Optirai 320

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Optiray 320 solution for injection and infusion, 678 mg/ml

(Ioversol)

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any further questions.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

Table of contents of the leaflet

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

1. What is Optiray and what is it used for

Optiray is used in adults for various radiological examinations, including:

• vascular imaging, both arterial and venous
• kidneys
• computed tomography

Optiray is a contrast agent containing iodine. Iodine blocks X-ray radiation, which allows for the visualization of blood vessels and internal organs through which blood flows.

2. Important information before using Optiray

When not to use Optiray:

• if the patient is allergicto iodine-containing contrast agentsor any of the other ingredients of this medicine (listed in section 6).
• if the patient has hyperthyroidism

Warnings and precautions

Before starting Optiray, consult a doctor if the patient has:

• asthma or a history of allergic reactions, such as nausea, vomiting, low blood pressure, skin symptoms
• heart failure, high blood pressure, circulatory disorders, or stroke, and if the patient is elderly
• diabetes
• kidney or liver disease
• brain disorders
• bone marrow disorders, such as certain blood cancers called paraproteinemia, multiple myeloma
• certain red blood cell disorders, called sickle cell anemia
• an adrenal gland tumor that affects blood pressure, called pheochromocytoma
• increased homocysteine levels due to abnormal metabolism
• recent gallbladder examination using a contrast agent
• planned thyroid examination using an iodine-containing substance. It should be postponed, as Optiray may affect the results for up to 16 days.

Severe skin reactions have been reported in patients who received Optiray, such as eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening. During the procedure or shortly after, a temporary brain disorder called encephalopathy may occur. Immediately inform a doctor if any symptoms related to this condition described in section 4 are noticed.

Children and adolescents under 18 years of age

Optiray 320 is not recommended for use in this age group. If a child is exposed to Optiray (direct exposure or newborns whose mothers received iodinated contrast agent during pregnancy), thyroid function should be evaluated after birth and in all children under 3 years of age, within one month of exposure.

Optiray and other medicines

Tell your doctor or radiologist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The following medicinesmay affect Optirayor Optiray may affect them:

• metformin:a medicine used to treat diabetes. The doctor will check kidney function before and after using Optiray. Depending on kidney function, the doctor may consider stopping metformin 48 hours before the examination and not restarting it for at least 48 hours after the examination, unless kidney function returns to normal.
• interleukins:medicines used to treat certain tumors
• certain blood pressure-lowering medicinesthat constrict blood vessels. To prevent the risk of neurological disorders with Optiray, these medicines should never be used during Optiray administration.
• general anesthetics. Increased frequency of side effects has been reported.
• diuretics:medicines that increase urine production and lower blood pressure. In cases of dehydration caused by diuretics, the use of iodinated contrast agents may increase the risk of acute kidney failure.

Optiray with food and drink

Consult a doctor. In patients with existing kidney disease, water intake should not be restricted, as it may further impair kidney function.

Pregnancy and breastfeeding

• Pregnancy. Tell your doctor if you are pregnant or think you may be pregnant. The doctor will only give you Optiray if it is absolutely necessary, as the medicine may harm the unborn child.
• Breastfeeding. Stop breastfeeding for one day after injection, as there is not enough data on the safety of use. Consult a doctor or radiologist.

Driving and using machines

Driving or operating machinery is not recommended for 1 hour afterinjection. Additionally, symptoms such as dizziness, drowsiness, weakness, and vision disturbances have been observed. If such symptoms occur, do not attempt to perform any activities that require concentration and proper reaction.

Optiray contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to use Optiray

Examinations with Optiray will be performed only by a doctor or radiologistwho will also decide on the dose. Optiray is injected into a blood vesseland distributed in the body through the bloodstream. Before use, the medicine is heated to body temperature and then injected once or several times during the radiological examination. The dose depends on the type of examination and other factors, such as the patient's condition and age. The smallest dose that allows for images of sufficient quality is used.

Using more than the recommended dose of Optiray

Overdose is potentially dangerous and may affect breathing, heart, and circulation. Immediately inform a doctor or radiologist if you notice any such symptoms after receiving Optiray. If you have any further questions about using this medicine, consult a doctor or radiologist.

4. Possible side effects

Like all medicines, Optiray can cause side effects, although not everybody gets them. Side effects related to Optiray are generally dose-independent. In most cases, they are mild or moderate and very rarely severe or life-threatening. Immediately contact a doctorif you experience any of the following severe side effects:

• cardiac arrest or respiratory arrest
• constriction of coronary arteries or blood clots
• stroke, cyanosis, fainting
• memory loss
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• skin rash, redness, or blisters that can develop into life-threatening skin reactions, including toxic epidermal necrolysis (TEN) or drug reaction with eosinophilia and systemic symptoms (DRESS)
• allergic reaction symptoms, such as anaphylactic shock, bronchospasm, hypotension, facial edema, and angioedema

Side effects may occur with the following frequency:

very common, occurring in more than 1 in 10 users

• feeling of heat

common, occurring in 1 to 10 in 100 users

• pain
• nausea

uncommon, occurring in 1 to 10 in 1,000 users

• hives
• redness, itching
• dizziness
• headache
• taste disturbance
• tingling or numbness
• vomiting
• coughing
• high blood pressure

rare, occurring in 1 to 10 in 10,000 users

• fainting
• dizziness
• blurred vision
• pulsating heartbeat
• low blood pressure
• flushing
• constriction of the airways, including laryngospasm
• difficulty breathing
• rhinitis, which causes sneezing and a stuffy nose
• cough, sore throat
• dry mouth
• rash
• urinary urgency
• facial edema, including eye edema
• chills
• involuntary trembling
• feeling cold

very rare, occurring in less than 1 in 10,000 users

• severe allergic reaction
• disorientation, anxiety, nervousness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• speech disorders
• hearing disorders
• allergic conjunctivitis, which causes redness, tearing, and itching of the eyes
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured by ECG
• stroke
• high blood pressure
• phlebitis, vasodilation
• fluid accumulation in the lungs
• sore throat
• low oxygen levels in the blood
• abdominal pain
• salivary gland inflammation, tongue swelling
• difficulty swallowing, increased saliva production
• most often painful, severe swelling of the deep skin layers, mainly on the face
• increased sweating
• muscle cramps
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, impaired urination
• edema due to excess fluid
• reactions at the injection site, including pain, redness, bleeding, or tissue degeneration
• feeling unwell or abnormal, fatigue, lethargy

unknown: frequency cannot be estimated from available data

• severe allergic reaction with anaphylactic shock
• transient hypothyroidism
• seizures
• temporary brain disorder (encephalopathy), which can cause disorientation, hallucinations, vision disturbances, blindness, seizures, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness
• movement disorder
• memory loss
• temporary blindness
• cardiac arrest, life-threatening irregular heartbeat
• extra heartbeats
• coronary artery spasms, palpitations
• blue discoloration of the skin (cyanosis) due to low oxygen levels in the blood
• shock
• blood clots or constriction in a blood vessel
• pallor
• respiratory arrest, asthma, bronchospasm
• reduced ability to produce voice using vocal organs
• diarrhea
• severe reaction involving the skin, blood, and internal organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS)
• red, scaling, widespread rash with nodules under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis)
• red bumps (papules or nodules)
• life-threatening reaction with flu-like symptoms and painful rash/blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• absence of or painful urination
• hypothyroidism in newborns
• fever

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optiray

Store the medicine out of sight and reach 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. Store the containers in the outer packaging to protect from light. Protect from X-ray radiation. Do not store above 30°C. Optiray 320 can be stored for one month at 37°C in a contrast agent storage warmer with air circulation. Do not use this medicine if you notice discoloration or solid particles.

6. Contents of the packaging and other information

What Optiray contains:

• The active substance is ioversol. One milliliter of Optiray 320 contains 678 mg of ioversol, which corresponds to 320 mg of organically bound iodine.
• Other ingredients are: sodium calcium edetate (stabilizer), trometamol, and trometamol hydrochloride (buffer), and water for injections. Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH to 6.0-7.4.

What Optiray looks like and contents of the packaging

Optiray 320 is packaged in:

• colorless glass vials with a capacity of 20 ml, equipped with bromobutyl rubber stoppers and aluminum caps. The box contains 10 vials.
• colorless glass bottles with a capacity of 50, 75, 100, or 200 ml, equipped with bromobutyl rubber stoppers and aluminum caps. The box contains the following number of bottles: 50 ml - 10 or 25 bottles, 100 ml - 10 or 12 bottles, 75 ml or 200 ml - 10 bottles.
• colorless glass bottles with a capacity of 500 ml, equipped with bromobutyl rubber stoppers and aluminum caps. The box contains 5, 6, or 10 bottles.

Optiray 320 is also supplied in prefilled syringes and syringes with a pressure injector, made of polypropylene. The syringe tip and plunger are made of natural rubber. Prefilled syringes: 50 ml. The box contains 10 syringes. Syringes with a pressure injector: 50, 100, or 125 ml. The box contains 10 syringes. Not all pack sizes and boxes may be marketed in all countries.

Marketing authorization holder and manufacturer:

• Address of the marketing authorization holder

Guerbet BP 57400
95943 Roissy CDG Cedex
France
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder: Guerbet Poland Sp. z o.o., tel. (22) 6684110.

• Manufacturer

Guerbet
BP 57400
95943 Roissy CDG Cedex
France
Manufacturing site: 16-24 rue Jean Chaptal, 93600 Aulnay sous Bois, France

Date of last revision of the leaflet:

Instructions for use of prefilled syringes

Prefilled syringe

Assembly and inspection

Caution: The outer surface of the syringe is not sterile.

The contents of the syringe and the surface under the blue cap and the reinforcing ribs of the plunger aresterileand therefore require caution during assembly.

Remove the syringe from the base and check for leaks around the blue capand on the outside of the plunger. Do not use the syringe if a leak is detected. After screwing the plunger into the syringe, it is essential to turn the plunger an additional ½ turn so that the blue plunger moves freely.

Before using the syringe, unscrew the blue capand discard it. The surface under the cap is sterile; be careful not to touch it during further handling. The syringe is now ready for needle or infusion tube attachment. After use, discard the syringe and any unused portion of the medicine.

Instructions for use of syringes with a pressure injector

Prefilled syringe

Assembly and inspection

Caution: The outer surface of the syringe is not sterile.

The contents of the syringe and the surface under the blue cap and the reinforcing ribs of the plunger aresterileand therefore require caution during assembly.

Remove the syringe from the base and check for leaks around the blue capand on the outside of the plunger. Do not use the syringe if a leak is detected. Place the syringe in the pressure injector.

To remove the blue cap, press it and twist it, then discard it after removal. The surface under the cap is sterile; be careful during further handling.

Then, remove the cap from the protective dust cover of the Luer connector by twisting it to break the visible seal. Discard the cap.

Screw the Luer connector to the syringe, holding the protective dust cover and tightening it until it stops. Remove and discard the protective dust cover immediately before attaching a sterile infusion tube. After use, discard the syringe and any unused portion of the medicine.