Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
HEPATIT A VIRUS ANTIGEN
Sanofi Pasteur MSD Ltd
J07BC02
HEPATIT A VIRUS ANTIGEN
160 D-ant. %v/v
Solution for Injection
Product subject to prescription which may not be renewed (A)
Hepatitis vaccines
Authorised
1997-02-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AVAXIM, SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE Hepatitis A vaccine (inactivated, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Avaxim is and what it is used for 2. Before Avaxim is given 3. How Avaxim is given 4. Possible side effects 5. How to store Avaxim 6. Further information 1. WHAT AVAXIM IS AND WHAT IT IS USED FOR Avaxim is a vaccine. Vaccines are used to protect you against infectious diseases. This vaccine helps to protect against hepatitis A infection in people 16 years of age and older. Hepatitis A infection is due to a virus that attacks the liver. It may be caught from food or drink that contains the virus. Symptoms include yellowing of the skin (jaundice) and feeling generally unwell. When you are given an injection of Avaxim, your body’s natural defences will produce protection against hepatitis A infection. 2. BEFORE AVAXIM IS GIVEN DO NOT HAVE THIS VACCINE IF YOU ARE: • allergic (hypersensitive) to any ingredients of Avaxim (listed in section 6) or to Avaxim • allergic (hypersensitive) to neomycin, an antibiotic used during vaccine production, which may be present in the vaccine in small amounts • ill with a high temperature, the vaccination will be delayed until you Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AVAXIM, suspension for injection in a pre-filled syringe Hepatitis A vaccine (inactivated, adsorbed) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 millilitre dose contains: Hepatitis A virus, GBM strain (inactivated) 1, 2 ……160 U 3 1 produced in human diploid (MRC-5) cells 2 adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al) 3 In the absence of an international standardised reference, the antigen content is expressed using an in-house reference Excipient(s): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in a pre-filled syringe Hepatitis A vaccine (inactivated, adsorbed) is a cloudy and white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above. The use of AVAXIM should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage for subjects of at least 16 years of age is 0.5 millilitre for each injection. Initial protection is achieved with one single dose of vaccine. Protective levels of antibody may not be reached until 14 days after administration of the vaccine. In order to provide long-term protection, a second dose (booster) of an inactivated hepatitis A vaccine should be given. The second dose is preferably given between 6 and 12 months but may be administered up to 36 months after the first dose (see section 5.1). It is predicted that HAV antibodies persist for many years (beyond 10 years) after the second dose. The vaccine may be used to provide the second dose (booster) in subjects from 16 years of age who receiv Pročitajte cijeli dokument