Leaflet DIGIFAB 40mg powder for solution for infusion

Indicated for: cardiac arrhythmias

Route of administration: infusion

Substance: antidigoxin antibodies (antiarrhythmic)

ATC: V03AB24 (Various | All other therapeutic products | Antidotes)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Narrow therapeutic index
Narrow therapeutic index

The dose must be followed strictly.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Antidigoxin antibodies are used as an antidote for the treatment of digoxin toxicity, a condition that can occur following excessive administration of digoxin, a medication used for heart failure and arrhythmias. These antibodies specifically bind to digoxin molecules in the blood, forming complexes that are then eliminated by the kidneys, thereby reducing the toxic effects of digoxin.

Antidigoxin antibodies are administered intravenously, usually in emergency situations, with the dosage calculated based on the serum digoxin level and the patient's weight.

Common side effects include injection site reactions, nausea, fever, and hypokalemia. In rare cases, severe allergic reactions or renal failure may occur.

Patients receiving antidigoxin antibodies should be closely monitored for signs of adverse reactions and serum digoxin levels. This treatment is essential for managing severe digoxin toxicity, providing a rapid and effective solution to reduce the risk of serious complications.

General data about DIGIFAB 40mg

  • Substance: antidigoxin antibodies
  • Date of latest medicines list: 01-07-2023
  • Product code: W69597001
  • Concentration: 40mg
  • Pharmaceutical form: powder for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: SERB - FRANTA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 801/2023/01