Leaflet RYMPHYSIA 500mg powder+solvent for solution for infusion


Indicated for: alpha-1 antitrypsin deficiency

Route of administration: infusion

Substance: human alfa-1 proteinase inhibitor (alpha-1 proteinase inhibitor)

ATC: B02AB02 (Blood and blood forming organs | Antifibrinolytics | Proteinase inhibitors)

Human alpha-1 proteinase inhibitor is used for the treatment of alpha-1 antitrypsin deficiency, a genetic condition that can lead to lung diseases such as emphysema. It works by protecting lung tissue from enzymatic degradation.

The medication is administered intravenously, as directed by a doctor. It is important to monitor the patient for adverse reactions during the infusion.

Side effects may include headache, fever, dizziness, or injection site reactions. In rare cases, severe allergic reactions may occur.

This medication is not recommended for patients with hypersensitivity to human plasma proteins or severe IgA deficiency.

General data about RYMPHYSIA 500mg

  • Substance: human alfa-1 proteinase inhibitor
  • Date of last drug list: 01-07-2022
  • Commercial code: W68873001
  • Concentration: 500mg
  • Pharmaceutical form: powder+solvent for solution for infusion
  • Quantity: 1
  • Product type: original
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: TAKEDA MANUFACTURING AUSTRIA AG - AUSTRIA
  • Holder: TAKEDA MANUFACTURING AUSTRIA AG - AUSTRIA
  • Number: 14494/2022/01
  • Shelf life: 24 months-after packaging for sale;after reconstitution-it is used immediately

Concentrations available for human alfa-1 proteinase inhibitor

  • 1000mg
  • 500mg