The Medicines and Healthcare products Regulatory Agency (MHRA) approved EpiPen auto-injectors in the new batch are affixed with a US label (Photo: iStock).

Pharmaceutical giant Mylan has released a batch of US-labelled auto-injectors in the UK to ensure patients have continuous access to Epipen 0.3mg.

The auto-injectors with the batch number 9FM766 have been approved by the UK regulator, Medicines and Health Regulatory Agency (MHRA).

The company website states that pharmacies are able to place orders and hold stock of EpiPen Jr 0.15mg and EpiPen 0.3mg AAI devices so that patient prescriptions can be fulfilled the same day.

The EpiPen auto-injectors in batch number is 9FM766) are affixed with a US label, and are packaged (as single packs) into UK cartons along with UK patient information leaflets.

The drug name is epinephrine in the US but is known as adrenaline in the UK. “Patients and carers familiar with the term adrenaline may be confused,” the company has warned.

 “The auto-injector device in this batch is exactly the same as the normal UK EpiPen in every way except for the information on the label on the device,” it added.

Other differences between the US-labelled and UK-labelled auto-injectors are:

  • The UK label has the instruction to ‘Dial 999, ask for ambulance and state ‘anaphylaxis!’, which is replaced with ‘Get emergency medical help!’ on the US label.
  • The warning ‘Keep of the reach and sight of children’ is omitted on the US auto-injector label. However, the UK carton and patient information leaflet include this statement.

The label on the EpiPen (epinephrine) auto-injector is meant for the US. Therefore, patients and carers should read the outer carton and enclosed patient information leaflet which is designed for UK patients.

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