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Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14)

Medicines Healthcare Products Regulatory Agency

March 4
14:00 2020

MDR Number

MDR 57-08/19

Company name

Pharmaswiss ?eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)

Product description

Product PL Number
Emerade 150 micrograms solution for injection in pre-filled syringe PL 33616/0013

Brief description of the problem

Pharmaswiss ?eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.

Results from manufacturer testing of Emerade auto-injectors recalled from patients in Europe indicate that approximately 13% of pens need higher than normal force to activate, implying a higher risk of activation failure than was previously understood. This applies to all strengths of Emerade.

For Emerade 150 micrograms auto-injectors, the MHRA, in conjunction with the Department of Health & Social Care (DHSC) has established that there are sufficient supplies of alternative auto-injectors to allow for a recall to patient level.

General Practitioners (GPs) should send the attached Patient Letter Advice for patients with an Emerade 150 microgram auto-injector to all patients and carers, as appropriate, who have been prescribed Emerade 150 micrograms auto-injectors.

GPs should also send the attached Patient Letter Advice for patients with Emerade 300 microgram or Emerade 500 microgram auto-injectors to all patients and carers for information.

Actions for healthcare professionals

All healthcare professionals in primary, secondary or specialist healthcare services who prescribe, supply or administer adrenaline auto-injectors, or who advise patients and their carers, should ensure that they:

Prescribers should issue no more than two adrenaline auto-injectors per patient (of any brand or strength) unless:

  • schools require separate pens to be kept on the school premises (e.g. in a medical room) in which case prescribers may need to consider issuing more than two but no more than four pens per child (of any brand or strength). See further information on the use of pens in school, page 4 of Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14);

  • for the rare scenario where patients might need more than two adrenaline pens prescribed (for example, a prior severe reaction resistant to treatment with adrenaline), where the prescriber may issue additional pens.

General Practitioners (GPs) should send the attached Patient Letter Advice for patients with an Emerade 150 microgram auto-injector to all patients and carers, as appropriate, who have been prescribed Emerade 150 micrograms auto-injectors.

Patients and carers should be told of the important differences between brands of adrenaline pen in how they are used.

  • healthcare professionals doctors, nurses and pharmacists should ensure they provide training to patients and carers in correct use of the new pen. Instructions for use can be found in the SmPC (prescribers information) and in the Patient Information Leaflets (PILs) that are supplied with the different pens and on the respective manufacturers websites where training videos are available. Training pens that do not contain adrenaline can also be obtained free of charge from the manufacturers. Healthcare professionals and patients are strongly recommended to obtain these to assist with training. The trainer pens can be used repeatedly, allowing patients to practise regularly with them so they are prepared for use in an emergency.

  • the following links provide training materials for the different devices:

EpiPen

Jext

Emerade

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