Hevascol

Package Leaflet: Information for the Patient

HEVASCOL 480 mg I/ml, Solution for Injection

Ethiodized Oil

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is HEVASCOL and what is it used for
• 2. Important information before using HEVASCOL
• 3. How to use HEVASCOL
• 4. Possible side effects
• 5. How to store HEVASCOL
• 6. Contents of the pack and other information

1. What is HEVASCOL and what is it used for

HEVASCOL belongs to a group of iodine-based contrast agents.
This medicine is for diagnostic use only (for examination purposes).
The medicine is used:

• In X-ray imaging: to visualize blood vessels and lymph nodes, as well as fistulas, or to examine the uterus and fallopian tubes to find the causes of infertility.
• In interventional radiology: for transcatheter chemoembolization (closing off blood vessels that feed a tumor using targeted drugs) of liver tumors (hepatocellular carcinoma).

2. Important information before using HEVASCOL

When not to use HEVASCOL

• if the patient is allergic to ethiodized oil,
• if the patient has hyperthyroidism (which may cause increased appetite, weight loss, or sweating),
• if the patient has recently experienced severe injury or bleeding,
• if the patient requires bronchography, a type of X-ray examination where the contrast agent is administered into the lower part of the lung,
• if the patient has active tuberculosis during the examination period,
• if the patient has severe disease (or diseases) affecting one or more organs of the body,
• if the patient has dilated bile ducts,
• if the patient is pregnant or thinks she may be pregnant and is to undergo hysterosalpingography (examination of the uterus and fallopian tubes),
• if the patient has pelvic inflammation (lower abdomen) involving the uterus, fallopian tubes, or ovaries and is to undergo hysterosalpingography (examination of the uterus and fallopian tubes).

Warnings and precautions

Before starting to use HEVASCOL, discuss it with your doctor or pharmacist.
As with all iodine-based contrast agents, regardless of the route of administration,
side effects may occur, which can be mild but can also be life-threatening. Such reactions
may occur within an hour of administration, but may also occur later, within a period of up to seven days.
They are often unpredictable, but the risk of their occurrence is higher if the patient has had any
reaction to a previous administration of an iodine-based contrast agent (see section 4 "Possible side effects"). In such a case, inform your doctor.
Tell your doctor:

• if the patient has had a reaction to this contrast agent during a previous examination,
• if the patient has had an allergic reaction to iodine in the past,
• if the patient has asthma,
• if the patient has heart or blood vessel disease,
• if the patient has lung disease,
• if the patient has liver disease,
• if the patient has kidney disease,
• if the patient has varicose veins (varices) in the esophagus,
• if the patient has thyroid disease or has had it in the past,
• if the patient is to undergo a thyroid examination or treatment with radioactive iodine in the near future,
• if the patient has swelling of part or all of the hand or foot, including fingers or toes, or swelling of the legs (lymphedema).

In all such cases, the doctor will administer HEVASCOL if the benefits of the examination outweigh the risks associated with the administration of this medicine.
If the patient is given this medicine, the attending physician will take the necessary precautions, and the administration of HEVASCOL will be closely monitored.
If the patient is a child or an elderly person, the doctor will exercise particular caution when administering this medicine.

HEVASCOL and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. This is especially important for the following medicines:

• medicines used to treat diabetes (metformin),
• medicines used to treat heart disease or high blood pressure (heart rate-lowering and blood pressure-lowering tablets), diuretics (medicines that remove water from the body),
• medicines known to have a harmful effect on the kidneys (such as certain antibiotics or antiviral medicines),
• interleukin-2 (a medicine used to treat cancer or to boost the immune system).

If the patient is taking medicines that affect the thyroid, they should inform their doctor before being given HEVASCOL.

HEVASCOL and alcohol

If the patient regularly drinks large amounts of alcohol, they should inform their doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

This medicine must not be given if the patient is pregnant or thinks she may be pregnant and is to undergo hysterosalpingography (examination of the uterus and fallopian tubes).

Breastfeeding

This medicine may pass into human milk.
The patient should not breastfeed for at least 24 hours after being given HEVASCOL.
Before taking any medicine, the patient should consult her doctor or pharmacist.

Driving and using machines

There are no known special risks.
If the patient does not feel well after the examination, they should not drive or operate machinery.

3. How to use HEVASCOL

Dose

The doctor will determine the dose to be given to the patient. The dose depends on several factors, including the type of examination or intervention the patient is to undergo.

Method of administration

This medicine will be given to the patient by injection (injection).
Before the examination or intervention, the patient may receive an infusion (drip) to ensure adequate fluid intake.
The patient may also receive antibiotics to prevent infection related to the examination or procedure.
During the examination, the patient will be closely monitored by the doctor. It may be necessary to leave the needle in the vein to allow the doctor to administer other medicines in case of a medical emergency.
If the patient has an allergic reaction, the administration of HEVASCOL will be stopped.
The accompanying staff knows what precautions to take in connection with the examination and is also aware of any potential complications that may arise.

Administration of a higher dose of HEVASCOL than recommended

It is very unlikely that the patient will receive too much of this medicine. This medicine will be administered in a medical facility by properly trained personnel. If such a situation occurs, the patient will receive appropriate care.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient may experience allergic reactions (including anaphylactic, pseudo-anaphylactic, and early allergic reactions). Allergies can be recognized based on the following symptoms:

• skin reactions with a very rapid onset (often within an hour) with blisters on the skin, redness (erythema), and itching (local or widespread), sudden swelling of the face and neck (angioedema),
• respiratory system reactions: cough, rhinitis (runny nose), feeling of constriction in the throat, difficulty breathing, throat swelling (laryngeal edema), difficulty breathing accompanied by cough (bronchospasm), cessation of breathing,
• cardiovascular system reactions: low blood pressure (hypotension), dizziness, malaise (weakness), arrhythmias, cardiac arrest. If the patient experiences any of these reactions during or after the administration of HEVASCOL, they should immediately inform their doctor.

Other possible side effects

The following side effects have been observed after the use of this medicine. The frequency of their occurrence is unknown (the frequency cannot be determined based on available data).

• nausea (vomiting),
• vomiting,
• diarrhea,
• pancreatitis,
• fever,
• pain at the injection site,
• hypothyroidism (which may cause fatigue or weight gain),
• hyperthyroidism (which may cause increased appetite, weight loss, or sweating),
• blockage of certain blood vessels in the lungs (pulmonary embolism), which may lead to excessive fluid retention in the lungs (pulmonary edema) and their surroundings (pleural effusion), critical respiratory failure (acute respiratory distress syndrome), and non-infectious pneumonia,
• embolism (blockage of blood vessels) in the brain. This may occur without causing any symptoms,
• worsening of lymphedema (swelling caused by abnormal lymphatic system function),
• shortness of breath,
• cough,
• liver damage leading to liver failure, abnormal accumulation of fluid in the abdominal cavity (ascites), inadequate blood supply, which may lead to liver damage (liver infarction) and disturbances of consciousness, which may be associated with other neurological symptoms of liver failure (hepatic encephalopathy),
• formation of abscesses (pockets of pus) in the liver,
• inflammation of the gallbladder, fallopian tubes, or peritoneum,
• formation of a bile collection in the abdominal cavity (biloma),
• skin necrosis (death of tissue),
• post-embolization syndrome (fever, abdominal pain, nausea, and vomiting), which may occur after the administration of this medicine during chemoembolization (closure of blood vessels that feed a tumor using targeted drugs),
• small amounts of HEVASCOL may enter the bloodstream and reach other parts of the body, such as blood vessels, including arteries.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to
the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store HEVASCOL

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule after "EXP".
The expiry date refers to the last day of the month stated.
Store the ampoule in the original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What HEVASCOL contains

The active substance of the medicine is ethiodized oil. 1 ml of the solution for injection contains 480 mg of iodine.
The medicine does not contain any excipients.

What HEVASCOL looks like and contents of the pack

HEVASCOL solution for injection is a clear oily liquid with a pale yellow to orange color.
The medicine is available in a pack containing 1 ampoule of 10 ml.

Marketing authorization holder and manufacturer

GUERBET
BP 57400
95943 ROISSY CDG CEDEX
France
For more detailed information on this medicine, please contact the representative of the marketing authorization holder: Guerbet Poland Sp. z o.o., phone: (22) 6684110.
Manufacturer
Guerbet
16-24 rue Jean Chaptal
93600 Aulnay Sous Bois
France

This medicine 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
Slovakia Lodiolip
Slovenia Hevascol
Spain Hevascol
Sweden Hevascol

Date of last revision of the leaflet: {month YYYY}

Information intended for healthcare professionals only:

Dosage and method of administration

Dosage

In diagnostic radiology:

Lymphography
Injection of HEVASCOL into a peripheral lymphatic vessel allows visualization of the lymphatic system up to the thoracic duct. Before injecting HEVASCOL, a injection of a suitable sterile dye solution may be given to locate the collecting lymphatic vessels. Typical injection sites are the dorsal side of the foot or hand in the first, third, or fourth interdigital space. After preparation under local anesthesia, the colored vessels are punctured with a special cannula; HEVASCOL must be injected when the patient is in a supine position. The use of an infusion pump is required to slowly administer the product. The infusion rate should not exceed 0.1 ml per minute and must be adapted to the transport capacity of the lymphatic system. If pain occurs during administration, the infusion rate should be reduced. The flow of the contrast agent should be verified by X-ray imaging, which allows for early detection of extravasation or improper placement. The infusion should be stopped when the level of the fifth lumbar vertebra is reached. Radiographs taken after the infusion (filling phase: lymphangiogram) and the next day (accumulation phase: lymphadenogram) provide information on morphological changes in the visualized vessels and lymph nodes.
Recommended dosage
Essentially, in adult patients, a maximum of 4 to 7 ml of HEVASCOL is administered per limb to visualize the inguinal, iliac, and peri-aortic lymph nodes. If the lymph nodes are clearly enlarged, a maximum of 10 ml is administered per limb. With a total dose greater than 14 ml, microemboli of fat may be observed in the lungs on the chest X-ray. The total dose of the contrast agent should not exceed 20 ml. In the absence of accumulation in the iliac and peri-aortic lymph nodes (following radiotherapy or lymph node resection), the dose should be reduced by half.
In the case of axillary lymph node imaging by injection into the dorsal side of the hand, a dose of 3 to 6 ml of HEVASCOL is sufficient.
Elderly
In elderly patients with circulatory failure, the dose should be adjusted accordingly or the examination should be avoided, as part of the administered product may temporarily block the pulmonary capillaries.
Product administration should be done with caution in patients over 65 years of age with underlying cardiovascular, respiratory, or neurological disease.
Children and adolescents
The dose should also be reduced in children and patients who are underweight. In children from 1 to 2 years of age, a dose of 1 ml per limb is sufficient.
Fistulography
The amount of contrast agent to be administered should be determined before the examination. The amount of contrast agent is determined based on the estimated size of the fistula.
For a single examination, HEVASCOL is usually administered in a single dose.
Hysterosalpingography
Under fluoroscopic control, slowly inject 2 ml of HEVASCOL into the uterine cavity at a time, until the patency of the fallopian tubes is confirmed.
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 administered during hysterosalpingography should be as small as possible to minimize the risk of disrupting thyroid function.
During hysterosalpingography, the product should be slowly injected into the cervical canal through an appropriate catheter or cannula.
If the patient experiences significant discomfort, the injection should be stopped.
Optimally, the examination should be performed during the follicular phase of the menstrual cycle.

In interventional radiology:

Transcatheter chemoembolization of hepatocellular carcinoma
The product is administered selectively through a catheter introduced into the hepatic artery. The procedure should be performed in an interventional radiology suite with appropriate equipment. The dose of HEVASCOL depends on the size of the lesion, but usually does not exceed a total dose of 15 ml in adult patients.
HEVASCOL can be mixed with anticancer drugs such as cisplatin, doxorubicin, epirubicin, and mitomycin.
Follow the instructions and precautions for the use of such anticancer drugs carefully.
Instructions for preparing the mixture of HEVASCOL with an anticancer drug:

• Prepare two syringes large enough to hold the entire volume of the mixture. The first syringe should contain the anticancer drug solution, and the second syringe should contain HEVASCOL.
• Connect the two syringes with a three-way stopcock valve.
• Perform 15 to 20 cycles of alternating pushing and pulling the plunger in both syringes to obtain a homogeneous mixture. It is recommended to start with the syringe containing the anticancer drug.
• The mixture should be prepared immediately before use and used quickly after preparation (within 3 hours). If necessary, during the interventional radiology procedure, the mixture can be rehomogenized in the above-mentioned manner.
• After obtaining the appropriate mixture, it should be injected into the microcatheter using a 1 to 3 ml syringe. This procedure can be repeated every 6 to 8 weeks, depending on the tumor response and the patient's condition.

Children and adolescents
The safety and efficacy of HEVASCOL in chemoembolization of hepatocellular carcinoma have not been established in the pediatric population.
Elderly
The product should be administered with caution in patients over 65 years of age with underlying cardiovascular, respiratory, or neurological disease.
Reducing the administered dose may prevent unwanted pulmonary embolism, which may occur during chemoembolization of liver tumors.
Method of administration
HEVASCOL should be administered using an appropriate glass syringe or other device whose compatibility with HEVASCOL has been verified in a test. Follow the current instructions for the use of such devices.

Incompatibilities

It has been shown that polystyrene dissolves in HEVASCOL; therefore, this product should not be administered using single-use syringes made of this material. HEVASCOL should be administered using an appropriate glass syringe or other device whose compatibility with HEVASCOL has been verified in a test. Follow the current instructions for the use of such devices.