ZINFORO - ZINFORO - CT 12539 - Version anglaise

Has

Description

Présentation ZINFORO 600 mg, poudre pour solution à diluer pour perfusion B/10 flacons- Code CIP : 3400926818432 Mis en ligne le 21 mai 2013 Substance active (DCI) ceftaroline fosamil (acétate de) monohydraté Infectiologie - Nouveau médicament Progrès thérapeutique mineur dans les infections compliquées de la peau et des tissus mous de gravité modérée à faibleAvis défavorable au remboursement dans les pneumonies communautaires ZINFORO est une céphalosporine I.V. à spectre large qui a l’AMM dans les infections compliquées de la peau et des tissus mous (ICPTM) et les pneumonies communautaires (PC) de l’adulte.Dans la prise en charge des ICPTM, en raison de son efficacité clinique et de son activité sur le staphylocoque résistant à la méticilline, il représente un progrès thérapeutique mineur, mais seulement dans les formes de gravité modérée à faible.D’efficacité insuffisamment documentée dans les PC, il n’a pas de place dans la stratégie thérapeutique. Code ATC J01DI02 Laboratoire / fabricant ASTRAZENECA ZINFORO 600 mg, poudre pour solution à diluer pour perfusion B/10 flacons- Code CIP : 3400926818432 Mis en ligne le 21 mai 2013

Sujets

• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 09 janvier 2013
• Nombre de lectures: 36
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

The legally binding text is the original French version  

    T RANSPARENCY C OMMITTEE   Opinion 9 January 2013       ZINFORO 600 mg, powder for concentrate for solution for infusion B/10 vials (CIP code: 34009 268 184 3 2)  Applicant: ASTRAZENECA

INN ATC Code (2011)

Reason for the review

List(s) concerned

Indication(s) concerned          

Ceftaroline J01DI02 (injectable cephalosporin)

Inclusion

Hospital use(French Public Health Code L.5123-2) 

“ - Complicated skin and soft tissue infections (cSSTI)  - Community-acquired pneumonias (CAP)”   . 

HAS - Medical, Economic and Public Health Assessment Division  

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Actual Benefit

Improvement in Actual Benefit

Therapeutic use

Recommendations

 

- substantialtreatment of complicated skin and soft tissue infections the  for cSSTI - insufficientfor the treatment of community-acquired pneumonias (CAP).     In view of: - its activity against methicillin-resistantStaphylococcus clinical efficacy and which is not inferior to that of the combination vancomycin/aztreonam in patients sufferin from mild to moderate skin or soft tissue infections, - a satisfactor safet profile similar to that of the in ectable cephalosporins which are currentl marketed, - simplification of treatment reduced number of in ections and less monitorin than vancom cin , the Committee considers that ZINFORO provides a minor improvement in actual benefit (IAB IV) for the management of “complicated skin and soft tissue infections”.   In the treatment of complicated skin and soft tissue infections, ceftaroline can be proposed for use in non-necrotisin care-related infections nosocomial or otherwise) such as extensive cellulitis, abscesses, superinfected wounds or sores without a history of previous colonisation withPseudomonas.It has the advantage of bein as effective as a combination of vancom cin/aztreonam antibiotics. In contrast, it is potentiall less effective in soft tissue and/or skin infection with necrosis or suspected Pseudomonas infection, because of its reducedin vitro activity and the lack of clinical data. Ceftaroline is no less well tolerated than vancomycin and does not require monitorin of plasma concentrations and renal function. In the treatment of CAP Ceftaroline has not been shown to be of use in communit -acquired pneumonias because of: - a lack of efficacy data in staphylococcal andS. pneumoniaepneumonias which are not sensitive to penicillin, - a risk of selectin resistance because of its broad spectrum. As a result, ceftaroline does not have a role in CAP in view of the alternative treatments available which are simpler to use and have a narrower spectrum.     The Transparency Committee recommends: -inclusion on the list of proprietary medicinal products approved for hospital use in the indication “treatment of complicated skin and soft tissue infections” -non-inclusion on the list of proprietary medicinal products approved for hospital use in the indication “community-acquired pneumonias”.  

HAS - Medical, Economic and Public Health Assessment Division  

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