Patient Leaflet Updated 06-Feb-2019 | Bayer plc
Urografin 150
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
UROGRAFIN®
Sodium amidotrizoate (sodium diatrizoate) and meglumine amidotrizoate (meglumine diatrizoate)
1. What Urografin is and what it is used for
2. What you need to know before you are given Urografin
3. How you will be given Urografin
4. Possible side effects
5. How to store Urografin
6. Contents of the pack and other information
Urografin is an injectable contrast medium (a dye) which contains iodine. It is used to clearly show on X-rays the area of your body that your doctor wants to investigate.
X-rays, like radio waves, can pass through objects and can be focused to make a picture. When you have an X-ray, the beam of rays goes through your body where it is absorbed to differing degrees by different tissues such as bones, muscles and organs. When the rays come out on the other side they make a pattern of light and shade on a film. Urografin helps to make this pattern clearer. The film is then examined by a specialist who will make a diagnosis.
This medicine is for diagnostic use only.
Talk to your doctor or the X-ray department staff/radiologist before receiving Urografin
You must tell the X-ray department staff if you have any of the following:
If any of these apply to you, you may be at a higher risk of having an allergic reaction or becoming unconscious/fainting.
If you have a phaeochromocytoma (tumour of the adrenal gland) you may be given a medicine called an alpha-receptor blocker before the investigation to prevent your blood pressure from rising.
Your thyroid function may be tested before receiving Urografin and you may be given thyreostatic medication (medication to reduce thyroid gland function).
Your doctor will test the thyroid function of newborns who have been exposed to Urografin either during pregnancy or after birth, because too much iodine can cause hypothyroidism (underactive thyroid gland), possibly requiring treatment.
Tell your doctor or the X-ray department staff/radiologist if you are taking, have recently taken or might take any other medicines. This is particularly important for:
Ask the X-ray department staff if you are not sure.
If the procedure is to look at your abdomen, kidneys or bladder you may be asked to avoid foods that cause flatulence (wind) for two days beforehand. These foods include:
You will be told not to eat after 6pm on the day before the examination, but you can still drink. Babies and young children, however, must not fast. If you have a disorder of your body water and body salts balance this will be corrected before the examination.
Do not reduce the amount you normally drink before the investigation, especially if you have any of the following:
Also, fluid intake must not be reduced in babies, young children, or in someone who is in a very poor general state of health where their body tissues are wasting away.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask the doctor or X-ray department staff /radiologist for advice before receiving this medicine.
You should not drive or operate machinery for 24 hours after the examination as you may have a delayed reaction to Urografin.
This medicine contains 362.50 mg of sodium (main component of cooking salt) in each dose (250 ml). This is equivalent to 18.1% of the recommended maximum daily dietary intake of sodium for an adult.
The X-ray department staff will decide how much Urografin is needed for your particular investigation. They will explain how everything works and what position you should lie in on the X-ray table.
The dose of Urografin varies depending on the investigation and your weight. The dose range is normally between 1 and 500 ml.
Once you lie down the Urografin will be injected into a vein. Sometimes, Urografin will be injected into your muscles or anus (back passage). The staff in the X-ray department will observe you for 30 minutes after the injection just in case you have any side effects.
Overdosing is unlikely. If it does happen the radiologist will treat any symptoms that follow.
If you have any further questions on the use of this medicine, ask your doctor or the X-ray department staff/radiologist for advice before receiving this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects you may get after being given a contrast medium like Urografin are usually mild and do not last long.
However, as with similar contrast media, severe and life-threatening reactions, as well as deaths, have been reported.
If you notice:
Tell the radiologist or X-ray staff immediately as these may be the first signs of allergic reaction or shock. Your investigation will need to be stopped, and you may need further treatment.
Apart from the symptoms listed above the other possible side effects of Urografin are:
Very rarely severe or even life-threatening side-effects may occur and in some cases have been fatal. These include:
lowered blood pressure
fainting (collapse)
circulatory failure
an irregular, rapid heart beat which may cause the heart to suddenly stop beating altogether (cardiac arrest)
fits or other brain related symptoms
a build-up of water in the air spaces of the lung
anaphylactic shock (a very severe allergic reaction).
If you are having a procedure where Urografin will reach the brain, you may have complications such as:
Delayed reactions can occasionally occur, if you are concerned you should contact your doctor.
If you get any side effects, talk to your doctor, radiologist or X-ray department staff. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Urografin after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Protect from light and secondary X-rays.
Urografin 150 is available in packs of ten 10 ml ampoules or packs of ten 20 ml ampoules.
Urografin 150 for infusion is available in 250 ml or 500 ml bottles.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in October 2018.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Urografin 150 00010/0569
Urografin 150 for Infusion 00010/0568
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