Clinical and pharmacological group: & nbsp

Ultrasound contrast media

Included in the formulation
АТХ:

V.08.D.A.02   Galactose microparticles

Pharmacodynamics:Galactose Used in the form of microgranules for intrauterine injection. When suspending the galactose microgranules (particles smaller than 1 μm) air is adsorbed on their surface (1 ml of the suspension contains 10-20 μl of air), which when released into the blood stream and in contact with tissues is released as microbubbles. These bubbles amplify the amplitude of the reflected echo signal, contribute to the contrast of the image during ultrasound examination, increase the contrast of the image during echography.
Pharmacokinetics:After intravenous administration galactose is primarily distributed in the extracellular space and is included in the metabolism of glucose. Galactose is partially deposited, mainly in the liver with the formation of galactose-1-phosphate, and is subjected to an isomerization process followed by the formation of CO2. Galactose is excreted by the kidneys.
Indications:Ultrasound of female genital organs, in particular, to detect congenital or acquired changes in the uterine cavity, to visualize the fallopian tubes and to check their patency (contrast hysterosalpingography). Echocardiography in newborns and children under 6 years, including for the detection of hemodynamic defects of the right side of the heart, veins and so on.

XX.Y40-Y59.Y57.6   Other diagnostic drugs

Contraindications:Hypersensitivity to the drug; metabolic disorders of galactose; acute heart failure.
Carefully:Inflammatory diseases of female genital organs; endocarditis. In patients with severe cardiovascular insufficiency, intravenous injection requires a careful calculation of the osmolar load when using galactose.
Pregnancy and lactation:Do not use during pregnancy! 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 caused teratogenic and embryotoxic effects.

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:Transcervical. When carrying out hysterosalpingography, 2.5 ml (using an intrauterine balloon catheter) is injected, in the study of fallopian tubes - an additional 1-2 ml; the maximum dose is 15 ml.

The drug is available in vials: one (volume of 20 ml) contains 0.3 g of granulate, in the other (volume, too, 20 ml) - 13.5 ml of 20% solution of D-galactose; A plastic cannula is used to prepare the suspension.

Using a cannula, a solution of D-galactose (13.5 ml) is taken and transferred to a vial of granulate, vigorously shaken (for 5 seconds) until a uniform suspension (milky white) is obtained. Use it for the next 5 minutes.

It is impossible to heat the suspension (do not hold vials for a long time!).

In contrast echocardiography in B-mode is administered intravenously bolus, adult 10 ml at a concentration of 300 mg / ml (in tissues with a weak conductivity of sound - 5-8 ml at a concentration of 40 mg / ml, when examining only the right heart - 4-10 ml in a concentration of 300 mg / ml).

Children are administered, depending on their age, 0.5-4 ml at a concentration of 200 or 300 mg / ml; the maximum dose is 6 single-dose injections.

Application in elderly patients

Use in the elderly has not been systematically studied. There is no data on the need to change the dosage or withdrawal of the drug in patients in this group.

Use in children

Clinical data on the use of the drug in children are absent.

Side effects:In rare cases: the unusual taste, dyspnea, change in blood pressure or heart rate, nausea, vomiting, headache, dizziness, transient nonspecific stimulation of vascular endothelium, dermal allergic reactions, brief pain and a feeling of heat or cold during or immediately after closure injections; pain and irritation of the tissues at the site of administration (in the case of perovascular administration).
Overdose:There were no cases of overdose. Symptomatic therapy is indicated.
Interaction:There are no clinical data on the interaction. The drug is not compatible with other drugs.
Special instructions:The suspension should be used within 5 minutes. It is necessary to avoid heating the suspension and creating excessive vacuum, since it is possible to reduce the concentration of microbubbles and form large air bubbles.
Instructions
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