Lipiodol^® Ultra-Fluid (Solution) Instructions for Use

Marketing Authorization Holder

Guerbet (France)

ATC Code

V08AD01 (Ethyl esters of iodinated fatty acids)

Dosage Form

Lipiodol® Ultra-Fluid

Endolymphatic solution (oil-based) 480 mg iodine/ml: amp. 10 ml 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Solution for endolymphatic administration (oil-based) in the form of a clear oily liquid from light yellow to amber in color.

10 ml – ampoules (1) – plastic trays (1) – cardboard packs.
10 ml – ampoules (50) – plastic trays (1) – cardboard packs.

Clinical-Pharmacological Group

Radiopaque diagnostic agent

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

After administration into a lymphatic vessel, Lipiodol^® Ultra-Fluid enters the bloodstream, then the liver and lungs; the oil droplets break down in the lung alveoli, spleen, and adipose tissue.

After uptake by tissues and storage organs, reabsorption of the drug occurs (release of the drug from tissues and storage organs), which continues from several days to several months or years.

It is continuous, and as long as the contrast is visualized on the images, iodides can be detected in the urine.

Indications

• Lymphography.

ICD codes

Dosage Regimen

Lipiodol^® Ultra-Fluid is intended only for administration into lymphatic vessels.

The drug should not be administered intra-arterially, intravenously, or into the subarachnoid space.

When performing lymphography, 5-7 ml of the drug is injected into a lymphatic vessel only for limb contrast (the dose is selected depending on the patient’s height); when performing bilateral lymphography of the lower limbs, 10 to 14 ml is administered.

The drug should be administered using a glass syringe.

Adverse Reactions

Allergic reactions up to anaphylactic shock may develop.

Within 24 hours after the diagnostic examination, an increase in temperature to 38-39°C (100.4-102.2°F) may be noted.

Transient miliary accumulation of Lipiodol is often noted on X-ray images, especially after administration of a large dose.

This usually does not manifest clinically.

In exceptional cases, pulmonary artery or cerebral artery embolism may occur.

Contraindications

• Hyperthyroidism;
• Large multinodular goiters in persons over 45 years of age, due to the high risk of hyperthyroidism;
• Breastfeeding.

With caution

Lipiodol^® Ultra-Fluid should be used with caution in patients with a history of allergy, in patients with cardiopulmonary insufficiency, and during chemotherapy or radiation therapy.

Use in Pregnancy and Lactation

Lipiodol^® Ultra-Fluid enters breast milk in high concentration.

Due to the risk of hypothyroidism in the newborn, the use of Lipiodol^® Ultra-Fluid during breastfeeding is contraindicated.

Use in Renal Impairment

In combination with metformin in diabetic patients, a decrease in renal function caused by the radiological examination may be a triggering factor for the development of lactic acidosis.

Geriatric Use

Contraindicated for persons over 45 years of age with large multinodular goiters, due to the high risk of hyperthyroidism.

Special Precautions

During lymphography, radiological monitoring of the lungs is necessary.

Caution is required to avoid the drug entering the vascular bed due to the risk of fat embolism, and the drug should not be injected into an area of hemorrhage or trauma.

After chemotherapy or radiation therapy, the size of the lymph nodes is significantly reduced, and they retain the contrast agent in a smaller amount, which is why the administered dose should be reduced.

In patients with cardiopulmonary insufficiency, especially in elderly patients, the dose should be selected individually, or the examination should be abandoned altogether, since part of the drug may cause temporary embolization of the pulmonary capillaries.

Any thyroid examinations should be performed before the radiological examination, as after lymphography the thyroid gland will be saturated with iodine for several months.

Overdose

After administration into a lymphatic vessel, complications from the cardiopulmonary system and central veins depend on the administered dose of Lipiodol^® Ultra-Fluid.

Overdose can be avoided by fluoroscopic or radiographic monitoring during the injection.

Drug Interactions

Drug combinations requiring precautionary measures

• Beta-blockers

In case of shock or hypotension upon administration of an iodine-containing contrast agent, beta-blockers suppress the compensatory reactions of the cardiovascular system.

Before performing a radiological examination, the use of beta-blockers should be discontinued if possible.

If the continuity of therapy is extremely important for the patient, appropriate resuscitation equipment should be ready.

• Diuretics

If diuretics have caused dehydration, this increases the risk of acute renal failure, especially when using large doses of iodine-containing contrast agent.

Precautions: the patient should be rehydrated before administration of the iodine-containing contrast agent.

• Metformin

In diabetic patients, a decrease in renal function caused by the radiological examination may be a triggering factor for the development of lactic acidosis.

Metformin intake should be temporarily discontinued 48 hours before and resumed only 2 days after the radiological examination.

Drug combinations to be taken into account

• Interleukin II

The risk of developing a reaction to the administration of contrast agents increases if the patient has previously received intravenous therapy with interleukin II: skin rash or, less commonly, hypotension, oliguria, and even renal failure.

Storage Conditions

Store at a temperature not exceeding 30°C (86°F), in a place protected from light.

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.