Optiray

Package leaflet: Information for the user

Optiray 240 mg/ml

Injectable solution
Active substance: ioversol
Please read this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of this leaflet

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 240 mg/ml is used in adults for various radiological procedures, including:

• visualization of blood vessels, both arteries and veins.

Optiray is an iodine-containing contrast medium for radiology. Iodine blocks X-rays,
allowing visualization of blood vessels and other internal organs containing blood.

2. What you need to know before using Optiray

Do not use Optiray

• if you are allergic to iodinated contrast media or to any of the other ingredients of this medicine (listed in section 6)
• if you have hyperactive thyroid gland.

Warnings and precautions
Talk to your doctor before using Optiray if you:

• have previously experienced allergic reactions such as nausea, vomiting, low blood pressure, skin symptoms
• have heart failure, high blood pressure, circulatory disorders, have had a stroke, or are very elderly
• have diabetes
• have kidney or liver disease
• have brain disorders
• have bone marrow disorders, such as certain blood tumors known as multiple myeloma and Waldenström's macroglobulinemia
• certain red blood cell disorders, 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
• recently underwent a gallbladder imaging procedure with contrast medium
• have a scheduled thyroid examination using an iodine-containing substance. This examination should be postponed, as Optiray may interfere with test results for up to 16 days.

Severe skin reactions have been reported after administration 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.
A short-term brain disorder called encephalopathy may occur during or shortly after the imaging procedure.
Inform your doctor immediately if you notice any symptoms related to this condition, described in section 4.
SYRINGES: the outer cap covering the tip of the syringe is made of latex rubber.
It may cause severe allergic reactions.
Children and adolescents under 18 years of age
Optiray 240 mg/ml is not recommended in this age group. In case of exposure (direct exposure or newborns whose mothers received an iodinated contrast medium during pregnancy), thyroid function should be evaluated at birth and in all pediatric patients under 3 years of age within one month of exposure.
Other medicines and Optiray
Inform your doctor or radiologist if you are taking, have recently taken, or might take any other
medicines.
The following medicines may interact with or be affected by Optiray:

• Metformin: a medicine used to treat diabetes. Your doctor will assess your kidney function before and after using Optiray. Depending on your kidney function, your doctor may decide to stop metformin 48 hours before the procedure until the time of examination. Metformin should not be restarted for at least 48 hours after the procedure and only after kidney function has returned to baseline levels.
• Interleukin: a medicine used to treat certain tumors.
• Some medicines used to increase blood pressure due to blood vessel constriction. To prevent potential risks of nervous system disorders, Optiray must never be used during treatment with these medicines.
• General anesthetics: A higher frequency of adverse effects has been reported.
• 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 failure.

Pregnancy, breastfeeding, and fertility
Pregnancy
Inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will administer Optiray during pregnancy only if absolutely necessary, as it may harm the unborn child.
Breastfeeding
Discontinue breastfeeding for one day after injection, as there is insufficient information regarding the safety of the medicine. Discuss this with your doctor or radiologist.
Fertility
Animal studies do not indicate direct or indirect harmful effects on fertility in humans. However, adequate and well-controlled clinical studies on fertility are not available.
Driving and using machines
It is not advisable to drive or operate machinery for 1 hour after injection.
In addition, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If you experience any of these, do not engage in any activity requiring concentration and the ability to react appropriately.
Optiray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “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 spreads throughout the body via the bloodstream. Prior to administration, it will be warmed to body temperature and then injected one or more times during the radiological procedure.
The dose depends on the specific procedure being performed and on other factors such as health status and age.
The lowest possible dose required to obtain adequate radiological images will be used.
If more Optiray is administered than intended
Overdosage is potentially dangerous and may affect the respiratory, cardiac, and circulatory systems. Inform your doctor or radiologist immediately if you notice any of these symptoms after receiving Optiray.
If you have any questions about the use of this medicine, consult your doctor or radiologist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects associated with Optiray are generally independent of the administered dose. In most cases, they are mild to moderate in severity and very rarely severe or potentially fatal.
Tell your doctor immediately if you develop any of the following signs of serious side effects:

• cardiac or respiratory arrest
• spasms of the heart vessels or blood clots
• stroke, blue lips, fainting
• memory loss
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• severe skin rash, sometimes with fever, blisters and/or swollen lymph nodes
• signs of allergic reactions, such as anaphylactic shock, narrowing of the airways, swelling of the larynx, throat or tongue, breathing difficulties, cough, sneezing

redness and/or swelling of the face and eyes
hives, skin rash and itching

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

• sensation of warmth

Common – occurs in 1 to 10 in 100 users

• pain
• nausea

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

• hives
• skin redness, itching
• dizziness
• headache
• taste disturbances
• abnormal sensations, such as tingling and numbness
• vomiting
• sneezing
• high blood pressure

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

• fainting
• vertigo
• blurred vision
• rapid heartbeat
• low blood pressure
• hot flushes
• laryngeal spasms
• swelling and narrowing of the airways, including sensation of throat tightness, shortness of breath
• breathing difficulties
• nasal inflammation causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• skin rash
• urgent need to urinate
• facial swelling, including eyes
• chills
• uncontrollable tremor
• feeling of cold

Very rare – occurs in fewer than 1 in 10,000 users

• severe allergic reaction
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• speech disorders
• reduced sense of touch or sensitivity
• allergic inflammation of the eyes causing redness, itching and tearing
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured by ECG
• illness affecting blood flow through the brain
• high blood pressure
• inflammation of veins, blood vessel dilation
• fluid accumulation in the lungs
• sore throat
• low oxygen levels in the blood
• abdominal pain
• inflammation of salivary glands, tongue swelling
• difficulty swallowing, increased salivation
• severe and painful swelling of deep skin layers, mainly of the face
• increased sweating
• muscle spasms
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, low urine output
• tissue swelling due to fluid retention
• injection site reactions, including pain, redness, bleeding or tissue necrosis
• feeling of discomfort or abnormality, fatigue, lethargy

Not known – frequency cannot be estimated from available data

• severe anaphylactic shock reaction
• transiently underactive thyroid
• seizures
• short-term brain disorders (encephalopathy) which may cause confusion, hallucinations, visual disturbances, blindness, seizures, loss of coordination, loss of movement on one side of the body, language problems and loss of consciousness
• movement disorders
• memory loss
• temporary blindness
• cardiac arrest, potentially fatal irregular heartbeat
• extra heartbeat
• coronary artery spasm, palpitations
• blue discoloration of the skin due to low oxygen in the blood
• shock
• blood clot or spasm in a blood vessel, pallor
• respiratory arrest, asthma, narrowing of the airways
• reduced ability to produce sounds using 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 beginning of treatment (Acute Generalized Exanthematous Pustulosis)
• red pimples (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) and/or swollen lymph nodes
• other skin diseases (erythema multiforme or polymorphous)
• absence of urination or difficult/painful urination
• transiently underactive thyroid in newborns
• fever

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optiray

Do not store above 25°C.
Keep the container in the outer packaging to protect it from light. Protect from X-rays.
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 that month.
Do not use this medicine if discoloration or particulate matter is observed.

6. Package contents and other information

What Optiray contains
The active substance is ioversol.
One millilitre of Optiray contains 509 mg of ioversol, equivalent to 240 mg of organically bound iodine.
The other components are sodium calcium edetate (stabilizer), tromethamine, and tromethamine hydrochloride (buffer), and water for injections.
Sodium hydroxide and hydrochloric acid may be used to adjust the pH between 6.0 and 7.4.

Description of the appearance of Optiray and contents of the pack
Optiray is supplied in colourless vials. The vials are fitted with 32 mm bromobutyl rubber stoppers and aluminium overseals.

• 50 ml vial
• 100 ml vial
• 200 ml vial

Optiray 240 mg/ml is also supplied in pre-filled syringes made of polypropylene. The syringe cap is made of natural rubber and the plunger is made of Teflon.
Ten (10) pre-filled syringes of 50 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France

Manufacturer
Guerbet Ireland ULC, Damastown, Mulhuddart, Dublin 15, Ireland
Or
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France, located at 16-24 rue Jean Chaptal, 93600 Aulnay sous Bois, France

Optiray syringes for manual injectors
Assembly and inspection

Warning:
The outside of the syringe is not sterile.
The contents of the syringe and the surfaces beneath the blue protective cap of the cone and the inner walls of the syringe are sterile and must be handled accordingly.

Remove the syringe from the holder and check the integrity of the area around the cone cap and the exterior of the plunger. If any cracks or fractures are observed, do not use.

Insert the rod into the plunger; when in contact, turn by half a turn so that the blue plunger head moves together with the plunger.

Remove the protective cap from the cone and connect the syringe to the needle or administration set.
Perform these operations carefully, as the area beneath the blue cone cap is sterile.
After use, dispose of the syringe and any unused solution.

Patient Information Leaflet: Information for the User

Optiray 300 mg/ml

injection solution
Active substance: ioversol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet

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. Package contents and other information

1. What Optiray is and what it is used for

Optiray 300 mg/ml is used for various types of radiological procedures, including:

• visualization of blood vessels, both arteries and veins (in adults and children)
• visualization of the kidneys (in adults and children)
• CT scans (in adults)

Optiray is an iodine-containing contrast medium for radiology. Iodine blocks X-rays,
allowing visualization of blood vessels and other internal organs containing blood.

2. What you need to know before using Optiray

Do not use Optiray

• if you are allergic to iodinated contrast media or to any of the other ingredients of this medicine (listed in section 6)
• if you have hyperactive thyroid gland.

Warnings and precautions
Talk to your doctor before using Optiray if you have

• or have previously had allergic reactions such as nausea, vomiting, low blood pressure, skin symptoms
• heart failure, high blood pressure, circulatory disorders, if you have had a stroke, or if you are very elderly
• diabetes
• kidney or liver disease
• brain disorders
• bone marrow disorders, such as certain blood tumors known as multiple myeloma and Waldenström's macroglobulinemia
• certain red blood cell disorders, 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
• recently undergone a gallbladder examination with contrast medium
• a scheduled thyroid examination using an iodine-containing substance. Such examination should be postponed, as Optiray may interfere with test results for up to 16 days.

Severe skin reactions have been reported after administration 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
can be life-threatening.
A short-term brain disorder called encephalopathy may occur during or shortly after the imaging procedure.
Inform your doctor immediately if you experience any of the symptoms related to this condition described in section 4.
SYRINGES: the outer cap covering the tip of the syringe is made of latex rubber.
It may cause severe allergic reactions.

Children and adolescents under 18 years of age
Optiray 300 mg/ml is used for visualization 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 tests should be performed 7–10 days and 1 month after administration of Optiray.
However, it is not recommended for children undergoing CT scans.
In newborns, and particularly in premature newborns, monitoring of thyroid hormones known as TSH and T4 is recommended. These tests should be performed 7–10 days and 1 month after administration of Optiray.

Other medicines and Optiray
Inform your doctor or radiologist if you are taking, have recently taken, or might take any other
medicines.
The following medicines may affect or be affected by Optiray:
Metformin: a medicine used to treat diabetes.
Your doctor will assess your kidney function before and after using Optiray. Depending on your level of kidney function, your doctor may decide to discontinue metformin 48 hours before the procedure and withhold it until after the examination. Metformin should not be restarted for at least 48 hours after the procedure and only after kidney function has returned to baseline levels.
Interleukin: a medicine used to treat certain tumors.
Some medicines used to increase blood pressure due to blood vessel constriction.
To prevent potential risks of nervous system disorders, Optiray must never be used during treatment with these medicines.
General anesthetics
An 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, the use of iodine-based contrast media may increase the risk of acute kidney injury.

Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will administer Optiray during pregnancy only if absolutely necessary, as it may harm the unborn child.
Breastfeeding
Discontinue breastfeeding for one day after injection, as there is insufficient information regarding the safety of the medicine. Discuss this with your doctor or radiologist.
Fertility
Animal studies do not indicate direct or indirect harmful effects on human fertility. However, adequate and well-controlled clinical studies on fertility are not available.
Driving and use of machines
It is not advisable to drive or operate machinery for 1 hour after injection.
In addition, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If you experience any of these, do not engage in any activity requiring concentration and the ability to react appropriately.
Optiray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “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 spreads throughout the body via the bloodstream. Prior to administration, it will be warmed to body temperature and then injected one or more times during the radiological procedure.
The dose depends on the specific procedure being performed and other factors such as health status and age.
The lowest possible dose will be used to obtain adequate radiological images.
If more Optiray is administered than intended
Overdosage is potentially dangerous and may affect the respiratory, cardiac, and circulatory systems. Inform your doctor or radiologist immediately if you notice any of these symptoms after receiving Optiray.
If you have any doubts about the use of this medicinal product, consult your doctor or radiologist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects associated with Optiray are generally independent of the administered dose.
In most cases, they are mild to moderate in severity and very rarely severe or potentially life-threatening.
Immediately inform your doctor if you develop any of the following signs of serious side effects:

• cardiac or respiratory arrest

• spasms of the heart vessels or blood clots

• stroke, blue lips, fainting

• memory loss

• speech disorders

• sudden movements

• temporary blindness

• acute kidney failure

• severe skin rash, sometimes with fever, blisters and/or swollen lymph nodes

• signs of allergic reactions, such as:

  anaphylactic shock
  narrowing of the airways
  swelling of the larynx, throat, or tongue
  breathing difficulties
  cough, sneezing
  redness and/or swelling of the face and eyes
  hives, skin rash, and itching

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

• sensation of warmth

Common – occurs in 1 to 10 in 100 people

• pain
• nausea

Uncommon – occurs in 1 to 10 in 1,000 people

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

Rare – occurs in 1 to 10 in 10,000 people

• fainting
• vertigo
• blurred vision
• rapid heartbeat
• low blood pressure
• hot flushes
• laryngeal spasms
• swelling and narrowing of the airways, including throat tightness, labored breathing
• breathing difficulties
• nasal inflammation causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• skin rash
• urgent need to urinate
• facial swelling, including around the eyes
• chills
• uncontrollable tremors
• feeling of cold

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

• severe allergic reaction
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• speech disorders
• reduced sense of touch or sensitivity
• allergic eye inflammation causing redness, itching, and tearing
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured by ECG
• illness affecting blood flow through the brain
• high blood pressure
• inflammation of veins, blood vessel dilation
• fluid accumulation in the lungs
• sore throat
• low oxygen in the blood
• abdominal pain
• inflammation of salivary glands, tongue swelling
• difficulty swallowing, increased salivation
• severe and painful swelling of deep skin layers, mainly in the face
• increased sweating
• muscle spasms
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, low urine output
• tissue swelling due to fluid retention
• injection site reactions, including pain, redness, bleeding, or cell degeneration
• feeling of discomfort or abnormality, fatigue, lethargy

Not known – frequency cannot be estimated from available data

• severe anaphylactic shock reaction
• temporary underactive thyroid
• seizures
• temporary brain disorders (encephalopathy) which may cause confusion, hallucinations, visual disturbances, blindness, seizures, loss of coordination, paralysis on one side of the body, speech problems, and loss of consciousness
• movement disorders
• memory loss
• temporary blindness
• cardiac arrest, potentially life-threatening irregular heartbeat
• extra heartbeats
• coronary artery spasm, palpitations
• blue discoloration of the skin due to low blood oxygen
• shock
• blood clot or spasm in a blood vessel
• pallor
• respiratory arrest, asthma, narrowing of the airways
• reduced ability to produce sounds using 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 subcutaneous nodules and blisters, accompanied by fever at the beginning of treatment (generalized pustular eruption)
• red pimples (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) and/or swollen lymph nodes
• other skin diseases (erythema multiforme or polymorphous)
• absence of urination or painful/difficult urination
• temporary underactive thyroid in newborns
• fever

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optiray

Do not store above 25°C.
Keep the container in the outer packaging to protect it from light. Protect from X-rays.
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 that month.
Do not use this medicine if discoloration or particulate matter is observed.

6. Package Contents and Other Information

What Optiray Contains

• The active substance is ioversol. One millilitre of Optiray contains 636 mg of ioversol, corresponding to 300 mg of organically bound iodine.
• The other components are edetate disodium calcium (stabilizer), trometamol and trometamol hydrochloride (buffer), and water for injections. Sodium hydroxide and hydrochloric acid may be used to adjust the pH between 6.0 and 7.4.

Description of the Appearance of Optiray and Package Contents

Optiray is supplied in colourless vials. The vials are fitted with 32 mm bromobutyl rubber stoppers and aluminium overseals.

• Vial of 50 ml
• Vial of 100 ml
• Vial of 150 ml
• Vial of 500 ml

Optiray 300 mg/ml is also supplied in pre-filled polypropylene syringes. The syringe cap is made of natural rubber and the plunger is made of Teflon.

• Ten (10) pre-filled syringes of 30 ml
• Ten (10) pre-filled syringes of 50 ml
• Ten (10) pre-filled syringes of 100 ml
• Twenty (20) pre-filled syringes of 100 ml
• Ten (10) pre-filled syringes of 125 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France

Manufacturer
Guerbet Ireland ULC, Damastown, Mulhuddart, Dublin 15, Ireland
Or
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France, located at 16-24 rue Jean Chaptal, 93600 Aulnay sous Bois, France

Optiray Syringes for Manual Injectors

Assembly and Inspection

Warning:
The outside of the syringe is not sterile.
The contents of the syringe and the surfaces beneath the blue protective cap covering the cone, as well as the inner walls of the syringe, are sterile and must be handled accordingly.

Remove the syringe from its holder and check
the integrity of the area around the cone cap
and the outer surface of the plunger. Do not use
if cracks or breakages are observed.

Insert the rod into the plunger; when they are
in contact, turn half a turn so that the blue head
of the plunger moves together with the plunger.

Remove the protective cap from the cone and
connect the syringe to the needle or infusion set.
During these operations, care must be taken, as
the area beneath the blue protective cap of the
cone is sterile.
After use, dispose of the syringe and any unused solution.

Optiray Syringes for Automatic Injectors

Assembly and Inspection

Warning:
The outside of the syringe is not sterile.
The contents of the syringe, the tip covered by the blue protective cap, and the plunger are sterile and must be handled accordingly.

Remove the syringe from its holder and check
the integrity of the area around the cone cap
and the outer surface of the plunger. Do not use
if cracks or breakages are observed. Place the
syringe into the injector.

To remove the blue cone cap, press and twist, then discard.
The area beneath the blue cone cap is sterile.
Handle with appropriate care.

Then remove the cap of the adapter's protective
capsule by breaking the closure seal through rotation.
Discard the cap.

Attach the adapter to the syringe by holding
the protective capsule and turning until it stops.
Remove and discard the protective capsule at the time
of connection to the sterile infusion line.
After use, dispose of the syringe and any unused solution.

Package leaflet: information for the user

Optiray 320 mg/ml

injection solution
Active substance: ioversol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet

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. Package contents and other information

1. What Optiray is and what it is used for

Optiray 320 mg/ml is used in adults for various types of radiological procedures, including:

• visualization of blood vessels, both arteries and veins
• visualization of the kidneys
• CT scans

Optiray is an iodine-containing radiological contrast agent. Iodine blocks X-rays,
allowing visualization of blood vessels and other internal organs containing blood.

2. What you need to know before using Optiray

Do not use Optiray

• if you are allergic to iodinated contrast media or to any of the other ingredients of this medicine (listed in section 6)
• if you have an overactive thyroid gland.

Warnings and precautions
Talk to your doctor before using Optiray if you have

• had allergic reactions previously, such as nausea, vomiting, low blood pressure, or skin symptoms
• heart failure, high blood pressure, circulatory disorders, have had a stroke, or are very elderly
• diabetes
• kidney or liver disease
• brain disorders
• bone marrow disorders, such as certain blood cancers known as multiple myeloma and Waldenström's macroglobulinaemia
• certain red blood cell disorders, known as sickle cell anaemia
• a tumour of the adrenal gland affecting blood pressure, known as phaeochromocytoma
• elevated levels of the amino acid homocysteine due to abnormal metabolism
• recently undergone a gallbladder imaging procedure using a contrast agent
• a scheduled thyroid examination using an iodine-containing substance. This examination should be postponed, as Optiray may interfere with test results for up to 16 days.

Severe skin reactions have been reported after administration of Optiray, including
drug reaction with 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 short-term brain disorder called encephalopathy may occur during or shortly after the imaging procedure.
Inform your doctor immediately if you experience any symptoms related to this condition described in section 4.
SYRINGES: the outer cap covering the tip of the syringe is made of latex rubber.
It may cause severe allergic reactions.
Children and adolescents under 18 years of age
Optiray 320 mg/ml is not recommended in this age group. In case of exposure (direct exposure or newborns whose mothers received an iodinated contrast agent during pregnancy), thyroid function should be evaluated at birth and in all paediatric patients under 3 years of age within one month of exposure.
Other medicines and Optiray
Inform your doctor or radiologist if you are taking, have recently taken, or might take any other
medicines.
The following medicines may affect or be affected by Optiray

• metformin: a medicine used to treat diabetes. Your doctor will assess your kidney function before and after using Optiray. Depending on your kidney function, your doctor may consider stopping metformin for 48 hours before the procedure until the time of examination. Metformin should not be restarted for at least 48 hours after the procedure and only after kidney function has returned to baseline levels.
• interleukin: a medicine used to treat certain tumours.
• some medicines used to increase blood pressure due to blood vessel constriction. To prevent potential risks of nervous system disorders, Optiray must never be used during treatment with these medicines.
• general anaesthetics A higher frequency of adverse effects has been reported.
• diuretics: medicines that increase urine production and lower blood pressure. If dehydration occurs due to diuretic use, the use of iodine-based contrast agents may increase the risk of acute kidney failure.

Pregnancy, breast-feeding and fertility
Pregnancy
Inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will only administer Optiray during pregnancy if absolutely necessary, as it may harm the unborn child.
Breast-feeding
Stop breast-feeding for one day after the injection, as there is insufficient information on the safety of the medicine. Discuss this with your doctor or radiologist.
Fertility
Animal studies do not indicate direct or indirect harmful effects regarding fertility in humans. However, adequate and well-controlled clinical studies on fertility are not available.
Driving and using machines
It is not advisable to drive or operate machinery for 1 hour after the injection.
In addition, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If you experience any of these, do not engage in any activity requiring concentration and the ability to react appropriately.
Optiray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Optiray

Examinations using Optiray will be performed exclusively by a physician or a radiology specialist, who will also determine the dosage.
Optiray is injected into a blood vessel and spreads throughout the body via the bloodstream. Before use, it will be warmed to body temperature and then injected one or more times during the radiological procedure.
The dose depends on the specific procedure being performed and other factors such as health status and age.
The lowest possible dose will be used to produce adequate radiological images.
If more Optiray is administered than intended
Overdosage may be potentially dangerous and can affect the respiratory, cardiac, and circulatory systems. Inform your doctor or radiologist immediately if you notice any of these symptoms after receiving Optiray.
If you have any doubts about the use of this medicine, consult your doctor or radiologist.

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 administered dose. In most cases,
they are mild to moderate in severity and very rarely severe or potentially life-threatening.
Immediately inform your doctor if you develop any of the following signs of serious side effects:

• cardiac or respiratory arrest
• spasms of the heart vessels or blood clots
• stroke, blue lips, fainting
• memory loss
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• severe skin rash, sometimes with fever, blisters and/or swollen lymph nodes
• signs of allergic reactions such as anaphylactic shock, narrowing of the airways, swelling of the larynx, throat or tongue, breathing difficulties, cough, sneezing, redness and/or swelling of the face and eyes

hives, skin rash and itching
Side effects may occur with the following frequencies:
Very common: occurs in more than 1 in 10 users

• sensation of warmth

Common: occurs in 1 to 10 in 100 users

• pain
• nausea

Uncommon: occurs in 1 to 10 in 1,000 users

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

Rare: occurs in 1 to 10 in 10,000 users

• fainting
• vertigo
• blurred vision
• rapid heartbeat
• low blood pressure
• hot flushes
• laryngeal spasms
• swelling and narrowing of the airways, including sensation of throat tightness, shortness of breath
• breathing difficulties
• inflammation inside the nose causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• skin rash
• urgent need to urinate
• facial swelling, including around the eyes
• chills
• uncontrollable tremors
• sensation of cold

Very rare: occurs in fewer than 1 in 10,000 users

• severe allergic reaction
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• speech disorders
• reduced sense of touch or sensitivity
• allergic inflammation of the eyes causing redness, itching and tearing
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity measured by ECG
• disease affecting blood flow through the brain
• high blood pressure
• inflammation of veins, dilation of blood vessels
• fluid accumulation in the lungs
• sore throat
• low oxygen levels in the blood
• abdominal pain
• inflammation of the salivary glands, tongue swelling
• difficulty swallowing, increased salivation
• severe and painful swelling of deep skin layers, mainly of the face
• increased sweating
• muscle spasms
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, low urine output
• tissue swelling due to fluid retention
• injection site reactions including pain, redness, bleeding or tissue cell degeneration
• feeling unwell or abnormal, fatigue, lethargy

Not known: frequency cannot be estimated from available data

• severe anaphylactic shock reaction
• temporary thyroid inactivity
• seizures
• temporary brain disorders (encephalopathy) which may cause confusion, hallucinations, visual disturbances, blindness, seizures, loss of coordination, loss of movement on one side of the body, language problems and loss of consciousness
• movement disorders
• memory loss
• temporary blindness
• cardiac arrest, potentially life-threatening irregular heartbeat
• extra heartbeat (extrasystoles)
• coronary artery spasm, palpitations
• blue discoloration of the skin due to low oxygen levels in the blood
• shock
• blood clot or spasm in a blood vessel
• pallor
• respiratory arrest, asthma, narrowing of the airways
• reduced ability to produce sounds using 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 beginning of treatment (generalized pustular eruption)
• red pimples (macular or papular eruptions)
• life-threatening reaction with flu-like symptoms and painful rash/blisters affecting the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis) and/or swollen lymph nodes
• other skin diseases (erythema multiforme or polymorphous)
• absence of urination or painful/difficult urination
• fever

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
consult your doctor or pharmacist. You can also report side effects directly via
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optiray

Do not store above 25°C.
Keep the container in the outer packaging to protect it from light. Protect from X-rays.
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 that month.
Do not use this medicine if discoloration or particulate matter is observed.

6. Package contents and other information

What Optiray contains

• The active substance is ioversol. One millilitre of Optiray contains 678 mg of ioversol, equivalent to 320 mg of organically bound iodine.
• The other components are edetate disodium calcium (stabilizer), trometamol and trometamol hydrochloride (buffer), and water for injections. Sodium hydroxide and hydrochloric acid may be used to adjust the pH between 6.0 and 7.4.

Description of the appearance of Optiray and contents of the pack
Optiray is supplied in colourless vials. The vials are fitted with bromobutyl rubber stoppers of either 20 mm or 32 mm and aluminium overseals.
20 ml vials
30 ml vials
50 ml vials
100 ml vials
150 ml vials
200 ml vials
500 ml vials
Optiray 320 mg/ml is also supplied in pre-filled polypropylene syringes. The syringe cap is made of natural rubber and the plunger is made of Teflon.
Ten (10) pre-filled syringes of 50 ml
Ten (10) pre-filled syringes of 100 ml
Twenty (20) pre-filled syringes of 100 ml
Ten (10) pre-filled syringes of 125 ml
Twenty (20) pre-filled syringes of 125 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France
Manufacturer
Guerbet Ireland ULC, Damastown, Mulhuddart, Dublin 15, Ireland
Or
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France, located at 16-24 rue Jean Chaptal, 93600 Aulnay sous Bois, France

Optiray syringes for manual injectors
Assembly and inspection
Warning:
The outside of the syringe is not sterile.
The contents of the syringe and the surfaces beneath the blue protective cap of the cone, as well as the inner walls of the syringe, are sterile and must be handled accordingly.

Remove the syringe from its holder and check
the integrity of the area around the cone cap
and the outer surface of the plunger. Do not use
if cracks or fractures are observed.

Insert the rod into the plunger; when fully
engaged, turn half a turn so that the blue
plunger head moves together with the plunger.

Remove the protective cap from the cone and
attach the syringe to the needle or infusion set.
During these operations, care must be taken
as the area beneath the blue cone cap is sterile.
After use, dispose of the syringe and any unused solution remaining.

Optiray syringes for automatic injectors
Assembly and inspection
Warning:
The outside of the syringe is not sterile.
The contents of the syringe, the tip covered by the blue protective cap, and the plunger are sterile and must be handled accordingly.

Remove the syringe from its holder and check
the integrity of the area around the cone cap
and the outer surface of the plunger. Do not use
if cracks or fractures are observed. Place the
syringe into the injector.

To remove the blue cone cap, press and twist, then discard.
The area beneath the blue cone cap is sterile.
Handle accordingly with care.

Then remove the cap from the adapter's protective capsule by breaking the closure seal through rotation. Discard the cap.

Attach the adapter to the syringe by grasping the protective capsule and turning until fully seated. Remove and discard the protective capsule at the time of connection to the sterile infusion line.
After use, dispose of the syringe and any unused solution remaining.

Package leaflet: information for the user

Optiray 350 mg/ml

injection solution
Active substance: ioversol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist.

Contents of this leaflet

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 350 mg/ml is used in adults for various radiological procedures, including:

• visualization of blood vessels, both arteries and veins
• visualization of the kidneys
• CT scans

Optiray is an iodine-containing contrast medium for radiology. Iodine blocks X-rays,
allowing visualization of blood vessels and other internal organs containing blood.

2. What you should know before using Optiray

Do not use Optiray

• if you are allergic to iodine-containing contrast media or to any of the other ingredients of this medicine (listed in section 6)
• if you have hyperactive thyroid gland.

Warnings and precautions
Talk to your doctor before using Optiray if you

• have had or previously experienced allergic reactions such as nausea, vomiting, low blood pressure, skin symptoms
• have heart failure, high blood pressure, circulatory disorders, have had a stroke, or are very elderly
• have diabetes
• have kidney or liver disease
• have brain disorders
• have bone marrow disorders, such as certain blood tumors known as multiple myeloma and Waldenström's macroglobulinemia
• certain red blood cell disorders, 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
• recently underwent gallbladder imaging with contrast medium
• have a scheduled thyroid examination using an iodine-containing substance. This examination should be postponed, as Optiray may interfere with test results for up to 16 days.

Severe skin reactions have been reported after administration 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
can be life-threatening.
A short-term brain disorder called encephalopathy may occur during or shortly after the imaging procedure.
Inform your doctor immediately if you notice any of the symptoms related to this condition described in section 4.
SYRINGES: The outer cap covering the tip of the syringe is made of latex rubber.
It may cause severe allergic reactions.
Children and adolescents under 18 years of age
Optiray 350 mg/ml is not recommended in this age group. In case of exposure (direct exposure or newborns whose mothers received an iodinated contrast medium during pregnancy), thyroid function should be evaluated at birth and in all pediatric patients under 3 years of age within one month of exposure.
Other medicines and Optiray
Tell your doctor or radiologist if you are taking, have recently taken, or might take any other
medicines.
The following medicines may affect or be affected by Optiray

• metformin: a medicine used to treat diabetes. Your doctor will measure your kidney function before and after using Optiray. Depending on your level of kidney function, your doctor may decide to have you stop taking metformin from 48 hours before until the time of the examination. Metformin should not be restarted for at least 48 hours after the examination and only when kidney function has returned to previous levels.
• interleukin: a medicine used to treat certain tumors.
• some medicines to increase blood pressure due to blood vessel constriction. To prevent potential risks of nervous system disorders, Optiray must never be used during treatment with such medicines.
• general anesthetics A higher frequency of adverse effects has been reported.
• diuretics: medicines that increase urine production and lower blood pressure. In case of dehydration caused by diuretic use, the use of iodine-based contrast media may increase the risk of acute kidney failure.

Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will
administer Optiray during pregnancy only if absolutely necessary, as it may harm the unborn child.
Breastfeeding
Discontinue breastfeeding for one day after injection, as there is insufficient information regarding the safety of the medicine. Discuss this with your doctor or radiologist.
Fertility
Animal studies do not indicate direct or indirect harmful effects on fertility in humans. However, adequate and well-controlled clinical studies on fertility are not available.
Driving and using machines
It is not advisable to drive or operate machinery for 1 hour after injection.
In addition, symptoms such as dizziness, drowsiness, fatigue, and visual disturbances have been reported. If you experience any of these, do not engage in any activity requiring concentration and the ability to react appropriately.
Optiray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free”.

3. How to use Optiray

Examinations using Optiray will be performed exclusively by a doctor or radiology specialist, who will also determine the dosage.
Optiray is injected into a blood vessel and spreads throughout the body via the bloodstream. Before use, it will be warmed to body temperature and then injected one or more times during the radiological procedure.
The dose depends on the specific procedure being performed and on other factors such as health status and age.
The lowest possible dose will be used to obtain adequate radiological images.
If more Optiray is administered than intended
Overdosage is potentially dangerous and may affect the respiratory, cardiac, and circulatory systems. Inform your doctor or radiologist immediately if you notice any of these symptoms after receiving Optiray.
If you have any doubts about the use of this medicinal product, consult your doctor or radiologist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects associated with Optiray are generally independent of the administered dose.
In most cases, they are mild to moderate in severity and very rarely severe or potentially life-threatening.
Immediately inform your doctor if you develop any of the following signs of serious side effects:

• cardiac or respiratory arrest
• spasms of the heart vessels or blood clots
• stroke, blue lips, fainting
• memory loss
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• severe skin rash, sometimes with fever, blisters and/or swollen lymph nodes
• signs of allergic reactions, such as anaphylactic shock, narrowing of the airways, swelling of the larynx, throat or tongue, breathing difficulties, cough, sneezing, redness and/or swelling of the face and eyes, hives, skin rash and itching.

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

• sensation of warmth

Common: occurs in 1 to 10 in 100 people

• pain
• nausea

Uncommon: occurs in 1 to 10 in 1,000 people

• urticaria (hives)
• skin redness, itching
• dizziness
• headache
• taste disturbances
• abnormal sensations, such as tingling and prickling
• vomiting
• sneezing
• high blood pressure

Rare: occurs in 1 to 10 in 10,000 people

• fainting
• vertigo
• blurred vision
• rapid heartbeat
• low blood pressure
• hot flushes
• laryngeal spasms
• swelling and narrowing of the airways, including sensation of throat tightness, labored breathing
• breathing difficulties
• nasal inflammation causing sneezing and nasal congestion
• cough, throat irritation
• dry mouth
• skin rash
• urgent need to urinate
• facial swelling, including eyes
• chills
• uncontrollable tremor
• sensation of cold

Very rare: occurs in fewer than 1 in 10,000 people

• severe allergic reaction
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• drowsiness
• stupor
• speech disorders
• reduced sense of touch or sensitivity
• allergic inflammation of the eyes causing redness, itching and tearing
• ringing or buzzing in the ears
• irregular heartbeat, slow pulse
• chest pain
• changes in heart activity as measured by ECG
• disease affecting blood flow through the brain
• high blood pressure
• inflammation of veins, blood vessel dilation
• fluid accumulation in the lungs
• sore throat
• low oxygen levels in the blood
• abdominal pain
• inflammation of salivary glands, tongue swelling
• difficulty swallowing, increased salivation
• severe and painful swelling of deep skin layers, mainly in the face
• increased sweating
• muscle spasms
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, low urine output
• tissue swelling due to fluid retention
• injection site reactions, including pain, redness, bleeding or tissue necrosis
• feeling unwell or abnormal, fatigue, lethargy

Not known: frequency cannot be estimated from available data

• severe anaphylactic shock reaction
• temporary thyroid inactivity
• seizures
• temporary brain disorders (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
• temporary blindness
• cardiac arrest, potentially life-threatening irregular heartbeat
• extra heartbeat
• coronary artery spasms, palpitations
• bluish discoloration of the skin due to low blood oxygen
• shock
• blood clot or spasm in a blood vessel
• pallor
• respiratory arrest, asthma, narrowing of the airways
• reduced ability to produce sounds using 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 subcutaneous bumps and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis)
• red pimples (macular or papular eruptions)
• life-threatening reaction with flu-like symptoms and painful rash/blisters affecting the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis) and/or swollen lymph nodes
• other skin diseases (erythema multiforme or polymorphous)
• absence of urination or painful/difficult urination
• temporary thyroid inactivity in newborns
• fever

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optiray

Do not store above 25°C.
Keep the container in the outer packaging to protect it from light. Protect from X-rays.
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 that month.
Do not use this medicine if discolouration or particulate matter is observed.

6. Package contents and other information

What Optiray contains

• The active substance is ioversol. One milliliter of Optiray contains 741 mg of ioversol, equivalent to 350 mg of organically bound iodine.
• The other components are edetate disodium calcium (stabilizer), trometamol and trometamol hydrochloride (buffer), and water for injectable preparations. Sodium hydroxide and hydrochloric acid may be used to adjust the pH between 6.0 and 7.4.

Description of the appearance of Optiray and package contents
Optiray is supplied in colorless vials. The vials are closed with 32 mm bromobutyl rubber stoppers and aluminum overseals.
50 ml vial
100 ml vial
150 ml vial
500 ml vial
Optiray 350 mg/ml is also available in pre-filled polypropylene syringes. The syringe cap is made of natural rubber and the plunger is made of Teflon.
Ten (10) pre-filled syringes of 75 ml
Twenty (20) pre-filled syringes of 75 ml
Ten (10) pre-filled syringes of 100 ml
Twenty (20) pre-filled syringes of 100 ml
Ten (10) pre-filled syringes of 125 ml
Twenty (20) pre-filled syringes of 125 ml
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France
Manufacturer
Guerbet Ireland ULC, Damastown, Mulhuddart, Dublin 15, Ireland
Or
Guerbet, BP 57400, 95943 - Roissy CdG Cedex, France located at 16-24 rue Jean Chaptal, 93600 Aulnay sous Bois, France

Optiray syringes for automatic injectors
Assembly and inspection
Warning:
The outside of the syringe is not sterile.
The contents of the syringe, the area under the blue protective cap, and the plunger are sterile and must be handled accordingly.

Remove the syringe from its holder and check
the integrity of the area around the conical stopper
and the outer surface of the plunger. Do not use
if cracks or breaks are observed. Place the syringe
into the injector.

To remove the blue conical cap, press and turn,
then discard it.
The area beneath the blue conical cap is sterile.
Handle with appropriate care.

Then remove the protective cap of the adapter
by breaking the closure seal through rotation.
Discard the cap.

Attach the adapter to the syringe by holding
the protective cap and turning until it stops.
Remove and discard the protective cap just before
connecting to the sterile infusion line.
After use, dispose of the syringe and any unused
residual solution.