Universal reference book for medicines
Product name: Optimark (OptiMark)

Active substance: gadoversetamide

Type: Contrast diagnostic drug for magnetic resonance imaging

Manufacturer: MALLINCKRODT CHEMICAL (USA)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Contrast diagnostic paramagnetic ionic agent.
It is a complex of a chelate compound of versetamide and a paramagnetic gadolinium ion.
When placed in a magnetic field, gadversetamid reduces the T1 and T2-relaxation times in the tissues in which it accumulates.
In the recommended dose, gadversetamid predominantly affects the T1-relaxation time, which leads to an increase in signal intensity in the tissues in which it accumulates. This provides increased contrast of the image during MRI and facilitates the visualization of abnormal structures in the organs and tissues under investigation.
Gadoversetamid does not penetrate intact GEB and therefore does not accumulate in normal brain tissue or lesions with intact GEB (eg, cysts, natural postoperative scars).
If the BBB is violated or pathological vascularization, the active substance accumulates in the lesions, such as tumors, abscesses and subacute infarction zones.
PHARMACOKINETICS
With intravenous administration, the pharmacokinetics of the gadversetamide is described by a two-compartment model with an average T 1/2 of 103.6 ± 19.5 min.Does not bind to plasma proteins in vitro.
V ss in healthy volunteers 162 ± 25 ml / kg. Biotransformation is not defined.
It is excreted mainly in urine 95.5 ± 17.4% within 24 hours after administration.
In small amounts is determined in the stool. The values ​​of renal and plasma clearance in healthy volunteers are close to 69 ± 15.4 and 72 ± 16.3 ml / h / kg, respectively.
With violations of kidney function removal of gadoversetamide is slowed down.
The kinetics of gadoversetamide in plasma in patients with impaired hepatic function and with normal renal function is the same as in healthy volunteers


INDICATIONS
To increase the contrast during MRI in patients with a violation of BBB or pathological vascularization of the brain, spinal cord and related tissues.

To increase the contrast in the MRI for the purpose of visualization of foci of pathological vascularization in the liver in patients with suspected structural liver disorders, identified with CT.

DOSING MODE
I / in the form of a bolus in a dose of 0.2 ml / kg (0.1 mmol / kg) at a rate of 1-2 ml / sec.
The visualization procedure should be completed within 1 hour after the introduction

SIDE EFFECT
From the nervous system: often - headache, dizziness, paresthesia;
less than 1% - agitation, anxiety, impaired consciousness, depersonalization, diplopia, dystonia, hallucinations, hyperesthesia, nervousness, drowsiness, tremor, vertigo.
From the cardiovascular system: often - vasodilation;
less than 1% - arrhythmia, chest pains, arterial hypertension, arterial hypotension, palpitation, syncope, tachycardia, vasospasm, pallor
From the digestive system: often - nausea, abdominal pain;
less than 1% - anorexia, increased appetite, constipation, dry mouth, dysphagia, eructation, flatulence, increased salivation, thirst, vomiting
On the part of the body as a whole: often - asthenia;
less than 1% - allergic reactions, face swelling, fever, flu-like syndrome, malaise, mucous membrane irritation neck stiffness, neck pain, pelvic pain, increased sweating.
On the part of the hematopoiesis system: less than 1% - thrombocytopenia.

On the part of metabolism: less than 1% - an increase in serum creatinine, edema, hypercalcemia, hyperglycemia, hypoglycemia, hyponatremia.

From the musculoskeletal system: often - pain in the back;
less than 1% - arthralgia, leg cramps, myalgia, myasthenia gravis, muscle spasm.
On the part of the respiratory system: less than 1% - asthma, cough, shortness of breath, epistaxis, hemoptysis, laryngospasm, pharyngitis, sinusitis, hoarseness.

Dermatological reactions: less than 1% - erythema multiforme, pruritus, maculopapular rash, vesicular rash, dry skin, urticaria.

From the sense organs: less than 1% - amblyopia, conjunctivitis, hyperacusis, impaired sense of smell, tinnitus.

On the part of the urinary system: less than 1% - dysuria, oliguria, frequent urination.

Local reactions: less than 1% - reactions at the site of administration, incl.
edema, thrombophlebitis, inflammation.
CONTRAINDICATIONS
Chronic, severe kidney disease (GFR <30 mL / min / 1.73 m 2 ).
Acute kidney disease. Hypersensitivity to gadoversetamidu, gadolinium, versetamide.
PREGNANCY AND LACTATION
Adequate and strictly controlled studies of the safety of gadoversetamide during pregnancy have not been conducted.
The application is only possible in cases where the expected benefit to the mother justifies the potential risk. With the introduction of the drug, breastfeeding should be discontinued and resumed 72 hours after the introduction of gadoversetamide.
In experimental studies, it was shown that gadoversetamide penetrates the placental barrier, is determined in the fetal tissues, in the mother's milk.

APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindications: chronic, severe kidney disease (GFR <30 ml / min / 1.73 m 2 ), acute kidney disease.

The risk of developing systemic nephrogenic fibrosis with the use of contrast agents based on gadolinium is increased in patients with chronic severe kidney disease with a glomerular filtration rate (GFR) of less than 30 ml / min / 1.73 m 2 , as well as in patients with acute kidney disease.
In such cases, do not use gadversetamid. In patients with chronic moderate renal disease with GFR 30-59 ml / min / 1.73 m 2 ), this risk is less, and even less in patients with mild renal disease (GFR 60-89 ml / min / 1.73 m 2 ). Systemic nephrotic fibrosis can lead to fatal or destructive fibrosis, which affects the skin, muscles and internal organs.
Do not use the drug in patients with acute kidney damage and other conditions that can lead to impaired renal function.
The risk of acute kidney damage is possible with surgical interventions, severe infections, toxic kidney damage, incl. It is caused by drugs with nephrotoxicity. Patients who have the risk of chronic kidney disease (including those over the age of 60, with diabetes, chronic hypertension) should be determined by GFR before the administration of gadoveretamide.
Factors that increase the risk of developing systemic nephrogenic fibrosis are repeated administration of contrast medium, administration in doses exceeding the recommended ones, the degree of renal dysfunction, exposure time.

APPLICATION FOR CHILDREN
The safety and effectiveness of gadoveretamide in pediatric use has not been established.
The risk of adverse reactions in children may be increased due to immaturity of the kidneys and / or latent kidney failure.
SPECIAL INSTRUCTIONS
Contrasting agents based on gadolinium increase the risk of developing systemic nephrogenic fibrosis in patients with impaired excretion of drugs.
Gadoversetamide should be avoided in this category of patients, except in cases when magnetic resonance imaging by other contrast agents is not available.
The risk of developing systemic nephrogenic fibrosis with the use of contrast agents based on gadolinium is increased in patients with chronic severe kidney disease with a glomerular filtration rate (GFR) of less than 30 ml / min / 1.73 m 2 , as well as in patients with acute kidney disease.
In such cases, do not use gadversetamid. In patients with chronic moderate renal disease with GFR 30-59 ml / min / 1.73 m 2 ), this risk is less, and even less in patients with mild renal disease (GFR 60-89 ml / min / 1.73 m 2 ). Systemic nephrotic fibrosis can lead to fatal or destructive fibrosis, which affects the skin, muscles and internal organs.
Do not use the drug in patients with acute kidney damage and other conditions that can lead to impaired renal function.
The risk of acute kidney damage is possible with surgical interventions, severe infections, toxic kidney damage, incl. It is caused by drugs with nephrotoxicity. Patients who have the risk of chronic kidney disease (including those over the age of 60, with diabetes, chronic hypertension) should be determined by GFR before introducing gadoveretamida.
Factors that increase the risk of developing systemic nephrogenic fibrosis are repeated administration of contrast medium, administration in doses exceeding the recommended ones, the degree of renal dysfunction, exposure time.

The safety of gadoveretamide in patients with sickle cell anemia has not been studied.

The potential risk of hemolysis after administration of gadoveretamide to patients with other types of hemolytic anemia has not been investigated.

Patients with a history of allergy, renal insufficiency, or hypersensitivity reactions to the administration of medications are required to observe for several hours after administration of the gadoveretamide.

Since gadversetamid is excreted from the body by glomerular filtration, care should be taken when administering the drug to patients with impaired renal function (GFR-30 and <90 mL / min / 1.73 m 2 ).
Dosing regimen for patients with impaired renal function is not established. Gadoversetamide is excreted from the body during dialysis.
The possibility of developing hypersensitivity reactions, including serious, life-threatening, fatal anaphylactoid or cardiovascular reactions, should always be considered, especially in patients with clinical symptoms of hypersensitivity, history of bronchial asthma and other respiratory diseases.

The safety of introducing gadoversetamide in repeated studies has not been studied.

Magnetic resonance imaging is performed under the supervision of a physician who has sufficient experience and knowledge about this procedure in conditions that allow for emergency therapy in the development of complications and severe reactions to the administration of contrast media.

The safety and effectiveness of gadoveretamide in pediatric use has not been established.
The risk of adverse reactions in children may be increased due to immaturity of the kidneys and / or latent kidney failure.
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