Titre (Assay): 500 mg de clarithromycine par flacon, poudre pour solution pour perfusion, en référence à Klaricid (Abbott)
Profil d'impuretés: Contrôlé selon ICH Q3A/Q3B ; documentation CTD UE disponible
Clarity of Solution: La solution reconstituée répond aux exigences de clarté pharmacopéiques pour usage en perfusion intraveineuse

Autres informations

Description supplémentaire:

Clarithromycin 500 mg per vial, powder for solution for infusion, referencing Klaricid (Abbott). Clarithromycin offers a longer serum half-life and better tissue penetration than erythromycin, allowing twice-daily dosing for most common infections. As a powder for solution for infusion, it is used whenever parenteral therapy is needed to treat susceptible-organism infections of the lower and upper respiratory tract, as well as skin and soft tissue infections. EU CTD dossier is available, with stability data covering Zone II and Zone IVb, a three-year shelf life, batch size of 20,000 vials, and packaging of one vial per box.