Question

Supply of US-labelled EpiPen® 0.3mg Adrenaline Auto-Injectors

EpiPen (Adrenaline) Auto-Injector 0.3 Mg: supply of a batch (no. 9FM766) with US-labelled auto-injectors packaged in UK cartons with a UK leaflet

• Mylan has released a batch of US-labelled EpiPen auto-injectors (Batch no. 9FM766) to enable continuous access of auto-injectors in the UK following approval from the MHRA.

• The EpiPen auto-injectors in this batch 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.

Further information on the safety concern and recommendations

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.

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.

Please see below a comparison of the US and UK labels on the autoinjectors:

 

UK EpiPen 0.3 mg label                                                      US EpiPen 0.3mg label

 

 

Reminder: Patients and carers should ‘Dial 999, ask for an ambulance and state anaphylaxis!’ after every use of the EpiPen auto-injector.

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.

Click here to download additional patient information leaflet

Contact Information

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