SPC, UK: ZELBAC Powder for solution for infusion (2020)

Product Name and Form

Zedbac 500 mg powder for solution for infusion.

Pharmaceutical form

Powder for solution for infusion.

Free white powder, with small aggregates.

Qualitative and Quantitative Composition

Each vial contains 500 mg of azithromycin (equivalent to 524.03 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 168.2 mg (7.31 mmol) sodium per vial.

For the full list of excipients, see Section 6.1.

List of excipients

Anhydrous citric acid

Sodium hydroxide 30% (for pH adjustment)

Pack sizes and Marketing

Azithromycin is packed in 10 ml glass (type II) vials with chlorobutyl rubber stopper and sealed with aluminium/plastic flip-off cap.

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

Marketing authorization holder
Authorization dates

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

19/09/2012

Marketing authorization number:

PL 35533/0026