Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
HEPATITIS A, VIRUS, INACTIVATED, ELISA
Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland
J07BC02
HEPATITIS A VIRUS (INACTIVATED) 720 ELISA unit/dose
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
HEPATITIS A VIRUS (INACTIVATED) 720 ELISA unit/dose
POM
VACCINES
Authorised
2006-11-22
- 1 PACKAGE LEAFLET: INFORMATION FOR THE USER HAVRIX JUNIOR MONODOSE VACCINE Hepatitis A Vaccine (Inactivated, adsorbed). 720 ELISA Units/ 0.5 ml Suspension for Injection in a pre-filled syringe 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, nurse or pharmacist. • This vaccine has been prescribed for your child only. Do not pass it on to others. It may harm them. • If you get any side-effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What Havrix Junior Monodose is and what it is used for 2 What you need to know before your child receives Havrix Junior Monodose 3 How Havrix Junior Monodose is given 4 Possible side effects 5 How to store Havrix Junior Monodose 6 Contents of the pack and other information Havrix Junior Monodose is a vaccine containing the inactivated hepatitis A virus. It is used to boost the body’s immune system to stop infection from hepatitis A in children and adolescents from 1 year up to and including 15 years of age. HOW HAVRIX JUNIOR MONODOSE WORKS • The virus is not alive so this vaccine cannot cause hepatitis A infection. • When your child is given Havrix Junior Monodose their body will make antibodies (the body’s natural defence system) against the hepatitis A virus. • After 2 to 4 weeks, these antibodies will have been produced and will protect your child against hepatitis A infection. • To ensure long term protection from hepatitis A of up to 40 years, your child should receive a second (booster) vaccination 6 to 12 months after their first dose. As long as the booster is given within 5 years, they should still be fully protected. Once the booster vaccination is given, they are not expected to need an additional dose of Havrix. • Having this vaccine will only protect against Διαβάστε το πλήρες έγγραφο
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Havrix Junior MONODOSE Vaccine Hepatitis A Vaccine (Inactivated, adsorbed). 720 ELISA Units/ 0.5ml Suspension for Injection in a pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hepatitis A virus antigen (HM175 strain)* 720 ELISA units/0.5 ml adsorbed on aluminium hydroxide (adjuvant) Total: 0.25 mg Al 3+ * Produced on MRC-5 human diploid cells Excipients with known effect: This vaccine contains phenylalanine 83 micrograms per dose (see section 4.4). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. Slightly opaque white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Havrix Junior Monodose vaccine is indicated for active immunisation against HAV infection in children and adolescents from 1 year up to and including 15 years of age. The vaccine is particularly indicated for those at increased risk of infection or transmission. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Children/adolescents (1-15 years) _ _ _ PRIMARY IMMUNISATION Primary immunisation consists of a single dose of Havrix Junior Monodose vaccine (720 ELISA units/0.5 ml) given intramuscularly. Havrix Junior Monodose confers protection against hepatitis A within two to three weeks (See Section 5.1, _Pharmacodynamic Effects_ ). If exposure to a high risk of contracting hepatitis A is expected within two weeks of the primary immunisation dose, human normal immunoglobulin may be given simultaneously with Havrix Junior Monodose at different injection sites. 2 Serological data indicate that there should be continuing protection against Hepatitis A for up to 5 years after the first dose of Havrix Junior Vaccine in subjects who responded to the initial vaccination. BOOSTER VACCINATION After primary vaccination with Havrix Junior Monodose Vaccine, a booster dose is recommended in order to ensure long term protection. This booster dose should be given at any time between 6 months and 5 years, but preferably Διαβάστε το πλήρες έγγραφο