Iodiscan (Solution) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

V08AB09 (Iodixanol)

Active Substance

Iodixanol (Rec.INN registered by WHO)

Dosage Forms

	Iodiscan	Solution for injection, oral and rectal administration 150 mg iodine/1 ml: fl. 20 ml, 50 ml, 100 ml, 200 ml or 500 ml 1, 10, 20, 24 or 28 pcs.
		Solution for injection, oral and rectal administration 270 mg iodine/1 ml: fl. 20 ml, 50 ml, 100 ml, 200 ml or 500 ml 1, 10, 20, 24 or 28 pcs.
		Solution for injection, oral and rectal administration 320 mg iodine/1 ml: fl. 20 ml, 50 ml, 100 ml, 200 ml or 500 ml 1, 10, 20, 24 or 28 pcs.

Dosage Form, Packaging, and Composition

Solution for injection, oral and rectal administration transparent, colorless or light yellow.

Excipients : trometamol – 1.2 mg, sodium chloride – 4.03 mg, calcium chloride dihydrate – 0.09 mg, sodium calcium edetate – 0.1 mg, hydrochloric acid 1M solution – to pH 6.8-7.7, water for injections – to 1 ml.

20 ml – bottles (1) – carton packs.
20 ml – bottles (10) – carton packs.
20 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
50 ml – bottles (1) – carton packs.
50 ml – bottles (10) – carton packs.
50 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
100 ml – bottles (1) – carton packs.
100 ml – bottles (10) – carton packs.
100 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
200 ml – bottles (1) – carton packs.
200 ml – bottles (10) – carton packs.
200 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
500 ml – bottles (1) – carton packs.
500 ml – bottles (10) – carton packs.
500 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).

Solution for injection, oral and rectal administration transparent, colorless or light yellow.

Excipients : trometamol – 1.2 mg, sodium chloride – 1.87 mg, calcium chloride dihydrate – 0.07 mg, sodium calcium edetate – 0.1 mg, hydrochloric acid 1M solution – to pH 6.8-7.7, water for injections – to 1 ml.

20 ml – bottles (1) – carton packs.
20 ml – bottles (10) – carton packs.
20 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
50 ml – bottles (1) – carton packs.
50 ml – bottles (10) – carton packs.
50 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
100 ml – bottles (1) – carton packs.
100 ml – bottles (10) – carton packs.
100 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
200 ml – bottles (1) – carton packs.
200 ml – bottles (10) – carton packs.
200 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
500 ml – bottles (1) – carton packs.
500 ml – bottles (10) – carton packs.
500 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).

Solution for injection, oral and rectal administration transparent, colorless or light yellow.

Excipients : trometamol – 1.2 mg, sodium chloride – 1.11 mg, calcium chloride dihydrate – 0.04 mg, sodium calcium edetate – 0.1 mg, hydrochloric acid 1M solution – to pH 6.8-7.7, water for injections – to 1 ml.

20 ml – bottles (1) – carton packs.
20 ml – bottles (10) – carton packs.
20 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
50 ml – bottles (1) – carton packs.
50 ml – bottles (10) – carton packs.
50 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
100 ml – bottles (1) – carton packs.
100 ml – bottles (10) – carton packs.
100 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
200 ml – bottles (1) – carton packs.
200 ml – bottles (10) – carton packs.
200 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).
500 ml – bottles (1) – carton packs.
500 ml – bottles (10) – carton packs.
500 ml – bottles (1, 10, 20, 24 or 28 pcs.) – carton boxes (for hospitals).

Clinical-Pharmacological Group

Radiocontrast non-ionic diagnostic agent for intravascular, intracavitary, subarachnoid and oral administration

Pharmacotherapeutic Group

Contrast agents; X-ray contrast agents containing iodine; water-soluble nephrotropic low-osmolar X-ray contrast agents

Pharmacological Action

Radiocontrast non-ionic dimeric agent. It is a hexaiodinated compound, water-soluble. Iodixanol contains approximately 49.1% iodine.

The organically bound iodine introduced into the bloodstream and entering the organs and tissues absorbs X-rays.

Aqueous solutions of iodixanol in all clinically used concentrations have lower osmolarity than whole blood and monomeric non-ionic radiocontrast agents in comparable concentrations.

Indications

Adults: selective cerebral arteriography, selective cerebral intra-arterial digital subtraction arteriography (DSA), aortography, peripheral arteriography, peripheral intra-arterial DSA, cardioangiography.

For intravenous administration: intravenous excretory urography, limb venography. Contrast enhancement in computed tomography. Gastrointestinal tract examinations. Examinations of the spinal cord and surrounding tissues (lumbar, thoracic and cervical myelography), arthrography, hysterosalpingography.

Children: cardioangiography, urography, contrast enhancement in computed tomography and gastrointestinal tract examination.

ICD codes

Dosage Regimen

Administer intra-arterially, intravenously, intrathecally, intracavitarily, or rectally.

Select the iodine concentration and total volume based on the specific diagnostic procedure, patient’s age, body weight, and clinical condition.

For intravascular administration, use the 270 mg I/ml or 320 mg I/ml concentrations.

For intrathecal administration (myelography), use only the low-osmolar 150 mg I/ml concentration.

For gastrointestinal tract examinations, administer orally or rectally; use the 150 mg I/ml or 270 mg I/ml concentrations.

For adult arteriography, typical doses range from 5 ml to 40 ml per injection, depending on the vascular territory.

For adult cardioangiography, typical ventricular or aortic root injections are 30-60 ml of 320 mg I/ml.

For intravenous urography in adults, administer approximately 1 ml per kg of body weight of 270 mg I/ml or 320 mg I/ml.

For contrast-enhanced computed tomography in adults, administer 50-150 ml intravenously.

For pediatric patients, calculate the dose based on body weight (ml/kg); do not exceed the total volume used for adults.

In patients with renal impairment, use the lowest necessary dose to obtain a diagnostic image.

Ensure patients are well-hydrated before and after administration to minimize the risk of contrast-induced nephropathy.

Warm the solution to body temperature before intravascular injection to improve patient comfort.

Inspect the solution visually for particulate matter and discoloration prior to administration; use only clear, colorless to pale yellow solutions.

Do not mix Iodiscan with other medications in the same syringe or infusion system.

For single-use only; discard any unused portion remaining in the vial.

Adverse Reactions

After intra-arterial or intravenous injection

Infrequent allergic reactions (hypersensitivity), headache, flushing, nausea, vomiting, rash or drug rash, itching, urticaria, acute kidney injury or toxic nephropathy (contrast-induced nephropathy, CIN), chest pain, sensation of body temperature change.

Rare dizziness, sensory disturbance, dysgeusia, paresthesia, parosmia, arrhythmia, tachycardia, bradycardia, myocardial infarction, arterial hypotension, cough, sneezing, chills, febrile state,
Pain and discomfort, injection site reactions, extravasation.

Very rare agitation, anxiety, acute cerebrovascular accident, amnesia, syncope, transient tremor, hypesthesia, transient cortical blindness, diplopia, blurred vision, eyelid edema, cardiac arrest; palpitations; increased blood pressure, ischemia, dyspnea, throat irritation, laryngeal edema, abdominal pain or discomfort, diarrhea,
Hoarseness, barking cough, difficult breathing, facial edema, eyelid, tongue, larynx (angioedema), skin redness, increased sweating (hyperhidrosis), back pain, muscle spasms, asthenic conditions (e.g., malaise, fatigue), facial edema, localized edema.

Frequency unknown thrombocytopenia, hyperthyroidism, hypothyroidism, confusion, coma, impaired consciousness, convulsions, temporary brain damage which may manifest as headache, dizziness, forgetfulness, absent-mindedness, irritability, obsessive movements, decreased vision and hearing (transient encephalopathy), palpitations, heart failure, ventricular hypokinesia, coronary vasospasm,
Cardiac and respiratory arrest, slow pulse, conduction disorder, coronary artery thrombosis, angina pectoris, shock, thrombophlebitis, non-cardiogenic pulmonary edema (related to pulmonary vessels), respiratory arrest, respiratory failure, bronchospasm, throat tightness, pharyngeal edema, acute pancreatitis, exacerbation of pancreatitis, salivary gland enlargement, skin rash, bullous or exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous
Pustulosis, drug rash with eosinophilia and systemic symptoms, arthralgia, increased blood creatinine concentration, swelling, iodism.

After intrathecal administration

Infrequent headache (may be severe and prolonged), vomiting.

Frequency unknown allergic reaction, including anaphylactic/anaphylactoid reactions, coma, impaired consciousness, convulsions, transient encephalopathy, nausea, muscle spasms, chills, injection site pain.

After uterus and fallopian tube examination

Very common abdominal pain, vaginal bleeding.

Common headache, nausea, fever.

Infrequent vomiting.

Frequency unknown allergic reaction (hypersensitivity), chills, injection site pain.

After joint injection

Common injection site pain.

Frequency unknown allergic reaction (hypersensitivity), including anaphylactic/ anaphylactoid reactions, chills.

After gastrointestinal tract examination

Common diarrhea, abdominal pain, nausea.

Infrequent vomiting.

Frequency unknown allergic reaction (hypersensitivity), including anaphylactic/anaphylactoid reactions, mild chills.

Contraindications

Manifest thyrotoxicosis, chronic heart failure in the decompensation phase, allergic reactions to iodine-containing radiocontrast agents, to Iodixanol.

Use in Pregnancy and Lactation

Iodixanol should be used during pregnancy only in cases of extreme necessity.

Breastfeeding should be discontinued before the administration of the radiocontrast agent and resumed no earlier than 24 hours after administration.

Use in Hepatic Impairment

Caution should be exercised when using non-ionic radiocontrast agents in patients with severe combined hepatic and renal impairment, as their clearance of radiocontrast agents is significantly reduced. High concentrations of this agent in the patient’s plasma may affect the results of laboratory tests for bilirubin concentration. Therefore, such tests should not be performed on the day of the examination.

Use in Renal Impairment

The risk of developing renal function impairment when using iodixanol is increased in patients with a history of kidney disease, diabetic nephropathy, and myeloma. In patients with impaired renal function, the clearance of iodixanol is reduced; with combined hepatic and renal impairment, a significant decrease in clearance occurs.

Pediatric Use

Used in children from birth according to indications.

Geriatric Use

Use with caution in elderly persons.

Special Precautions

Strict adherence to the correspondence of the used dosage form to the indications for use must be observed.

Use with caution in patients with bronchial asthma, hyperthyroidism, cardiovascular diseases, and in elderly persons. If there is a history of bronchial asthma attacks, allergic reactions to the administration of iodine-containing drugs, premedication with corticosteroids or antihistamines may be used.

It is recommended to use Iodixanol only when conditions for emergency measures are available in case of severe adverse reactions, including anaphylactic shock.

The risk of developing renal function impairment when using iodixanol is increased in patients with a history of kidney disease, diabetic nephropathy, and myeloma. In patients with impaired renal function, the clearance of iodixanol is reduced; with combined hepatic and renal impairment, a significant decrease in clearance occurs.

Dehydration should be avoided before the administration of the contrast agent.

On the day of iodixanol administration, the content of bilirubin, proteins, iron, copper, calcium, phosphates in blood plasma should not be determined. Within 2 weeks after the use of iodixanol, the iodine-binding capacity of the thyroid tissue is reduced.

Effect on ability to drive vehicles and mechanisms

Do not engage in potentially hazardous activities for 24 hours after the use of iodixanol.

Drug Interactions

When used concomitantly with antipsychotics, analgesics and antidepressants, Iodixanol may lower the seizure threshold, increasing the risk of adverse reactions.

The use of iodixanol in patients with diabetic nephropathy taking biguanides (metformin) may lead to transient impairment of renal function and the development of lactic acidosis. As a precaution, it is necessary to discontinue biguanides 48 hours before the examination and resume after complete stabilization of renal function.

Patients who have taken interleukin-2 less than 2 weeks before the examination are prone to an increased frequency of delayed adverse reactions (flu-like conditions or skin reactions).

In patients taking beta-blockers, the manifestations of anaphylaxis when using iodixanol may be atypical and mistakenly taken for vagal reactions. Patients with bronchial asthma receiving concomitant therapy with beta-blockers are at greater risk.

All iodine-containing contrast agents can affect the ability of the thyroid gland to bind iodine, which may be reduced for several weeks, which will affect the results of the iodine uptake test (using radioactive iodine).

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.