ZEDBAC Powder for solution for infusion Ref.[8683] Active ingredients: Azithromycin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Product name and form

Zedbac 500 mg powder for solution for infusion.

Pharmaceutical Form
Powder for solution for infusion. Free white powder.

Qualitative and quantitative composition

Each vial contains 500 mg of azithromycin (equivalent to 524.1 mg of azithromycin dihydrate), which after reconstitution results in a 100 mg/ml azithromycin solution. The concentrate should be further diluted to 1 mg/ml or 2 mg/ml.

Excipient(s) with known effect: This medicinal product contains 114 mg (4.96 mmol) sodium per vial.

For the full list of excipients, see Section 6.1.

Active Ingredient	Description
Azithromycin	Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by means of binding to the ribosomal 50S sub-unit and inhibition of peptide translocation.

List of Excipients
Anhydrous citric acid Sodium hydroxide 30% (for pH adjustment)

Pack sizes and marketing

Azithromycin is packed in 12 ml glass (type I) vials with bromobutyl rubber stopper and sealed with aluminium/plastic flip-off cap.

Pack sizes of 1 vial with powder for solution for infusion.

Marketing authorization holder

Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL 35533/0026

19/09/2012

Drugs

Drug	Countries
ZEDBAC	Estonia, Ireland, United Kingdom

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