Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Human plasma protein; Hbs antibodies
Biotest Pharma GmbH
J06BB; J06BB04
Human plasma protein; Hbs antibodies
50 international unit(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Specific immunoglobulins; hepatitis B immunoglobulin
Marketed
2008-08-22
Hepatect CP 50 IU/ml solution for infusion Package leaflet 1/7 PACKAGE LEAFLET: INFORMATION FOR THE USER HEPATECT CP 50 IU/ML SOLUTION FOR INFUSION Human hepatitis B immunoglobulin for intravenous administration READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Hepatect CP is and what it is used for 2. What you need to know before you use Hepatect CP 3. How to use Hepatect CP 4. Possible side effects 5. How to store Hepatect CP 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE HEPATECT CP DO NOT USE HEPATECT CP: if you are allergic to h Lestu allt skjalið
Health Products Regulatory Authority 28 January 2020 CRN009L3F Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hepatect CP 50 IU/ml; solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. Human protein 50 g/l of which at least 96 % is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml Each vial of 2 ml contains: 100 IU Each vial of 10 ml contains: 500 IU Each vial of 40 ml contains: 2000 IU Each vial of 100 ml contains: 5000 IU Distribution of IgG subclasses (approx. values): IgG1: 59% IgG2: 35 % IgG3: 3 % IgG4: 3 % The maximum IgA content is 2,000 micrograms/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion The solution is clear or slightly opalescent and colourless to pale yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure. Immunoprophylaxis of hepatitis B In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown). In haemodialysed patients, until vaccination has become effective. In the newborn of a hepatitis B virus carrier-mother. In 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver_ _failure:_ Health Products Regulatory Authority 28 January 2020 CRN009L3F Page 2 of 9 In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40-200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100-150 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients. In children: Posology Lestu allt skjalið