Consumer Information for: LIPIODOL ULTRA FLUID

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


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Serious Warnings and Precautions

LIPIODOL ULTRA FLUID is given by a doctor who knows how to treat life threatening reactions. Your doctor will watch your health before, during and after the exam. They know what safety measures to take. They are aware of the possible complications. They are experienced in doing X-ray tests. This drug is only used at sites with drugs, equipment and staff that can handle serious emergencies. They will monitor you for at least 30 minutes after the drug is given. Each patient must have an intravenous line open for use. LIPIODOL ULTRA FLUID should be given slowly with X-ray monitoring. The doctor should not exceed the recommended dose.

Serious or fatal events can occur when LIPIODOL ULTRA FLUID is used. They include:

  •     Blockage of certain blood vessels in the brain (cerebral embolism) or in the lung (pulmonary embolism)
  •     Worsening chronic liver disease which may last over a period of six months.
    • What the medication is used for

    It is a drug used in X-ray tests.

    LIPIODOL ULTRA FLUID is indicated for:

  • Lymphography: to see lymphatic vessels and lymph nodes in adults and children.
  • Hysterosalpingography: to see the uterus and fallopian tubes in adult women.
  • Sialography: to see the salivary glands in adults.
  • Fistulography: to see fistulas, a kind of abnormal channel in the body, in adults.
  • Selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC): to see tumors in the liver, in adults.
    • What it does

    LIPIODOL ULTRA FLUID helps tissues to appear darker or brighter depending on the test. This makes it easier for the doctor to detect any abnormalities.

    Your doctor performs the test immediately after using LIPIODOL ULTRA FLUID. Your doctor may need to repeat the test after 24-48 hours.

    When it should not be used
  • you ever had an allergic reaction to LIPIODOL ULTRA FLUID or to any other iodine product. This can also be called Allergic Disorders,
  • you have hyperthyroidism,
  • you have traumatic injuries or recent bleeding,
  • you have acute parotiditis (swelling of the salivary gland) and are imaging salivary glands,
  • you are undergoing bronchography. This is a type of X-ray exam of the lung,
  • you are pregnant or have disease, infection, bleeding or recent surgical procedures of the genital organs. This applies if you need to have an exam of the uterus and fallopian tubes,
  • you suffer from heart or lung disease; you have a tumor, recent surgery or radiation therapy that blocks lymph nodes. This applies if you will receive lymphography.
  • you have a liver disease and you have blocked bile ducts, unless a drainage tube is in place before the test; you have advanced liver failure or cancer in veins of the liver; or you have cancer spread from the liver. These apply if you will receive LIPIODOL ULTRA FLUID in your liver.
    • What the medicinal ingredient is

    ethyl esters of iodized fatty acids of poppy-seed oil.

    What the non-medicinal ingredients are

    none

    What dosage form it comes in
  • a solution for injection,
  • supplied as 380 mg iodine/g (38% w/w), corresponding to 480 mg iodine/ mL,
  • packaged in a self-breaking 10 mL ampoule.
    • Warnings and precautions

    To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIPIODOL ULTRA FLUID. Talk about any health conditions or problems you may have, including if:

  • you suffer or have suffered from an allergy (eg, hay fever, hives) or asthma,
  • you suffer from lung or cardiac diseases,
  • you have an over-active thyroid,
  • you have diabetes,
  • you have uterine bleeding and infection,
  • you have pelvic inflammation,
  • you are pregnant or planning to get pregnant. LIPIODOL ULTRA- FLUID can result in brain damage and permanent hypothyroidism in the baby.
  • you are breastfeeding. LIPIODOL ULTRA- FLUID can pass through breast milk. It can result in hypothyroidism in the baby.
  • you are in the a few days before or immediately after your monthly period,
  • you have a disease of the kidney,
  • you suffer from an accumulation of fluid in your body,
  • you plan to have an examination of the thyroid,
  • you are over 65 years old

    • Other warnings you should know about:
    LIPIODOL ULTRA FLUID can cause:

  • A decease in how well your kidneys work
  • Existing kidney problems to get worse

    • It can also cause:

      Thyroid Dysfunction
    • Hyperthyroidism: an over-active thyroid gland
    • Hypothyroidism: an under-active thyroid gland
    • Thyroiditis: inflammation of the thyroid gland

      • Allergic Disorders including Hypersensitivity, Anaphylactic or Anaphylactoid Reactions
      These are uncommon and can be mild to severe including death.

      Most allergic disorders occur within 30 minutes. Reactions can also occur for up to several days. Your doctor should discuss symptoms of delayed allergic reactions with you.

      Cerebral Embolism and Blockages to Other Organs: blockage of certain blood vessels in the brain.

      Pulmonary Embolism: blockage of certain blood vessels in the lung. It usually occurs right away but can be delayed for hours to days.

      Worsening Chronic Liver Disease: disease of the liver which lasts over a period of six months. It can cause heart problems, infection, irreversible liver damage and death.

      Lymphoedema Aggravation: an accumulation of fluid in a body part. It is caused by a block of the lymph flow.

    Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

    Interactions with this medication
  • beta-blockers, diuretics, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers: these are drugs to treat eye disease, heart disease or high blood pressure,
  • interleukin II drugs: These are drugs to treat cancer or to reinforce your immune system, i.e. your internal defence system,
  • metformin: Drugs to treat diabetes. Your doctor should stop this drug 48 hours before the exam. It can be restarted 2 days after the exam,
  • drugs that may cause damage to the kidney.
    • Proper use of this medication

    Your doctor will prepare and inject this product before the exam. The route and method of injection depend on the reason the drug is being used.

    Usual Dose

    These depend on the reasons why LIPIODOL ULTRA FLUID is being used.

    Your doctor will determine the dose to inject.

    Overdose

    If you think you received too much LIPIODOL ULTRA FLUID, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

    Missed Dose

    Side effects and what to do about them

    These are not all possible side effects that you may feel when taking LIPIODOL ULTRA FLUID. If you experience any side effects not listed here, contact your healthcare professional. Please also see the Serious Warnings and Precautions box.

    Side effects can include:
    Shortness of breath and cough
    Injection site pain and redness

    LIPIODOL ULTRA FLUID can cause abnormal blood test results. Your doctor will decide when to preform blood tests and will interpret the results.

    LIPIODOL ULTRA FLUID may interfere with thyroid diagnostic tests. It can cause changes to how the thyroid gland works. You may need to have a blood test to check the thyroid gland before using it. Thyroid blood test results can be affected for up to two years after taking LIPIODOL ULTRA FLUID.

    Serious side effects and what to do about them
    Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
    Thyroid Dysfunction:
    Hypothyroidism:     fatigue,increased sensitivity to cold, constipation, dry skin, weight gain, puffy face, hoarseness, muscle weakness, slowed heart rate, depression, impaired memory
    Hyperthyroidism: difficulty concentrating, frequent bowel movements, goiter (visibly enlarged thyroid gland) or thyroid nodules, hair loss, hand tremor, heat intolerance, increased sweating, nervousness, weight loss, high blood pressure, bulging eyes
    Thyroiditis: feeling of fullness or pain in the neck, other symptoms similar to those of hypothyroidism or hyperthyroidism    		   ✔  
    Nausea, vomiting, diarrhoea   ✔  
    Fever, pain   ✔  
    Granuloma: pain or tenderness in the lower abdominal area, vaginal infection   ✔  
    Hepatic vein thrombosis: vomiting blood, black stools, enlarged spleen, swelling of lower limbs, abdominal pain (mainly in the upper right part of the abdomen), jaundice (yellowing of the skin and eyes).   ✔  
    Allergic Disorder: rash or hives, flushing, pimples, itching and/or sudden swelling of the face, eyelids, lips, tongue or throat. Difficulty breathing or swallowing, wheezing, plugged nose, sneezing, coughing, dry throat, fever, chills, nausea, vomiting, diarrhoea, low blood pressure, and joint pain. Decreased urine output.   ✔  
    Cerebral Embolism and Blockages to Other Organs: severe headache, blurred vision, fainting, loss of consciousness, drowsiness, convulsion, confusion.   ✔  
    Pulmonary Embolism: shortness of breath, fast or difficult breathing, cough.   ✔  
    Lymphoedema Aggravation: swelling, heaviness, fullness and aching of body parts. Full or heavy sensation in the limb(s), tightness of the skin or tissue, decreased flexibility in the hand/wrist/foot/ankle, difficulty fitting into clothing in one specific area, or ring/wristwatch/bracelet tightness   ✔  
    Worsening Chronic Liver Disease: fever, chills, swollen or painful abdomen. Jaundice with yellow color to skin, eyes and dark urine. Increased blood pressure, headache and dizziness.   ✔  
    Retinal Vein Thrombosis (Blood clot in the eye): sudden loss of all or part of your vision or double vision.   ✔  
    Salivary Duct Inflammation: Abnormal or foul tastes, decreased ability to open the mouth, dry mouth, fever, mouth or facial pain, especially when eating, swelling of the face   ✔  
    Decreased kidney Function: Fatigue, lethargy, weakness, swelling, shortness of breath and confusion   ✔  
    Worsening existing asthma: Cough, wheezing, shortness of breath, chest pain or pressure   ✔  

    If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

    How to store

    protect from light. Store at room temperature up to 30°C.

    Keep out of reach and sight of children.

    Reporting side effects

    You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

    3 ways to report:

    • Report online at MedEffect
    • By calling 1-866-234-2345 (toll-free);
    • By completing a Consumer Side Effect Reporting Form and sending it by:
      • Fax to 1-866-678-6789 (toll-free), or
      • Mail to: Canada Vigilance Program
        Health Canada, Postal Locator 0701E
        Ottawa, ON
        K1A 0K9
        Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at MedEffect.

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information
  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the importer’s website www.methapharm.com or by calling 1-800-287-7686 ext 7840.

    • This leaflet was prepared by Guerbet, BP 57400, 95943 ROISSY CDG Cedex, FRANCE.

    Last Revised: July 12, 2017

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