Pays: Union européenne
Langue: anglais
Source: 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
Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection.Protection against hepatitis-B infections may not be obtained until after the second dose.Therefore:Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course;it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.
Revision: 17
Authorised
2002-08-30
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER AMBIRIX, 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/YOUR CHILD STARTS 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, nurse or pharmacist. • This vaccine has been prescribed for you/your child only. Do not pass it on to others. • If you/your child gets any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be given to adolescents and children so you may be reading it for your child. WHAT IS IN THIS LEAFLET 1. What Ambirix is and what it is used for 2. What you need to know before you receive Ambirix 3. How Ambirix is given 4. Possible side effects 5. How to store Ambirix 6. Contents of the pack and other information 1. WHAT AMBIRIX IS AND WHAT IT IS USED FOR Ambirix is a vaccine used in infants, children and young people from 1 year up to and including 15 years. It is used to prevent two diseases: hepatitis A and hepatitis B. • HEPATITIS A: Infection with the hepatitis A virus may cause the liver to become swollen (inflamed). The virus is usually caught from food or drink that contains the virus. However, it is sometimes caught in other ways, such as by swimming in water that has sewage in it or from another infected person. The virus is found in body fluids such as faeces, serum or saliva. Symptoms begin 3 to 6 weeks after infection. Some people can feel sick, have a fever and aches and pains. After a few days they may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice). The severity and type of symptoms can vary. Young children may not get all symptoms. Most children reco Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ambirix, 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+ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Ambirix is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection. Protection against hepatitis B infections may not be obtained until after the second dose (see section 5.1). Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course. - It is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY - Dosage A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age. - Primary vaccination schedule The standard primary course of vaccination consists of two doses, the first administered at the elected date and the second between 6 and 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 In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given. The safety and immunogenicity of Ambirix a Lire le document complet