PharmacovigilanceOfficial

Slovak regulator publishes Respreeza DHPC on vial integrity and missed-dose or infection risk

🇸🇰 ŠÚKL · Wed 04 Nov 2026

ŠÚKL has released a Direct Healthcare Professional Communication on Respreeza, citing possible compromised injection vial integrity that could lead to a missed dose or potential infection.

The State Institute for Drug Control (ŠÚKL) in Slovakia published a Direct Healthcare Professional Communication (DHPC) on 4 November 2026 concerning Respreeza, an alpha1-proteinase inhibitor (human).

The communication addresses the risk of a missed dose or a potential infection resulting from compromised integrity of the product's injection vial. The notice therefore touches on both dose delivery and the sterility of the medicine.

ŠÚKL describes a DHPC as direct communication to healthcare professionals that provides new important information on the safety, efficacy or correct use of a medicine. The notice appears in the regulator's medicines safety section, with the DHPC available as a PDF download of about 0.17 MB.

The text available on the ŠÚKL page does not set out the cause of the vial problem, the affected batches, the number of reports or the specific actions requested. Those details are contained in the DHPC document itself, which healthcare professionals should consult.

What it means for your team

  • Regulatory and quality teams should obtain the full DHPC PDF from ŠÚKL to confirm scope, affected batches and the required actions, as the web notice gives none of these.
  • Pharmacovigilance teams may wish to check whether reports of missed doses or infections linked to Respreeza vials need review or follow-up.
  • Healthcare professionals handling the product should follow the instructions in the DHPC, given the potential impact on dose delivery and sterility.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

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