Edit the instructions. Gadodiamide in drug form solution for intravenous administration

January 16, 2017
Active substances:
ICD-10:
XXI.Z00-Z13.Z03    Medical surveillance and evaluation in case of suspected disease or pathological condition
Gadodiamide, omniscan, contrast enhancement during MRI, contrast agent with MRI

The need to supplement the instructions for the use of medicinal products with the following information is revealed:

1 The section "With caution" should be presented in the following edition: "anemia (sickle cell, hemolytic), hemoglobinopathy, hepatic insufficiency, patients with impaired renal function (GFR 30-59 ml / min / 1.73 m2), patients with hepatorenal syndrome, allergies, bronchial asthma, epilepsy, brain diseases, the presence in the anamnesis of unwanted reactions to the introduction of radiopaque substance (with the exception of allergic reactions). "

2 The section "Impact on the ability to drive vehicles and mechanisms" is presented in the following edition: "Studies on the impact on the ability to manage vehicles and mechanisms have not been carried out. It is not recommended to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed psychomotor reactions, within 24 hours after the study. "