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Dosage form: & nbspsolution for endolymphatic administration [oily]
Composition:

1 ml of the solution contains:

Active substances:

Ethyl esters of iodinated fatty acids of poppy oil.

The iodine content is 480 mg / ml.

Description:

Transparent oily liquid from light yellow to brownish yellow.

Pharmacotherapeutic group:X-ray contrast medium
ATX: & nbsp
  • Ethyl esters of iodinated fatty acids
  • Pharmacodynamics:

    Lipiodol® Ultra-Fluid is a radiopaque iodine-containing agent for carrying out lymphography.

    Pharmacokinetics:

    After introduction into the lymphatic vessel, Lipiodol® Ultra-Fluid penetrates into the blood, then into the liver and lungs; oil droplets disintegrate in the alveoli of the lungs, spleen and adipose tissue. After seizure by tissues and depositing organs, reabsorption occurs (release of the drug from tissues and depositing organs), which lasts from several days to several months or several years. It is continuous and regular, and while the contrast is visualized in the pictures, iodides can be found in the urine.

    Indications:

    Lymphography of the vessels of the extremities and other localizations.

    Contraindications:
    • Hypersensitivity to the components of the drug;
    • hyperthyroidism;
    • large multinodular goiter in people over 45 years of age, which is associated with a high risk of hyperthyroidism;
    • pregnancy and lactation;
    • childhood.
    Carefully:

    Lipiodol® Ultra-Fluid should be used with caution in patients with anamnestic indications of allergy, in patients with cardiopulmonary insufficiency, as well as in chemo- or radiotherapy.

    Pregnancy and lactation:

    Lipiodol® Ultra-Fluid is concentrated in breast milk in high concentration. Because of the risk of developing hypothyroidism in a newborn, Lipiodol® Ultra-Fluid is contraindicated in breastfeeding.

    Dosing and Administration:

    Lipiodol® Ultra-Fluid is intended only for administration to lymphatic vessels. The drug should not be administered intraarterially, intravenously or in the subshell.

    Lymphography: with a contrast test of the limb - 5-7 ml inside the lymphatic vessel (the dose is selected depending on the patient's growth); when carrying out bilateral bilateral lymphography of the lower extremities - 10-14ml.

    The drug should be administered in a prone position, with a rate of 0.09-0.2, ml / min.

    Side effects:

    Allergic reactions can develop up to anaphylactic shock.

    Within 24 hours "after the diagnostic examination, the temperature may rise to 38-39 ° C.

    X-ray images often indicate a transient miliary accumulation of the drug, especially after the administration of a large dose. Clinically this usually does not manifest itself. In exceptional cases, embolism of the pulmonary artery or cerebral arteries can be noted.

    Overdose:

    With endolymphatic administration, the likelihood of cardiopulmonary and central venous complications depends on the administered dose of the drug. The total dose of Lipiodol® ® Ultra-Fluid administered should not exceed 20 ml. The functions of the basic vital organs must be restored an emergency prescription for symptomatic treatment. When carrying out an X-ray examination, appropriate resuscitation equipment and medicines needed for resuscitation should be readily available.

    Interaction:

    Combinations of drugs requiring compliance with precautionary measures:

    - Beta-blockers:

    In the case of anaphylactic shock or a sharp drop in blood pressure when iodine-containing contrast is introduced, beta-adrenoblockers suppress compensatory reactions from the cardiovascular system.

    Before the X-ray examination, the use of beta-blockers should be stopped, if possible. If continuity of therapy is extremely important for the patient, you should have appropriate resuscitation equipment at hand.

    -Diuretics:

    If diuretics are caused, dehydration, it increases the risk of developing acute kidney failure, especially when using large doses of iodine-containing contrast.

    Precautions: before the introduction of iodine-containing contrast, the patient should be adequately hydrated before and after the administration of the drug.

    - Metformin:

    In patients with diabetes mellitus, a decrease in renal function caused by an X-ray examination may be a triggering factor for the development of lactic acidosis (lactic acidosis).

    Metformin should be temporarily discontinued 48 hours before and resumed only 2 days after the X-ray examination.

    Combinations of drugs that should be taken into account:

    - Interleukin II:

    Patients who took less than 2 weeks before the study of interleukin II are prone to an increased incidence of delayed adverse reactions (skin rash, significant reduction in blood pressure oliguria).

    Special instructions:

    When carrying out lymphography, an x-ray examination of the lungs is necessary.

    Care must be taken to avoid getting the drug into the vascular bed due to the risk of fat embolism, and do not administer the drug to the area of ​​hemorrhage or trauma.

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

    In patients with cardiopulmonary insufficiency, especially in senile patients, the dose should be selected individually or even abandoned, as some drugs can cause temporary embolization of pulmonary capillaries.

    Any examination of the thyroid gland should be carried out before the X-ray examination, since after the lymphography the thyroid gland will be saturated with iodine for several months.

    Effect on the ability to drive transp. cf. and fur:

    Perhaps the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, so use with caution.

    Form release / dosage:

    Solution for endolymphatic administration [oily] 480 mg iodine / ml (ampoules) 10 ml.

    Packaging:1 or 50 10 ml ampoules in a plastic tray together with instructions for use are placed in a cardboard box.
    Storage conditions:

    Store at a temperature of no higher than 30 ° C, in a place protected from light.

    Shelf life:

    3 years. Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N008677
    Date of registration:21.04.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:GerbeGerbe France
    Manufacturer: & nbsp
    GUERBET France
    Representation: & nbspNGO ASTA, CJSCNGO ASTA, CJSCRussia
    Information update date: & nbsp10.04.2018
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