국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hepatitis B immunoglobulin human
Biotest (UK) Ltd
J06BB04
Hepatitis B immunoglobulin human
50unit/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 04036124014599
Hepatect CP 50 IU/ml solution for infusion Package leaflet PIL / UK / Hepatect CP 1/6 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 of the 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 a 전체 문서 읽기
OBJECT 1 HEPATECT CP Summary of Product Characteristics Updated 01-May-2015 | Biotest (UK) Ltd 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: IgG1: 59% IgG2: 35 % IgG3: 3 % IgG4: 3 % IgA max 2,000 micrograms/ml. For excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion The solution is clear or slightly opalescent. 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: 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 should be adjusted according to body surface area, on the basis of 10 000 IU/1.73 m 2 . IMMUNOPROPHYLAXIS OF HEPATITIS B: - Prevention of hepatitis B in case of accidental exposure 전체 문서 읽기