OPTIRAY ULTRAJECT 320 mg/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Optiray Ultraject 320 mg/ml solution for injection

Ioversol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What is Optiray Ultraject 320 and what is it used for
2. What you need to know before you use Optiray Ultraject 320
3. How to use Optiray Ultraject 320
4. Possible side effects
5. Storing Optiray Ultraject 320
6. Contents of the pack and other information

1. What is Optiray Ultraject 320 and what is it used for

Optiray Ultraject 320 is used in adults for different types of X-ray procedures, including:

• imaging of vessels, arteries and veins
• kidneys
• CT scan

Optiray Ultraject 320 is a contrast medium that contains iodine. Iodine does not allow X-rays to pass through, allowing vessels and other organs to be observed

2. What you need to know before you use Optiray Ultraject 320

Do not take Optiray Ultraject 320

• if you are allergic to iodine-containing contrast media or to any of the other ingredients of this medicine (listed in section 6).
• if you have clinical hyperthyroidism

Warnings and precautions

Talk to your doctor before using Optiray Ultraject 320 if you have

• asthma or have previously had allergic reactions such as nausea, vomiting, low blood pressure, skin symptoms
• heart failure, high blood pressure, circulatory problems, or have had a stroke, and if you are very elderly
• diabetes
• kidney or liver disease
• brain problems
• bone marrow problems, such as certain types of blood cancer known as multiple myeloma, Waldenström's macroglobulinemia
• certain red blood cell abnormalities, known as sickle cell anemia
• adrenal gland tumor, which affects blood pressure, known as pheochromocytoma
• increased level of the amino acid homocysteine, due to abnormal metabolism
• a recent gallbladder study with contrast medium
• a planned thyroid gland study using a substance that contains iodine. This can be postponed since Optiray Ultraject 320 can influence the results for up to 16 days.

With the use of Optiray, serious skin reactions have been reported, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (Lyell syndrome or NET), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening.

During the imaging procedure or shortly after, you may experience a short-term brain disorder called encephalopathy. Inform your doctor immediately if you experience any of the symptoms related to this condition described in section 4.

Children under 18 years

Optiray Ultraject 320 is not recommended in this age group

In case of exposure (direct exposure or newborns whose mothers have received an iodinated contrast medium during pregnancy), thyroid function should be evaluated at birth and in all pediatric patients under 3 years within the month following exposure.

Using Optiray Ultraject 320 with other medicines

Tell your doctor or radiologist if you are using or have recently used or may use other medicines.

The following medicinesmay interact, influence or be influenced by Optiray Ultraject 320:

• metformin: medicine to treat diabetes

Your doctor will measure your kidney function before and after using Optiray Ultraject 320. Depending on the level of your kidney function, your doctor may consider stopping the use of metformin 48 hours before and during the test. It should not be resumed until at least 48 hours later and only if your kidney function has returned to normal

• interleukin: medicine to treat some tumors
• certain medicines to increase blood pressuredue to narrowing of the blood vessels and to prevent any risk of nervous disorders. Optiray should never be used while using these medicines
• general anesthetics

Adverse effects have been reported with high frequency

• diuretics: medicines that increase urine production and decrease blood pressure.

In case of dehydration caused by the use of diuretics, the use of iodinated contrast media may increase the risk of acute kidney failure.

Using Optiray Ultraject 320 with food and drinks:

Limit food intake before the test. Please consult your doctor if you have any doubts. If you have kidney disease, do not limit fluid intake as it may reduce kidney function.

Pregnancy and breastfeeding

• Pregnancy

Talk to your doctor if you are pregnant or think you may be. Your doctor will administer Optiray Ultraject during pregnancy only if it is absolutely necessary, as it may harm the fetus.

• Breastfeeding

Stop breastfeeding for one day after the injection, as there is not enough information about safety. Consult your doctor or X-ray specialist.

Driving and using machines:

It is not recommended to drive or use machines for up to one hourafter the injection. Additionally, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If this affects you, do not perform any activity that requires concentration and adequate reaction.

Excipient warnings

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially “sodium-free”.

3. How to use Optiray Ultraject 320

The use of Optiray Ultraject 320 should onlybe performed under the direction of a specialist X-ray doctor, who will decide the dose.

Optiray is injected into a blood vesseland distributed throughout the body through the bloodstream. It should be warmed to body temperature before use and then injected one or more times during the X-ray procedure.

The dose depends on the specific procedure and other factors such as health and age.

The lowest possible dose will be used to obtain adequate X-ray images.

If you use more Optiray Ultraject 320 than you should:

Overdose can be potentially dangerous and affect breathing, heart, and circulatory system. Inform your doctor or X-ray specialist immediately if you notice any of these symptoms after receiving Optiray.

If you have any further questions on the use of this medicine, ask your doctor or X-ray specialist.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 91 5620420.

4. Possible side effects

Like all medicines, Optiray 240 can cause side effects, although not everybody gets them. The adverse reactions associated with Optiray are generally dose-independent. In most cases, they are moderate, although in rare cases they can be severe or life-threatening.

Tell your doctor immediatelyif you develop any of the following signs of serious side effects:

• cardiac or respiratory arrest
• spasms in the heart vessels or blood clots
• stroke, blue lips, fainting
• memory loss
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• skin rash, redness or blisters, which can become life-threatening skin reactions, including widespread skin peeling (toxic epidermal necrolysis) or a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS)
• signs of allergic reactions such as:
• • anaphylactic shock
  • constriction of airways
  • inflammation of the vocal cords, throat or tongue
  • breathing difficulties
  • cough, sneezing
  • redness and/or inflammation of the face and eyes
  • itching, rash and hives

Side effects can occur with the following frequencies:

Very common, (occur in more than 1 in 10 patients)

• feeling of heat

Common, (occur in up to 1 in 10 patients)

• pain
• nausea

Uncommon, (occur in up to 1 in 100 patients)

• hives
• redness of the skin, itching
• dizziness
• headache
• alteration of taste
• abnormal sensation, such as pins and needles, tingling
• vomiting
• sneezing
• high blood pressure

Rare, (occur in up to 1 in 1,000 patients)

• fainting
• vertigo
• blurred vision
• rapid heartbeat
• low blood pressure
• flushing
• laryngeal spasms
• inflammation and narrowing of the airways, including narrowing of the throat, wheezing
• difficulty breathing
• inflammation of the nasal passages that causes sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• rash
• urgent need to urinate
• inflammation of the face including the eyes
• chills
• involuntary tremors
• feeling of cold

Very rare, (occur in less than 1 in 10,000 patients)

• severe allergic reactions
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis

• drowsiness
• stupor

• speech disorders
• language disorders
• reduced touch or sensitivity
• allergic inflammation of the eye causing red, wet and itchy eyes
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured using an ECG
• disease that alters blood flow to the brain
• venous inflammation, dilation of blood vessels
• fluid accumulation in the lungs
• sores in the throat
• low oxygen levels in the blood
• abdominal pain
• inflammation of the salivary glands and tongue
• difficulty swallowing, increased salivation
• severe inflammation of the deep layers of the skin, mostly painful, mainly on the face
• increased sweating
• muscle spasms
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, decreased urination
• inflammation of tissue caused by excess fluid
• reactions at the injection site including pain, redness, bleeding or cell degeneration
• feeling of discomfort or abnormal, fatigue, slowness

Frequency not known(cannot be estimated from the available data)

• severe allergic reaction
• temporary low thyroid activity
• seizures
• short-term brain disorders (encephalopathy), which can cause confusion, hallucinations, visual disturbances, blindness, convulsions, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness
• movement disorders
• memory loss
• temporary blindness
• cardiac arrest, life-threatening irregular heartbeats
• extra heartbeats
• contractions of the heart artery, hitting the heart
• blue discoloration of the skin due to low oxygen levels in the blood
• shock
• blood clots or spasms of the blood vessels
• pallor
• respiratory arrest, asthma, narrowing of airways
• reduced ability to produce sounds with the vocal organs
• diarrhea
• severe reaction that affects the skin, blood, and internal organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS, or hypersensitivity syndrome)
• red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis)
• red bumps (macular or papular rash)
• life-threatening reaction with flu-like symptoms and painful/blistering rash that affects the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• painful urination, with difficulty or absence of urination
• temporary low thyroid activity in newborns
• fever

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Optiray Ultraject 320

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.

Keep the container in the outer cardboard box to protect it from light. Protect from X-rays. Do not store above 30 °C. Do not freeze. This product can also be stored at 37 °C for one month, in a contrast medium warmer using a circulating air current.

Do not use Optiray Ultraject 320 if it shows significant color changes.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Optiray 240

• the active substance is Ioversol
• the other ingredients are: trometamol, trometamol hydrochloride, calcium and sodium edetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injectable preparations

Appearance and packaging of the product

This product is supplied in neutral type I glass vials (Ph. Eur.) sealed with latex-free bromobutyl rubber stoppers (Ph. Eur.) and with anodized aluminum caps in single doses of 50 or 100 ml.

Pre-filled syringes of 50 ml for manual use and pre-filled syringes for use with auto-injector/pump of 75, 100, and 125 ml are also available.

Package sizes:

1 and 10 vials of 50 ml

1, 10, and 12 vials of 100 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Guerbet

BP 57400

95943 Roissy CdG Cedex, France

Manufacturer:

Guerbet BP 57400

95943 Roissy CdG Cedex France,

located at Jean Chaptal 16-24, 93600 Aulnay sous Bois, France

For any information about this medicine, please contact the Local Representative of the Marketing Authorization Holder:

Laboratorios Farmacéuticos Guerbet, S.A.

Pº de la Castellana, 91, 3ª planta

28046 Madrid

+ (34) 91 504 50 00

Date of last revision of this leaflet: November 2023

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