Tomoscan (iopamidol) solution for injections 370 mg/ml. 100 ml. vial №1

Description

Tomoscan (iopamidol) solution for injections 370 mg/ml. 100 ml. vial №1

Composition

active substance: iopamidol;

• 1 ml of the drug contains iopamidol 612.4 mg, in terms of iodine – 300 mg;
• 1 ml of the drug contains iopamidol 755.2 mg, in terms of iodine – 370 mg.

Excipients: tromethamine (trometamol), calcium edetate sodium, concentrated hydrochloric acid, water for injections.

Dosage form

Solution for injection.

Main physical and chemical properties: clear colorless or slightly yellowish liquid without visible inclusions.

• Tomoscan 300: osmotic pressure at 37 ° C – 1.59 MPa, viscosity at 37 ° C – 5.0 MPa.s.
• Tomoscan 370: osmotic pressure at 37 ° C – 2.08 mPa, viscosity at 37 ° C – 12.5 mPa.s.

Pharmacotherapeutic group

Contrasting agents. Iodine-containing X-ray contrast agents.
ATX code V08A B04.

Pharmacological properties

It is an iodine-containing X-ray contrast agent. When administered intravascularly, it makes the blood flow opaque to X-rays, which provides radiographic visualization of the circulatory system.

Indications

Tomoscan solution 370 mg/ml is shown:

• for lumbar, thoracocervical myelography;
• for cerebral angiography;
• for peripheral angiography and venography;
• for contrast enhancement in computed tomography, arthrography, urography.

Tomoscan solution 370 mg/ml is shown:

• for peripheral arteriography;
• for angiocardiography;
• for carrying out left ventricular ventriculography;
• for cerebral arteriography;
• for carrying out retrograde aortography;
• for selective renal arteriography;
• for selective visceral angiography;
• for digital subtraction angiography;
• for excretory urography.

Contraindications

The drug Tomoscan solution 370 mg/ml is not used:

• with hypersensitivity to iodine-containing substances;
• in case of intolerance to excipients;
• with severe hyperthyroidism.

Apply with caution:

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

Use during pregnancy and breastfeeding

Studies do not indicate a direct or indirect negative impact on pregnancy, embryonic development, childbirth, postnatal development. However, sufficiently controlled studies have not been performed, so during pregnancy it is necessary to use the drug with extreme caution.
The ability of yoversol 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 when administering intravascularly to nursing patients. It is recommended to stop feeding for 24 hours.

Method of application and dose

Tomoscan solution 370 mg/ml is used according to the schemes in the instructions.
Apply the lowest dose that provides adequate visualization.

Overdose

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

Side effects:

• Immune disorders: manifestations of allergies, including anaphylactoid reactions, anaphylactic shock.
• Mental disorders: agitation, confusion, anxiety.
• Neurological disorders: fainting, vertigo, tremor, headache, delirium, paresthesias, taste disturbances, loss of consciousness, speech impairment, paralysis, drowsiness, aphasia, stupor, dysphasia, hypoaesthesia, dyskinesia, convulsions, amnesia.
• Ophthalmic disorders: blurred vision, allergic conjunctivitis, eye irritation, tearing, redness, conjunctival edema, transient blindness.
• Otolaryngological disorders: ringing in the ears.
• Cardiovascular disorders: tachycardia, heart block, ECG changes, bradycardia, arrhythmia, angina, atrial fibrillation, cardiac arrest, coronary artery spasm, ventricular fibrillation, cyanosis, palpitations, extrasystole, hypertension / hypotension, hypotension, hypotension, hypotension phlebitis, vasodilation, vasospasm, shock, thrombosis, hemodynamic collapse.
• Respiratory disorders: laryngospasm, edema, airway obstruction, nasal congestion, stridor, shortness of breath, sneezing, cough, sore throat, pulmonary edema, hypoxia, pharyngitis, respiratory arrest, bronchospasm, apnea, asthma, dysphonia.
• Gastrointestinal disorders: dry mouth, nausea, sialadenitis, swelling of the tongue, abdominal pain, dysphagia, diarrhea, hypersalivation.
• Dermatological disorders: urticaria, rash, erythema, pruritus, Quincke’s edema, pallor, hyperhidrosis, toxic epidermal necrolysis.
• Musculoskeletal disorders: muscle cramps.
• Urinary disorders: involuntary urination, renal failure, decreased creatinine clearance, incontinence, hematuria, increased urea, dysuria, anuria, oliguria.
• General: fever, edema, pharyngeal edema, chills, tremor, changes in the injection site (pain, hemorrhage, erythema, necrosis), asthenic conditions, malaise, chest pain, hyperthermia.