Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg, Luxembourg
Vaborem 1 g/1 g powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to light yellow powder. |
Each vial contains meropenem trihydrate equivalent to 1 g meropenem, and 1 g vaborbactam.
After reconstitution, 1 ml of the solution contains 50 mg meropenem and 50 mg vaborbactam (see section 6.6).
Excipient with known effect: Each vial contains 10.9 mmol of sodium (approximately 250 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Meropenem |
Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). |
|
| Meropenem and Vaborbactam |
Meropenem exerts bactericidal activity by inhibiting peptidoglycan cell wall synthesis as a result of binding to and inhibition of activity of essential penicillin-binding proteins (PBPs). Vaborbactam is a non-beta-lactam inhibitor of class A and class C serine beta-lactamases, including Klebsiella pneumoniae carbapenemase, KPC. It acts by forming a covalent adduct with beta-lactamases and is stable to beta-lactamase-mediated hydrolysis. |
| List of Excipients |
|---|
|
Sodium carbonate |
50 ml clear glass vial (Type 1) closed with a rubber (bromobutyl) stopper and aluminium overseal with flip-off cap.
The medicinal product is supplied in packs of 6 vials.
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg, Luxembourg
EU/1/18/1334/001
Date of first authorisation: 20 November 2018
| Drug | Countries | |
|---|---|---|
| VABOREM | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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