HEVASCOL 480 MG IODO/ML INJECTABLE SOLUTION

2. What you need to know before starting to use Hevascol

Hevascol should not be used

• if you are allergic to ethiodized oil.
• if you have an overactive thyroid gland (which can cause increased appetite, weight loss, or sweating).
• if you have recently had a serious injury or bleeding.
• if you need a bronchogram, a type of radiological examination in which a dye is instilled in the lower part of the lung.
• if you have tuberculosis at the time of the examination.
• if you have one or more serious diseases that affect one or more organs of the body.
• if you have dilated bile ducts.
• if you are pregnant or think you may be pregnant and are going to undergo a hysterosalpingogram (examination of the uterus and fallopian tubes).
• if you have pelvic inflammation (in the lower abdomen) that affects the uterus, fallopian tubes, or ovaries and are going to undergo a hysterosalpingogram (examination of the uterus and fallopian tubes).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hevascol.

As with all iodinated contrast media, regardless of the route of administration or dose, adverse effects may occur, which can be mild, but can also be fatal. These effects can appear within an hour of administration or later, up to seven days. They are usually unpredictable, but the risk is greater if you have already had a reaction during a previous administration of an iodinated contrast medium (see section 4, "Possible adverse effects"). In such cases, you should inform your doctor.

Tell your doctor,

• if you have had previous reactions to this contrast medium during an examination;
• if you have a history of allergic reaction to iodine;
• if you have asthma;
• if you have any disease that affects the heart or blood vessels;
• if you have a disease that affects the lungs;
• if you have a disease that affects the liver;
• if you have a disease that affects the kidneys;
• if you have dilated veins in the esophagus;
• if you have a thyroid gland disease or have a history of thyroid gland disease;
• if you are going to undergo a thyroid examination in the near future or receive radioactive iodine treatment;
• if you have swelling in part or all of the hand or foot, including the fingers, or in the legs (lymphedema).

In all these cases, your doctor will administer Hevascol if the benefits of the examination outweigh the risks.

If you are given this medication, your doctor will take the necessary precautions and administer Hevascol under close supervision.

If you are a child or an elderly patient, your doctor will be especially careful when administering this medication.

Other medications and Hevascol

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This mainly affects the following medications:

• a medication for the treatment of diabetes (metformin)
• a medication for the treatment of heart disease or high blood pressure (heart rate calming tablets and blood pressure reducing tablets), diuretics (medications to eliminate water from the body)
• those that are known to be toxic to the kidneys (such as certain antibiotics, antiviral medications)
• interleukin-2 (a medication used to treat cancer or to boost your immune system)

If you are taking medication for your thyroid, inform the doctor in charge before you are given Hevascol.

Use of Hevascol with alcohol

If you regularly drink large amounts of alcohol, you should inform your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before you are given this medication.

Pregnancy

You should not receive this medication if you are pregnant or think you may be pregnant and are going to undergo a hysterosalpingogram (examination of the uterus and fallopian tubes).

Breastfeeding

This medication may be excreted in breast milk.

You should not breastfeed for at least 24 hours after receiving Hevascol.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

No specific risks are known.

If you feel unwell after the examination, you should not drive or operate machinery.

3. How to use Hevascol

Dose

Your doctor will determine the dose that will be administered to you. The dose will depend on several factors, such as the type of examination or intervention you will undergo.

Method of administration

This medication is administered by injection.

You may be given an infusion before the examination or intervention and after, to ensure you have sufficient fluids.

You may be given antibiotics to prevent any infection that may occur due to the examination or procedure.

During the examination, you will be under the supervision of a doctor. You may be left with a needle in the vein. This is in case your doctor needs to administer other medications in case of acute discomfort.

If you experience an allergic reaction, the administration of Hevascol will be interrupted.

The specialized personnel are aware of the precautions that must be taken for the examination, as well as the possible complications that may occur.

If you are given more Hevascol than you should

It is unlikely that you will suffer an overdose of this medication. You will receive this medication in a medical center by qualified personnel. If this situation occurs, you will receive the necessary attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

You may experience allergic reactions (including anaphylactic, anaphylactoid, and rapid-onset allergic reactions). Allergies can be recognized by the following effects:

• skin reactions that appear rapidly (in many cases, within the first hour) with blisters on the skin, redness (erythema), and itching (urticaria, localized or widespread), sudden swelling of the face and neck (angioneurotic edema)
• effects on the respiratory tract: cough, nasal inflammation (runny nose), throat tightness, difficulty breathing, throat inflammation (laryngeal edema), difficulty breathing along with cough (bronchospasm), respiratory arrest
• effects on the heart and blood vessels: low blood pressure (hypotension), dizziness, discomfort (weakness), heart rhythm problems, cardiac arrest

If you experience any of these effects during the administration of Hevascol or after, inform your doctor immediately.

Other possible adverse effects

The following adverse effects have been observed after the use of this medication. Their frequency is not known (cannot be estimated from the available data).

• nausea (general discomfort)
• vomiting (general discomfort)
• diarrhea
• pancreatitis (inflammation of the pancreas)
• fever
• pain at the injection site
• underactive thyroid gland (which can cause fatigue or weight gain)
• overactive thyroid gland (which can cause increased appetite, weight loss, or sweating)
• obstruction of certain blood vessels in the lungs (pulmonary embolism), which can cause excessive fluid retention in the lungs (pulmonary edema) and surrounding areas (pleural effusion), critical respiratory failure (acute respiratory distress syndrome), pneumonia
• embolism (obstruction of blood vessels) in the brain. This can occur without clinical signs.
• worsening of lymphedema (swelling caused by the malfunction of the lymphatic system)
• shortness of breath
• cough
• liver damage that causes liver failure, abnormal accumulation of fluid in the abdominal cavity (ascites), insufficient blood perfusion, which can cause liver damage (hepatic infarction), alteration of the level of consciousness, which can be related to other neurological symptoms caused by liver failure (hepatic encephalopathy)
• abscesses (pus-filled formations) in the liver
• inflammation of the gallbladder or fallopian tubes, or peritonitis
• accumulation of bile in the abdominal cavity (biloma)
• skin necrosis (tissue death)
• the post-embolization syndrome (fever, abdominal pain, nausea, and vomiting) may occur after the administration of this medication during transarterial chemoembolization
• small amounts of Hevascol may filter into the bloodstream and end up in other parts of the body, such as blood vessels or arteries.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or radiologist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hevascol

Keep the ampoule in the outer packaging to protect it from light.

Do not use this medication after the expiration date shown on the ampoule as CAD.

The expiration date is the last day of the month indicated.

Keep the ampoule in the outer box to protect it from light.

Medications should not be disposed of through wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

Hevascol composition

The active principle is ethiodized oil. 1 ml of injectable solution contains 480 mg of iodine.

This medication does not contain any excipients.

Product appearance and container contents

The Hevascol injectable solution is a transparent, pale yellow to amber, oily liquid.

It is presented in 1x10 ml ampoules.

Marketing authorization holder and manufacturer

Guerbet

BP 57400

95943 Roissy CDG Cedex

France

This medication is authorized in the member states of the European Economic Area under the following names:

Croatia Lodiolip

Cyprus Hevascol

Czech Republic Hevascol

Finland Hevascol

Greece Hevascol

Norway Hevascol

Poland HEVASCOL

Romania Hevascol

Slovak Republic Lodiolip

Slovenia Hevascol

Spain Hevascol

Sweden Hevascol

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Date of the last revision of this prospectus:June 2022

This information is intended solely for healthcare professionals:

Posology and method of administration

Posology

In diagnostic radiology:

Lymphangiadenography

The injection of Hevascol into a peripheral lymphatic vessel allows visualization of the lymphatic system up to the thoracic duct. Before the injection of Hevascol, an injection of a suitable sterile dye solution may be administered for the localization of the lymphatic collectors. The usual places of administration are the dorsum of the foot or hand in the first, third, or fourth interdigital space. After dissection under local anesthesia, the stained vessels are punctured with a special cannula; Hevascol must be injected with the patient in a supine position. An infusion pump is required for slow administration. The infusion rate should not exceed 0.1 ml per minute and should be adapted to the transport capacity of the lymphatic system. If pain occurs in the injection area, the injection rate should be reduced. The flow of the contrast medium must be verified by radiography to allow early detection of extravasation or incorrect puncture. The infusion should be terminated once the level of the fifth lumbar vertebra is reached. The radiographs taken after the end of the infusion (filling phase: lymphangiogram) and the next day (storage phase: lymphadenogram) provide information on morphological changes in the lymphatic vessels and lymph nodes that have been imaged.

Recommended dose

Generally, a maximum of 4 to 7 ml of Hevascol is administered per extremity to adults for the visualization of inguinal, iliac, and paraaortic lymph nodes. When the lymph nodes are clearly enlarged, up to 10 ml is injected per extremity. Fatty microembolisms in the lung may be observed in a chest radiograph from a total dose exceeding 14 ml. The maximum total dose of 20 ml of contrast medium should not be exceeded. In the absence of storage function in the iliac and paraaortic lymph nodes (after radiotherapy or lymphadenectomy), the dose should be reduced by half.

For imaging of axillary lymph nodes using the dorsum of the hand, 3 to 6 ml of Hevascol is sufficient.

Elderly patients

In elderly patients with cardiopulmonary insufficiency, the dose should be adjusted or the examination should be cancelled, as part of the product will temporarily embolize the pulmonary capillaries. The medication should be administered with caution in patients over 65 years of age with underlying cardiovascular, respiratory, or neurological disorders.

Pediatric population

The dose should also be decreased proportionally in children and in patients with low weight. In infants between 1 and 2 years, a dose of 1 ml per extremity is sufficient.

Fistulography

The amount of contrast medium to be administered should be determined before the examination. The amount of contrast medium is based on the estimated dimensions of the fistula.

For a single examination, Hevascol is generally administered as a single dose.

Hysterosalpingography

Under fluoroscopic guidance, slowly inject 2 ml of Hevascol at a time into the intrauterine cavity to determine the permeability of the tubes.

The total volume to be injected depends on the capacity of the uterine cavity and usually does not exceed 15 ml.

The dose of Hevascol for hysterosalpingography should be kept as low as possible to minimize the potential risk of thyroid dysfunction.

During hysterosalpingography, the medium is slowly injected into the cervical canal through a suitable catheter or cannula.

If the patient experiences significant discomfort, the administration of the injection should be interrupted.

The examination should be performed preferably during the follicular phase of the menstrual cycle.

In interventional radiology:

Transarterial chemoembolization of hepatocellular carcinoma

Administration is performed by selective intraarterial catheterization of the hepatic artery. The procedure should be performed in a typical interventional radiology setting with suitable equipment. The dose of Hevascol depends on the extent of the lesion but normally should not exceed a total dose of 15 ml in adult patients.

Hevascol can be mixed with antineoplastic medications such as cisplatin, doxorubicin, epirubicin, and mitomycin.

The instructions and precautions for use of the antineoplastic medications should be strictly followed.

Instructions for preparing the Hevascol mixture with the anticancer medication:

• Prepare two syringes large enough to contain the total volume of the mixture. The first syringe contains the solution of the antineoplastic medication, the second syringe contains Hevascol.
• Connect the two syringes to a 3-way stopcock.
• Perform 15 to 20 back-and-forth movements between the two syringes to obtain a homogeneous mixture. It is recommended to start pressing the syringe with the antineoplastic medication.
• The mixture should be prepared at the time of use and should be used quickly after preparation (before 3 hours). If necessary during the interventional radiology procedure, the mixture can be rehomogenized as described above.
• When the suitable mixture is obtained, use a 1 to 3 ml syringe to inject into the microcatheter.

The procedure could be repeated every 6 or 8 weeks according to the tumor response and the patient's conditions.

Pediatric population

The efficacy and safety of Hevascol in the transarterial chemoembolization of hepatocellular carcinoma have not been established in the pediatric population.

Elderly patients

The product should be administered with special caution in patients over 65 years of age with underlying cardiovascular, respiratory, or neurological disorders.

A reduction in the administered dose may prevent unwanted pulmonary embolism, which may occur during hepatic chemoembolization.

Method of administration

Hevascol should be administered using a suitable glass syringe or another device for which a study has been conducted to confirm compatibility with Hevascol. The valid instructions for use applicable to these devices should be followed.

Incompatibilities

It has been shown that Hevascol dissolves polystyrene; for this reason, disposable syringes made of this material should not be used to administer this preparation. Hevascol should be administered using a suitable glass syringe or another device for which a study has been conducted to confirm compatibility with Hevascol. The valid instructions for use applicable to these devices should be followed.