Lipiodol Ultra Fluid

/ Promedico

This drug must be administered by slow injection or by catheter, using an appropriate glass syringe and a catheter (see Section 6.2 – Incompatibilities). In diagnostic radiology:
– Lymphography
Administer via a catheter inserted into a lymph duct. A dye can first be injected to locate the lymph ducts. The usual dose is 5 to 7 mL via the strict lymphatic route to enhance contrast in an extremity (depending on the height of the subject), i.e. 10 to 14 mL for bilateral lymphography of the feet. Patients with low weight The dose must be reduced proportionally in this population. Elderly The product must be administered with special care in patients over 65 years of age with underlying diseases of the cardiovascular, respiratory or nervous systems. Keeping in mind that part of the product temporarily embolises the pulmonary capillaries, the dose must be adjusted in elderly patients with cardiorespiratory failure or the examination must be cancelled.

Sialography, urethrography, dacryocystography, versiculography, visualization of the nasal and other sinuses, explor. of abscesses and fistulae, cholangiography, lymphography.
See prescribing information for full details.

This product must not be administered by intra-arterial, intravenous or intrathecal injection.
– Hypersensitivity  (ethyl esters of iodised fatty acids of poppyseed oil).
– Confirmed hyperthyroidism.
– Traumatic lesions, haemorrhage or recent bleeding (risk of extravasation or embolism).
– Bronchography (the product rapidly inundates the bronchioles and alveoli).

LIPIODOL ULTRA-FLUID must not be administered intravenously, intra-arterially (apart from selective catheterisation) or intrathecally. There is a risk of hypersensitivity whatever the dose administered.
Lymphography: Pulmonary embolism occurs in most patients undergoing lymphography with injection of LIPIODOL ULTRA-FLUID, as part of the product temporarily embolises the pulmonary capillaries. It is uncommon for this embolism to be manifested clinically; should this occur, the signs are immediate (though they may appear several hours or even several days after administration) and are usually transient. For this reason, doses must be adjusted or the examination cancelled in subjects with impaired respiratory function, cardiorespiratory failure or right ventricular overload, particularly if the patient is elderly. Doses must also be reduced after antineoplastic chemotherapy or radiotherapy because lymph nodes shrink significantly and retain very little contrast agent. The injection should be carried out with radiological or endoscopic guidance. Pulmonary invasion can be reduced to the minimum by intraarterial, confirming radiologically that the injection is strictly intralymphatic (and not intravenous or intrathecal injection) and by discontinuing the examination as soon as the contrast agent becomes visible in the thoracic duct or as soon as lymphatic obstruction is observed.
Hypersensitivity: All iodinated contrast agents may cause minor or major hypersensitivity reactions that may be lifethreatening. These hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non-allergic. They may be immediate (within 60 minutes) or delayed (up to 7 days). Anaphylactic reactions occur immediately and can be fatal. They are independent of the dose, can occur after even the first dose of the product, and are often unpredictable. Emergency resuscitation equipment must be immediately available due to the risk of a major reaction. Patients who have previously experienced a reaction during administration of LIPIODOL ULTRAFLUID or who have a history of hypersensitivity to iodine are at higher risk for another reaction if the product is again administered. They are thus considered to be patients at risk. Injection of this product may exacerbate symptoms of asthma. In patients whose asthma is not controlled by treatment, the decision to use this product must be based on a careful consideration of the benefit-to-risk ratio.
Thyroid: Because of the free iodine content in iodinated contrast agents, they may modify thyroid function and cause hyperthyroidism in predisposed patients. Patients at risk are those with latent hyperthyroidism or thyroid autonomy. Iodism occurs more commonly with LIPIODOL ULTRA-FLUID than with watersoluble organic iodine derivatives. Lymphography saturates the thyroid with iodine for several months and consequently thyroid function tests must be carried out before the radiological examination.
Embolisation: with surgical glues An early polymerisation reaction may exceptionally occur between LIPIODOL ULTRA-FLUID and certain surgical glues, or even certain batches of glue. Before using new batches or surgical glue, the compatibility of LIPIODOL ULTRA-FLUID and the glue must be tested in vitro.
Precautions for use
Hypersensitivity: Before the examination: identify patients at risk in a detailed interview on their history. Corticosteroids and H1 antihistamines have been proposed as premedication in patients at greatest risk for hypersensitivity reactions (patients with known hypersensitivity to a contrast agent). However, they do not prevent the occurrence of serious or fatal anaphylactic shock. Throughout the examination, maintain:
– medical monitoring
– an indwelling intravenous catheter. After the examination: After contrast agent administration, the patient must be monitored for at least 30 minutes, as most serious adverse reactions occur within this time period. The patient must be warned of the possibility of delayed reactions (for up to seven days).
Thyroid: Possible thyroid risk factors must be investigated to prevent metabolic disorders. If iodinated contrast agents are to be administered to patients at risk, thyroid function tests must be carried out before the examination.

Most of the adverse reactions are dose-related and consequently the dose should be as low as possible.
Use of this product causes a foreign body reaction, with the formation of macrophages and foreign-body giant cells and the occurrence of sinus catarrh, plasmacytosis and subsequently changes in lymph node connective tissue. Healthy lymph nodes tolerate the resulting decrease in transport capacity. In patients with lymph node lesions or hypoplasia, these changes may exacerbate lymph stasis.
Hypersensitivity reactions are possible. A sharp increase in temperature followed by a fever of 38 to 39°C may occur within 24 hours following the examination. Fat micro-embolisms may occur, with or without symptoms. In very rare cases, they may resemble embolisms originating in the body, in terms of their appearance and size. They usually appear as punctiform opacities on radiographic images of the lungs. Transient increases in temperature are possible. Fat micro-embolisms usually occur following an overdose of contrast agent or excessively rapid infusion. Anatomic anomalies such as lymphovenous fistulas or a decrease in the capacity of lymph nodes to retain the contrast agent (in elderly patients or after radiotherapy or cytostatic therapy) favour their occurrence. Patients with a right-to-left cardiac shunt and those with a massive pulmonary embolism are particularly at risk for fat micro-embolisms in the brain.
For full details see prescribing information.

Interactions with other medicines
–  Metformin In diabetic patients, intra-arterial administration may cause lactic acidosis induced by diminished renal function. In patients undergoing embolisation, metformin must be discontinued 48 hours before the examination and resumed no earlier than two days after the examination. Combinations requiring caution + Beta-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists. These medicinal products reduce the efficacy of cardiovascular compensation mechanisms for blood pressure disorders. The physician must be aware of this before administering and emergency measures must be available.
– Diuretics As diuretics may cause dehydration, the risk of acute renal failure is increased, particularly when high doses of contrast agents are administered.
Precautions for use: rehydration before intra-arterial administration for embolisation.
– Interleukin 2 Reactions to contrast agents may be increased if the patient has recently been treated with interleukin 2 (i.v.), i.e. skin eruptions or more rarely hypotension, oliguria, or renal failure. Interference with laboratory tests As this drug remains in the body for several months, thyroid laboratory tests may be falsified for as long as two years after lymphography.

Pregnancy: The safety of this product has not been demonstrated in pregnant women. The use during pregnancy increases the transplacental transfer of iodine, which probably interferes with thyroid function in the fœtus. Although transient, this abnormality may involve a risk of cerebral lesions and permanent hypothyroidism, calling for monitoring of thyroid function and close medical follow-up of the neonate. Consequently, it should not be used in pregnant women unless it is absolutely necessary, and only with strict medical monitoring.
Breastfeeding: Pharmacokinetic studies have shown significant secretion of iodine in breast milk after intramuscular administration of this product. It has been demonstrated that the iodine enters the vascular system of the breastfed infant via the gastrointestinal tract and this could interfere with thyroid function. Consequently, breastfeeding should be discontinued if this product must be used, or else thyroid function should monitored more frequently in the neonate.

Overdose can cause respiratory, cardiac or cerebral complications, which can be fatal. The frequency of micro-embolisms may be increased after an overdose. The total dose of LIPIODOL ULTRA-FLUID must not exceed 20 mL. The treatment of an overdose involves immediate symptomatic treatment and maintenance of vital functions. Establishments performing examinations with contrast agents must have emergency medicines and equipment available.