patient information leaflet biliscopin 50 infusion

PATIENT INFORMATION LEAFLET

BILISCOPIN® (meglumine iotroxate)

A guide to Biliscopin 50 Infusion

This leaflet gives you some information about Biliscopin. If you have any problems or are not sure about anything, ask the X-ray Department staff.

Your doctor has arranged for you to have an X-ray examination of your bile ducts and gallbladder.

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

For 24 hours before your investigation you may be asked to follow a low-fat diet and avoid foods which cause flatulence. You MAY eat easily digestible food and clear liquids such as tea without milk or clear soup without fat. You MAY NOT eat eggs, rusks, fruit, oatmeal, pasta and milk products.

You should not eat anything on the day of your investigation. After being given Biliscopin you may drink water or weak tea if you are thirsty but may not smoke until the end of the examination.

The name of this diagnostic aid is: Biliscopin (meglumine iotroxate)

What does your medicine contain?

1ml Biliscopin contains 105 mg meglumine iotroxate

It also contains the inactive ingredients:

Sodium calcium edetate
Sodium hydrogen carbonate
Sodium chloride
Water for injection

Biliscopin is a solution for intravenous infusion (slow injection into a vein) and is available in packs of 10 x 100ml bottles.

Biliscopin is an injectable X-ray contrast medium (a dye) which contains iodine. It is used to show clearly on X-rays the area your doctor wants to investigate.

Reasons for not using Biliscopin

You should not be given this medicine if:

you have severe heart disease
you are, or suspect you are, hypersensitive (allergic) to iodine or iodine-containing contrast media
you have manifest hyperthyroidism (a condition caused by too much thyroid hormone)
you have severe liver or kidney problems
you have macroglobulinaemia (an imbalance of certain types of antibody in your blood).

What you should know before you are given Biliscopin

Tell the X-ray department staff if any of the following apply to you:

you have any disease of the liver or kidney
you have cerebral arteriosclerosis ( a disease of blood vessels in the brain)
you have epilepsy, diabetes or poor general health
you have pulmonary emphysema (damaged lungs which may cause shortness of breath)
you have hyperthyroidism (an overactive thyroid gland) or benign nodular goitre (a swollen neck due to an enlarged thyroid gland)
you have multiple myeloma (a disease of the bone marrow)
you are pregnant, think you may be pregnant or you are breast-feeding.

You must also tell the X-ray department staff if:

you have a history of allergy or have a tendency to develop hypersensitivity reactions ( for example you have hay fever, asthma, eczema)
you have poor heart function or blood circulation
you have previously had an unexpected reaction to a medicine like Biliscopin (a contrast medium).

If any of these apply to you, you may be given a type of medicine called a corticoid or antihistamine.

If side-effects or suspected allergic reactions occur during injection and do not go away, or even get worse when the injection is briefly stopped, it may mean that you are hypersensitive and the investigation will be stopped. Tell the X-ray department staff if you have itching of the skin, sneezing, violent yawns, tickling in the throat or hoarseness or coughing attacks.

If you are going to have an iodine test for thyroid disease, tell your doctor if you have received Biliscopin in the last 8 - 10 weeks as it may affect the results of the test.

If you have diabetes and are taking a type of medicine called a biguanide ( for example metformin) you should inform the doctor who will probably ask you to stop taking the biguanide 48 hours before the examination. Ask the X-ray staff if you are not sure.

You should tell the X-ray department staff about any other medicine you are taking, in particular beta-blockers (drugs used to treat heart or blood pressure problems) or if you have been treated with a drug called interleukin.

You should not drive or operate machinery for 24 hours after the investigation as you may have a delayed reaction to Biliscopin.

Biliscopin may affect the results of certain laboratory tests e.g. liver function tests. Always tell your doctor or the laboratory staff that you have been given Biliscopin recently.

How you will be given Biliscopin

Adults: One 100ml bottle will be given as an infusion (with a drip) into a vein over at least a 15 minute period.

You will be lying down while the infusion is given and will be kept under observation by the X-ray staff for at least 30 minutes after the infusion.

Children: The X-ray department staff will calculate the appropriate dose.

Overdosage

Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.

Side-effects

You may experience nausea, vomiting, erythema (flushing of the skin caused by dilated blood vessels), a sensation of pain and a general feeling of warmth after injection of contrast media.

Other symptoms which you may get are:-

Chills, fever, sweating, headache, dizziness, pallor (going abnormally pale), weakness, gagging and a feeling of suffocation, gasping, a rise or fall of blood pressure ( you may feel faint or light-headed), itching, urticaria (red wheals on skin), rashes, a build-up of excess water in the body (you may have swollen legs or ankles or feel bloated), cramp, tremor, sneezing and excess tears.

If you get any of these symptoms, tell the doctor at once as it may be the first sign of shock. The injection of contrast medium may be stopped.

If side-effects or suspected allergic conditions occur during injection and do not go away, or even get worse, when the injection is briefly stopped, it may mean that you are hypersensitive and the investigation will be stopped. Tell the staff in the X-ray department if you have itching of the skin, sneezing, violent yawns, tickling in the throat, or hoarseness or coughing attacks.

In rare cases your kidneys may temporarily stop working properly.

Very rarely coma, temporary drowsiness, or epileptic fits may occur.

Very rarely, severe or even life-threatening side-effects may occur and in some cases have been fatal. These include expansion of the blood vessels causing lowered blood pressure and faster heart rate, collapse, circulatory failure, an irregular, rapid heart beat (ventricular fibrillation) which may suddenly stop the heart beating altogether (cardiac arrest), fits, a build-up of water in the air spaces of the lung (pulmonary oedema), a very severe allergic reaction (anaphylactic shock) or other, less severe, allergic effects such as skin rashes.

If the contrast medium is not injected into the blood vessel properly you may experience pain and reddening at the injection site or other tissue reactions, but this is rare.

You should tell the X-ray department staff about any changes in your health or general sense of well-being that you notice while Biliscopin is being given or afterwards as delayed reactions can occasionally occur.

Expiry date

The expiry date is printed on the label. The contrast medium should not be used after this date.

Storage

Protect from light, and secondary X-rays.

Medicine: biliscopin 50 infusion