Leaflet GADOVIST 1.0mmol / ml solution for injection

Indicated for: diagnostic imaging contrast enhancement

Route of administration: injectable

Substance: gadobutrol (contrast agent)

ATC: V08CA09 (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.

Gadobutrol is a contrast agent used in magnetic resonance imaging (MRI) to highlight internal structures of the body. This gadolinium-based contrast agent helps doctors obtain clearer images of organs, blood vessels, and tissues, making it easier to diagnose conditions such as tumors, inflammation, or vascular lesions.

Gadobutrol is administered intravenously, usually just before or during the MRI procedure. The dose is determined by the doctor based on the patient's weight and the type of examination. The procedure is quick and generally well tolerated by most patients.

Side effects may include a sensation of warmth, metallic taste, nausea, or reactions at the injection site. In rare cases, severe allergic reactions or impaired kidney function may occur, especially in people with pre-existing kidney problems. It is important to inform your doctor about any conditions or allergies before the examination.

Gadobutrol is an effective and safe contrast agent for most patients, but its use requires medical supervision. Follow the medical team's instructions and report any unusual symptoms after the examination to prevent complications.

General data about GADOVIST 1.0mmol / ml

  • Substance: gadobutrol
  • Date of latest medicines list: 01-06-2026
  • Product code: W64838003
  • Concentration: 1.0mmol / ml
  • Pharmaceutical form: solution for injection
  • Packing volume: 15 ml
  • Product type: Original
  • Price: 401.87 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: 10724/2018/03
  • Shelf life: 3 years-after packing for marketing;after the first opening of the bottle-24h la 20-25°C

Pharmaceutical forms available for gadobutrol

Concentrations available for gadobutrol

  • 1.0mmol/ml
  • 1mmol/ml