Leaflet PROTAMINSULFAT LEO PHARMA 1400 ANTI-HEPARINUI/ml 10mg / ml solution for injection / infusion

Product code:
W69119001
Quantity:
5
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 | 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 PROTAMINSULFAT LEO PHARMA 1400 ANTI-HEPARINUI/ml 10mg / ml

Substance:
protamine sulfate
Date of latest medicines list:
01-10-2025
Product code:
W69119001
Concentration:
10mg / ml
Pharmaceutical form:
solution for injection / infusion
Quantity:
5
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:
CENEXI SAS - FRANTA
Holder:
ALLIANCE HEALTHCARE ROMANIA S.R.L. - ROMANIA
Number:
745/2022/01
Shelf life:
3 years

Pharmaceutical forms available for protamine sulfate

Concentrations available for protamine sulfate

  • 10mg/ml
  • 1400Ui/ml