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Vancomycin hydrochloride

(manufactured in Budapest, Hungary)

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 severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used due to 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 Clostridium difficile infections.

Product grades

Non-sterile, non-micronized

Compliance

Ph. Eur.

USP

JP

Manufacturing site

Xellia Pharmaceuticals Ltd., Budapest, Hungary

Release site

Xellia Pharmaceuticals Ltd., Budapest, Hungary

Site registered

EU GMP issued by Hungarian National Institute of Pharmacy

US FDA

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Agreed upon with customer

Packaging material

Primary: Aluminum bag laminated with Polyethylene, heat sealed

Secondary: Same as primary

Shelf life

2 years (according to Ph. Eur.)

3 years (according to USP)

Storage conditions

Below 8°C (46°F)