HEPATECT CP 50 IU/ML SOLUTION FOR INFUSION
Active substance: HUMAN HEPATITIS B IMMUNOGLOBULIN
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PACKAGE LEAFLET: INFORMATION FOR THE USER
50 IU/ml solution for infusion Human hepatitis B immunoglobulin for intravenous administration Information for medical or health care professionals is provided at the end of this leaflet in a separate section. Read all of this leaflet carefully before you start using this medicine - Keep this leaflet. You may want to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What HEPATECT CP is and what it is used for 2. Before you use HEPATECT CP 3. How to use HEPATECT CP 4. Possible side-effects 5. How to store HEPATECT CP 6. Further information 1. WHAT HEPATECT CP IS AND WHAT IT IS USED FOR HEPATECT CP contains the active ingredient human hepatitis B immunoglobulin, which can protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus. HEPATECT CP is a solution for infusion (into a vein) and comes in vials containing 2 ml (100 International Units [IU]), 10 ml (500 IU), 40 ml (2000 IU) and 100 ml (5000 IU). HEPATECT CP is used to give immediate and long-term immunity (protection) to: - prevent hepatitis B infection in patients who have not been vaccinated or fully vaccinated against hepatitis B and who are at risk of infection with hepatitis B. - prevent infection of a transplanted liver in patients who test positive for hepatitis B. - newborn babies whose mothers are infected with the hepatitis B virus. - protect patients for whom hepatitis B vaccination has not provided adequate protection.
2. BEFORE YOU USE HEPATECT CP You should not be given HEPATECT CP if you, - are allergic (hypersensitive) to human immunoglobulin or any of the other ingredients of HEPATECT CP (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. - have already been fully vaccinated against hepatitis B and you are immune. Take special care with HEPATECT CP (and talk to your doctor) if you - suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia) - have had a reaction to other antibodies (in rare cases you may be at risk of allergic reactions) Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume (hypovolaemia), have an IgA deficiency, have problems with your blood vessels (vascular diseases) or are at risk for thrombotic events. Inform your doctor if you have been vaccinated against hepatitis B within the past four weeks. You may need to be re-vaccinated if you are given HEPATECT CP. Please note - reactions You will be carefully observed during the infusion period with HEPATECT CP to make sure that you do not suffer a reaction. Your doctor will make sure that the rate at which HEPATECT CP is infused is suitable for you. If you have a reaction during the infusion of HEPATECT CP, tell your doctor immediately. The rate of infusion can be slowed or the infusion can be stopped altogether. Information on transmission of infectious agents HEPATECT CP is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, it is important to prevent infections being passed on to patients. Blood donors are tested for viruses and infections. Manufacturers of these products also process the blood or plasma to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are given, the possibility of passing on infection cannot be totally excluded. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription. HEPATECT CP can reduce the effectiveness of some vaccines such as: - measles - rubella - mumps - chicken pox You may have to wait up to 3 months before you can have some vaccines.
Effects on blood tests HEPATECT CP can affect blood tests. If you have a blood test after receiving HEPATECT CP, please inform the person taking your blood or your doctor that you have received HEPATECT CP. Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine. Your doctor will decide if HEPATECT CP may be used during pregnancy and breastfeeding. Driving and using machines HEPATECT CP has no known effects on your ability to drive or use machines. 3. HOW TO USE HEPATECT CP HEPATECT CP is intended for intravenous administration (infusion into a vein). It is given to you by a doctor or nurse. The dose will depend on your condition and your body weight. Your doctor will know the right amount to give you. At the beginning of your infusion you will receive HEPATECT CP at a slow rate. Your doctor may then gradually increase the infusion rate. If you have any further questions on the use of this product, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, HEPATECT CP can have side effects, although not everybody gets them. Rarely, the following may occur: - chills - headache - fever - vomiting - malaise (feeling sick) - nausea (urge to vomit) - low blood pressure - allergic reactions - skin (cutaneous) reactions such as erythema (redness), itching - tachycardia (faster heart beat) Very rarely, the following may occur: - severe allergic reactions (anaphylactic shock) - joint pain
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: Method of administration HEPATECT CP should be infused intravenously at an initial rate of 0.1 ml/kg body weight/hour for 10 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 1 ml/kg body weight/hour. Clinical experience in newborns of hepatitis B virus carrier mothers has shown, that HEPATECT CP intravenously used at an infusion rate of 2 ml in-between 5 to 15 minutes has been well tolerated. Special Precautions Thromboembolic complications have been associated with the use of normal IVIg. Therefore, caution is recommended especially for patients with thrombotic risk factors. Patients should be monitored for serum anti-HBs antibody levels regularly. Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under Method of administration must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Any infusion-related adverse events should be treated by lowering the infusion rate or by stopping the infusion. HEPATECT CP contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with HEPATECT CP against the potential risk of hypersensitivity reactions. During graft re-infection preventive therapy very rare cases of intolerance reactions may be linked to an interval increase between administrations. It is strongly recommended that every time HEPATECT CP is administered to a patient, the name and batch number of the product is recorded. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Incompatibilities This medicinal product must not be mixed with other medicinal products. No other preparations may be added to the HEPATECT CP solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins. Instructions for handling and disposal Do not use HEPATECT CP after the expiry date which is stated on the label and outer carton. The expiry date refers to the last day of that month. The product must be brought to room or body temperature before use. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. The product once opened should be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements. Dosage Unless otherwise prescribed, the following recommendations apply: Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure: In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100150 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients. In children: Posology should be adjusted according to body surface area, on the basis of 10 000 IU/1.73 mC. Immunoprophylaxis of hepatitis B: - Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 IU (10 ml), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 - 72 hours.
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- Immunoprophylaxis of hepatitis B in haemodialysed patients: 8-12 IU (0.16-0.24 ml)/kg with a maximum of 500 IU (10 ml), 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 (0.6-2 ml)/kg. The hepatitis B immunoglobulin administration may be repeated until seroconversion following vaccination. In all these situations, 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. 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 (10 ml) to adults and 8 IU (0.16 ml)/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/mL.
With human immunoglobulin the following has been observed: - temporary meningitis (inflammation of the brain lining) - decrease of red blood cells (reversible haemolytic anaemia/haemolysis) - an increase in the serum creatinine (a waste product) and/or sudden kidney failure - cases of blood clots in the veins (thromboembolic reactions) have been reported in the elderly, in patients with signs of cerebral or cardiac ischemia, and in overweight and patients with very low blood volume (severely hypovolaemic). If a side effect occurs, the infusion rate will be decreased or stopped. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE HEPATECT CP Keep out of the reach and sight of children. Your pharmacist or doctor knows how to store HEPATECT CP. It should be kept in the outer carton to protect it from light. HEPATECT CP should be stored in a refrigerator at 2-8 C. Do not freeze. 6. FURTHER INFORMATION What HEPATECT CP contains: - The active substance of HEPATECT CP is human hepatitis B immunoglobulin for intravenous administration. HEPATECT CP contains 50 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG). The content of hepatitis B antibody is 50 IU/ml. The maximum immunoglobulin A (IgA) content is 2 mg/ml. The IgG subclass distribution is approx. 59 % IgG1, 35 % IgG2, 3 % IgG3 and 3 % IgG4. - The other ingredients are glycine and water for injections. What HEPATECT CP looks like and the contents of the pack HEPATECT CP is a solution for infusion. The solution is clear to faintly opalescent (milky colours like an opal) and colourless to pale yellow. Pack containing 1 vial with 100 IU in 2 ml solution Pack containing 1 vial with 500 IU in 10 ml solution Pack containing 1 vial with 2000 IU in 40 ml solution Pack containing 1 vial with 5000 IU in 100 ml solution
Marketing Authorisation Holder and Manufacturer: Biotest Pharma GmbH Landsteinerstrasse 5 63303 Dreieich Germany Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150 mail@biotest.de For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Biotest (UK) Ltd. 28 Monkspath Business Park Highlands Road Shirley Solihull West Midlands B90 4NZ Tel: +44 (0)121 733 3393 Fax: +44(0)121 733 3066 medicinesinformation@biotestuk.com PL 04500/0006 This leaflet was last approved in 04/2011
50 IU/ml solution for infusion Human hepatitis B immunoglobulin for intravenous administration Information for medical or health care professionals is provided at the end of this leaflet in a separate section. Read all of this leaflet carefully before you start using this medicine - Keep this leaflet. You may want to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What HEPATECT CP is and what it is used for 2. Before you use HEPATECT CP 3. How to use HEPATECT CP 4. Possible side-effects 5. How to store HEPATECT CP 6. Further information 1. WHAT HEPATECT CP IS AND WHAT IT IS USED FOR HEPATECT CP contains the active ingredient human hepatitis B immunoglobulin, which can protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus. HEPATECT CP is a solution for infusion (into a vein) and comes in vials containing 2 ml (100 International Units [IU]), 10 ml (500 IU), 40 ml (2000 IU) and 100 ml (5000 IU). HEPATECT CP is used to give immediate and long-term immunity (protection) to: - prevent hepatitis B infection in patients who have not been vaccinated or fully vaccinated against hepatitis B and who are at risk of infection with hepatitis B. - prevent infection of a transplanted liver in patients who test positive for hepatitis B. - newborn babies whose mothers are infected with the hepatitis B virus. - protect patients for whom hepatitis B vaccination has not provided adequate protection.
2. BEFORE YOU USE HEPATECT CP You should not be given HEPATECT CP if you, - are allergic (hypersensitive) to human immunoglobulin or any of the other ingredients of HEPATECT CP (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. - have already been fully vaccinated against hepatitis B and you are immune. Take special care with HEPATECT CP (and talk to your doctor) if you - suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia) - have had a reaction to other antibodies (in rare cases you may be at risk of allergic reactions) Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume (hypovolaemia), have an IgA deficiency, have problems with your blood vessels (vascular diseases) or are at risk for thrombotic events. Inform your doctor if you have been vaccinated against hepatitis B within the past four weeks. You may need to be re-vaccinated if you are given HEPATECT CP. Please note - reactions You will be carefully observed during the infusion period with HEPATECT CP to make sure that you do not suffer a reaction. Your doctor will make sure that the rate at which HEPATECT CP is infused is suitable for you. If you have a reaction during the infusion of HEPATECT CP, tell your doctor immediately. The rate of infusion can be slowed or the infusion can be stopped altogether. Information on transmission of infectious agents HEPATECT CP is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, it is important to prevent infections being passed on to patients. Blood donors are tested for viruses and infections. Manufacturers of these products also process the blood or plasma to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are given, the possibility of passing on infection cannot be totally excluded. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription. HEPATECT CP can reduce the effectiveness of some vaccines such as: - measles - rubella - mumps - chicken pox You may have to wait up to 3 months before you can have some vaccines.
Effects on blood tests HEPATECT CP can affect blood tests. If you have a blood test after receiving HEPATECT CP, please inform the person taking your blood or your doctor that you have received HEPATECT CP. Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine. Your doctor will decide if HEPATECT CP may be used during pregnancy and breastfeeding. Driving and using machines HEPATECT CP has no known effects on your ability to drive or use machines. 3. HOW TO USE HEPATECT CP HEPATECT CP is intended for intravenous administration (infusion into a vein). It is given to you by a doctor or nurse. The dose will depend on your condition and your body weight. Your doctor will know the right amount to give you. At the beginning of your infusion you will receive HEPATECT CP at a slow rate. Your doctor may then gradually increase the infusion rate. If you have any further questions on the use of this product, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, HEPATECT CP can have side effects, although not everybody gets them. Rarely, the following may occur: - chills - headache - fever - vomiting - malaise (feeling sick) - nausea (urge to vomit) - low blood pressure - allergic reactions - skin (cutaneous) reactions such as erythema (redness), itching - tachycardia (faster heart beat) Very rarely, the following may occur: - severe allergic reactions (anaphylactic shock) - joint pain
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: Method of administration HEPATECT CP should be infused intravenously at an initial rate of 0.1 ml/kg body weight/hour for 10 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 1 ml/kg body weight/hour. Clinical experience in newborns of hepatitis B virus carrier mothers has shown, that HEPATECT CP intravenously used at an infusion rate of 2 ml in-between 5 to 15 minutes has been well tolerated. Special Precautions Thromboembolic complications have been associated with the use of normal IVIg. Therefore, caution is recommended especially for patients with thrombotic risk factors. Patients should be monitored for serum anti-HBs antibody levels regularly. Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under Method of administration must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Any infusion-related adverse events should be treated by lowering the infusion rate or by stopping the infusion. HEPATECT CP contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with HEPATECT CP against the potential risk of hypersensitivity reactions. During graft re-infection preventive therapy very rare cases of intolerance reactions may be linked to an interval increase between administrations. It is strongly recommended that every time HEPATECT CP is administered to a patient, the name and batch number of the product is recorded. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Incompatibilities This medicinal product must not be mixed with other medicinal products. No other preparations may be added to the HEPATECT CP solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins. Instructions for handling and disposal Do not use HEPATECT CP after the expiry date which is stated on the label and outer carton. The expiry date refers to the last day of that month. The product must be brought to room or body temperature before use. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. The product once opened should be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements. Dosage Unless otherwise prescribed, the following recommendations apply: Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure: In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100150 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients. In children: Posology should be adjusted according to body surface area, on the basis of 10 000 IU/1.73 mC. Immunoprophylaxis of hepatitis B: - Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 IU (10 ml), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 - 72 hours.
185968 003
- Immunoprophylaxis of hepatitis B in haemodialysed patients: 8-12 IU (0.16-0.24 ml)/kg with a maximum of 500 IU (10 ml), 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 (0.6-2 ml)/kg. The hepatitis B immunoglobulin administration may be repeated until seroconversion following vaccination. In all these situations, 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. 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 (10 ml) to adults and 8 IU (0.16 ml)/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/mL.
With human immunoglobulin the following has been observed: - temporary meningitis (inflammation of the brain lining) - decrease of red blood cells (reversible haemolytic anaemia/haemolysis) - an increase in the serum creatinine (a waste product) and/or sudden kidney failure - cases of blood clots in the veins (thromboembolic reactions) have been reported in the elderly, in patients with signs of cerebral or cardiac ischemia, and in overweight and patients with very low blood volume (severely hypovolaemic). If a side effect occurs, the infusion rate will be decreased or stopped. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE HEPATECT CP Keep out of the reach and sight of children. Your pharmacist or doctor knows how to store HEPATECT CP. It should be kept in the outer carton to protect it from light. HEPATECT CP should be stored in a refrigerator at 2-8 C. Do not freeze. 6. FURTHER INFORMATION What HEPATECT CP contains: - The active substance of HEPATECT CP is human hepatitis B immunoglobulin for intravenous administration. HEPATECT CP contains 50 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG). The content of hepatitis B antibody is 50 IU/ml. The maximum immunoglobulin A (IgA) content is 2 mg/ml. The IgG subclass distribution is approx. 59 % IgG1, 35 % IgG2, 3 % IgG3 and 3 % IgG4. - The other ingredients are glycine and water for injections. What HEPATECT CP looks like and the contents of the pack HEPATECT CP is a solution for infusion. The solution is clear to faintly opalescent (milky colours like an opal) and colourless to pale yellow. Pack containing 1 vial with 100 IU in 2 ml solution Pack containing 1 vial with 500 IU in 10 ml solution Pack containing 1 vial with 2000 IU in 40 ml solution Pack containing 1 vial with 5000 IU in 100 ml solution
Marketing Authorisation Holder and Manufacturer: Biotest Pharma GmbH Landsteinerstrasse 5 63303 Dreieich Germany Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150 mail@biotest.de For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Biotest (UK) Ltd. 28 Monkspath Business Park Highlands Road Shirley Solihull West Midlands B90 4NZ Tel: +44 (0)121 733 3393 Fax: +44(0)121 733 3066 medicinesinformation@biotestuk.com PL 04500/0006 This leaflet was last approved in 04/2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
