国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
HEPATITIS A VIRUS (STRAIN RG-SB)
Crucell Italy S.r.l.
Suspension for Injection
2000-01-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epaxal suspension for injection in a prefilled syringe Hepatitis A vaccine (inactivated, virosome). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vaccine dose (0.5 ml) contains at least 24 IU of inactivated hepatitis A virus (strain RG-SB), propagated in human diploid (MRC-5) cells. The virus particles are adsorbed on virosomes as the adjuvant system, composed of highly purified influenza virus surface antigens (10 micrograms haemagglutinin) of the A/Singapore/6/86 (H1N1) strain and the phospholipids lecithin (80 micrograms) and cephalin (20 micrograms). For more information on the adjuvant, _see section 5.1._ For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Suspension for injection in a prefilled syringe. Clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against hepatitis A of children from 1 year of age and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One dose of 0.5 ml is injected intramuscularly. To ensure optimal immune response, the vaccine should be injected into the deltoid muscle. In patients with coagulation disorders, the vaccine may be administered subcutaneously in the upper arm. In order to provide long-term protection, a second (booster) dose of 0.5 ml should be administered. This is preferably given between 6-12 months after the first dose but may be given up to 10 years later based on limited experience in healthy adult travellers (see section 5.1). Epaxal can be used interchangeably with other inactivated hepatitis A vaccines for the first and second (booster) dose. _Simultaneous active and passive immunisation_ If immediate protection against hepatitis A is necessary, Epaxal can be administered concomitantly with human 完全なドキュメントを読む