Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Advanz Pharma Limited, Unit 17 Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland
EXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to yellowish powder. |
Each vial contains cefepime dihydrochloride monohydrate equivalent to 2 g cefepime and 0.5 g of enmetazobactam.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cefepime |
Cefepime is a broad-spectrum, bactericidal antibiotic, with activity against a wide range of Gram-positive and Gram-negative bacteria, including many strains resistant to aminoglycosides or third generation cephalosporins. It has a reduced affinity for beta-lactamases. |
|
| Cefepime and Enmetazobactam |
Cefepime exerts bactericidal activity by inhibiting peptidoglycan cell wall synthesis as a result of binding to and inhibition of penicillin-binding proteins (PBPs). Enmetazobactam is a penicillanic acid sulfone beta-lactamase inhibitor structurally related to penicillin. Enmetazobactam binds to β-lactamases and prevents the hydrolysis of cefepime. It is active against class A ESBLs. |
| List of Excipients |
|---|
|
L-arginine |
20 mL vial (Type I clear glass) with stopper (bromobutyl rubber) and flip-off seal.
Pack size of 10 vials.
Advanz Pharma Limited, Unit 17 Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland
EU/1/24/1794/001
| Drug | Countries | |
|---|---|---|
| EXBLIFEP | Lithuania, United States |
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