EPARs human use - Ketek//telithromycin

FICHA FARMACOLÓGICA de telithromycin. 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. JUNIO 09, 2009.-

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EPARs for authorised medicinal products for human use - Ketek

Active Substance
Telithromycin
International Nonproprietary Name or Common Name
Telithromycin
Pharmaco-therapeutic Group
macrolides, lincosamides and streptogramins
ATC Code
JO1FA15

Therapeutic Indication:
When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agentsand the local prevalence of resistance.

Ketek is indicated for the treatment of the following infections:

In patients of 18 years and older:
• Community-acquired pneumonia, mild or moderate

• When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin.
- Acute exacerbation of chronic bronchitis,
- Acute sinusitis

In patients of 12 years and older:
•Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA.

Date of issue of Marketing Authorisation valid throughout the European Union
9 July 2001