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Optiray

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Document: Optiray 300 mg I per ml solution for injection or infusion, multidose container ENG PL change

Package leaflet: Information for the user


Optiray 300 mg I/ml,

solution for injection or infusion, multidose container


Active substance: Ioversol


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

What Optiray is and what it is used for

What you need to know before you use Optiray

How to use Optiray

Possible side effects

How to store Optiray

Contents of the pack and other information


1. What Optiray is and what it is used for

Optiray is used for several types of X-ray procedures including:


Optiray is an X-ray contrast medium containing iodine. The iodine blocks the X-rays, allowing vessels and the inner organs supplied with blood to be seen.


2. What you need to know before you use Optiray

Do not use Optiray


Warnings and precautions

Talk to your doctor before using Optiray if you have


Children younger than 18 years

Optiray is used for imaging of vessels or kidneys in this age group. However, it is not recommended for children undergoing CT scans.

With newborn babies and particularly for premature infants, controls of thyroid hormones known as TSH and T4 are recommended. These checks take place 7-10 days and 1 month after administration of Optiray.


Other medicines and Optiray

Tell your doctor or X-ray specialist if you are using, have recently used or might use any other medicines.


The following medicines can influence or be influenced by Optiray


Pregnancy and breast-feeding

Pregnancy
Tell your doctor if you are pregnant or think you could be. Your doctor will only administer Optiray during pregnancy if it is absolutely necessary, as it could harm the unborn child.


Breast-feeding
Discontinue breast-feeding for one day after the injection, as insufficient information exists concerning safety. Discuss this with your doctor or X-ray specialist.


Driving and using machines

Driving or operating machines is not advisable for up to 1 hour after injection.

In addition, symptoms such as dizziness, drowsiness, fatigue and visual disturbances have been reported. If this affects you, do not attempt any activities which require concentration and the ability to react appropriately.


3. How to use Optiray

Optiray investigations will only be performed by a doctor or X-ray specialist, who will also decide the dose.

Optiray is injected into a blood vessel and distributed throughout the body by the blood stream. It will be warmed to body temperature before use, then injected once or more during the X-ray procedure.

The dose depends on the specific procedure you are having and other factors such as your health and age.

The lowest dose possible will be used to produce adequate X-ray images.


If more Optiray is given than it should

Overdoses are potentially dangerous and may affect the breathing, heart and circulation system. Inform your doctor or X-ray specialist immediately if you notice any of these symptoms after receiving Optiray.


If you have any further questions on the use of this medicine, ask your doctor or X-ray 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 given. In the majority of cases they are mild or moderate and very rarely serious or life-threatening.


Inform your doctor immediately if you develop any of the following signs of serious side effects:


Side effects can occur with the following frequencies:

very common, occurs in more than 1 of 10 users

feeling hot


common, occurs in 1 to 10 per 100 users

pain


uncommon, occurs in 1 to 10 per 1,000 users


rare, occurs in 1 to 10 per 10,000 users


very rare, occurs in fewer than 1 per 10,000 users


not known: frequency cannot be estimated from the available data


If you get any side effects, talk to your doctor or X-ray specialist. This includes any side effects not listed in this leaflet.


You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Optiray

Keep this medicine out of sight and reach of children.


Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.


Keep the container in the outer carton in order to protect from light. Protect from X-rays. Do not store above 30°C. Optiray 300 can be stored for one month at 37°C in a contrast media warmer with circulating air.


Do not use this medicine if you notice discolouration or particulate matter.


6. Contents of the pack and other information

What Optiray contains


What Optiray looks like and contents of the pack

Optiray is packaged in uncoloured bottles. Bottles are fitted with 32 mm bromobutyl rubber closures and aluminium cap seals.

Pack sizes: 1x500 ml and 5x500 ml, respectively.


Not all pack sizes and box sizes may be marketed in all countries.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

<[To be completed nationally]>


Manufacturer
Mallinckrodt Medical Imaging Ireland, Damastown, Mulhuddart, Dublin 15, Ireland


This leaflet was last revised in 2015-03-18



The following information is intended for medical or healthcare professionals only:


Special warnings and precautions for use

Serious or fatal reactions have been associated with the administration of iodinated X‑ray contrast media. It is important to be prepared to treat any contrast medium reaction.


Such procedures, which involve the use of iodinated intravascular agents, should be performed under the direction of personnel skilled and experienced in the particular procedure to be performed. A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognising and treating adverse reactions of all types should always be available. Since severe delayed reactions have been known to occur, the patient should be observed and emergency facilities and competent personnel should be available for at least 30 to 60 minutes after administration.


The anticoagulant effect of non-ionic X-ray contrast media has been shown, in vitro, to be less than that of conventional ionic agents at comparable concentrations. Similar results were found in some in vivo studies. For this reason, meticulous angiographic techniques are recommended, e.g. frequent flushing of standard angiographic catheters and avoiding prolonged contact of blood with the contrast agent in syringes and catheters.


Optiray should be injected with caution to avoid perivascular application. Serioustissue damage (e.g. ulceration) has been reported in isolated cases requiring surgical treatment.


Incompatibilities

No other medicinal product should be mixed with Optiray.


Administration

Optiray 500 ml bottles must only be used with administration devices, e.g. infusion pumps or dual head injectors which are provided with reliable connecting tubes.

Optiray 500 ml bottles have a rubber stopper which can only be pierced once.

The manufacturer’s instructions for the device must be followed.


Shelf life

Any Optiray in 500 ml bottles which is unused at the end of the day must be discarded.


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