Beur schreef op 1 maart 2018 16:53:
[...]Summary of the situation: The Spanish Agency for Medicines and Healthcare Products (AEMPS) has been notified of a controlled distribution of C1-inhibitor CSL-Behring plasma concentrate (Berinert®), for which Dr. TeresaCaballero, coordinator of the Spanish Group of Study of Bradykinin-mediated Angioedema (GEAB) of the Spanish Society of Allergy and Clinical Immunology (SEAIC) has had a meeting at the AEMPS with different responsible on 01/24/2018 and has since maintained contact with the AEMPS to try to find solutions. Controlled Berinert® (CSL-Behring) is attributed to the distribution problems of the C1-inhibitor Cinryze® plasma (Shire HGT) and to an increase in demand.Shire HGT has been carrying out a controlled distribution of Cinryze® since June 2017, acute September 2017, and has reported to the AEMPS supply problems of Cinryze® throughout 2018. Sanofi has informed the AEMPS a stock break of Danatrol® (danazol) from mid-January 2018 to mid-March 2018.
Major problem in the distribution of Berinert® is foreseen for February-March 2018, with improvement in April-May 2018. An important improvement is expected for October 2018.
The AEMPS is doing the procedures to import Ruconest® * (C1 recombinant inhibitor) approved by theEMA for the treatment of acute attacks of AE in patients with AEH-C1-INH> 12 years. At the moment it is not available, but it will be reported as soon as it is. With all this information, GEAB has prepared this document to reduce the consumption of plasma inhibitor C1 and promote other alternatives during the period of C1 inhibitorplasmático deficiency, some of which they indicate below. This note will be sent to the SEAIC, to the Spanish Society of Clinical Immunology, Allergology and Pediatric Asthma (SEICAP), to the Spanish Society of Immunology (SEI), to the Spanish Academy of Dermatology and Venereology (AEDV), to the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Medicine of Emergencies and Emergencies (SEMES).
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