Vancomycin Hydrochloride is a glycopeptide antibiotic active against a wide variety of aerobic Gram-positive bacteria, most important being staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), but also active against: diphtheroids , enterococci, (e.g., Enterococcus faecalis), Streptococcus bovis, Viridans group streptococci.
Indication: Used in the treatment of patients with severe and/or methicillin-resistant staphylococcal infections (endocarditis, bone infections, lower respiratory tract infections, septicemia and skin structure infections) and treatment of preoperative prophylaxis of streptococcal or diphteroid endocarditis where other antibiotics cannot be used due to intolerance or drug resistance.
Application: Administered as intravenous infusions for systemic therapy.
Dosage form |
Lyophilized vials |
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Strength |
0.5 g (Copenhagen) 1 g (Copenhagen) 5 g (Copenhagen) 10 g (Copenhagen) |
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Compliance |
USP Currently no monograph in Ph Eur for Vancomycin Vials The active ingredient Vancomycin hydrochloride complies with Ph. Eur. and USP |
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Manufacturing site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Release site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Site registered |
EU GMP issued by Danish Medicines Agency (Xellia Copenhagen) US FDA (Xellia Copenhagen) Other Health Authorities |
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Regulatory documentation |
US dossier EU dossier RoW* dossier |
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Regulatory documentation |
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* Rest of the world
