Product information
MDR number
MDR 049-12/17
Company name
Techdow Europe AB
Product description
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.
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
Brief description of the problem
Techdow Europe AB has issued the Direct Healthcare Professional Communication (DHCP) attached 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.
Advice for healthcare professionals
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.