Availability of Epipen 0.15mg and 0.3mg adrenaline auto-injectors – US labelled EpiPen 0.3mg

Availability of Epipen 0.15mg and 0.3mg adrenaline auto-injectors – US labelled EpiPen 0.3mg

June 30, 2020

Mylan have advised that to ensure continuous access to Epipen 0.3mg auto-injectors in the UK they have, following approval from the MHRA, released a batch of US labelled auto injectors. The batch number is 9FM766

• 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.

UK Epipen 0.3mg label                                                       US Epipen 0.3mg label

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. Additional patient information leaflets can be downloaded here

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

Mylan can be contacted on 01707 853 000 or by email on info@mylan.co.uk



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