Land: Zypern
Sprache: Griechisch
Quelle: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
HEPATITIS A VIRUS (GBM STRAIN) INACTIVATED
SANOFI PASTEUR. (0000010487) 14 ESPACE HENRY VALLEE, LYON, 69007
J07BC02
HEPATITIS A, INACTIVATED, WHOLE VIRUS
160 ANTIGEN UNITS/0.5ML
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
HEPATITIS A VIRUS (GBM STRAIN) INACTIVATED (8000003025) 160U
INTRAMUSCULAR USE
Εθνική Διαδικασία
HEPATITIS A, INACTIVATED, WHOLE VIRUS
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 PRE-FILLED SYRIGNE X 0.5ML (970040701) 1 SYRINGE - Εγκεκριμένο - Με Ιατρική Συνταγή
IIIB PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER AVAXIM 160U, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE HEPATITIS A VACCINE (INACTIVATED, ADSORBED) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED. - Keep this leaflet until you have completed the vaccination schedule. You may need to read it again. - Follow carefully the advice of your doctor or nurse. If you need more information or advice, please ask you doctor or nurse. - Make sure you complete the full vaccination schedule. Otherwise, you may not fully protected. WHAT IS IN THIS LEAFLET 1. What Avaxim 160U is and what it is used for 2. What you need to know before you use Avaxim 160U 3. How to use Avaxim 160U 4. Possible side effects 5. How to store Avaxim 160U 6. Contents of the pack and other information 1. WHAT AVAXIM 160U IS AND WHAT IT IS USED FOR This medicinal product is a VACCINE in the form of a suspension for injection (0.5 ml in a prefilled syringe with or without needles in a box of 1, 5, 10 or 20) This vaccine is indicated for the prevention of infection caused by the hepatitis A virus in adolescents from 16 years of age and in adults. It does not protect against infection due to other types of hepatitis virus or other known pathogens of the liver. This vaccine should be administered in accordance with official recommendations. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AVAXIM 160U DO NOT USE AVAXIM 160U - in the event of fever, acute disease, progressive chronic disease (it is preferable to postpone vaccination). - in the event of allergy to one of the vaccine components or following a previous injection. TAKE SPECIAL CARE WITH AVAXIM 160 U - do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel; - this vaccine is not to be injected into the buttocks (due to the presence of varying amounts of adipose tissue), nor administered intradermally, since these methods of administration may induce a weaker immune response; - immunosuppressant treatment or a state of immune deficiency Lesen Sie das vollständige Dokument
1 N AME OF THE MEDICINAL PRODUCT AVAXIM 160 U, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE HEPATITIS A VACCINE (INACTIVATED, ADSORBED) 2 Q UALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Hepatitis A virus, GBM strain* (inactivated**) .................................................... 160 units*** * cultured on MRC-5 human diploid cells ** adsorbed on aluminium hydroxide (quantity corresponding to 0.3 mg of aluminium) *** antigen units measured using an in-house manufacturer’s reference. For the full list of excipients, see section 6.1 3 P HARMACEUTICAL FORM Suspension for injection in a prefilled syringe. 4 C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This vaccine is indicated for active immunisation against infection caused by the hepatitis A virus in adolescents from 16 years of age and in adults. The vaccine does not protect against infection caused by hepatitis B, hepatitis C, or hepatitis E viruses, or any other known liver pathogens. Transmission of the hepatitis A virus is usually through the ingestion of contaminated water or food. Persons in contact with contaminated subjects are usually infected through the oro-faecal route. The possibility of transmission by blood or by sexual contact (oral-anal relations) has also been demonstrated. This vaccine should be administered in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage for subjects from 16 years of age is 0.5 ml. The initial protection is obtained after one single injection. In order to obtain a long-term protection against infections caused by the Hepatitis A virus, in adolescents from 16 years of age and in adults, a booster dose should be administered, preferably between 6 and 12 months after the first vaccination and can be administered up to 36 months after the first vaccination (see section 5.1). It is estimated that anti-VHA antibodies persist several years (at least 10 years) after the second dose (booster). This vaccine can also be administered a Lesen Sie das vollständige Dokument