ImmunoGam
human hepatitis B immunoglobulin
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Human Hepatitis B Immunoglobulin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
What ImmunoGam is and what it is used for
Before you receive ImmunoGam
How ImmunoGam is administered
Possible side effects
How to store ImmunoGam
Further information
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ImmunoGam belongs to a group of medicines containing immunoglobulins (antibodies which can protect against certain infections), which are present in your blood. ImmunoGam contains increased levels of human hepatitis B immunoglobulins mainly immunoglobulin G (IgG) and is obtained from blood plasma of screened donors from the USA.
ImmunoGam provides protection against hepatitis B virus for a short period of time and it is used to treat the following:
Accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown).
Haemodialysed patients, until vaccination has become effective.
Newborn of a hepatitis B virus carrier-mother.
Subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
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if you have previously developed an allergic reaction to human immunoglobulins, to other blood products or to any of the other ingredients of ImmunoGam.
if you have an IgA deficiency such that you have developed an allergic reaction to IgA containing products
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General warnings related to ImmunoGam:
Immunoglobulins in general may cause adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain.
Patients should be monitored for antibodies against human hepatitis B immunoglobulin regularly.
Human hepatitis B immunoglobulin injections can induce a drop in blood pressure with an allergic reaction, even in patients who have tolerated previous treatments with immunoglobulin. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatments for shock should be administered.
Immunoglobulin A: Please tell your doctor if your blood does not have immunoglobulin A (IgA).
ImmunoGam contains small amounts of IgA. Patients who have an IgA deficiency may develop an allergic reaction to this medicine.
ImmunoGam contains maltose (10%w/w).
Serological Testing
ImmunoGam may cause a rise of various transferred antibodies which may result in misleading positive results of certain blood serum tests. Also transmission of antibodies to blood group antigens may interfere with some blood tests for red cell allo-antibodies (e.g. Coombs’ test).
Blood Glucose Testing
Blood glucose testing: when administering ImmunoGam, the measurement of blood glucose must be done with a glucose-specific method. This is because Some types of blood glucose testing systems falsely interpret the maltose contained in ImmunoGam as glucose. This may result in falsely elevated glucose readings and
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consequently in the inappropriate administration of insulin which may result in hypoglycemia. Also cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.”
Viral Safety
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed from blood donors on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove 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 viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.
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The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and 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 ImmunoGam, the name and batch number of the product are recorded in your physician’s notes in order to maintain a record of the batches used.
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Please tell your doctor or nurse, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription e.g. herbal medicines.
Please inform your doctor if you are planning to receive a vaccine or have been recently vaccinated in the last three months. This is because ImmunoGam may interfere with the response to some attenuated vaccines, such as measles, rubella, mumps, and chicken pox.
There are no available data on drug interactions of ImmunoGam with other medications.
Ask your doctor for advice before using this medicine.
Your doctor will decide if ImmunoGam can be used during pregnancy and breastfeeding.
ImmunoGam does not effect your ability to drive or use machines.
ImmunoGam contains 0.16 g of maltose in a 500 IU dose. This should be taken into account in patients with diabetes mellitus.
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The quantity of ImmunoGam you will need will be determined by your doctor or nurse. The table below provides a recommended dose. Vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected on the same day as human hepatitis B immunoglobulin, however in different sites.
Indication | Dose | Frequency of Administration |
Prevention of hepatitis B in case of accidental exposure in non-immunised subjects | At least 500 IU | 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 seroconversion following vaccination. |
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 seroconversion following vaccination |
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ImmunoGam should be brought to room temperature (approximately 20°C to 25°C ) before use. The solution should be clear to slightly opalescent and colourless or pale yellow essentially free of foreign particles. Do not use solutions that are cloudy or have deposits.
For intramuscular administration, ImmunoGam should be injected into the upper part of the shoulder (deltoid muscle), or into the right part of the thigh in the front (anteriolateral thigh) in newborn children.
If a large volume (greater than 2 ml for children or greater than 5 ml for adults) is required, it is recommended that the administration of ImmunoGam be divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
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No data is available in the event of an overdose. For intramuscular administration of ImmunoGam, the only manifestations of overdose would be pain and tenderness at the injection site.
Like all medicines, ImmunoGam can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convension:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)
Undesirable effects reported during clinical trials with ImmunoGam, that was administered intramuscularly (injected into a muscle), were uncommon (affects 1 to 10 users in 1,000). These undesirable effects were reported within the first 7 days after receiving ImmunoGam: nausea, fatigue, induration (swelling and firmness) at the injection site, feeling unwell, pain, fever, joint pain, back pain, muscle pain, headache and dizziness.
The following side effect can be serious and has been observed occasionally.
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hives, flushed skin or rash, swelling of a specific area such as the injection site or face
chest tightness, shortness of breath, wheezing
rapid increase in heart beat, sudden drop in blood pressure and/or shock
These symptoms may be early signs of an allergic reaction. Depending on the nature and severity of the
allergic reaction, your doctor may give you an additional treatment or your doctor may decide to stop the injection immediately.
In case of intramuscular administration, some discomfort may occur occasionally at the site of injection such as local pain or tenderness. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, ImmunoGam should be given only if the expected benefits outweigh the potential risks.
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Keep out of the reach and sight of children.
Do not use ImmunoGam after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 to 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Do not use ImmunoGam if the solution appears cloudy or has deposits. Medicines should not be disposed via wastewater or household waste. Any unused product should be disposed of in accordance with local requirements. These measures will help to protect the environment.
The active substance is Human hepatitis B immunoglobulin. ImmunoGam comes in a 1 ml or 5 ml vial containing 30-70 mg/ml of human plasma protein of which 96% (312 IU/ml) is Immunoglobulin G (IgG).
The other ingredients are maltose and polysorbate 80.
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ImmunoGam is presented as a solution for injection in a glass vial. It is clear to slightly opalescent and colourless or pale yellow liquid.
Pack size of 1 vial.
Marketing Authorisation Holder Cangene Europe Limited Parkshot House
5 Kew Road
Richmond, Surrey TW9 2PR United Kingdom
Telephone: +44 (0) 208 334 8527
Telefax: +44 (0) 208 334 8557
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Manufacturer Cangene Corporation 155 Innovation Drive Winnipeg, MA
R3T 5Y3
Canada
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Prevention of hepatitis B in case of accidental exposure in non-immunised subjects:
At least 500 IU, 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 seroconversion following vaccination.
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 seroconversion following vaccination.
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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.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to adults and 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.
Consideration should also be given to dose and dose schedules for human hepatitis B immunoglobulin for intramuscular use recommended in other official guidance.
ImmunoGam should be administered via the intramuscular route.
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.
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When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
ImmunoGam should be brought to room temperature (approximately 20°C to 25°C) before use
The solution should be clear to slightly opalescent and colourless or pale yellow. Do not use solutions that are cloudy or have deposits. Any unused product or waste material should be disposed of in accordance with local requirements.