Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: 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
Immunization; Hepatitis B; Hepatitis A
Twinrix Paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-A and hepatitis-B infection.
Revision: 23
Authorised
1997-02-10
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE USER TWINRIX PAEDIATRIC, 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/ 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 or your pharmacist. - This vaccine has been prescribed for you/ your child only. Do not pass it on to others. - If you get / your child gets any side effects, talk to your doctor 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 Twinrix Paediatric is and what it is used for 2. What you need to know before you receive Twinrix Paediatric 3. How Twinrix Paediatric is given 4. Possible side effects 5. How to store Twinrix Paediatric 6. Contents of the pack and other information 1. WHAT TWINRIX PAEDIATRIC IS AND WHAT IT IS USED FOR Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years 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 va Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric, suspension for injection in pre-filled syringe _ _ Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Hepatitis A virus (inactivated) 1,2 360 ELISA Units Hepatitis B surface antigen 3,4 10 micrograms 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al 3+ 3 Produced in yeast cells ( _Saccharomyces_ _cerevisiae_ ) by recombinant DNA technology 4 Adsorbed on aluminium phosphate 0.2 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 Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology - Dosage The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age. - Primary vaccination schedule The standard primary course of vaccination with Twinrix Paediatric 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. 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 Twinrix Paediatric administered as a booster 3 dose following a three-dose primary course have not been evaluated. Long-term antibody persistence data f Belgenin tamamını okuyun