Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
АТХ:V.08.C.A Paramagnetic contrast media
Pharmacodynamics:Gadoversetamide is a paramagnetic contrast medium with a gadolinium ion chelate complex and versetamide in its structure. Like all the preparations of his group, gadoversetamide is highly hydrophilic and accumulates in areas of increased blood supply, for example in tumors, hemangiomas, hematomas and others. When placed in a magnetic field, the drug reduces T1 and T2 the relaxation time, which greatly increases the signal power in the tissues of accumulation. This visually enhances the contrast and "visibility" of different formations on MRI shots compared to those made without contrast.
Pharmacokinetics:An intact blood-brain barrier is an insurmountable barrier to the hydrophilic molecule of gadoversetamide. At the same time, in the presence of violations of the blood-brain barrier or foci of pathological vascularization (stroke, hematoma, abscess, tumor and the like), the substance accumulates in the affected area. Elimination half-life in the study in vitro 103,6±19.7 minutes.In experiments, the phenomenon of biotransformation has not been proved, that is, the drug is excreted unchanged. 95.5% of the drug is excreted by the kidneys within 1 day after intravenous administration. In small amounts, it is excreted with feces. Plasma and kidney clearance in healthy people coincide and make up 69±17.3 ml / h / kg. In patients with impaired renal function, the kinetics of the drug slows down. With diseases of the liver parenchyma, the removal of gadoversetamide remains practically at the same level.
Indications:To increase the contrast of the image when magnetic resonance imaging in patients with damage to the blood-brain barrier or pathological vascularization of the brain and spinal cord and surrounding tissues. To increase the contrast in the magnetic resonance imaging of the foci of pathological vascularization (hemangioma, hematoma) in the liver in patients with previously revealed on computer tomography its structural anomalies.
XXI.Z00-Z13.Z03 Medical surveillance and evaluation in case of suspected disease or pathological condition
Contraindications:Hypersensitivity to the drug or to one of its components (gadolinium,vercetamide); pregnancy and the period of breastfeeding - use only in case of emergency; children under 6 years of age (safety and efficacy not studied). Severe renal dysfunction (glomerular filtration rate is less than 30 ml / min / 1.73 m2.
Carefully:Mild and moderate renal dysfunction, especially acute; The dosage regimen for patients in this group is not defined. Earlier episodes of an allergy to a contrast substance with gadolinium; adverse allergic anamnesis. Repeated studies involving gadoveretamid. The safety of such studies has not been specifically studied.
Pregnancy and lactation:Use in pregnant women can be possible only with the obvious clinical need for research. The action category for the fetus by the FDA is C. There have not been well-controlled studies on humans. In animal experiments, the drug penetrated the placental barrier and was detected in the fetal tissues. Lactation: Do not use the drug in lactation or stop breastfeeding for the period of treatment. There is no data on the penetration of the drug into breast milk.
Dosing and Administration:Enter the bolus intravenously at a dosage of 0.1 mmol / kg (0.2 ml solution) at a rate of 1-2 ml per second. Visualization is most reliable within 1 hour after drug administration. Application in elderly patients
Use in the elderly has not been systematically studied. There is no data on the need to reduce the dosage of the drug in patients in this group, except for:
- cases of severe renal failure;
- a dubious allergological anamnesis.
Use in children
The safety of the drug in pediatrics has not been studied. There is a higher risk of adverse reactions and kidney damage due to their functional immaturity in children and possible subclinical renal failure.
Side effects:The most frequent adverse reactions (≥ 0.5%) that were observed in patients receiving the drug are: headache, nausea and dizziness. The most serious adverse reactions in patients receiving the drug are cardiac arrest, severe anaphylactic / anaphylactoid reactions.
Delayed allergic reactions (a few hours or days) were rare.
In most cases, the side effects were characterized by a mild or moderate degree of severity.
Overdose:There were no cases of overdose. The goals of therapy with a possible overdose are maintenance of vital functions, rapid administration of symptomatic therapy. The drug can be removed from the body by hemodialysis.
Interaction:Gadoversetamide pharmacologically incompatible with other drugs.
Special instructions:There have been reports of the development of nephrogenic systemic fibrosis due to the introduction of gadolinium-containing contrast agents, including gadoversetamide, patients with the following diseases / conditions: - Acute or chronic renal failure (glomerular filtration rate less than 30 ml / min / 1.73 m2);
- Acute renal failure of any severity caused by hepatorenal syndrome, or in the period before and after liver transplantation.
The drug can be removed from the body by hemodialysis. As a consequence, the possibility of dialysis to patients with a drug poisoning clinic should be provided.