| Information for
patients
|
| Drug Information |
This product is a solution containing a large quantity of hepatitis B antibodies. It is prepared from blood plasma from screened donors. Human Hepatitis B Immunoglobulin is given by injection into a muscle (intramuscular) such as the buttock or thigh. Your doctor or nurse will give you the injection. It is used to protect against infection by the hepatitis B virus and is normally given with hepatitis B vaccine. Your doctor will explain further why this medicine has been given to you.
This product is usually given to you if:
•you have not had previous vaccination, or have not been properly vaccinated, to hepatitis B and have been accidentally exposed to infection by skin pricks, cuts, spillage into the eye or mouth, from infectious material such as blood, or from bites.
•you are having kidney dialysis while waiting for vaccination to be fully effective.
•you have not responded to hepatitis B vaccination, but you remain at risk of infection, perhaps because of your job.
• you are within seven days of sexual contact with someone who has hepatitis B. The product can also be given to newborn babies whose mother has hepatitis B. |
| Drug Alert |
| Alert |
no data available |
| Before Consuming
the Medicine
|
| Avoid Drug |
•suffering from any blood disorders which interfere with clotting
•alergic to any of the ingredients in this product. |
| Drug Special Care |
•develop an allergic reaction. If you suffer from any of these, or just feel unwell, tell your doctor.
•suffer from a blood disorder. Inform your doctor before this medicine is injected.
Your doctor or nurse may inject this product just under the skin under these circumstances.
•have had any vaccinations recently or know you are about to have any vaccinations. Tell your doctor if this is the case.
•have had this product recently as it may give misleading results if you have a blood test. Tell your doctor if this is the case. |
| Drug Drug Interactions |
Please tell your doctor if you are taking, or have recently taken, any other medicines, including those obtained without a prescription. This solution for injection must not be mixed with other medicinal products for injection. Your doctor will advise you about any vaccinations you may need in addition to giving you this product. |
| Drug Pregnancy Interaction |
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before this medicine is injected. |
| Drug Breast feeding Interaction |
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before this medicine is injected. |
| Drug Machinery Interaction |
There are no known effects of this product on your ability to drive or operate machinery. |
| Drug More Information |
no data available |
| How to take the
Medicine
|
| Consumption Info |
no data available |
| Drug quanitty |
Doses
After accidental exposure to possible hepatitis B infection:
Adults: The dose is at least 500 IU.
Children: 10 years and older: 500 IU (as adult); 5 to 9 years: 300 IU; Birth to 4 years: 200 IU.
A second dose is usually given 4 weeks later. Your doctor will advise you on the dose for you and whether you need a second dose.
On kidney dialysis a dose of 8 to 12 IU/kg body weight (maximum 500 IU) is given every 2 months while waiting for vaccination to become fully effective.
Newborns whose mother has hepatitis B a dose of 30 to 100 IU/kg is given, preferably within 24 hours of birth. Further doses may be necessary until vaccination has become fully effective.
Within one week of sexual contact with a person with hepatitis B, the dose is at least 500 IU. |
| Drug Dose |
This product must always be injected by a doctor or nurse. Human Hepatitis B Immunoglobulin must never be injected into a vein; it must be injected slowly into a large muscle such as the buttock or thigh. Human Hepatitis B Immunoglobulin does not work if you already have hepatitis B. A blood test to see whether you have the infection may be done before injection. However, the injection should not be delayed for more than 48 hours after you have been exposed to a possible hepatitis B infection. In any case, the dose should be given within one week after exposure to the infection. |
| Excess Drug Consumption |
Dail 1066. OR Contact doctor immediately |
| Forgot Drug Consumption |
Contact Your doctor |
| Stop Drug Consumption |
no data available |
| Possible Side
Effects
|
| General Information |
Please note
The possibility of infection from using medicines made from human blood plasma cannot be totally ruled out. This warning includes known, unknown and new viruses as well as some other germs. Several different steps have been taken to make this possibility very unlikely. These include the careful selection of donors and testing of the plasma they provide for specific types of infection. Furthermore, the method used to produce the medicine from their blood plasma includes steps to kill or remove viruses like HIV, hepatitis B and hepatitis C. 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 Human Hepatitis B Immunoglobulin the name and batch number of the product are recorded in order to maintain a record of the batches used.
Please remember
Since hepatitis B can kill you the expected benefits of your medicine will usually be greater than the risks of suffering any harmful side effects. |
| Common Drug Side Effects |
chest pain, shortness of breath, shaking, dizziness, swelling of the face, coating of the tongue, mouth ulcers, joint pains, slight fever. |
| Rare Drug Side Effects |
no data available |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
no data available |
| How to Store the
Medicine
|
| How to Store the Medicine |
•Keep out of the reach and sight of children.
•You should store the medicine in its carton to protect it from light, in the refrigerator (2-8°C). Do not freeze. Short periods (up to one week) of storage at room temperature (25°C), in the dark, will not damage the product.
•Do not use the medicine after the expiry date which is printed as “EXP” on the containers (the expiry date refers to the last day of the month stated).
•Do not use the medicine if it is cloudy or any small bits can be seen in it.
Disposal
After injection of the correct dose, your doctor or nurse will dispose of any solution that remains, along with used syringes, needles and containers. Medicines should not be disposed of via wastewater or household waste. |
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