Sterility: Conforme aux exigences de l'essai de stérilité selon USP <71>/Ph.Eur. 2.6.1 pour les produits parentéraux.
Bacterial Endotoxins: Conforme aux limites d'endotoxines bactériennes selon USP <85>/Ph.Eur. 2.6.14, confirmées par un test LAL validé.
Particulate Matter: Conforme aux limites de particules sous-visibles selon USP <788>/Ph.Eur. 2.9.19.
Container Closure Integrity: Système de fermeture de contenant validé pour maintenir la stérilité et l'intégrité du produit pendant toute la durée de conservation.

Autres informations

Description supplémentaire:

Ertapenem 1 g powder for concentrate for solution for infusion, referencing Invanz (MSD). Ertapenem is a carbapenem antibiotic indicated for pediatric patients and adults for infections caused by bacteria known or highly likely to be susceptible, when parenteral therapy is required, including intra-abdominal infections, community-acquired pneumonia, acute gynecological infections, and diabetic foot skin/soft-tissue infections, and in adults for prophylaxis against surgical site infection following elective colorectal surgery. The dossier is in progress with timelines to be defined, stability studies cover Zone II and Zone IVb, the originator's shelf life is two years, and batch and pack sizes are to be determined (originator packs of 1 or 10 vials).