Unipak (yogexol) solution for injections 350 mg/ml. 100 ml. №1 vial

Description

Unipak (yogexol) solution for injections 350 mg/ml. 100 ml. №1 vial

Composition

active substance: yogexol;

• 1 ml of a solution of 240 mg / ml contains: iogexol 518 mg, equivalent to iodine 240 mg / ml;
• 1 ml of a solution of 300 mg / ml contains: iogexol 647 mg, equivalent to iodine 300 mg / ml;
• 1 ml of a solution of 350 mg / ml contains: iogexol 755 mg, equivalent to iodine 350 mg / ml;

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

Dosage form

Solution for injection.

Main physical and chemical properties: clear, colorless or pale yellow 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 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

Unipak 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 Unipak 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

The drug is intended for intra-arterial, intravenous, intrathecal, intracavitary administration, oral and rectal administration to adults and children.

When administering the drug, the patient should be in a horizontal position.

The dose depends on the test method, age, body weight, cardiac output, general condition of the patient and the technique of administration. The same concentration and volume of iodine is usually used as for other iodine-containing X-ray contrast media. Adequate hydration of the body must be provided before and after the application of the contrast agent.

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, incl. anaphylactoid reactions, anaphylactic shock.
Mental disorders: agitation, confusion, anxiety.
Neurological disorders: fainting, vertigo, tremor, headache, delirium, paresthesia, taste disturbances, loss of consciousness, speech impairment, paralysis, drowsiness, aphasia, stupor, dysphasia, hypesthesia, dyskinesia, convulsions, amnesia.
Ophthalmic disorders: blurred vision, allergic conjunctivitis, eye irritation, lacrimation, redness, conjunctival edema, transient blindness.
Otolaryngological disorders: ringing in the ears.
Cardiovascular disorders: tachycardia, heart block, ECG changes, bradycardia, arrhythmia, angina pectoris, atrial fibrillation, cardiac arrest, coronary artery spasm, ventricular fibrillation, cyanosis, palpitations, extrasystole, arterial hypotension, circulatory hypertension, hypotension / hypertension, 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, tongue edema, 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 levels, dysuria, anuria, oliguria.
General: fever, facial edema, pharyngeal edema, chills, tremors, changes at the injection site (pain, hemorrhage, erythema, necrosis), asthenic conditions, feeling unwell, chest pain, hyperthermia.