Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Recarbrio 500 mg/500 mg/250 mg powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. A white to light yellow powder. |
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem, cilastatin sodium equivalent to 500 mg cilastatin, and relebactam monohydrate equivalent to 250 mg relebactam.
Excipient(s) with known effect: The total amount of sodium in each vial is 37.5 mg (1.6 mmol).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cilastatin |
|
|
| Imipemide |
Imipenem is a semi-synthetic derivative of thienamycin, the parent compound produced by the filamentous bacterium Streptomyces cattleya. Imipenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). |
|
| Imipenem, Cilastatin and Relebactam |
The bactericidal activity of imipenem results from the inhibition of penicillin binding proteins (PBPs) leading to inhibition of peptidoglycan cell wall synthesis. Cilastatin limits the renal metabolism of imipenem and does not have antibacterial activity. Relebactam is a non-beta lactam inhibitor of Ambler class A and class C beta-lactamases, including class A Klebsiella pneumoniae carbapenemase (KPC) and extended-spectrum beta-lactamases (ESBLs), and class C (AmpC-type) beta-lactamases including Pseudomonas-Derived Cephalosporinase (PDC). Relebactam does not inhibit class B enzymes (metallo-beta-lactamases) or class D carbapenemases. Relebactam has no antibacterial activity. |
| List of Excipients |
|---|
|
Sodium hydrogen carbonate |
20 mL glass vial, with 20 mm rubber stopper and aluminium crimp cap seal.
This medicinal product is supplied in packs of 25 vials.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/19/1420/001
Date of first authorisation: 13 February 2020
| Drug | Countries | |
|---|---|---|
| RECARBRIO | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Romania, United Kingdom, United States |
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