Hevascol

Package leaflet: Information for the patient

HEVASCOL 480 mg I/ml, solution for injection
Oleum ethiodatum
Please read all of this leaflet carefully before this medicine is administered because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, you must inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What HEVASCOL is and what it is used for
2. What you need to know before receiving 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 HEVASCOL is and what it is used for

HEVASCOL belongs to the group of iodinated contrast media.
This medicine is intended for diagnostic use only (for imaging purposes).
HEVASCOL 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 in the investigation of infertility causes.
• In interventional radiology: for transarterial chemoembolization (blocking blood vessels supplying a tumor using targeted drugs) of liver tumors (hepatocellular carcinoma).

2. Important information before administering HEVASCOL

When must HEVASCOL not be given

• 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 suffered a severe injury or bleeding,
• if the patient requires bronchography, a type of X-ray examination in which contrast medium is administered into the lower part of the lung,
• if the patient has active tuberculosis at the time of the examination,
• if the patient has a severe illness (or illnesses) affecting one or more organs,
• if the patient has dilated bile ducts,
• if the patient is pregnant or suspects she may be pregnant and is scheduled for hysterosalpingography (examination of the uterus and fallopian tubes),
• if the patient has pelvic inflammatory disease involving the uterus, fallopian tubes, or ovaries and is scheduled for hysterosalpingography (examination of the uterus and fallopian tubes).

Warnings and precautions
Before starting treatment with HEVASCOL, discuss it with your doctor or pharmacist.
As with all iodinated contrast media, regardless of the route of administration, adverse reactions may occur. These reactions may be mild, but may also be life-threatening. Such reactions may occur within an hour after administration of the drug, but may also appear later, within seven days.
They are often unpredictable, but the risk is higher if the patient previously experienced any reaction after receiving an iodinated contrast medium (see section 4 "Possible side effects"). In such cases, inform your doctor.
Tell your doctor:

• if the patient previously had a reaction to this contrast agent during an 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 esophageal varices (enlarged veins in the esophagus),
• if the patient has thyroid disease or has had it in the past,
• if the patient has a thyroid examination or radioactive iodine treatment scheduled in the near future,
• if the patient has swelling of part or all of the hand or foot, including fingers, or swelling of the legs (lymphedema).

In all such cases, the doctor will administer HEVASCOL only if the benefits of the examination outweigh the risks associated with administering this medicine.
If the patient is given this medicine, the treating physician will take necessary precautions, and administration of HEVASCOL will be closely monitored.
If the patient is a child or 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 currently taking or has recently taken, as well as any medicines the patient plans to take. This particularly includes the following medicines:

• a medicine used in the treatment of diabetes (metformin),
• medicines used in the treatment of heart disease or high blood pressure (beta-blockers and antihypertensives), diuretics (medicines that remove water from the body),
• medicines known to have harmful effects on the kidneys (such as certain antibiotics or antiviral drugs),
• interleukin-2 (a medicine used in cancer treatment or to boost the immune system).

If the patient is taking medicines affecting the thyroid gland, the patient should inform the doctor before receiving HEVASCOL.

HEVASCOL and alcohol
If the patient regularly drinks large amounts of alcohol, he or she should inform the doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 suspects she may be pregnant and is scheduled for 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 receiving HEVASCOL.
Before taking any medicine, the patient should consult her doctor or pharmacist.

Driving and operating machinery
There are no known specific hazards.
If the patient does not feel well after the examination, he or she should not drive or operate machinery.

3. How to use HEVASCOL

Dosage
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 administered to the patient as an injection.
Before the examination or intervention, the patient may receive an infusion (intravenous drip) to ensure adequate
fluid levels in the body.
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 physician. It may be necessary to leave
an intravenous cannula in place so that the doctor can administer other medications in case of a medical emergency.
If the patient experiences an allergic reaction, administration of HEVASCOL will be discontinued.
The attending staff are aware of the precautions necessary for the examination and are familiar with potential
complications that may occur.
Administration of a higher than recommended dose of HEVASCOL
It is highly unlikely that the patient would receive an excessive dose of this medicine. This medicine will be administered
in a medical facility by appropriately trained personnel. In the event of such a situation, the patient will receive appropriate care.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The patient may experience allergic reactions (including anaphylactic, anaphylactoid, and early allergic reactions). Allergies may be recognized by the following symptoms:

• Skin reactions with very rapid onset (often within one hour), including skin blisters, redness (erythema), and itching (localized or widespread); sudden swelling of the face and neck (angioedema),
• Respiratory tract symptoms: cough, inflammation of nasal passages (nasal discharge), sensation of throat tightness, breathing difficulties, throat swelling (laryngeal edema), breathing difficulties combined with cough (bronchospasm), respiratory arrest,
• Effects on the heart and blood vessels: low blood pressure (hypotension), dizziness, malaise (weakness), heart rhythm disturbances, cardiac arrest. If the patient experiences any of these symptoms during or after administration of HEVASCOL, the physician must be informed immediately.

Other possible adverse reactions
The following adverse reactions have been observed after administration of this medicine. The frequency of these reactions is unknown (cannot be estimated from available data).

• nausea,
• 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 accumulation in the lungs (pulmonary edema) and its surrounding tissues (pleural effusion), critical respiratory failure (acute respiratory distress syndrome), and non-infectious lung inflammation,
• embolism (blockage of blood vessels) in the brain. This may occur without causing any symptoms,
• worsening of lymphedema (swelling caused by impaired lymphatic system function),
• dyspnea (shortness of breath),
• cough,
• liver damage leading to liver failure, abnormal accumulation of fluid in the abdominal cavity (ascites), inadequate blood supply potentially leading to liver damage (liver infarction), and disturbances in consciousness that may be associated with other neurological symptoms of liver failure (hepatic encephalopathy),
• formation of pus-filled cavities (abscesses) in the liver,
• inflammation of the gallbladder, bile ducts, or peritoneum,
• formation of a bile collection in the abdominal cavity (bile collection, biloma),
• skin necrosis (tissue death),
• post-embolization syndrome (fever, abdominal pain, nausea, and vomiting), which may occur after administration of this medicine during chemoembolization procedures (blocking blood vessels supplying the tumor using targeted drugs),
• small amounts of HEVASCOL may enter the systemic circulation and reach other parts of the body, such as blood vessels, including arteries.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a physician, pharmacist, or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store HEVASCOL

Keep the medicine out of the 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 stated month.
Store the ampoule in the original packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

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

What HEVASCOL looks like and contents of the pack
HEVASCOL injection solution is a clear, oily liquid ranging in colour from pale yellow to orange.
The medicine is available in packaging containing 1 ampoule of 10 ml.

Marketing Authorisation Holder and Manufacturer
GUERBET
BP 57400
95943 ROISSY CDG CEDEX
France

For further information about this medicine, please contact the representative of the marketing authorisation holder: Guerbet Poland Sp. z o.o., tel. (22) 6684110.

Manufacturer
Guerbet
16-24 rue Jean Chaptal
93600 Aulnay Sous Bois
France

This medicine is authorised in the following European Economic Area countries 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

Information intended exclusively for healthcare professionals:

Dosage and method of administration

Dosage

In diagnostic radiology:

Lymphography
Injection of HEVASCOL into a peripheral lymphatic vessel enables imaging of the lymphatic system up to the thoracic duct. Prior to injection of HEVASCOL, an injection of a suitable sterile dye solution may be administered to facilitate localisation of collecting lymphatic vessels. Typical injection sites include the dorsal surface of the foot or hand, in the first, third or fourth interdigital space. After surgical exposure under local anaesthesia, stained vessels should be cannulated with a special cannula; HEVASCOL must be administered while the patient is in the supine position. An infusion pump must be used to ensure slow administration. The infusion rate must not exceed 0.1 ml per minute and should be adjusted according to the transport capacity of the lymphatic system. If pain occurs during administration, the infusion rate should be reduced. Radiographic monitoring of contrast medium flow should be performed to allow early detection of extravasation or incorrect cannulation. The infusion should be stopped once the level of the fifth lumbar vertebra is reached. Radiographic images obtained immediately after completion of the infusion (filling phase: lymphangiogram) and the following day (accumulation phase: lymphadenogram) provide information on morphological changes in the visualised vessels and lymph nodes.

Recommended dosage
In general, a maximum of 4 to 7 ml of HEVASCOL per limb is administered in adult patients to visualise inguinal, iliac and para-aortic lymph nodes. If lymph nodes are clearly enlarged, up to 10 ml per limb may be administered. When the total dose exceeds 14 ml, pulmonary microembolisation may be observed on chest X-ray. The total dose of contrast medium must not exceed 20 ml. If there is lack of accumulation in iliac and para-aortic lymph nodes (e.g. following radiotherapy or lymph node resection), the dose should be halved.

For imaging of axillary lymph nodes by injection into the dorsal hand, a dose of 3 to 6 ml of HEVASCOL is sufficient.

Elderly patients
In elderly patients with circulatory insufficiency, the dose should be appropriately adjusted or the examination should be avoided, as part of the administered product may transiently block pulmonary capillaries. The product should be administered with caution in patients over 65 years of age who have underlying cardiovascular, respiratory or neurological disease.

Children and adolescents
The dose should also be appropriately reduced in children and underweight patients. In children aged 1 to 2 years, a dose of 1 ml per limb is sufficient.

Fistulography
The amount of contrast medium to be administered should be determined prior to the examination. The volume is estimated based on the expected size of the fistula.

HEVASCOL is usually administered as a single dose for individual examinations.

Hysterosalpingography
Under fluoroscopic control, inject slowly 2 ml of HEVASCOL into the uterine cavity at a time until tubal patency is confirmed.
The total volume to be injected depends on the uterine cavity capacity and usually does not exceed 15 ml.
The dose of HEVASCOL used in hysterosalpingography should be as low as possible to minimise the risk of thyroid dysfunction.

During hysterosalpingography, HEVASCOL should be slowly injected into the cervical canal via an appropriate catheter or cannula.

If the patient experiences significant discomfort, administration should be stopped.

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

In interventional radiology:

Transarterial chemoembolisation of hepatocellular carcinoma
The product is administered selectively via a catheter inserted into the hepatic artery. The procedure should be performed in an interventional radiology suite equipped appropriately. The dose of HEVASCOL depends on tumour size but usually should not exceed a total dose of 15 ml in adult patients.

HEVASCOL may be mixed with anticancer drugs such as cisplatin, doxorubicin, epirubicin and mitomycin.

Strict adherence to instructions and precautions regarding the use of such anticancer drugs is required.

Instructions for preparing the HEVASCOL-anticancer drug mixture:

• Prepare two sufficiently large syringes to accommodate the entire volume of the mixture. One syringe should contain the solution of the anticancer drug, and the other syringe – HEVASCOL.
• Connect both syringes using a three-way stopcock valve.
• Perform 15 to 20 cycles of alternating plunger push and withdrawal in both syringes to achieve a homogeneous mixture. It is recommended to start with pushing the plunger of the syringe containing the anticancer drug.
• The mixture should be prepared immediately before use and used promptly (within 3 hours). If necessary, during the interventional radiology procedure, the mixture may be re-homogenised using the method described above.
• After obtaining the appropriate mixture, inject it into a microcatheter using a 1 to 3 ml syringe. This procedure may be repeated every 6 to 8 weeks, depending on tumour response and patient condition.

Children and adolescents
The safety and efficacy of HEVASCOL in chemoembolisation of hepatocellular carcinoma in the paediatric and adolescent population have not been established.

Elderly patients
The product should be administered with particular caution in patients over 65 years of age with underlying cardiovascular, respiratory or neurological disease.
Reducing the administered dose may prevent unwanted pulmonary embolisation, which may occur during chemoembolisation of liver cancer.

Method of administration
HEVASCOL should be administered using an appropriate glass syringe or another device whose compatibility with HEVASCOL has been confirmed in testing. Current instructions for use of such devices should be followed.

Pharmaceutical incompatibilities
Polystyrene has been shown to dissolve in HEVASCOL; therefore, this product must not be administered using disposable syringes made of this material. HEVASCOL should be administered using an appropriate glass syringe or another device whose compatibility with HEVASCOL has been confirmed in testing. Current instructions for use of such devices should be followed.