Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion.
Pharmaceutical Form |
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Powder for concentrate for solution for infusion (powder for concentrate). White to slightly yellow lyophilised cake. |
Each vial contains 1.5 g aztreonam and avibactam sodium equivalent to 0.5 g avibactam.
After reconstitution, 1 mL of solution contains 131.2 mg of aztreonam and 43.7 mg of avibactam (see section 6.6).
Excipient(s) with known effect: Emblaveo contains approximately 44.6 mg sodium per vial.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Avibactam |
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Aztreonam |
Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, including P. aeruginosa. Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis, followed by filamentation and cell lysis. |
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Aztreonam and Avibactam |
Aztreonam inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin-binding proteins (PBPs), which leads to bacterial cell lysis and death. Avibactam is a non β-lactam, β-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. Avibactam inhibits both Ambler class A and class C β-lactamases and some class D enzymes, including extended-spectrum β-lactamases (ESBLs), Klebsiella pneumoniae carbapenemase (KPC) and OXA-48 carbapenemases, and AmpC enzymes. |
List of Excipients |
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Arginine |
30 mL glass vial (Type I) closed with a rubber (chlorobutyl) stopper and aluminium seal with flip-off cap.
The medicinal product is supplied in packs of 10 vials.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
EU/1/24/1808/001
Drug | Countries | |
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EMBLAVEO | Lithuania |
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