TYGACIL, (tigecycline), glycylcyclines
INFECTIOUS DISEASES - Focus
Opinions on drugs -
Posted on
Oct 12 2016
Reason for request
Extension of Inclusion
No clinical benefit demonstrated in the management of complicated intra-abdominal, skin and soft tissue infections in children
- TYGACIL now has Marketing Authorisation in children aged 8 years and older for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections (cSSTIs), except for diabetic foot infections.
- Its potential benefit is based on its broad spectrum of activity, including Gram (+) and Gram (-) bacteria that are resistant to several antibiotics.
- The Marketing Authorisation is restricted to clinical situations where no suitable antibiotic is available.
- Given the characteristics of the product and current uncertainties about its clinical efficacy and safety in severe infections and/or infections caused by multidrug-resistant bacteria, the therapeutic decision must be made in consultation with an antibiotics handling expert.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
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