Optiray Ultraject 350 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Optiray Ultraject 350 mg/ml solution for injection

Ioversol

Read the entire 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 adverse reactions, consult your doctor, even if they are not listed in this leaflet.

Leaflet contents:

1. What Optiray Ultraject 350 is and what it is used for
2. What you need to know before using Optiray Ultraject 350
3. How to use Optiray Ultraject 350
4. Possible side effects
5. How to store Optiray Ultraject 350
6. Contents of the pack and other information

1. What Optiray Ultraject 350 is and what it is used for

Optiray Ultraject 350 is used in adults for various X-ray procedures, including:

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

Optiray Ultraject 350 is an iodine-containing contrast medium. Iodine is radiopaque, which allows blood vessels and other organs to be visualized during X-ray examinations.

2. What you need to know before using Optiray Ultraject 350

Do not take Optiray Ultraject 300:

• if you are allergic to iodine-containing contrast media 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 red blood cell abnormalities, known as sickle cell anemia
• an adrenal gland tumor affecting blood pressure, known as pheochromocytoma
• elevated levels of the amino acid homocysteine due to abnormal metabolism
• recently undergone a gallbladder imaging study with contrast medium
• planned a thyroid gland imaging 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.

Severe 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 disturbance known as encephalopathy. Inform your doctor immediately if you experience any symptoms related to this condition described in section 4.

Children under 18 years

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 medium 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.

Use of 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 with, be influenced by, or influence Optiray Ultraject 300:

• Metformin: a medicine used to treat diabetes

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

• Interleukin: a medicine used to treat certain tumors
• Some medicines used to increase blood pressure due to blood vessel constriction and to prevent potential neurological risks. Optiray must never be used while these medicines are being administered
• General anesthetics

Adverse effects have been frequently reported with:

• Diuretics: medicines that increase urine production and lower blood pressure

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

Use of 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 this may further impair 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 the 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 by these, do not perform any activity requiring concentration and adequate reaction capability.

Warnings related to excipients

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

3. How to use Optiray Ultraject 350

The use of Optiray Ultraject 350 must only be carried out under the supervision of a physician specialized in X-rays, who will determine the dose.

Optiray is injected into a blood vessel and distributed throughout the body via the bloodstream. It must be warmed to body temperature before use and then injected, either as a single dose or in multiple doses during the X-ray procedure.

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

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

If you are given more Optiray Ultraject 350 than you should have:

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

If you have further questions about the use of this medicine, consult your doctor or X-ray specialist.

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 to moderate, although in rare instances they may be severe or life-threatening.

Immediately inform your doctor if you develop any of the following signs of serious adverse reactions:

• cardiac or respiratory arrest
• spasms in the heart vessels or blood clots
• stroke, blue lips, collapse
• memory loss
• speech disorders
• sudden movements
• transient blindness
• acute kidney failure
• skin rash, redness or blisters, which may progress to serious skin reactions that could be life-threatening, including extensive peeling of the skin (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 of the nasal lining causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• rash
• urgent need to urinate
• facial swelling including eyes
• chills
• uncontrollable tremors
• sensation of cold

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

• severe allergic reactions
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• somnolence
• stupor
• speech disorders
• language disorders
• reduced sense of touch or sensitivity
• allergic eye inflammation causing red, watery, itchy eyes
• ringing or noises in the ear
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured by 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
• inflammation 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 cell degeneration
• general feeling of discomfort or abnormality, fatigue, sluggishness

Frequency not known (cannot be estimated from available data)

• severe allergic reaction
• temporary underactivity of the thyroid gland
• seizures
• short-term brain disturbances (encephalopathy), which may cause confusion, hallucinations, visual disturbances, blindness, convulsions, loss of coordination, paralysis 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 coronary artery affecting the heart
• bluish discoloration of the skin 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 the 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 the skin, mouth, eyes and genitals (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• painful urination, difficulty or inability to urinate
• temporary underactivity of the thyroid gland 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. Conservation of Optiray Ultraject 350

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 may also be stored at 37°C for one month in a contrast medium warmer using a circulating hot air system.

Do not use Optiray Ultraject 350 if there are 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 bromobutyl rubber stoppers free from latex (Ph. Eur.) and fitted with an anodized aluminium cap, 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 autoinjector/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 Local Representative of the Marketing Authorization Holder:

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/