País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
hepatitis A virus (inactivated), hepatitis B surface antigen
GlaxoSmithKline Biologicals S.A.
J07BC20
hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Vaccines
Hepatitis B; Hepatitis A; Immunization
Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Revision: 23
Authorised
1996-09-19
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE USER TWINRIX ADULT, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 your 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 Twinrix Adult is and what it is used for 2. What you need to know before you receive Twinrix Adult 3. How Twinrix Adult is given 4. Possible side effects 5. How to store Twinrix Adult 6. Contents of the pack and other information 1. WHAT TWINRIX ADULT IS AND WHAT IT IS USED FOR Twinrix Adult is a vaccine used in adults and adolescents 16 years of age and above to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. • HEPATITIS A: Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people ill for about a month. • HEPATITIS B: Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). The virus is fou Leer el documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1 ml) contains: Hepatitis A virus (inactivated) 1,2 720 ELISA Units Hepatitis B surface antigen 3,4 20 micrograms 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al 3+ 3 Produced in yeast cells ( _Saccharomyces_ _cerevisiae_ ) by recombinant DNA technology 4 Adsorbed on aluminium phosphate 0.4 milligrams Al 3+ The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology - Dosage A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above. _ _ - Primary vaccination schedule The standard primary course of vaccination with Twinrix Adult consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose. In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose. 3 The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine. - Booster dose Long-term an Leer el documento completo