SPC, UK: CLARITHROMYCIN Powder for concentrate for solution for infusion (2018)

Product Name and Form

Clarithromycin 500 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

White to off white cake lyophilized sterile powder for reconstitution and administration by intravenous infusion.

Qualitative and Quantitative Composition

Each vial contains 739.5 mg clarithromycin lactobionate, corresponding to 500 mg clarithromycin.

Excipient(s) with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

List of excipients

Sodium hydroxide (pH adjuster)

Pack sizes and Marketing

Uncoloured clear glass vial type I (15 ml), sealed with brombutyl rubber stopper and aluminium cap with plastic flip-off seal.

The following pack sizes are available for Clarithromycin 500 mg powder for concentrate for solution for infusion:

1, 5 or 10 vial(s) containing 500 mg of clarithromycin.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

hameln pharma plus gmbh, Langes Feld 13, 31789, Hameln, Germany

16/05/2018

Marketing authorization number:

PL 25215/0033