Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
hepatitis B surface antigen
GlaxoSmithKline Biologicals S.A.
J07BC01
hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Vaccines
Hepatitis B; Immunization
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Revision: 12
Authorised
2005-02-02
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE USER FENDRIX SUSPENSION FOR INJECTION Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE 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 or pharmacist. • This vaccine has been prescribed for you only. Do not pass it on to others. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Fendrix is and what it is used for 2. What you need to know before you receive Fendrix 3. How Fendrix is given 4. Possible side effects 5. How to store Fendrix 6. Contents of the pack and other information 1. WHAT FENDRIX IS AND WHAT IT IS USED FOR Fendrix is a vaccine which prevents hepatitis B. It is used for patients with kidney problems: • patients having “haemo-dialysis”- where a “dialysis” machine removes waste products from the blood • patients who are going to have “haemo-dialysis” in the future. Fendrix is for adults and young people aged 15 years and above. WHAT IS HEPATITIS B? Hepatitis B is caused by a virus which makes the liver swollen. • Signs may not be seen for 6 weeks to 6 months after infection. • The main signs of the illness include mild signs of flu such as headache or fever, feeling very tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice). These or other signs may mean the person might need treatment in hospital. Most people fully recover from the illness. • Some people with hepatitis B do not look or feel ill - they do not have any signs of illness. • The virus is found in body fluids such as in the vagina, blood, semen, or saliva (spit). CARRIERS OF HEPATITIS B • The hepatitis B virus stays in the body of some people all through their lives. • This means they can still infect other people and are k Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3 20 micrograms 1 adjuvanted by AS04C containing: - 3- _O_ -desacyl-4’- monophosphoryl lipid A (MPL) 2 50 micrograms 2 adsorbed on aluminium phosphate (0.5 milligrams Al 3+ in total) 3 produced in yeast cells ( _Saccharomyces cerevisiae_ ) by recombinant DNA technology. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology PRIMARY IMMUNISATION: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine. BOOSTER DOSE: As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines. 3 Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine. SPECIAL POSOLOGY RECOMMENDATION FOR KNOWN OR PRESUMED EXPOSURE TO HBV: Data on concomitant a Прочетете целия документ