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Vancomycin HCI vials

Vancomycin hydrochloride (HCI) 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 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.

 

Dosage form

Lyophilized vials

Strength

0.5 g (Copenhagen)

1 g (Copenhagen)

5 g for US only (Copenhagen)

10 g for US only (Copenhagen)

Compliance

USP

Currently no monograph in Ph. Eur. for vancomycin vials

The active ingredient vancomycin hydrochloride complies with Ph. Eur. and USP

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Danish Medicines Agency (Xellia Copenhagen)

US FDA (Xellia Copenhagen)

Other health authorities

Batch size

0.5 g

1 g

5 g for US only

10 g for US only

Copenhagen

Copenhagen

Copenhagen

Copenhagen

80000 vials

51000 vials

8100 vials

8300 vials

Regulatory documentation

US dossier

RoW* dossier

Packaging sizes

0.5 g / 1 g

5 g for US only / 10 g for US only

1 vial/pack

10 vials/pack

25 vials/pack

1 vial/pack

Possibility for different packaging configuration as well as option for unlabelled vial supply can be discussed with your Sales Representative

Shelf life

24 months

Storage conditions

Between 15-25°C (59-77°F) depending on territory

* Rest of the World