Emerade Range of treatments for Acute Allergic Reactions – Important Information for Users and Healthcare Professionals

Notice type: Advisory

Date: 04/07/2018

 

Product name or type:
Emerade 150 micrograms solution for injection in pre-filled pen Emerade 300 micrograms solution for injection in pre-filled pen Emerade 500 micrograms solution for injection in pre-filled pen


Reference:
QDR-H-18-352, QDR-H-18-353 & QDR-H-18-354


Authorisation Number:
PA1696/009/001, PA1696/009/002 & PA1696/009/003


Active Substance:
Adrenaline


Product Classification:

Prescription-only medicine



Serial Or Batch Number And Expiry Date:
All in-date batches


Prescription Required:
Yes


Recall Classification:
Advisory


Target Audience:
  • Patients
  • Carers 
  • Pharmacists and
  • other relevant Healthcare Professionals



Problem Or Issue:

The Health Products Regulatory Authority (HPRA) wishes to inform users and healthcare professionals of the following potential quality defect for the Emerade range of treatments

  • There is a possibility that a small percentage (0.015%) of Emerade pens on the Irish market may not deliver a dose of adrenaline.
  • This is due to the potential for a blocked syringe needle to be in place.
  • A blocked needle has been identified by the manufacturer in one Emerade syringe during standard product stability testing.
  • While no confirmed reports of a blocked needle have been received from the marketplace for Emerade to date, there is the potential for units on the market to have a blocked needle, and this could lead to an Emerade auto-injector not firing.
  • The risk presented by this defect can be reduced by the patient always carrying two pens as described in the approved patient information for Emerade.



Background Information Or Related Documents:
Caution-In-Use Notification letter issued to pharmacists


Actions To Be Taken:

Advice to Patients

The advice to patients in Ireland is to adhere to current medical advice that they carry two pens.  The package leaflet supplied with Emerade advises patients that, in circumstances where a single dose of adrenaline does not completely reverse the effect of an allergic reaction, a repeat injection may be given after 10 to 15 minutes.  For this reason, it is important for users to always carry two pens with them at any one time.  Please see the package leaflet supplied with your pens for full information on how to safely use this product.

Emerade is indicated as an emergency supportive therapy and the HPRA reminds patients of the need to seek immediate medical attention following administration. It also recommends that patients with any concerns in relation to this matter should consult their doctor or pharmacist.

Specific Information for Pharmacists and other Healthcare Professionals:

For All Pharmacists:

A Caution-in-Use Notification has been issued to Pharmacists by Bausch + Lomb, requesting that they perform the following actions:

  1. Please endeavor to contact patients to whom you have dispensed any in-date batch of Emerade. (The shelf-life of Emerade is 18 months, so the earliest relevant dispensing date would be January 2017.)
  2. If any patient that you contact is in possession of an in-date Emerade pen, please remind them of the importance of always carrying two Emerade pens, in accordance with the Package Leaflet.
  3. When dispensing new Emerade pens, please ensure that all patients are advised to carry two pens at all times, in accordance with the Package Leaflet.

 

For Hospital Pharmacists only:

We kindly request that this communication is highlighted and made available to the relevant healthcare professionals within your hospital; for example Dermatologists, Immunologists, Emergency Medical Officers and Paediatricians

For Healthcare Professionals:

Healthcare Professionals should be aware of the information in this Advisory Notice and they are requested to re-iterate to patients the importance of reading the package leaflet for Emerade.  The package leaflet supplied with these pens advises patients that, in circumstances where a single dose of adrenaline does not completely reverse the effect of an allergic reaction, a repeat injection may be given after 10 to 15 minutes.  For this reason, it is important for users to always carry two pens with them at any one time.



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