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Caution in use: Gonal-F 900IU/1.5ml solution for injection

Merck Serono UK is alerting pharmacists to an error in the title of the package leaflet for some batches (see below) of Gonal-F 900IU/1.5ml solution for injection in pre-filled pens.

The title of the package leaflet incorrectly states that the concentration of the pen is 900IU/0.5ml. The label on the pen, the external packaging and the body of the text of the package leaflet are correct.

The error should not affect administration of Gonal-F since the packageleaflet specifies that the dose should be set in IU, not by volume.

Batch number

Expiry date

Pack size

First distributed

Y10B0063 03/2010 1 06/06/2008
Y10B2052 03/2010 1 25/07/2008
Y10B4293 04/2010 1 18/08/2008
Y10B7228 04/2010 112/09/2008
Y10B8889 04/2010 1 17/10/2008
Y11B2580 05/2010 131/10/2008
Y11B3841 06/2010 1 11/11/2008

The Medicines and Healthcare products Regulatory Agency is asking pharmacists to advise patients of the error when dispensing Gonal-F.

Distribution of the affected stock will continue. Corrected leaflets are not expected to be supplied until January 2009.

Further information from Merck Serono medical information on 0208 818 7373.

Citation: The Pharmaceutical Journal URI: 10043389

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