Optiray 350

Package leaflet: Information for the user

Optiray 350 injection and infusion solution, 741 mg/ml
( Ioversol )
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Speak to your 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, please inform your doctor or pharmacist.

Leaflet contents

1. What Optiray is and what it is used for
2. What you need to know 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 adults for various radiological imaging procedures, including:

• imaging of blood vessels, both arteries and veins
• kidneys
• computed tomography (CT)

Optiray is an iodine-containing contrast medium. Iodine blocks X-rays, allowing blood vessels and internal organs through which blood flows to be visualized.

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 components 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 red blood cell abnormalities 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 examination with contrast medium
• planned thyroid examination using iodine-containing substances – 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.
A 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
Optiray 350 is not recommended for use in this age group.
In case of exposure of a child to Optiray (direct exposure or newborns whose mothers received an
iodinated contrast agent during pregnancy), thyroid function should be assessed after birth and in
all children under 3 years of age within one month of exposure.
Optiray and other medicines
Inform the 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 in the treatment of diabetes. The doctor will assess kidney function before and after administration of Optiray. Depending on the level of 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 in the treatment of certain tumours
• certain medicines increasing blood pressure due to vasoconstriction. To prevent the risk of neurological disorders, 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. Dehydration caused by diuretic use may increase the risk of acute kidney injury following administration of iodinated contrast media.

Optiray with food and drink
Consult a 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 the doctor if the patient is pregnant or suspects she may be pregnant. Optiray will be administered to pregnant patients only if absolutely necessary, as the medicine may harm the unborn child.
• Breastfeeding Breastfeeding should be interrupted for one day after injection, as sufficient safety data are not available. Consult the doctor or radiologist.

Driving and operating machinery
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.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Optiray

Examinations using Optiray will be performed exclusively by a physician or radiologist,
who will also determine the dosage.
Optiray is injected into a blood vessel and distributed throughout the body via the bloodstream.
Before use, the medication is warmed to body temperature, 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 lowest possible dose that allows acquisition of images of adequate quality will be used.
Administration of a dose higher than recommended of Optiray
Overdose is potentially dangerous and may affect respiration, heart, and circulatory system.
The physician or radiologist should be notified immediately if the patient experiences any such
symptoms after receiving Optiray.
If you have any further doubts regarding the use of this medication, consult your physician or
radiologist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions associated with Optiray are generally independent of the administered dose. In
most cases, they are mild or moderate and very rarely severe or life-threatening.
You should contact your doctor immediately if any of the following symptoms of serious adverse reactions occur:

• cardiac or respiratory arrest
• coronary vasospasm or blood clots
• stroke, cyanosis of the lips, fainting
• memory loss
• speech disturbances
• sudden movements
• temporary 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)
• symptoms of hypersensitivity reactions such as anaphylactic shock, constricted airways, laryngeal, throat or tongue swelling, breathing difficulties, cough, sneezing, redness and/or facial and eye swelling, itching, rash and urticaria

Adverse reactions may occur with the following frequencies:
Very common – occurring in more than 1 in 10 users

• sensation of warmth

Common – occurring in 1 to 10 in 100 users

• pain
• nausea

Uncommon – occurring in 1 to 10 in 1,000 users

• urticaria
• skin redness, itching
• dizziness
• headache
• taste disturbance
• sensory disturbances such as pricking, tingling
• vomiting
• sneezing
• high blood pressure

Rare – occurring in 1 to 10 in 10,000 users

• fainting
• dizziness
• blurred vision
• pulsating heartbeat
• low blood pressure
• sudden facial flushing
• laryngeal spasm
• swelling and narrowing of the 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 – occurring in fewer than 1 in 10,000 users

• severe allergic reaction
• disorientation, restlessness, nervousness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• voice disturbances
• speech disturbances
• decreased sensitivity to touch or sensation
• allergic conjunctivitis causing eye redness, tearing and itching
• 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, reduced urine output
• tissue swelling due to fluid overload
• injection site reactions, including pain, redness, bleeding or tissue necrosis
• general malaise, fatigue, somnolence

Unknown 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, convulsions, loss of coordination, hemiparesis, speech difficulties and loss of consciousness
• movement disorder
• memory loss
• temporary blindness
• cardiac arrest, life-threatening irregular heartbeat
• extra heartbeats
• coronary artery spasm, rapid heartbeat
• bluish discoloration of the skin (cyanosis) due to low blood oxygen levels
• shock
• blood clot or vessel spasm
• pallor
• respiratory arrest, asthma, constricted airways
• reduced ability to produce voice via vocal organs
• diarrhea
• severe reaction involving the 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 adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the responsible entity. Reporting adverse reactions helps to improve the safety information available for this medicine.

5. How to store Optiray

Keep the 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 stated month.
Store containers in the outer packaging to protect from light. Protect from X-radiation. Do not store at temperatures above 30°C. Optiray 350 may be stored for one month at 37ºC in a warming cabinet intended for storage of contrast agents, with provision for 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 350 contains 741 mg of ioversol, corresponding to 350 mg of organically bound iodine.
• The other ingredients are: calcium disodium 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 350 is packed in:

• colourless bottles with a capacity of 30, 50, 100 or 200 ml, equipped with bromobutyl rubber closures and aluminium caps. The carton contains the following numbers of bottles:
  30 ml capacity – 10 bottles.
  50 ml capacity – 10 or 25 bottles.
  100 ml capacity – 10 or 12 bottles.
  200 ml capacity – 10 or 12 bottles.
• colourless bottles with a capacity of 500 ml, equipped with bromobutyl rubber closures and aluminium caps. The carton contains 5, 6 or 10 bottles.

Optiray 350 is also supplied in pre-filled hand-held syringes and in syringes for use with a power injector, made of polypropylene.
The syringe tip cap and plunger are made of natural rubber latex.
Pre-filled hand-held syringes with a capacity of 30 or 50 ml are packed in cartons containing 10 syringes.
Syringes for use with a power injector with a capacity of 50, 100 or 125 ml are packed in cartons containing 10 or 20 syringes. Capacity of 75 ml. The carton contains 10 syringes.
Not all pack sizes and carton quantities may be marketed in all countries.

Marketing Authorisation Holder and Manufacturer:

• Address of the Marketing Authorisation Holder
  Guerbet
  BP 57400
  95943 Roissy CDG Cedex
  France
  For further information about this medicinal product, 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

Note: 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 screwing the pusher onto the syringe
plunger, it is important to turn the pusher
an additional half-turn so that the blue
plunger rotates freely.

Before using the syringe, 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 syringes for use with a power injector
Pre-filled syringe
Assembly and inspection

Note: 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 jacket.

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

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

Screw the Luer connector onto the syringe,
holding it by the dust-protective cover, and
tighten it 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.