- in people who did not show an immune response (i.e. people in whom the vaccination did not have an effect) after vaccination and for whom continued preventive treatment is necessary due to the continued risk of becoming infected with hepatitis B
What you need to know before using Venbig
Do not use Venbig
- If you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
- If you have antibodies against IgA immunoglobulins in your blood because administration of an IgA preparation can cause a severe allergic reaction.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Venbig. Clot formation in blood vessels ( thrombosis ) has been associated with the use of normal immunoglobulin given intravenously. The doctor will therefore be particularly careful when using this medicine if you have any risk factors for blood clots ( thrombosis ).
The number of antibodies against hepatitis B in the blood will be checked regularly.
Some side effects may occur more frequently:
– in case of a high infusion rate;
– if you have signs of uncontrolled infection (e.g. fever) or signs of chronic inflammation;
– if you receive human normal immunoglobulins for the first time;
– in rare cases where preparations with human normal immunoglobulins have been changed, or when there has been a long interval since the previous infusion.
- In certain circumstances, immunoglobulins can increase the risk of heart attack, stroke, pulmonary embolism, or deep vein thrombosis, because they increase the viscosity of the blood
The doctor will therefore be particularly careful in the following circumstances;
– if you are overweight
– if you are older,
– you suffer from high blood pressure ( hypertension ),
– you have too little blood volume ( hypovolemia ),
– you have or have had problems with the blood vessels ( vascular disease)
– you have an increased tendency for the blood to clot (hereditary or acquired thrombotic disease)
– you suffer from episodes of blood clots
– you have a disease that makes your blood thicker (have higher viscosity )
– you have been bedridden for a long time,
– you have or have had kidney problems or if you are taking medicines that can damage the kidneys (nephrotoxic medicines) when cases of acute kidney failure have been reported. In case of kidney problems, the doctor will consider stopping the treatment.
- You can be allergic (hypersensitive) to immunoglobulins ( antibodies ) without knowing it.
This can occur even if you have previously received human normal immunoglobulins and tolerated this well. It can happen, especially if you do not have immunoglobulins of the IgA type ( IgA deficiency with anti-IgA antibodies). In these rare cases, allergic reactions (hypersensitivity) such as a sudden drop in blood pressure or shock may occur.
Whoever gives you this medicine will carefully follow the infusion rate recommended in section 3 “How to use Venbig”. This is necessary because some side effects can be linked to the infusion rate. In addition, you will be carefully observed and monitored throughout the infusion, so that any symptoms of side effects can be detected.
If any side effect occurs, your doctor may decide to either lower the infusion rate or stop the infusion. In addition, your doctor will decide what treatment is required depending on the signs of the disease and the severity of the side effect.
Venbig contains a small amount of IgA. If you are deficient in IgA, there is a risk that you can develop anti-IgA antibodies and you can have anaphylactic reactions after the administration of blood components that contain IgA. The physician must weigh the benefit of treatment with Venbig against the potential risk of hypersensitivity reaction.
Human hepatitis B immunoglobulin can rarely induce a drop in blood pressure with an anaphylactic reaction, even if you have previously tolerated treatment with immunoglobulin.
If you suffer from impaired kidney function, your doctor must consider stopping treatment with IVIg. Reports of renal dysfunction and acute renal failure have been associated with the use of many of the registered IVIg products containing various excipients such as sucrose, glucose, and maltose. Those containing sucrose as a stabilizer accounted for a disproportionately large share of the total. In patients at risk of acute renal failure or thromboembolic side effects, IVIg products should be administered at the lowest possible infusion rate and dose.
During treatment with immunoglobulin, you may suffer lung damage associated with the treatment, called transfusion-related lung injury (TRALI). If you experience shortness of breath and feel that you are breathing rapidly during or within several hours of the infusion, tell your doctor or nurse immediately as these symptoms may require immediate treatment.
Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of injection. In the event of shock, standard medical treatment for shock must be instituted.
Tell your doctor if at least one of the above conditions applies to you, your doctor will be especially careful when prescribing and administering Venbig to you.
IVIg products may contain blood group antibodies that, in rare cases, can cause the breakdown of red blood cells ( hemolysis ). After IVIg treatment, some form of anemia ( anemia ) may develop due to abnormal breakdown of red blood cells ( hemolytic anemia ). During treatment with IVIg, you will be monitored for signs and symptoms of hemolysis.
Blood samples
Venbig may interfere with some blood tests due to the temporary increase of the passively transferred antibodies in the blood after injection of immunoglobulin; The elevated antibody levels can lead to misleading results in serological tests. Passive transfer of antibodies to erythrocyte antigens, e.g. A, B, D (which determine blood type), can affect certain serological tests of antibodies to red blood cells, e.g. antiglobulin test (Coombs test).
Virus security
When medicines are prepared from human blood or plasma, special measures are taken to prevent infection from being transmitted to patients. These include:
- a careful selection of blood and plasma donors to ensure that persons who may be carriers are excluded.
- testing of blood or plasma to ensure that there are no infectious agents and/or viruses
- measures to remove or disable viruses during manufacturing
Despite these measures, 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 non-enveloped hepatitis A virus (HAV).
The measures may be of limited value against non-enveloped viruses such as parvovirus B19.
Immunoglobulins have not been able to be linked to infection by hepatitis A or parvovirus B19, probably because the antibodies in the medicine against these infections are protective.
It is strongly recommended that the product name and batch number be recorded each time Venbig is administered to a patient so that a link between the patient and the product batch can be maintained.
Children
No special measures or monitoring are required.
Other medicines and Venedig
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Human immunoglobulin against hepatitis B for intravenous use must not be mixed with other medicines.
Live attenuated virus vaccines
Venbig can affect the development of the immune response to vaccines with live attenuated viruses such as rubella, mumps, measles, and chicken pox. The use of immunoglobulin may affect the effectiveness of these vaccines for a period of up to 3 months. After administration of Venbig, wait at least 3 months before vaccination with the live attenuated virus is performed.
Human hepatitis B immunoglobulin should be given three to four weeks after vaccination with such a live attenuated vaccine. In cases where the use of human hepatitis B immunoglobulin is essential 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 breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The doctor will decide whether Venbig can be used during pregnancy and breastfeeding.
- No clinical trials have been conducted with Venbig in pregnant women. IVIg preparations have been shown to cross the placenta, to an increasing extent during the last three months of pregnancy. However, antibody-containing drugs have been used by pregnant women for many years and it has been shown that no harmful effects on the course of pregnancy, the fetus, or the newborn are to be expected. If you breastfeed and receive Venbig, the antibodies in the medicine can pass into the breast milk. The child can thereby be protected against certain infections.
- Clinical experience with immunoglobulins suggests that no adverse effects on fertility are expected.
Driving ability and use of machinery
Venbig has no or negligible effect 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.
Venbig contains sodium and sucrose
This medicine contains 39 mg and 175.5 mg of sodium (the main ingredient in common/table salt) per 10 ml vial and 45 ml vial, respectively. This corresponds to 1.9% and 8.7% of the maximum recommended daily intake of sodium for adults, respectively.
This medicine contains up to 92 mg of sucrose (91.9 mg/ml) per ml. This should be considered by patients at risk of acute renal failure.
How to use Venbig
Venbig is only given in hospitals or healthcare centers by doctors or healthcare professionals.
The dosage and treatment schedule depend on the indication. The doctor will decide which dose is suitable for you.
At the beginning of infusion one, you receive Venbig at a low infusion rate. If you tolerate this well, your doctor may gradually increase the infusion rate.
For further information see the section “The following information is intended for healthcare professionals only”.
If you have used too much Venbig
The consequences of overdose are not known.
If you take more IVIg than you should, you may get an excess of protein in your blood and it will therefore become too thick (hyper viscous); it may particularly affect at-risk patients, especially elderly patients or patients with reduced heart or kidney function.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of these side effects, contact your doctor immediately or the nearest hospital:
- Allergic reactions (hypersensitivity). This side effect can in some cases develop into acute allergic reactions (anaphylactic shock ): e.g. itching, skin reactions, swelling of the lips, face, and tongue, difficulty swallowing, difficulty breathing, fainting
- Acute kidney failure (eg reduced or absent urine output, fluid retention, shortness of breath).
The following side effects can generally occur after treatment with human immunoglobulins given intravenously:
- chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain ( arthralgia ), low blood pressure, and moderate pain in the lower back may sometimes occur;
- in rare cases transient reduction in the number of red blood cells ( reversible hemolytic reactions / reversible hemolysis ), especially in patients with blood group A, B, and AB, and in rare cases hemolytic anemia ( blood deficiency ) requiring transfusion
- in rare cases, a sudden drop in blood pressure ( hypotension ) has been reported and, in isolated cases, a hypersensitivity reaction (anaphylactic shock ) may occur, even when the patient has not shown hypersensitivity during the previous administration.
- rare cases of transient skin reactions have been observed;
- in very rare cases, thromboembolic reactions (formation of blood clots) which can cause heart attack, stroke, obstruction of the pulmonary artery (blood clot in the lung), and deep vein thrombosis (blood clot in the leg) have been reported;
- cases of transient non-infectious meningitis ( reversible aseptic meningitis; meningitis )
- cases of increased serum creatinine level and/or occurrence of acute renal failure
- cases of transfusion-related lung injury (TRALI)
The following side effects have been reported during the post-marketing administration of Venbig (the frequency cannot be estimated from the available data):
- Headache
- Fast heartbeat ( tachycardia )
- Drop in blood pressure ( hypotension )
- Nausea
- Vomiting
- Skin reactions, redness ( erythema ), itching
- Joint pain ( arthralgia )
- Fever
- Feeling of illness
- Overindulge
For information on virus security, see section 2 “What you need to know before using Venbig”
How Venbig should be stored
Store out of sight and reach of children.
Use before the expiry date stated on the outer carton and the label after EXP and EXP.
The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
Store in the outer carton. Light sensitive.
Do not freeze.
Venbig should be used immediately after mixing with the solvent.
Do not use this product if the solution is cloudy or contains particles. (See also the appearance and packaging sizes of the medicine in section 6).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines 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
| Venbig 500 IU | Venbig 2500 IU | |
|---|---|---|
| Human protein | 50 g/l | 50 g/l |
| of which human immunoglobulin G to last | 95% | 95% |
| the antibody is against HBs antigen (anti – HBs) not less than | 500 IU / vial | 2500 IU / vial |
| antibody ar against HBs antigen (anti – HBs) after mixing with the solvent no less than | 50 IU/ml | 50 IU/ml |
IgG (type G immunoglobulins) subgroups have the following distribution:
IgG 1 26.0 – 40.0 mg/ml
IgG 2 13.0 – 25.0 mg/ml
IgG 3 1.20 – 2.50 mg/ml
IgG 4 0.15 – 0.50 mg/ml
Maximum IgA content 0.05 mg/ml
Made from human plasma.
Other ingredients are sucrose, sodium chloride, and water for injections.
The vial with powder contains human immunoglobulin against hepatitis B, sucrose, and sodium chloride.
The diluent vial contains sodium chloride and water for injections.
Appearance and package sizes of the medicine
The pack of Venbig contains a vial of powder and a vial of diluent used to prepare the solution for infusion.
Venbig is white or pale yellow powder or a solid friable lump.
After preparation, the solution is clear or slightly opalescent, colorless, or slightly yellow.
Prepared products should be visually inspected for particulate matter or discoloration before administration. Do not use a solution that is cloudy or contains particles.
Venbig 50 IU/ml powder and liquid for infusion, solution:
Vial with 500 IU powder + vial with 10 ml diluent + infusion set (1 syringe with needle + 1 needle for administration )
Vial with 2500 IU powder + vial with 45 ml diluent + infusion set
Kedrion SpA – Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca), Italy
Manufacturer
Kedrion SpA – SS 7 bis Km 19.5, S. Antimo (Naples), Italy