Leaflet PRIMOVIST 0.25mmol/ml 181.430mg solution for injection in pre-filled syringe

Product code:
W63890007
Quantity:
1
Indicated for:
diagnostic imaging contrast enhancement
Route of administration:
injectable
Substance:
gadoxetic acid (contrast agent)
ATC
V08CA10 — Various | Magnetic resonance imaging contrast media | Paramagnetic contrast media

Precautions:

Anaphylaxis

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

Additional monitoring

This medicine is subject to additional monitoring.

Nephrotoxicity

Nephrotoxicity

This medicine may affect the kidneys.

Gadoxetic acid is a contrast agent used in magnetic resonance imaging (MRI), particularly for liver evaluation. It contains gadolinium, a metal that helps improve the clarity of MRI images.

It is commonly used for diagnosing liver lesions, including tumors or other hepatic conditions. Administration is done intravenously, and the substance is eliminated from the body through the kidneys and liver.

Side effects are rare but may include nausea, headaches, or allergic reactions. In patients with severe renal impairment, there is a very small risk of nephrogenic systemic fibrosis.

Patients should inform their doctor about any kidney or liver conditions before administration. The use of this contrast agent should be supervised by a specialist to minimize risks.

General data about PRIMOVIST 0.25mmol/ml 181.430mg

Substance:
gadoxetic acid
Date of latest medicines list:
01-06-2026
Product code:
W63890007
Concentration:
181.430mg
Pharmaceutical form:
solution for injection in pre-filled syringe
Packing volume:
10 ml
Product type:
Original
Price:
677.84 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
BAYER AG - GERMANIA
Holder:
BAYER AG - GERMANIA
Number:
13707/2021/01
Shelf life:
5 years

Pharmaceutical forms available for gadoxetic acid

Concentrations available for gadoxetic acid

  • 181.430mg
  • 181.43mg/ml