Class 4 MHRA drug alert – Inhixa solution for injection in pre-filled syringe (Techdow Europe AB)

Class 4 MHRA drug alert – Inhixa solution for injection in pre-filled syringe (Techdow Europe AB)

April 18, 2018

Drug alert number: EL (18)A/07

Date issued: 18th April 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Inhixa solution for injection in pre-filled syringe 2,000 IU (20 mg) in 0.2 mL; 4,000 IU (40 mg) in 0.4 mL; 6,000 IU (60 mg) in 0.6 mL; 8,000 IU (80 mg) in 0.8 mL; 10,000 IU (100 mg) in 1.0 mL (Techdow Europe AB)

Marketing Authorisation number:

  • EU/1/16/1132/012
  • EU/1/16/1132/014
  • EU/1/16/1132/016
  • EU/1/16/1132/018
  • EU/1/16/1132/020

Techdow Europe AB has issued this Direct Healthcare Professional Communication (DHCP) due to rare cases of premature self-activation of the safety device in unused, unopened pre-filled Inhixa syringes as shown in the DHCP diagrams. When premature activation has occurred, administration is not possible.

To minimise the risk of missed doses:

  • Pharmacists should visually check all Inhixa syringes before dispensing to check if they are affected by the self-activation defect as shown in the DHCP diagrams. Do not open the syringe blisters.
  • Individual syringes that are affected by the self-activation defect should not be dispensed to patients.
  • Pharmacists should make sure they have sufficient stock of Inhixa available as replacements.

Techdow Pharma England Limited can be contacted on 01271 334 609.

To view the alert please visit the GOV.uk website.

 



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