Tomohexol (iohexol) solution for injections 300 mg/ml. 100 ml. №1 vial

Description

Tomohexol (iohexol) solution for injections 300 mg/ml. 100 ml. №1 vial

Composition and form of release

Active ingredient: iohexol 647 mg / ml (equivalent to 300 mg / ml iodine).

Tomohexol is available as a solution for injection / infusion.

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

Dosage form

Solution for injection.

Main physical and chemical properties: clear colorless or light yellow liquid (solution).

Pharmacotherapeutic group

Iodine-containing X-ray contrast agents. Water-soluble low-osmolar nephrotropic X-ray contrast agents.
ATX code V08A B02.

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

Tomohexol solution 300 mg/ml is used:

• for angiography;
• for arthrography;
• for arteriography;
• for urography;
• for phlebography;
• for contrast enhancement in computed tomography;
• for cervical, thoracic, lumbar myelography;
• for CT cisternography;
• for hysterosalpingography;
• for sialography;
• for endoscopic retrograde pancreatography (ERPG);
• for endoscopic retrograde cholangiopancreatography (ERCP);
• for herniography;
• for studies of the gastrointestinal tract.

Contraindications

The drug Tomohexol solution 300 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

Tomohexol solution 300 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.