Vancomycin hydrochloride is a glycopeptide antibiotic active against a wide variety of 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 lower respiratory tract infections, septicemia, bone, skin and skin structure infections, and infective endocarditis due to severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used because of intolerance or drug resistance. May be administered orally for treating antibiotic-associated pseudomembranous colitis produced by Clostridium difficile and for staphylococcal enterocolitis.
Application: Administered systemically as intravenous infusions and as capsules for oral administration. IV form can also be used orally for the treatment of antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis.
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Non-sterile, non-micronized | ||
Compliance |
Ph. Eur. USP JP |
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Manufacturing site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Release site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Site registered |
EU GMP issued by Hungarian National Institute of Pharmacy recognized by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA) |
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Regulatory documentation |
EU Drug Master File (DMF)/Certificate of Suitability (CEP) US Drug Master File (DMF) Japan Drug Master File (JDMF) DMF also available in other selected countries outside EU/US/Japan |
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