Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
IMMUNOGLOBULIN ANTIHEPATITIS
Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom
J06BB04
IMMUNOGLOBULIN ANTIHEPATITIS B 100 IU/ml
SOLUTION FOR INJECTION
IMMUNOGLOBULIN ANTIHEPATITIS B 100 IU/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Withdrawn
2007-10-01
BPL 0792 18.05.12 PROOF: THREE 90 x 290MM COLOURS: Black BPL PO No.: 261148 PMS 273 PMS 430 PATIENT INFORMATION LEAFLET HUMAN HEPATITIS B IMMUNOGLOBULIN 100 IU/ML STERILE SOLUTION SHDNL2 PLEASE READ ALL OF THIS LEAFL ET CAREFULLY BEFORE USING THIS MEDICINE. • Keep this leafl et. You may need to read it again. • If you have any further questions, please ask your doctor. • This medicine has been prescribed for you personally. 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 get serious, or if you notice any side effects not listed in this leafl et, please tell your doctor. Is this leafl et hard to see or read? Phone 020 8258 2200. IN THIS LEAFL ET: 1. What Human Hepatitis B Immunoglobulin is and what it is used for 2. Before you are given Human Hepatitis B Immunoglobulin 3. How you are given Human Hepatitis B Immunoglobulin 4. Possible side effects 5. How to store Human Hepatitis B Immunoglobulin 6. Further information 1. WHAT HUMAN HEPATITIS B IMMUNOGLOBULIN IS AND WHAT IT IS USED FOR 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 Διαβάστε το πλήρες έγγραφο
_ _ _ _ _ _ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF PRODUCT Human Hepatitis B Immunoglobulin. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human Hepatitis B Immunoglobulin Ph.Eur. * Human Hepatitis B Immunoglobulin is presented as two vial sizes of 200 iu and 500 iu. Each millilitre contains: 10-100 mg/ml human protein of which at least 95% are gammaglobulins. This product is prepared from plasma from screened donors. Donors are selected from the USA. * One millilitre contains not less than 100 iu of hepatitis B antibody. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Human Hepatitis B Immunoglobulin is indicated for: i. Post exposure prophylaxis in persons who have not received prior vaccination, or whose vaccination regimen is incomplete, or when the antibody level is inadequate (i.e. <10 iu/L). ii. The passive immunisation of people at increased risk of exposure should be used in combination with hepatitis B vaccination. iii. Accidental exposure (skin pricks, contamination of abrasions, spillage into eye or mouth, bites or scratches) to blood or other material containing HBsAg. Contamination of intact skin is not included unless there is heavy contamination of a large area. iv. Sexual contacts of patients with acute hepatitis B. v. Non-immune staff and patients of dialysis units for temporary protection after a patient in the unit is found to be HBsAg positive, and for haemodialysis patients and recipients of certain blood products unable to develop adequate protec Διαβάστε το πλήρες έγγραφο