Aurum Pre-Filled Syringe (PFS) Range, Caution-in-use notification (CIUN), 07/08/2025

07/08/2025
Medicines for human use Caution-in-use notification (CIUN)

The below listed Aurum Pre-Filled Syringe (PFS) products are supplied as Exempt Medicinal Products (EMP) in Ireland:

  • Adrenaline (Epinephrine) Injection 1:10,000 (glass pre-filled syringe) (PL12064/0006)
  • Amiodarone 30mg/ml Solution for injection/infusion in pre-filled syringe (PL12064/0047)
  • Calcium Chloride 10% w/v Intravenous Infusion, pre-filled syringe (PL12064/0020)
  • Naloxone Hydrochloride 1mg/ml Solution for Injection in a pre-filled syringe (PL12064/0060)

Based on a communication issued by the UK Medicines & Healthcare products Regulatory Agency (MHRA) the HPRA wishes to bring your attention to important safety information

A new 10 ml CONNECT syringe barrel has been introduced for the Aurum range of pre-filled syringes in July 2025. The new 10 ml CONNECT syringe barrel is compatible with a wider range of needle-free connectors (NFCs) than the established syringe design.

There will be a transition period where both the new CONNECT syringe and the established syringe will be available for concerned products. 

All NFCs that are compatible with the established barrel will continue to be compatible with the new CONNECT syringe barrel. However, it is possible that an NFC that is compatible with the new CONNECT syringe barrel may not be compatible with the established barrel. Therefore, during the transition phase, while both barrels remain in circulation,  there remains a risk of inadvertently using an incorrect NFC.

Thus, health care professionals (HCPs) must exercise caution while the established syringe stock remains on the market (note - the listed products have a shelf life of up to three years).

It is vital that HCPs use compatible NFCs with the Aurum pre-filled syringes to ensure that the products can be administered to patients in an emergency situation without delay.  Full information in relation to this issue is available at the following link: Caution-in-Use Notification (CIUN) which was issued by the Medicines & Healthcare products Regulatory Agency (MHRA)

Product information

Product name
Adrenaline (Epinephrine) Injection 1:10000 (glass pre-filled syringe) (PL12064/0006)
Amiodarone 30mg/ml Solution for injection/infusion in pre-filled syringe (PL12064/0047)
Calcium Chloride 10% w/v Intravenous Infusion pre-filled syringe (PL12064/0020)
Naloxone Hydrochloride 1mg/ml Solution for Injection in a pre-filled syringe (PL12064/0060)
Authorisation holder
The products are distributed in Ireland as EMPs. (The UK marketing authorisation holder is Aurum Pharmaceuticals Ltd.)
Authorisation number

The products are supplied in Ireland as EMPs, please see the Product Name section above for the UK marketing authorisation numbers.

Serial or batch number and expiry date
All
Human or veterinary medicine
Human Medicines
Target audience
All HCPs, including but not limited to those in anaesthetics and in intensive care, critical care, general surgery, theatre practitioners, emergency medicine, ambulance service/paramedics and hospital pharmacies.
CIUN level
User level

Actions to be taken

Information for HCPs and Pharmacists

HCPs and Pharmacists are requested to:

  1. Immediately check your stock and your inventory management system for in-date packs of any of the above-listed products supplied to you since 1st July 2025.
  2. If packs from any of the above listed products are within your facility at this time, or if you intend to source any of the products going forward, please put controls in place to ensure that the above linked Caution-in-Use Notification (CIUN) is shared with all users in your facility.  
  3. If you have supplied any packs of any of the above listed products to another hospital or pharmacy from 1st July 2025 onwards, please share the above linked CIUN with them.
  4. Please bring this notice to the attention of all HCPs at your facility, including but not limited to anaesthetics and intensive care, critical care, general surgery, theatre practitioners, emergency medicine, ambulance service/paramedics and hospital pharmacies.

Information for Users, Patients and Public

If you have any of these products in your possession and require clarification on the above linked CIUN, please contact your pharmacist.

Information for EMP notifiers

EMP notifiers are requested to perform the following actions:

  1. Bring this notice to the attention of the Responsible Person at your facility. 
  2. Immediately check your inventory management system for in-date batches of any of the above-listed products. This request includes current stock within your facility and stock which has been supplied to customers.
  3. If units from any of the above listed products are within your facility at this time, or if you intend to source any of the products for the Irish market, please put controls in place to ensure the attached CIUN is issued to all wholesale and pharmacy customers who you intend to supply. In relation to your wholesale customers, please request them to issue the CIUN to their wholesale and/or pharmacy customers.
  4. If in-date units of any of the above listed products have already been supplied, please identify your wholesale and pharmacy customers and issue the attached CIUN to them. In relation to your wholesale customers, please request them to issue the CIUN to their wholesale and/or pharmacy customers.