lunes, 20 de abril de 2009
EPARs - Prevenar//Pneumococcal saccharide conjugated vaccine, adsorbed
FICHA FARMACOLÓGICA de Pneumococcal saccharide conjugated vaccine, adsorbed. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. ABRIL 20, 2009.- [Esta monografía no ha sido actualizada ni modificada. Se publica a expresa solicitud profesional de un equipo médico de pediatría].-
ABRIR AQUÍ:
EPARs for authorised medicinal products for human use - Prevenar
Active Substance
Pneumococcal saccharide conjugated vaccine, adsorbed
International Nonproprietary Name or Common Name
Pneumococcal saccharide conjugated vaccine, adsorbed
Pharmaco-therapeutic Group
Pneumococcal vaccines
ATC Code
J07 AL02
Therapeutic Indication:
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from 2 months up to 5 years of age (see sections 4.2, 4.4 and 5.1).
For the number of doses to be administered in the different age groups, see section 4.2.
The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1)
Date of issue of Marketing Authorisation valid throughout the European Union
2 February 2001
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