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«PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ULTRAVIST® 150 ULTRAVIST® 240 ULTRAVIST® 300 ULTRAVIST® 370 Iopromide Read all of this leaflet ...»

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.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ULTRAVIST® 150 ULTRAVIST® 240 ULTRAVIST® 300 ULTRAVIST® 370 Iopromide Read all of this leaflet carefully before you are given this medicine.

Keep this leaflet. You may need to read it again.

- If you have any further questions, ask the doctor giving you Ultravist (the radiologist) or the X-ray

- department staff.

If you get any side effects, talk to your doctor or the X-ray department staff/radiologist. This includes

- any possible side effects not listed in this leaflet.

In this leaflet:

1. What Ultravist is and what it is used for 2. Before you are given Ultravist 3. How you will be given Ultravist 4. Possible side effects 5. How to store Ultravist 6. Further information

1. What Ultravist is and what it is used for Ultravist 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 picture.

Ultravist helps to make this pattern clearer. The picture is then examined by a specialist who will make a diagnosis.

This medicine is for diagnostic use only.

2. Before you are given Ultravist Do not use Ultravist if you have a condition caused by too much thyroid hormone (uncontrolled thyrotoxicosis).

Take special care with Ultravist Tell your doctor or the X-ray department staff if you are, or suspect you are, allergic (hypersensitive) to iodine or iodine-containing contrast media or any of the other ingredients of Ultravist (see Section 6: Further Information)

Tell your doctor or the X-ray department staff if you have any of the following:

 reduced liver or kidney function  epilepsy, a history of seizures, or any other condition affecting the brain  reduced urine production (oliguria) or passing large volumes of urine (polyuria)  gout (high level of uric acid in the blood)  a disease of blood vessels in the brain (cerebral arteriosclerosis)  diabetes mellitus  damaged lungs (pulmonary emphysema)  poor general health  an overactive thyroid gland (hyperthyroidism) or a swollen neck due to an enlarged thyroid gland (benign nodular goitre)  multiple myeloma (cancer of the plasma cells in bone marrow) / paraproteinaemia (excessive amounts of a paraprotein in the blood)  had repetitive and/or large doses of iodinated contrast media like Ultravist  a history of allergy or a tendency to develop hypersensitivity reactions (for example if you have hay fever, asthma or eczema). Your doctor might give you a corticosteroid (a medicine used to treat inflammation) prior to your examination  heart or blood circulation problems, because in the rare event that you have an allergic reaction, it is more likely to be serious or fatal  previously had a reaction to any contrast media.

 chronic disorder of the muscles (myasthenia gravis) Allergy-like reactions may occur after the use of Ultravist. Severe reactions are possible (see ‘Possible side effects’).

Most of these reactions occur within 30 minutes after administration. Therefore, you will be observed for at least 30 minutes after the injection. However, delayed reactions (after hours to days) may occur.

If you have a phaeochromocytoma (tumour of the adrenal gland) you may be at an increased risk of getting a hypertensive crisis (severe form of high blood pressure).

Ultravist may affect the results of an iodine test for thyroid disease. Always tell your doctor or the laboratory staff that you have been given Ultravist recently.

Before you are given Ultravist, tell your doctor or the radiologist if you are feeling anxious – pronounced states of excitement, anxiety and pain may increase the risk of side effects or intensify contrast-medium-related reactions (see ‘Possible side effects’).

Taking or using other medicines Please tell the radiologist or X-ray department staff if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription. This is particularly important for:

 beta-blockers (medicines used to treat high blood pressure), as beta-agonists (which may be used to treat any side effects caused by Ultravist) may not be effective.

 if you have been treated with a drug called interleukin, because there is a higher chance of getting delayed reactions (e.g. fever flu-like symptoms, joint pain and pruritus (itching))  if you have kidney disease due to diabetes (diabetic nephropathy) and are taking a type of medicine called biguanides (metformin) because you may be at increased risk of developing lactic acidosis (too much acid in the blood).





Ask the X-ray department staff if you are not sure.

Using with food and drink 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:

peas, beans, lentils, salads, fruit brown or granary bread all kinds of uncooked vegetables.

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:

- multiple myeloma (disease of the bone marrow)

- diabetes mellitus

- polyuria (production of large amounts of urine which is pale in colour)

- oliguria (production of small amounts of urine)

- gout.

Also, do not reduce the fluid intake of babies, young children, or in someone who is in a very poor general state of health.

Pregnancy and breast-feeding Tell the X-ray department staff if you are pregnant, are planning pregnancy, think you may be pregnant, or are breast feeding.

Driving and using machines There is no known effect on the ability to drive or operate machines. However, you should not drive or operate machinery for 30 minutes after the examination as you may have a delayed reaction to Ultravist.

Important information about some of the ingredients of Ultravist Ultravist contains less than 1 mmol (23 mg) sodium per dose (based on the average amount given to a 70 kg person), i.e. essentially ‘sodium-free’.

3. How you will be given Ultravist The staff in the X-ray department will decide how much Ultravist 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 Ultravist varies depending on the investigation and your weight. The dose range is normally between 1 and 200ml.

Once you lie down the Ultravist will be injected into a blood vessel or body cavity.

If you receive more Ultravist than you should Overdosing is unlikely. If it does happen the radiologist will treat any symptoms that follow.

4. Possible side effects Like all medicines, Ultravist can cause side effects, although not everybody gets them.

Side effects you may get after being given a contrast medium like Ultravist are usually mild to moderate and do not last long.

However, as with similar contrast media, severe and life-threatening reactions including life-threatening skin rashes (Stevens-Johnson syndrome), as well as deaths, have been reported.

–  –  –

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.

Delayed reactions can occur, hours to days, after you have been given Ultravist. If you develop a severe form of a skin rash with flushing, fever, blisters,or ulcers, pain in your joints or muscles or inflammation of the eye (Stevens Johnson syndrome) you should seek immediate medical attention.

Apart from the symptoms listed above, these are the other side effects of Ultravist, starting with the more common

ones:

Common may affect 1 to 10 users in 100

–  –  –

Uncommon may affect 1 to 10 users in 1,000 allergic reaction including allergy-like shock, itching, wheals on the skin (urticaria), sneezing; cough; runny nose; difficulty breathing; stopped breathing (respiratory arrest); asthma; swelling of the throat, tongue or face, membranes and tissues; itchy or watery eyes; throat irritation or hoarseness fainting confusion restlessness numbness and tingling; abnormal skin sensation, such as burning, prickling or itching; changes in body temperature drowsiness changes to heart beat; low blood pressure shortness of breath abdominal pain swelling Rare may affect 1 to 10 users in 10,000 anxiety cardiac arrest (heart stops); pain or tightness in the chest; fast, slow or irregular heart beats Other side effects (frequency unknown) altered thyroid gland function or a severe form of overactive thyroid (thyrotoxic crisis) unconsciousness; coma; shakiness; fit (convulsion); weakness causing loss of movement; paralysis;

decreased blood flow to parts of the brain; stroke swelling of the brain temporary total or partial loss of vision agitation; loss of memory; problems with speech or hearing fast or slow heart beat; heart attack; heart failure; blue lips; blue or pale skin; shock; blockage of a blood vessel by a clot; spasm in blood vessels causing decreased blood flow;

partial or complete loss of movement fluid in the lungs; severe skin disease (e.g. red, blistered, bleeding, painful skin, which may affect the lips, eyes, mouth, nose and genitals too) difficulty breathing, aspiration (taking foreign material into the lungs) difficulty swallowing; swelling of the salivary glands in and around the mouth diarrhoea excessive sweating, changes in body temperature if the injection does not go directly into the blood vessel, pressure in a muscle leading to muscle and nerve damage and problems with blood flow kidney problems, kidney failure feeling unwell, chills, pale skin rash; redness of the skin Delayed reactions can occur, if you are concerned you should contact your doctor.

If you get any side effects, talk to your doctor or the X-ray department staff / radiologist. This includes any possible side effects not listed in this leaflet.

5. How to store Ultravist Keep out of the reach and sight of children.

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

Protect from light and X-rays. Do not store above 30°C.

6. Further Information What Ultravist contains The active substance is iopromide.

1ml Ultravist 150 contains 312mg of iopromide (equivalent to 150mg iodine).

1ml Ultravist 240 contains 499mg of iopromide (equivalent to 240mg iodine).

1ml Ultravist 300 contains 623mg of iopromide (equivalent to 300mg iodine).

1ml Ultravist 370 contains 769mg of iopromide (equivalent to 370mg iodine).

The other ingredients are sodium calcium edetate (E 385), trometamol, hydrochloric acid (diluted, 10%) and water for injections.

What Ultravist looks like and contents of the pack Ultravist is a solution for injection Ultravist 150 is available in packs of ten 50ml vials.

Ultravist 240 is available in packs of ten 50ml bottles.

Ultravist 300 is available in packs of ten 20ml vials, packs of ten 50ml, or 75ml bottles and in single 100ml and 200ml bottles.

Ultravist 370 is available in packs of ten 50ml, or 75ml bottles and in single 100ml and 200ml bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

–  –  –

This leaflet was last revised in May 2012 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:

–  –  –

This is a service provided by the Royal National Institute of the Blind.



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