Ultravist 300 (iopromide) solution for injection 300 mg/ml. 100 ml. vial №1

Description

Ultravist 300 (iopromide) solution for injection 300 mg/ml. 100 ml. vial №1

Composition

active substance: iopromide;

Ultravist 300: 1 ml contains 0.623 g of iopromide, corresponding to 300 mg of iodine;

Ultravist 370: 1 ml contains 0.769 g of iopromide, corresponding to 370 mg of iodine;

Excipients: edetate calcium sodium, trometamol, dilute hydrochloric acid, water for injections.

Dosage form

Solution for injection and infusion.

Basic physical and chemical properties: clear solution, free of particles.

Pharmacological properties

It is an iodine-containing radiopaque substance. When injected intravascularly, it makes the blood flow opaque to X-rays, which provides radiographic imaging of the circulatory system of organs.

Indications

Ultravist 300 is shown:

•  for contrast enhancement in computed tomography;
•  for arteriography, phlebography, including internal arterial digital subtraction angiography;
•  for intravenous urography;
•  for the study of body cavities (arthrography, hysterosalpingography), with the exception of the subarachnoid space.

Contraindications

The drug Ultravist 300 is not used:

•  with increased sensitivity to iodine-containing substances;
•  with intolerance to excipients;
•  with severe hyperthyroidism.

Used with caution:

•  in case of impaired renal function;
•  with diseases of the kidneys, liver;
•  with homozygous sickle cell anemia;
•  with multiple myeloma, other paraproteinemia;
•  with anuria;
•  with diabetes mellitus.

Application during pregnancy and lactation

Studies do not indicate a direct or indirect negative impact on the course of pregnancy, embryo development, childbirth, postnatal development. However, sufficiently controlled studies have not been conducted, therefore, during pregnancy, it is necessary to use the drug with extreme caution.
The ability of Joversol to be excreted in breast milk is unknown. But it is known that many injectable contrast agents are excreted unchanged in breast milk (approximately 1% of the administered dose). Although no adverse reactions have been identified, caution should be exercised with intravascular administration to nursing patients. It is recommended to stop feeding for 24 hours.

Method of administration and dosage

Dosage should be adjusted according to age, body weight, heart and kidney function, general condition of the patient, the task set before the clinician, the study technique and the study area.

The doctor determines the appropriate iodine concentration and volume required on an individual basis. The recommended volumes of iopromide solutions of different concentrations for each body part are given in Table 1.

The dose should not exceed 1.5 g iodine / kg body weight on any day of the study. For Ultravist 300, this corresponds to a volume of 5 ml / kg body weight, and for Ultravist 370, a volume of approximately 4 ml / kg body weight.

Overdose

Overdose can be potentially life-threatening, manifested by cardiovascular and respiratory disorders.
Treatment is symptomatic, hemodialysis is indicated.

Side effects

The most common side effects seen in patients receiving Ultravist are headache, nausea and varicose veins.

The most serious adverse reactions in patients receiving Ultravist were anaphylactoid shock, respiratory arrest, bronchospasm, laryngeal edema, pharyngeal edema, asthma, coma, cerebral infarction, stroke, cerebral edema, cerebral seizures / convulsions, cardiac arrhythmia, arrhythmia, , myocardial infarction, heart failure, bradycardia, cyanosis, hypotension, shock, dyspnea, pulmonary edema, respiratory failure and aspiration.