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EMA changes to dosage labelling

A change to the way in which liquid medicines dosage is described on pack could cause confusion for prescribers and patients. A European Medicines Agency (EMA) ruling in 2009, states that the dosage strength should be standardised in mg/ml on new products. However, existing licensed products may not change to this expression of dosage, meaning that some medicines are labelled in a mg per ml format and others as mg per 5ml.

Jan Flynn, Marketing Manager, Rosemont Pharmaceuticals says: ‘Many of Rosemont’s more recently introduced products are labelled in mg/ml as they are licensed in several EU countries.  Rosemont specials have both the mg per 5ml and the mg/ml equivalent to help customers during this transition period. 

It is important when looking for a particular strength of medicine that the volume is checked. The active ingredient in 5ml of liquid would usually equate to the active found in a tablet alternative. It is therefore possible that where a strength is stated per ml it may need to be multiplied by five to achieve the correct corresponding dose. If this is not recognised and understood by prescribers a special may be inadvertently ordered because the strength has not been recognised.