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.
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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