Leaflet DOTAREM 0.5mmol / ml solution for injection in pre-filled syringe

Product code:
W43810004
Quantity:
1
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:
01-07-2025
Product code:
W43810004
Concentration:
0.5mmol / ml
Pharmaceutical form:
solution for injection in pre-filled syringe
Packing volume:
15 ml
Product type:
Original
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:
1988/2009/02
Shelf life:
3 years