البلد: السويد
اللغة: السويدية
المصدر: Läkemedelsverket (Medical Products Agency)
hepatit A-virus, inaktiverat antigen
Pharmachim AB
J07BC02
hepatitis A virus, inactivated antigen
Injektionsvätska, suspension, förfylld spruta
hepatit A-virus, inaktiverat antigen 160 E Aktiv substans; aluminiumoxid, hydratiserad Adjuvans; formaldehyd Hjälpämne
Receptbelagt
inaktiverat helvirusvaccin
Avregistrerad
2013-04-10
Page 1 of 6 PACKAGE LEAFLET Page 2 of 6 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 START USING THIS MEDICINE 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 pharmacist, or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Avaxim is and what it is used for 2. What you need to know before you use Avaxim 3. How to use Avaxim 4. Possible side effects 5. How to store Avaxim 6. Contents of the pack and other 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 defenses will produce protection against hepatitis A infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AVAXIM DO NOT USE AVAXIM : - if you are allergic to: • the active ingredient or any ingredients of Avaxim (listed in section 6), or • neomycin, an antibiotic used during vaccine production, which may be present in the vaccine in small amounts, or • Avaxim, - if you are ill with a high temperature, the vaccination will be delayed until you have recovered. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Avaxim, if you have: • liver disease. • a اقرأ الوثيقة كاملة
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 7 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 EU 3 1 produced in human diploid (MRC-5) cells 2 adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al 3+ ) 3 ELISA Unit. In the absence of an international standardised reference, the antigen content is expressed using an in- house reference Excipient(s) with known effect: Ethanol anhydrous…………2.5 microlitres Phenylalanine………………10 micrograms For the 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 millilitres 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 received another inactivated hepatitis A vaccine (monovale اقرأ الوثيقة كاملة