VANCOMYCIN Powder for solution for intravenous infusion / oral use Ref.[7139] Active ingredients: Vancomycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Wockhardt UK Limited, Ash Road North, Wrexham LL13 9UF, United Kingdom

Product name and form

Vancomycin 1g Powder for Solution for Infusion.

Pharmaceutical Form

Powder for solution for intravenous infusion.

Powder for solution for oral use.

‘A white to cream coloured porous cake’.

Qualitative and quantitative composition

Each vial contains 1000 mg vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vancomycin

Vancomycin is a tricyclic glycopeptide antibiotic that inhibits the synthesis of the cell wall in sensitive bacteria by binding with high affinity to the D-alanyl-D-alanine terminus of cell wall precursor units.

List of Excipients

None.

Pack sizes and marketing

Packs* of one, two, five or ten Type II colourless glass 20ml vials stoppered with Type I rubber stopper, capped with a flip-off cap.

* Not all pack sizes may be marketed.

Marketing authorization holder

Wockhardt UK Limited, Ash Road North, Wrexham LL13 9UF, United Kingdom

Marketing authorization dates and numbers

PL 29831/0322

Date of first authorisation: 4 April 2008

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