Optiray 300

Package leaflet: Information for the user

Optiray 300 injection solution for injection and infusion, 636 mg/ml
( Ioversol )
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Table of contents of the leaflet

1. What Optiray is and what it is 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 pack and other information

1. What Optiray is and what it is used for

Optiray is used in various radiological examinations, including:

• imaging of blood vessels, both arteries and veins (in adults and children)
• kidneys (in adults and children)
• computed tomography (in adults)

Optiray is a contrast medium containing iodine. Iodine blocks X-rays, enabling 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 has hypersensitivity to iodinated contrast media or to 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 previous allergic reactions such as nausea, vomiting, low blood pressure, skin symptoms
• heart failure, hypertension, circulatory disorders or stroke, or if the patient is elderly
• diabetes
• kidney or liver disease
• brain disorders
• bone marrow disorders, such as certain blood cancers called paraproteinaemia, multiple myeloma
• certain abnormalities of red blood cells called sickle cell anaemia
• an adrenal gland tumour affecting blood pressure, called a phaeochromocytoma
• elevated levels of the amino acid homocysteine due to a metabolic disorder
• recent gallbladder imaging with a contrast agent
• planned thyroid examination using an iodine-containing substance – this should be postponed, as Optiray may interfere with test results for up to 16 days.

Severe skin adverse reactions have been reported in patients receiving Optiray, such as
eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal
necrolysis (Lyell's syndrome or TEN), and acute generalized exanthematous pustulosis (AGEP),
which may be life-threatening.
Transient brain dysfunction called encephalopathy may occur during or shortly after the imaging
procedure. Inform the doctor immediately if any symptoms related to this condition described in
section 4 are observed.

Children and adolescents under 18 years of age
Children under 18 years of age
Optiray 300 is used for vascular or renal imaging in this age group.
However, it is not recommended for use in children undergoing computed tomography (CT) scans.
In newborns, especially premature infants, monitoring of thyroid hormones (TSH and T4) is
recommended. Such monitoring should be performed 7–10 days and 1 month after administration of
Optiray.
In children under 3 years of age, including newborns whose mothers received iodinated contrast
medium during pregnancy, monitoring of thyroid hormones (TSH and T4) is recommended. These
checks should be performed 7–10 days and 1 month after administration of Optiray.

Optiray with other medicines
Tell your doctor or radiologist about all medicines currently used, recently used, or planned to be used.
The following medicines may interact with Optiray or Optiray may affect them:

• Metformin: a medicine used to treat diabetes. The doctor will assess kidney function before and after administration of Optiray. Depending on kidney function, the doctor may consider discontinuing metformin from 48 hours before the procedure. Metformin should not be restarted for at least 48 hours after the procedure and only if kidney function has returned to baseline levels.
• Interleukins: medicines used to treat certain tumours
• Certain medicines that increase blood pressure due to vasoconstriction. To prevent the risk of neurological adverse events, Optiray must never be administered during treatment with these medicines.
• General anaesthetics: increased frequency of adverse reactions has been reported.
• Diuretics: medicines that increase urine production and lower blood pressure. In cases of dehydration caused by diuretic use, administration of iodinated contrast media may increase the risk of acute kidney injury.

Optiray with food and drink
Consult your doctor. In patients with existing kidney disease, fluid intake should not be restricted, as this may further impair kidney function.

Pregnancy and breastfeeding

• Pregnancy Inform your doctor if you are pregnant or suspect you may be pregnant. Optiray will be administered to pregnant patients only if absolutely necessary, as it may harm the unborn child.
• Breastfeeding Breastfeeding should be interrupted for one day after injection, as sufficient data on safety are not available. Consult your doctor or radiologist.

Driving and using machines
Driving or operating machinery is not recommended for 1 hour after
injection.
Additionally, symptoms such as dizziness, drowsiness, weakness, and visual disturbances have been observed. If such symptoms occur, the patient should not attempt any activity requiring concentration and prompt reaction.

Optiray contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Optiray

Examinations using Optiray will be performed exclusively by a physician or radiology specialist,
who will also determine the dosage.
Optiray is injected into a blood vessel and distributed throughout the body via the bloodstream.
Prior to administration, the medication is warmed to body temperature, then injected once or
repeatedly during the radiological examination.
The dose depends on the type of examination and other factors such as the patient's condition and age.
The lowest dose enabling acquisition of images of adequate quality will be used.
Administration of a higher than recommended dose of Optiray
Overdose is potentially dangerous and may affect respiration, heart, and circulatory system.
The physician or radiology specialist should be informed immediately if the patient experiences
any such symptoms after receiving Optiray.
If you have any further questions regarding the use of this medicine, consult your physician or radiology specialist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects associated with Optiray are generally independent of the dose administered. In
most cases, they are mild or moderate and very rarely severe or life-threatening.
You should contact a doctor immediately if any of the following symptoms of serious side effects occur:

• cardiac arrest or respiratory arrest
• constriction of blood vessels in the heart or blood clots
• stroke, bluish discoloration of the lips, fainting
• memory loss
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• skin rash, redness or blisters, which may develop into 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)
• symptoms of allergic reactions, such as anaphylactic shock, constricted airways, swelling of the larynx, throat or tongue, breathing difficulties, cough, sneezing, redness and/or swelling of the face and eyes, itching, rash and hives

Side effects may occur with the following frequencies:
Very common – affects more than 1 in 10 people

• sensation of warmth

Common – affects 1 to 10 in 100 people

• pain
• nausea

Uncommon – affects 1 to 10 in 1,000 people

• hives
• skin redness, itching
• dizziness
• headache
• taste disturbances
• sensory disturbances such as prickling, tingling
• vomiting
• sneezing
• high blood pressure

Rare – affects 1 to 10 in 10,000 people

• fainting
• dizziness
• blurred vision
• pulsating heartbeat
• low blood pressure
• sudden facial flushing
• laryngeal spasms
• swelling and narrowing of airways, including throat tightness, wheezing
• breathing difficulties
• nasal inflammation causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• rash
• urge to urinate
• facial swelling, including eyes
• chills
• uncontrollable trembling
• sensation of cold

Very rare – affects fewer than 1 in 10,000 people

• severe allergic reaction
• disorientation, restlessness, nervousness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• voice disturbances
• speech disorders
• reduced sensitivity to touch or sensation
• allergic conjunctivitis causing red, watery, itchy eyes
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured by ECG
• disease impairing blood flow to the brain
• high blood pressure
• phlebitis, blood vessel dilation
• fluid accumulation in the lungs
• sore throat
• low blood oxygen levels
• abdominal pain
• sialadenitis, tongue swelling
• difficulty swallowing, increased salivation
• usually painful, severe swelling of deep skin layers, mainly in the face
• increased sweating
• muscle cramps
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, weakened urine passage
• tissue swelling due to fluid accumulation
• injection site reactions, including pain, redness, bleeding or tissue necrosis
• malaise, fatigue, somnolence

Not known – frequency cannot be estimated from available data

• severe allergic reaction with shock
• transient hypothyroidism
• seizures
• transient brain dysfunction (encephalopathy) which may cause disorientation, hallucinations, visual 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
• constriction of coronary arteries, rapid heartbeat
• bluish skin discoloration (cyanosis) due to low blood oxygen levels
• shock
• blood clot or constriction in a blood vessel
• pallor
• respiratory arrest, asthma, constricted airways
• reduced ability to produce voice via vocal organs
• diarrhea
• severe reaction involving skin, blood and internal organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome)
• red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis)
• red spots (macules or papules)
• 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, painful or difficult urination
• hypothyroidism in newborns
• fever

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Optiray

Keep this medicine out of the 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 specified month.
Store containers in the outer packaging to protect from light.
Protect from X-radiation.
Do not store at temperatures above 30°C.
Optiray 300 may be stored for one month at 37°C in a heater designed for storage of contrast media, with ensured air circulation.
Do not use this medicine if discolouration or solid particles are observed.

6. Contents of the pack and other information

What Optiray contains:

• The active substance is ioversol. One millilitre of Optiray 300 contains 636 mg of ioversol, corresponding to 300 mg of organically bound iodine.
• The 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 a level between 6.0 and 7.4.

What Optiray looks like and contents of the pack
Optiray 300 is packed in:

• colourless vials with a capacity of 10 or 20 ml, equipped with bromobutyl rubber closures and aluminium caps. A carton contains 10 vials.
• colourless bottles with a capacity of 50, 75, 100, 150 or 200 ml, equipped with bromobutyl rubber closures and aluminium caps. A carton contains the following quantities of bottles: 50 ml – 10 or 25 bottles; 100 ml – 10 or 12 bottles; 75 ml, 150 ml or 200 ml – 10 bottles.
• colourless bottles with a capacity of 500 ml, equipped with bromobutyl rubber closures and aluminium caps. A carton contains 5, 6 or 10 bottles.

Optiray 300 is also supplied in hand-held pre-filled syringes and pressure injector syringes made of polypropylene. The syringe nozzle and plunger are made of natural rubber.

• Hand-held pre-filled syringes with a capacity of 30 or 50 ml. A carton contains 10 syringes. Hand-held pre-filled syringes with a capacity of 50 ml. A carton contains 20 syringes.
• Pressure injector syringes with a capacity of: 50 ml or 100 ml. A carton contains 10 or 20 syringes. 125 ml. A carton contains 10 syringes.

Not all pack sizes and carton quantities may be marketed in all countries.

Marketing Authorisation Holder:

• Address of the Marketing Authorisation Holder
  Guerbet
  BP 57400
  95943 Roissy CDG Cedex
  France
  For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Guerbet Poland Sp. z o.o., tel. (22) 6684110.

• Manufacturer

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

Instructions for use of hand-held syringes
Pre-filled syringe

Assembly and inspection

Caution: The outer surface of the syringe is not sterile.
The contents of the syringe and the surfaces under the blue cap and the reinforcing ribs of the plunger are sterile. Therefore, care must be taken during assembly.

Remove the syringe from the base and check for leaks around the blue cap and on the outside of the plunger. Do not use the syringe if any leakage is observed.

After inserting the plunger into the syringe barrel, it is important to turn the plunger an additional half turn so that the blue plunger rotates freely.

Before use, unscrew and discard the blue cap. The surface under the cap is sterile; care must be taken not to touch it during subsequent steps. The syringe is now ready for attachment of a needle or infusion tubing. After use, dispose of the syringe and any unused portion of the medicinal product.

Instructions for use of pressure injector syringes
Pre-filled syringe

Assembly and inspection

Caution: The outer surface of the syringe is not sterile.
The contents of the syringe and the surfaces under the blue cap and the reinforcing ribs of the plunger are sterile. Therefore, care must be taken during assembly.

Remove the syringe from the base and check for leaks around the blue cap and on the outside of the plunger. Do not use the syringe if any leakage is observed. Place the syringe into the pressure housing.

To remove the blue cap, press it down and turn to remove, then discard. The surface under the cap is sterile. Care must be taken during subsequent steps.

Next, remove the cap from the dust-protective cover of the Luer connector by turning it to break the visible security ring. Discard the cap.

Screw the Luer connector onto the syringe, holding the dust-protective cover, and tighten fully. Remove and discard the dust-protective cover immediately before connecting the sterile connector tubing.

After use, dispose of the syringe and any unused portion of the medicinal product.