240 mg iodine / ml, solution for injection or infusion .
Active substance: joversol
What Optiray is and what it is used for
Optiray is used in adults for several different types of X-ray examinations, including:
- imaging of vessels , both arteries and veins
- kidneys
- DT scan
Optiray is iodine -containing X-ray contrast agent. Iodine blocks the X-rays and can therefore mark out blood vessels and internal organs that are supplied with blood.
What you need to know before using Optiray
Do not use Optiray
- if you are allergic to iodinated contrast media or any of the other ingredients of this medicine (listed in section 6).
- if you have an overactive thyroid gland
Warnings and cautions
Talk to your doctor before using Optiray if you have any
- asthma or have previously had allergic reactions such as nausea, vomiting, low blood pressure , skin symptoms
- heart failure , high blood pressure , circulatory disorders, or have had a stroke or if you are very old
- diabetes
- kidney or liver disease
- brain injury
- bone marrow disease, such as certain forms of blood cancer, called paraproteinemia, multiple myeloma
- a disorder of the red blood cells called sickle cell disease
- adrenal tumor that affects your blood pressure ( pheochromocytoma )
- increased level of the amino acid homocysteine due to abnormal metabolism
- recently conducted gallbladder examination with contrast medium
- a planned thyroid examination using an iodine-containing substance.
This should be postponed, as Optiray can affect the results for up to 16 days.
Severe skin reactions that may be life-threatening and a drug reaction called DRESS have been reported in patients receiving Optiray. For signs and symptoms of these side effects, see section 4 “Possible side effects”.
Children under 18 years
Optiray 240 is not recommended in this age group.
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: for the treatment of diabetes
Your doctor measures kidney function before and after using Optiray. Metformin should be discontinued prior to examination. It should not be reinserted for at least 48 hours and not until your kidney function has returned to previous values. - interleukin: for the treatment of certain tumors
- Certain medicines that raise blood pressure due to narrowing of the blood vessels
To prevent the risk of neurological disorders, Optiray should never be used when taking these medicines. - anesthetics
A higher frequency of side effects has been reported.
Optiray with food and drink
Limit your food intake before the examination. Consult your doctor. If you have kidney disease, do not limit your fluid intake, as this may further reduce kidney function.
Pregnancy and breastfeeding
- Pregnancy
Tell your doctor if you are or think you may be pregnant. Your doctor will only prescribe Optiray during pregnancy if absolutely necessary, as it may harm the unborn baby. - Breast -feeding Stop breast-feeding
for one day after injection , as there is not enough safety information. Talk to your doctor or radiologist about this.
Driving and using machines
Do not drive or use machines for up to 1 hour after injection.
Symptoms such as dizziness, drowsiness, lethargy, and visual disturbances have been reported. If you are affected in any of these ways, do not try to perform any activities that require concentration and good reactivity.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Optiray contains excipients
Optiray contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, ie essentially ‘sodium-free’.
How to use Optiray
Optiray examinations are only performed by a doctor or X-ray specialist, who also determines the dose.
Optiray is injected into a blood vessel and the circulatory system distributes it throughout the body. It is warmed to body temperature before use and is then injected one or more times during the X-ray examination.
Dose one depends on the specific examination you are going to undergo as well as other factors, such as your health and age.
The lowest possible dose to produce adequate X-rays will be used.
If you have used more Optiray than you should
Overdose is potentially dangerous and can affect breathing, heart, and circulatory system. Tell your doctor or radiologist immediately if you experience any of these symptoms after receiving Optiray.
If you have any further questions on the use of this product, ask your doctor or X-ray specialist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects associated with Optiray are generally not dependent on the dose used. In most cases, the side effects are mild or moderate and in very rare cases severe or life-threatening.
Tell your doctor immediately if you develop any of the following signs of serious side effects:
- heart attack or inability to breathe
- severe chest pain, which may indicate angina pectoris or blood clots
- stroke , blue lips, fainting
- memory loss
- speech disorders
- sudden movements,
- temporary blindness
- acute renal failure
- skin rash, redness or blisters, which can develop into life-threatening skin reactions with extensive skin flaking (toxic epidermal necrolysis ) or a drug reaction that causes rash, fever, inflammation of internal organs, blood clots and systemic disease (DRESS)
- signs of allergic reactions, e.g.
- allergic shock
- narrow airways
- swelling of the larynx / throat / tongue
- breathing difficulties
- cough, sneezing
- redness or swelling of the face and eyes
- itching , hives and other rashes
Side effects can occur with the following frequencies:
very common, affecting more than 1 user in 10
- feeling of warmth
common, 1 to 10 per 100 users affected:
- pain
uncommon, 1 to 10 per 1,000 users affected:
- nausea
- hives
rare, 1 to 10 per 10,000 users affected:
- fainting
- uncontrollable tremors
- dizziness, instability
- headache
- deviant sensation, e.g. knitting
- taste disorders
- dimsyn
- fast pulse
- low blood pressure
- hemorrhage
- cramp in the larynx
- swollen and narrow airways, including feeling of tightness in the throat, wheezing and wheezing
- breathing difficulties
- inflammation of the nose leading to sneezing and nasal congestion
- cough, throat irritation
- vomiting
- dry mouth
- redness, itching , rash
- urinary incontinence
- swelling of the face and eyes
- chills, feeling cold
very rare, less than 1 in 10,000 users affected:
- severe allergic reaction
- confusion, anxiety, restlessness
- unconsciousness, numbness
- paralysis
- somnolence
- speech disorders
- impaired sense of touch and sensation
- allergic eye inflammation that leads to red, watery and itchy eyes
- ringing or hissing in the ears
- irregular heartbeat, slow pulse
- chest pain
- changes in cardiac activity measured by ECG
- disease that disrupts blood flow to the brain
- high blood pressure
- venous inflammation, dilation of blood vessels
- fluid accumulation in the lungs
- sore throat
- low oxygen content in the blood
- abdominal pain
- salivary gland inflammation, swelling of the tongue
- difficulty swallowing, increased salivation
- often painful, severe swelling of deep layers of skin, mainly on the face.
- increased sweating
- muscle cramps
- acute renal failure or abnormal renal function
- urinary incontinence, blood in the urine, small amount of urine
- tissue swelling due to excess fluid
- injection site reactions including pain, redness , bleeding or degradation of cells
- malaise or abnormal fatigue, inertia
No known frequency (can not be calculated from the available data)
- severe allergic shock
- temporarily underactive thyroid gland in newborns
- attack
- movement disorders
- memory loss
- temporary blindness
- cardiac arrest, life-threatening irregular heartbeat
- extra heartbeat
- heart artery spasm, throbbing heart
- blue skin due to low oxygen content in the blood
- shock
- blood clot or spasm in a blood vessel
- inability to breathe, asthma , narrow airways
- impaired ability to create sound with the vocal cords
- diarrhea
- pallor
- inability to urinate or painful / difficult to urinate
- fever
How to store Optiray
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
Store the bottle in the outer carton. Sensitive to light. Must be protected from X-rays. Do not store above 30 ° C. Optiray 240 can be stored for one month at 37 ° C in a contrast medium heater with circulating air.
Do not use this medicine if the solution is discolored or contains particles.
Contents of the pack and other information
Content declaration
- The active substance is joversol.
One milliliter of Optiray contains 509 mg of joversol, equivalent to 240 mg of organically bound iodine. - The other ingredients are: sodium calcium edetate (stabilizer), trometamol and trometamol hydrochloride ( buffer ) and water for injections.
Sodium hydroxide or hydrochloric acid can be used to adjust the pH from 6.0 to 7.4.
What the medicine looks like and contents of the pack
Optiray is packaged in colorless bottles. The bottles are equipped with 32 mm closures of bromobutyl rubber and aluminum caps.
50 ml (carton with 1 or 10 and 25 bottles)
100 ml (carton with 1 or 10 and 12 bottles)
Optiray is also available in pre-filled handheld syringes and auto-injector syringes made of polypropylene. The syringe tip and piston are made of natural rubber.
Pre-filled hand-held syringes: 50 ml (carton with 1 or 10 and 20 syringes)
Syringes for auto-injector: 75, 125 ml (carton with 1 or 10 auto-injector syringes)
Not all pack sizes and carton 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