Leaflet DOTAREM 0.5mmol / ml single-dose solution for injection

Indicated for: diagnostic imaging contrast enhancement

Route of administration: injectable

Substance: gadoteric acid (contrast agent)

ATC: V08CA02 (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.

Gadoteric acid is a contrast agent used in magnetic resonance imaging (MRI) to improve image quality. It contains gadolinium, a metal that helps highlight anatomical and pathological details.

It is commonly used for diagnosing central nervous system conditions, tumors, or vascular issues. Administration is done intravenously, and the substance is eliminated from the body through the kidneys.

Side effects are rare and include nausea, dizziness, 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 conditions or allergies before administration. The use of this contrast agent should be supervised by a specialist to minimize risks.

General data about DOTAREM 0.5mmol / ml

  • Substance: gadoteric acid
  • Date of latest medicines list: 01-06-2026
  • Product code: W43811003
  • Concentration: 0.5mmol / ml
  • Pharmaceutical form: single-dose solution for injection
  • Packing volume: 15 ml
  • Product type: Original
  • Price: 145.44 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: GUERBET - FRANTA
  • Holder: GUERBET - FRANTA
  • Number: 1989/2009/03
  • Shelf life: 3 years