EMBLAVEO Powder for solution for infusion Ref.[110084] Active ingredients: Avibactam Aztreonam Aztreonam and Avibactam

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium

Product name and form

Emblaveo 1.5 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 slightly yellow lyophilised cake.

Qualitative and quantitative composition

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
Avibactam
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.

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

Arginine

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium

Marketing authorization dates and numbers

EU/1/24/1808/001

Drugs

Drug Countries
EMBLAVEO Lithuania

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