Vancomycin hydrochloride (HCl) 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 and 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, skin 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. It may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis.
Application: Administered as intravenous infusions for systemic therapy. May be administered orally for treatment of antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis.
Dosage form |
Lyophilized vials |
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Strength |
0.5 g 1 g 5 g 10 g |
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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 Xellia Pharmaceuticals, Cleveland, USA |
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Release site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark Xellia Pharmaceuticals, Cleveland, USA |
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Site registered |
EU GMP issued by Danish Medicines Agency (Xellia Copenhagen) US FDA (Xellia Copenhagen & Cleveland) Other health authorities (Xellia Copenhagen) |
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Batch size |
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Regulatory documentation |
US dossier RoW* dossier |
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Packaging sizes |
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Shelf life |
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* Rest of the World
