References
- Scurti V, Romero M, Tognoni G. A plea for a more epidemiological and patient-oriented pharmacovigilance. Eur. J. Clin. Pharmacol. 68, 11–19 (2012).
- Mayorga Pérez O, Herzog C, Zellmeyer M, Loáisiga A, Frösner G, Egger M. Efficacy of virosome hepatitis A vaccine in toddlers in Nicaragua: randomised placebo-controlled trial. J. Infect. Dis. 188, 671–677 (2003).
- Usonis V, Bakasénas V, Valentelis R, Katiliene G, Vidzeniene D, Herzog C. Antibody titres after primary and booster vaccination of infants and young children with a virosomal hepatitis A vaccine (Epaxal). Vaccine 21, 4588–4592 (2003).
- Van Der Wielen M, Vertruyen A, Froesner G et al. Immunogenicity and safety of a pediatric dose of a virosome-adjuvanted hepatitis A vaccine: a controlled trial in children aged 1–16 years. Pediatr. Infect. Dis. J. 26, 705–710 (2007).
- Bovier PA, Farinelli T, Loutan L. Interchangeability and tolerability of a virosomal and an aluminium-adsorbed hepatitis A vaccine. Vaccine 23, 2422–2427 (2005).
- Holzer BR, Hatz C, Schmidt-Sissolak D, Glück R, Althaus B, EggerM. Immunogenicity and adverse effects of inactivated virosome versus alum-absorbed hepatitis A vaccine: a randomized controlled trial. Vaccine 14, 982–986 (1996).
- Clarke PD, Adams P, Ibanez R, Herzog C. Rate, intensity, and duration of local reactions to a virosome-adjuvanted vs. an aluminium-adsorbed hepatitis A vaccine in UK travellers. Travel Med. Infect. Dis. 4, 313–318 (2006).
- Schenk N, Koller-Doser A, Herzog C, Hartmann K. Safety and tolerability of the aluminium-free hepatitis A vaccine Epaxal®: analysis of spontaneous case reports and comparison to published cases. Presented at: 6th World Congress of the World Society of Pediatric Infectious Diseases, Buenos Aires, Argentina, 18–22 November 2009.
- Hatz C, Beck B, Steffen R et al. Real-life versus package insert: a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers. Vaccine 29, 5000–5006 (2011).
- Berry DC, Knapp P, Raynor DK. Provision of information about drug side-effects to patients. Lancet 359, 853–854 (2002).
- Lipkus IM. Numeric, verbal, and visual formats of conveying health risks: suggested best practices and future recommendations. Med. Decis. Making 27, 696–713 (2007).
- Knapp P, Raynor DK, Berry DC. Comparison of two methods of presenting risk information to patients about the side effects of medicines. Qual. Saf. Health Care 13, 176–180 (2004).
- Berry DC, Knapp PR, Raynor T. Is 15 percent very common? Informing people about the risks of medication side effects. Int. J. Pharmacy Practice 10, 145–151 (2002).
- Borg JJ, Aislaitner G, Pirozynski M, Mifsud S. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Safety 34, 187–197 (2011).
Websites
- European Commission. A guideline on the readability of the label and package leaflet of medicinal products for human use. EC Pharmaceutical Committee (1998). www.alims.gov.rs/download_eng/regulativa/gl981002.pdf (Accessed 22 January 2012)
- European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use (Revision 1, 12 January 2009). ENTR/F/2/SF/jr (2009)D/869. http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf (Accessed 22 January 2012)
- European Medicine Agency (EMA). Product information. Regulatory and procedural guidance: QRD Templates: Appendix II–Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 ‘undesirable effects’ of the summary of product characteristics. www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000267.jsp&mid=WC0b01ac05800b378b&jsenabled=true#section2 (Accessed 22 January 2012)
- Communicating Risks and Benefits: An Evidence-Based User's Guide. Fischhoff B, Brewer NT, Downs JS (Eds). US Department of Health and Human Services, US FDA. www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/ default.htm (Accessed 18 January 2012)