Leaflet SULFAT DE PROTAMINA LEO PHARMA 1400UI ANTI-HEPARINA/ml 10mg / ml solution for injection / infusion

Indicated for: reversal of heparin anticoagulation; heparin overdose

Route of administration: injectable / infusion

Substance: protamine sulfate (antidote; heparin antagonist)

ATC: V03AB14 (Various | All other therapeutic products | Antidotes)

Protamine sulfate is used to neutralize the anticoagulant effects of heparin, particularly during surgical procedures or in cases of heparin overdose. It works by forming a stable complex with heparin, inhibiting its activity.

The medication is administered intravenously, as directed by a doctor, usually as a slow injection. It is important for patients to be monitored for adverse reactions during administration.

Patients should be aware of potential side effects, such as allergic reactions, hypotension, or bradycardia. It is important to inform the doctor of any unusual symptoms.

Common side effects include allergic reactions, hypotension, and bradycardia. In rare cases, severe reactions such as anaphylactic shock may occur. Patients should be informed of these risks before use.

General data about SULFAT DE PROTAMINA LEO PHARMA 1400UI ANTI-HEPARINA/ml 10mg / ml

  • Substance: protamine sulfate
  • Date of latest medicines list: 01-06-2026
  • Product code: W69743001
  • Concentration: 10mg / ml
  • Pharmaceutical form: solution for injection / infusion
  • Quantity: 5
  • Product type: Generic medicine
  • Price: 224.17 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: CENEXI SAS - FRANTA
  • Holder: LEO PHARMA A/S - DANEMARCA
  • Number: 6/2023/01
  • Shelf life: 3 years-dupa amb. pt comercializare; after openinga fiolei-se util. imediat

Pharmaceutical forms available for protamine sulfate

Concentrations available for protamine sulfate

  • 10mg/ml
  • 1400Ui/ml