Optiray Ultraject 320 mg/ml solution for injection

Package leaflet: Information for the user

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 as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor, even if they are side effects not listed in this leaflet.

Contents of this leaflet:

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

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

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

• imaging of blood vessels, arteries, and veins
• kidneys
• CT scans

Optiray Ultraject 320 is a contrast medium containing iodine. Iodine is radiopaque, which allows blood vessels and other organs to be visualized under X-ray imaging.

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

Do not take Optiray Ultraject 300:

• if you are allergic to iodine-containing contrast agents or to any of the other components of this medicine (listed in section 6).

• if you have clinical hyperthyroidism

Warnings and precautions

Talk to your doctor before using Optiray Ultraject 300 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, stroke, or if you are elderly
• diabetes
• kidney or liver disease
• brain disorders
• bone marrow disorders, such as certain blood cancers known as multiple myeloma, Waldenström's macroglobulinemia
• certain abnormalities of red blood cells, known as sickle cell anemia
• a tumor of the adrenal gland affecting blood pressure, known as pheochromocytoma
• elevated levels of the amino acid homocysteine due to abnormal metabolism
• a recent imaging study of the gallbladder using contrast medium
• planned a thyroid gland study using an iodine-containing substance. This may need to be postponed, as Optiray Ultraject 300 may interfere with test results for up to 16 days.

Serious skin reactions have been reported with the use of Optiray, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (Lyell syndrome or TEN), and Acute Generalized Exanthematous Pustulosis (AGEP), which may be life-threatening.

Signs of allergic reaction to this medicine, including breathing difficulties and chest pain, have been reported with Optiray. If you experience any of these signs, inform your doctor immediately.

During or shortly after the imaging procedure, you may experience a temporary brain disorder known as encephalopathy. Inform your doctor immediately if you experience any symptoms related to this condition described in section 4.

Children under 18 years of age

Optiray Ultraject 300 is used for imaging of blood vessels or kidneys in this age group.

In pediatric patients under 3 years of age, including newborns whose mothers received an iodinated contrast agent during pregnancy, monitoring of thyroid hormones (known as TSH and T4) is recommended. These checks should be performed 7–10 days and 1 month after administration of Optiray.

Using Optiray Ultraject 300 with other medicines

Tell your doctor or radiologist if you are taking, have recently taken, or might take any other medicines.

The following medicines may interact, affect or be affected by Optiray Ultraject 300:

• metformin: medicine used to treat diabetes

Your doctor will assess your kidney function before and after using Optiray Ultraject 300. Depending on your level of kidney function, your doctor may consider stopping metformin for up to 48 hours before and during the procedure. Metformin should not be restarted until at least 48 hours after the procedure and only if kidney function has returned to normal.

• interleukin: medicine used to treat certain tumors
• certain medicines used to increase blood pressure due to blood vessel constriction and to prevent risks of neurological disturbances. Optiray must never be used while these medicines are being administered.
• general anesthetics

Adverse effects have been reported with high frequency.

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

If dehydration occurs due to diuretic use, the use of iodinated contrast agents may increase the risk of acute kidney injury.

Using Optiray Ultraject 300 with food and drink:

Limit food intake before the procedure. Please consult your doctor if you have any questions. If you have kidney disease, do not restrict fluid intake, as dehydration may reduce kidney function.

Pregnancy and breastfeeding

• Pregnancy

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

• Breastfeeding

Discontinue breastfeeding for one day after injection, as there is insufficient information regarding safety. Discuss this with your doctor or radiologist.

Driving and use of machines:

Driving or operating machinery is not recommended for at least one hour after injection. In addition, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If you are affected, do not engage in any activity requiring concentration and adequate reaction ability.

Warnings related to excipients

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

3. How to use Optiray Ultraject 320

Optiray Ultraject 320 must only be used under the supervision of a physician specialized in radiology, who will determine the dose.

Optiray is injected into a blood vessel and distributed throughout the body via the bloodstream. It should be warmed to body temperature before use and then injected in one or more administrations during the radiographic procedure.

The dose depends on the specific procedure and other factors such as health status 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 may be potentially dangerous and affect breathing, the heart, and the circulatory system. Inform your doctor or radiologist immediately if you experience any of these symptoms after receiving Optiray.

If you have any further questions about the use of this medicine, consult your doctor or radiologist.

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

4. Possible adverse effects

Like all medicines, Optiray 240 may have adverse effects, although not everyone experiences them. Adverse reactions associated with Optiray are generally independent of the administered dose. In most cases, they are mild, although rarely they may be severe or life-threatening.

Inform your doctor immediately if you develop any of the following signs of serious adverse effects:

• cardiac or respiratory arrest
• spasms in the heart vessels or blood clots
• stroke, blue lips, fainting
• memory loss
• speech disorders
• sudden movements
• transient blindness
• acute kidney failure
• skin rash, redness or blisters, which may progress to life-threatening skin reactions, including extensive skin peeling (toxic epidermal necrolysis) or a drug reaction causing rash, fever, internal organ inflammation, hematological abnormalities, and systemic illness (DRESS)
• signs of allergic reactions such as:
  • anaphylactic shock
  • narrowing of airways
  • swelling of vocal cords, throat or tongue
  • breathing difficulties
  • cough, sneezing
  • redness and/or swelling of face and eyes
  • itching, rash and hives

Adverse effects may occur with the following frequencies:

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

• sensation of warmth

Common (occur in up to 1 in 10 patients)

• pain
• nausea

Uncommon (occur in up to 1 in 100 patients)

• hives
• skin redness, itching
• dizziness
• headache
• altered taste
• abnormal sensations such as pricking, tingling
• vomiting
• sneezing
• high blood pressure

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

• fainting
• vertigo
• blurred vision
• rapid pulse
• low blood pressure
• flushing
• laryngeal spasms
• swelling and narrowing of airways, including throat constriction, wheezing
• difficulty breathing
• inflammation inside the nose causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• rash
• urgent need to urinate
• facial swelling including eyes
• chills
• uncontrollable tremors
• feeling cold

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

• severe allergic reactions
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• somnolence
• stupor
• speech disorders
• language disorders
• reduced sensation or sensitivity
• allergic eye inflammation causing red, watery, itchy eyes
• noises or ringing in the ear
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured using an ECG
• condition affecting blood flow to the brain
• venous inflammation, blood vessel dilation
• fluid accumulation in the lungs
• sores in the throat
• low blood oxygen levels
• abdominal pain
• swelling of salivary glands and tongue
• difficulty swallowing, increased salivation
• severe swelling of deep skin layers, often painful, mainly in the face
• increased sweating
• muscle spasms
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, reduced urination
• tissue swelling due to fluid accumulation
• injection site reactions including pain, redness, bleeding or tissue cell degeneration
• feeling unwell or abnormal, fatigue, sluggishness

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Optiray Ultraject 320

Keep out of the reach and sight of children.

Do not use this medicinal product 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 may also be stored at 37 °C for one month in a contrast medium warmer using a circulating current of warm air.

Do not use Optiray Ultraject 320 if there are any significant changes in colour.

Disposal of unused medicine and of all materials that have come into contact with it must 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 components are: trometamol, trometamol hydrochloride, calcium disodium edetate, hydrochloric acid, and sodium hydroxide (for pH adjustment), and water for injections

Nature of the product and pack contents

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

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

Pack sizes:

1 and 10 vials of 50 ml

1, 10 and 12 vials of 100 ml

Only some 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 medicinal product, please contact the Marketing Authorization Holder's Local Representative:

Laboratorios Farmacéuticos Guerbet, S.A.

Pº de la Castellana, 91, 3rd floor

28046 Madrid, Spain

• (34) 91 504 50 00

Date of the most recent revision of this leaflet: May 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/