Consumer medicine information

Biliscopin

Iotroxate meglumine

BRAND INFORMATION

Brand name

Biliscopin

Active ingredient

Iotroxate meglumine

Schedule

Unscheduled

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Biliscopin. It does not contain all the available information. It does not take the place of talking to your doctor.

All diagnostic agents have risks and benefits. Your doctor has weighed the risks of you using Biliscopin against the benefits they expect it will have for you.

The doctors conducting your X-ray examination are able to weigh up all the relevant facts and you should consult them about all aspects of this medicine as it relates to you.

If you have any concerns about using this diagnostic agent, ask your doctor or radiologist.

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

WHAT BILISCOPIN IS USED FOR

Biliscopin is an X-ray contrast medium or X-ray dye that is injected directly into the bloodstream before X-rays are taken. All injectable X-ray dyes, including Biliscopin, contain iodine. X-rays are able to pass through bones in your body and thus produce a `picture' but X-rays are unable to pass through the iodine in contrast agents.

When Biliscopin is injected into your body it is excreted by your liver into the bile. It is used by X-ray specialist doctors (radiologists) who are able to see the X-ray dye in your gall bladder and other areas where bile flows.

Biliscopin is only available in X-ray departments and X-ray practices for use in conjunction with the taking of X-rays.

The radiologist will advise the use of Biliscopin if he/she feels that it is likely to assist the X-ray examination in finding out more about your medical condition.

Ask your doctor if you have any questions about why Biliscopin is being used in you. Your doctor may be using it for another reason.

BEFORE YOU ARE GIVEN BILISCOPIN

When you must not be given it

You must not be given Biliscopin if you have an allergy to:

iotroxate meglumine, the active ingredient
iodine containing contrast agents
any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin

You must not be given Biliscopin if:

you have a condition where a protein in your blood known as IgM is markedly increased, e.g. in a type of cancer known as Waldenstrom’s disease)
you have a severe heart and circulatory disease
you have an overactive thyroid gland which is not being adequately treated
you have severe disturbances of liver or kidney function
you have a type of cancer that affects the blood cells (myelomatosis)
you have an inherited condition known as Dubin-Johnson syndrome
you are pregnant
you are less than 14 years of age.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

In some cases you may need special care with Biliscopin and your doctor will need to consider whether to give you Biliscopin.

Tell your doctor if you have, or have had, any medical conditions especially the following:

any allergies (e.g. seafood allergy, hay fever, hives)
bronchial asthma
diabetes
overactive thyroid gland or goitre (swelling of the neck caused by enlargement of the thyroid gland)
kidney problems
liver disease
heart failure
blood vessel disease or high blood pressure
very poor general health
anxiety
gout
cancer of the blood cells (multiple myeloma) or overproduction of special proteins (paraproteinaemia)
a rare tumour of the adrenal gland which sits near the kidney and causes high blood pressure (pheochromocytoma)
dehydration, where your body does not have as much water and fluids as it should; you might feel thirsty, have a dry mouth or your urine might be darker than usual.

Tell your doctor if you are pregnant, or think you may be pregnant, or if you are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Biliscopin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, or health food shop.

Some medicines and Biliscopin may interfere with each other. These include:

interleukin (used to treat some forms of cancer)
pethidine (moderate to severe pain medication)
oral contraceptives
beta blockers (medicines used to treat high blood pressure or other heart conditions)
biguanides, e.g. metformin (used to treat diabetes)
antihistamine injections (to relieve allergic reactions)
corticosteroid injections (treatment of inflammation)

This medicine may be affected by Biliscopin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.

Your doctor has more information on medicines to be careful with or to avoid while receiving Biliscopin.

HOW BILISCOPIN IS GIVEN

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions given, ask your doctor.

You should go on a low-fibre non-gas-forming diet 24 hours before the examination. Easily digestible foods and clear fluids, e.g. tea without milk, fruit juice or clear fat-free soup can be taken. You should not eat eggs, fruit, pulpy foods, pasta or milk products. If your doctor prescribes a laxative, this should be taken about 20 hours before the examination.

On the day of the examination you should not eat anything at all prior to examination. You can however drink water or weak tea if thirsty. You should not smoke.

How much is given

The actual dose of Biliscopin that is right for you will be worked out by your radiologist.

The speed at which it Biliscopin injected and the length of time until the X-rays are taken will also be determined by your radiologist.

How it is given

Biliscopin will be injected by the radiologist, assisted by nursing or other X-ray staff.

Biliscopin is usually slowly administered over 30-60 minutes via a drip into a vein in your elbow or the back of your hand.

If you are given too much (overdose)

As Biliscopin is administered by a doctor, overdose is unlikely. If it does happen, the doctor will treat any symptoms that follow.

Immediately tell your doctor or other medical staff or telephone the Poisons Information Centre on 13 11 26 for advice if you think that you or anyone else may have been given too much Biliscopin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

AFTER RECEIVING BILISCOPIN

Things you must do

Follow carefully the directions given to you by your doctor and other medical staff.

You may also be advised to take fluids before and after the procedure to help protect your kidneys.

If you are going to have a test on your thyroid, tell your doctor and the medical staff that you have received Biliscopin. Biliscopin can affect thyroid tests for about 8-10 weeks after receiving it.

Things to be careful of

Delayed reactions may occur. In this case Biliscopin could prevent you from driving safely and the ability to operate any tools or machines may be impaired.

SIDE EFFECTS

Tell your doctor/radiologist as soon as possible if you do not feel well whilst receiving or after being given Biliscopin.

All contrast media can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor/radiologist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

unpleasant sensations of taste
nausea
vomiting or increased saliva
fatigue
restlessness
flushing or feeling warm
sensation of pain
temporary effects on breathing
rash
headache
stomach pain
redness of skin.

The above list includes the more common side effects of Biliscopin. They are usually mild and short-lived. If they persist or get worse, tell your doctor.

Tell your doctor immediately if you notice any of the following:

swelling of the face, eyelids, lips, tongue or other parts of the body
watering, sore or inflamed eyes
violent yawning
sneezing, runny nose, coughing or throat irritation
itching or hives
difficulty breathing, gasping
gagging, feeling of suffocation
fever
chest pain or abnormal heart beat
sharp back pain, little or no urine
yellowing of skin and eyes (jaundice)

This list includes side effects that can be mild and temporary or may be more serious.

Some of these side effects could be the first signs of an allergic reaction. You may need urgent medical attention or hospitalisation.

Allergic reactions occur more frequently in patients with an allergic disposition.

Severe reactions requiring emergency treatment can occur, causing low blood pressure, increase in heart rate, difficulty breathing, agitation, confusion and "turning blue", possibly leading to unconsciousness.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. Rarely, delayed reactions can occur.

STORING BILISCOPIN

Storage

The X-ray department or X-ray practice will store Biliscopin under conditions advised by the manufacturer. Shelf-life and storage conditions are printed on the bottle.

PRODUCT DESCRIPTION

What it looks like

Biliscopin is presented in bottles containing 100 mL of liquid.

Active ingredients:

Biliscopin contains 10.5 g iotroxate meglumine per 100 mL of solution.

Inactive ingredients:

sodium chloride
sodium calcium edetate
sodium bicarbonate
water for injections.

Australian Registration Number

AUST R 52765

Supplier

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

www.bayer.com.au

Date of Preparation

December 2019

See TGA website (www.ebs.tga.gov.au ) for latest Australian Consumer Medicine Information.

® Registered Trademark of the Bayer group, Germany

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Biliscopin

Active ingredient

Iotroxate meglumine

Schedule

Unscheduled

1 Name of Medicine

Iotroxate meglumine.

2 Qualitative and Quantitative Composition

Each 1 mL Biliscopin for infusion contains 0.105 g iotroxate meglumine.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Biliscopin for infusion is a radiocontrast medium for cholangiography and cholecystography.

4 Clinical Particulars

4.1 Therapeutic Indications

Biliscopin for infusion is indicated for radiological examination of the hepatic and biliary ducts and gallbladder when examination by oral technique is unsuccessful or inappropriate.

4.2 Dose and Method of Administration

General information.

Contrast media should not be used in case of occurrence of particulate matter or defective container. The infusion bottle should not be attached to the infusion set until immediately before the examination. Contrast medium solution not used in one examination session must be discarded.

Dietary suggestions.

In cholegraphy the diagnostic yield can be increased by ensuring that the bowels are empty of faecal matter and gas by avoiding stimulation of the gallbladder. Patients should therefore be put on a minimum, low residue, non-gas forming diet 24 hours before the examination. Easily digestible foods and clear liquids, e.g. tea without milk, fruit juice or clear fat free soup can be given. The patient should not be given eggs, rusks, fruit, pulpy goods, paste or milk products. If a laxative is prescribed, it should be taken about 20 hours before the examination.
Patient should fast on the day of the examination, which is best carried out in the morning. After administration of Biliscopin for infusion, the patient should not eat or smoke until the examination is complete, but is allowed to drink water or weak tea if thirsty.

Hydration.

Adequate hydration must be assured before and after contrast medium administration. Disorders of water and electrolyte balance must be corrected before the examination.

Anxiety.

Pronounced states of excitement, anxiety and pain may increase the risk of side effects or intensify contrast medium related reactions. These patients may be given a sedative.

Pretesting.

Sensitivity testing using a small test dose of contrast medium is not recommended as it has no predictive value. Furthermore, sensitivity testing itself has occasionally led to serious and even fatal hypersensitivity reactions.

Dosage.

One bottle (100 mL) of Biliscopin for infusion (1 mL = 20 drops). See Table 1.

Note.

The probability of adverse reactions increases with increasing doses and, therefore, the minimum dose consistent with diagnostic need should be used.
Infusion time: not less than 30 minutes; the tolerance will increase with longer infusion times.
The infusion should always be started at a low rate and then increased to the final, higher rate after 3-5 minutes. This technique reduces heterotopic excretion and improves the tolerance.

Administration of the contrast medium.

Biliscopin for infusion is administered with the patient lying down.
It is advisable to keep the patient under observation at least between the end of administration and the taking of films.
Warming the infusion bottle to body temperature helps eliminate the sensation of cold which is sometimes experienced by sensitive patients at the start of the infusion.
The duration of administration should never be less than the values given under Dosage, since the tolerance will otherwise be reduced. It is therefore advisable to choose a longer time, particularly as this is often accompanied by a better diagnostic yield.

Exposure times.

With Biliscopin for infusion, optimal visualisation depends, amongst other factors, on the duration of infusion (see Table 2).

Contrast delineation which cannot be detected using the normal technique can frequently be detected by tomography or zonography.

Testing the gallbladder reflex.

For testing the reflex of the gallbladder, the best time to take the picture is about 30-45 minutes after the fatty meal. If the pictures are taken at about 30 minutes, they will be optimal for the common bile duct because the gallbladder starts to empty at this time; if taken at about 45 minutes, the gallbladder can be visualised in its state of maximum contraction.

Tissue tolerance to paravasation.

Inadvertent paravenous administration of Biliscopin for infusion can cause pain, but experience has shown that it is not followed by serious tissue reactions. Field block with a local anaesthetic helps to relieve the pain. For more extensive paravasation, it is recommended that a hyaluronidase preparation be injected into the affected area to hasten absorption.

4.3 Contraindications

Severe cardiovascular insufficiency, particularly right ventricular failure or cardiac decompensation, hypersensitivity to iodine containing contrast media, thyrotoxicosis, severe functional disturbance of the liver or of the kidneys, monoclonal IgM gammopathy, e.g. macroglobulinaemia (Waldenstrom's disease), myelomatosis, Dubin-Johnson syndrome. Children below 14 years. Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).

4.4 Special Warnings and Precautions for Use

Hydration.

Adequate hydration must be assured before and after contrast medium administration. Disorders of the water and electrolyte balance must be corrected before the examination.

Hypersensitivity.

Occasionally, allergy-like hypersensitivity reactions have been observed after use of X-ray contrast media such as Biliscopin (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions are usually manifest as non-serious respiratory or cutaneous symptoms, as mild respiratory distress, reddening of the skin (erythema), urticaria, itching or facial oedema. Serious events such as angioedema, subglottic oedema, bronchospasm and allergic shock are possible. Generally these reactions occur within one hour after administration of contrast media. However, in rare cases delayed reactions may occur (after hours to days).
Patients with hypersensitivity or a previous reaction to iodinated contrast media are at increased risk of having a severe reaction.
Before any contrast medium is injected, the patient should be questioned for a history of allergy (e.g. seafood allergy, hay fever, hives), sensitivity to iodine or to radiographic media and bronchial asthma as the reported incidence of adverse reactions to contrast media is higher in patients with these conditions and premedication with antihistamines and/or glucocorticoids may be considered.
Patients with bronchial asthma are at special risk of having bronchospasms or a hypersensitivity reaction.
There is an increased risk of severe reactions in individuals with heart failure and coronary artery disease.
Hypersensitivity reactions can be aggravated in patients on beta-blockers, particularly in people with bronchial asthma. Moreover, it should be considered that patients on beta-blockers may be refractory to standard treatment of hypersensitivity reactions with beta-agonists.
If hypersensitivity reactions occur (see Section 4.8 Adverse Effects (Undesirable Effects)), administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via a venous access. It is therefore advisable to use a flexible indwelling cannula for intravenous contrast medium administration. To permit immediate countermeasures to be taken in emergencies, appropriate drugs, an endotracheal tube and a respirator should be ready at hand.

Individual hypersensitivity.

With Biliscopin for infusion, as with any contrast medium, the possibility that there are some patients who will prove hypersensitive to the substance must be considered. If marked side effects or suspected allergic reactions occur during infusion, and do not disappear or even get worse when the infusion is briefly interrupted, it is probable that the patient has such a hypersensitivity and the investigation must be abandoned. However, the cannula should be left in the blood vessel for some time in order to maintain access for therapeutic measures. Even relatively minor symptoms such as itching of the skin, sneezing, violent yawns, tickling in the throat, hoarseness, or attacks of coughing may be early signs of a severe reaction (including shock) and therefore merit careful attention.

Thyroid dysfunction.

The small amount of free inorganic iodide from iodinated contrast media might interfere with thyroid function. Therefore, the need for examination merits particularly careful consideration in patients with latent hyperthyroidism or goiter.
Since iodine containing contrast agents may alter the results of thyroid function tests, such tests, if indicated, should be performed prior to the administration of this preparation. The capacity of the thyroid tissue to take up iodine will be reduced for about eight to ten weeks or more by iodinated biliary X-ray contrast media.
Patients with hyperthyroidism are at risk (although not at acute risk) in the period following administration of intravenous cholegraphic agents, because the high protein affinity of these agents may also affect proteins of the thyroid gland and hence exacerbate the disease.
In neonates, especially preterm infants, who have been exposed to Biliscopin, either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as an exposure to excess iodine may cause hypothyroidism, possibly requiring treatment.

Renal failure.

Temporary renal failure may occur in very rare cases. Preventive measures against acute renal failure following contrast medium administration include:
Identification of high risk patients, e.g. patients with a history of renal disease, pre-existing renal insufficiency, previous renal failure after contrast medium administration, diabetes mellitus with nephropathy, volume depletion, multiple myeloma, age greater than 60 years, advanced vascular disease, paraproteinemia, severe and chronic hypertension, gout, patients receiving large or repeated doses.
Most cholecystographic agents exert a uricosuric effect and thereby an increased risk of renal damage in hyperuricaemic patients.
In the presence of severe advanced liver disease a greater amount of Biliscopin may be diverted to the kidneys for excretion. In such patients renal function should be assessed before and a few days after cholecystography.

Use in hepatic impairment.

In case of impaired hepatic function, the risk of renal failure is increased if the recommended dosages and infusion times are not considered.
Administration of urographic agents should be postponed in patients with known or suspected hepatic or biliary disease who have recently undergone cholecystography.

Metformin therapy.

The use of renally or partially renally excreted intravascular X-ray contrast media can lead to transient impairment of kidney function. This may result in lactic acidosis in patients taking biguanides.
As a precaution, biguanides should be stopped 48 hours before and until at least 48 hours after contrast medium administration and reinstated only after normal renal function has been regained.

Phaeochromocytoma.

Patients with pheocromocytoma may develop a severe (occasionally uncontrollable) hypertensive crisis following intravascular contrast medium use. Premedication with alpha-receptor blockers is recommended.
The administration of radiopaque materials to patients known or suspected of having phaeochromocytoma should only take place when the physician deems that the possible benefits outweigh the considered risks and then only with extreme caution while keeping the volume of drug to an absolute minimum. Blood pressure should be assessed throughout the procedure and measures for treating hypertensive crises should be readily available.

Anxiety.

Pronounced states of excitement, anxiety and pain may increase the risk of side effects or intensify contrast medium related reactions. These patients may be given a sedative.

Very poor state of health.

The need for examination merits particularly careful consideration in patients with a very poor general state of health. Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease.
X-ray examination with contrast media should be employed in severely ill patients, or in patients whose general condition is very poor, only if considered absolutely necessary. Special caution is required in patients with marked hypertension.
This also applies to patients with an allergic disposition, e.g. bronchial asthma, since experience has shown that these patients are prone to exhibit hypersensitivity reactions to drugs.
Some radiologists give an antihistamine or corticoid prophylactically in these cases. However, because of the possibility of precipitation, contrast medium and prophylactic agents must not be administered as a mixed solution. Particular caution should be exercised in allergic patients who had previously tolerated injectable iodine containing contrast media without any complication, since they may have become sensitized to these substances in the meantime.
The possibility of thrombosis or other complications due to mechanical trauma of the intravenous procedure should be borne in mind.
Although not an absolute contraindication to use, any history of sensitivity to iodine per se or to any contrast agent calls for extreme caution in administration.
The recommended dose of Biliscopin should not be exceeded.
Serious and even fatal reactions have been associated with the administration of radiopaque media. It is of the utmost importance that a course of action be planned in advance for the immediate treatment of serious reactions and that adequate and appropriate facilities be available to deal with these.
Caution should be exercised in patients with coronary artery disease. Blood pressure should be monitored following administration of Biliscopin to these patients.
The use of intravenous biliary contrast media in patients with monoclonal IgM gammopathy, e.g. macroglobulinaemia (Waldenstrom's disease), leads to gelatinous changes in the blood which can have serious consequences.
It is theoretically conceivable, if not yet confirmed by relevant reports, that the risks attending i.v. cholegraphy are increased in multiple myeloma. The decision to perform i.v. cholegraphy in the presence of multiple myeloma should therefore only be made after very careful consideration of the circumstances.

Paediatric use.

Safety and effectiveness in children below the age of 14 years has not been established.
In neonates, especially preterm infants, who have been exposed to Biliscopin, either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as an exposure to excess iodine may cause hypothyroidism, possibly requiring treatment. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction.

Use in the elderly.

No data available.

Effects on laboratory tests.

Interference with diagnostic tests.

Thyroid function can increase for some time after the examination with biliary contrast media.
The capacity of the thyroid gland to take up iodine will be reduced for about 8-10 weeks by iodinated biliary X-ray contrast media.
The drug may interfere with some chemical determinations made on urine specimens; therefore urine specimens should be collected before administration of the drug or two or three days afterwards.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant administration of pethidine may produce spasms of the sphincter of Oddi.
Adverse reactions are believed to be more common in women taking oral contraceptives. Antihistamines or corticoids should not be administered for prophylaxis as a mixed injection, as precipitation may occur.
Hypersensitivity reactions can be aggravated in patients on beta-blockers.
The prevalence of delayed reactions (e.g. fever, rash, flu-like symptoms, joint pain and pruritus) to contrast media is higher in patients who have received interleukin.
Diabetic nephropathy may predispose to renal impairment following intravascular contrast medium administration. This may precipitate lactic acidosis in patients who are taking biguanides. As a precaution, biguanides should be stopped 48 hours prior to the contrast medium examination and reinstated only after adequate renal function has been regained.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
X-ray examinations should, if possible, be avoided during pregnancy. Safety for use in pregnancy in humans has not been established. Biliscopin is embryotoxic in rabbits.
Most authorities consider elective contrast radiography of the abdomen contraindicated during pregnancy. Biliscopin for infusion may be used in pregnant women only if in the judgment of the treating clinician such use is deemed essential to the patient's welfare and the expected benefits outweigh any potential risks to the patient or the fetus. Caution should be exercised when using Biliscopin in pregnant women. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction, Paediatric use.
It is not known whether Biliscopin is excreted in milk; most cholecystographic media are so excreted. In the newborn they can cause significant hyperbilirubinaemia, specifically during the first eight weeks of life. Alternative arrangements for feeding the infant should, therefore, be made. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction, Paediatric use.

4.7 Effects on Ability to Drive and Use Machines

As with all iodinated contrast media, in rare cases there is a possibility of delayed reactions following contrast medium administration that could impair the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

In order to give an approximate indication of incidence the following definitions apply when the words "common", "uncommon" and "rare" appear in the text. Common: incidence ≥ 1:100; uncommon: incidence < 1:100 but ≥ 1:1,000; rare: incidence < 1:1,000 but ≥ 1:10,000; very rare: incidence < 1:10,000.
Side effects in association with the use of iodinated intravascular contrast media are usually mild to moderate and transient in nature. However, severe and life threatening reactions, as well as deaths have been reported.

Anaphylactoid reactions/ hypersensitivity.

Violent yawns, tickling in the throat, hoarseness, asthma, oedema of the glottis and swollen eyelids. Angioedema, conjunctivitis, coughing, pruritus, rhinitis, sneezing and urticaria have been reported commonly. These reactions, which can occur irrespective of the amount administered and the mode of administration, may be the first signs of incipient state of shock. Severe reactions can occur in the form of a circulatory reaction accompanied by peripheral vasodilatation and subsequent hypotension, reflex tachycardia, dyspnoea, agitation, confusion and cyanosis, possibly leading to unconsciousness and shock. Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via a venous access. It is therefore advisable to use a flexible indwelling cannula for the administration of the contrast medium. To permit immediate countermeasures to be taken in emergencies, appropriate drugs, an endotracheal tube and a ventilator should be ready to hand. (See Section 4.4 Special Warnings and Precautions for Use.)
Effects on the liver and kidneys are dose related and may take some days to manifest themselves. In view of the above possibility, special caution must be exercised in patients with pre-existing hepatic or renal disease.
Delayed contrast medium reactions are rare.

Cardiovascular disorders.

Ventricular fibrillation and collapse. Clinically relevant transient disturbance in heart rate, blood pressure, cardiac rhythm or function and cardiac arrest are uncommon.

Cerebrovascular disorders.

Even status epilepticus. Transient neurological complications such as dizziness, headache, agitation or confusion, amnesia, disturbed speech, vision and hearing, convulsions, tremor, photophobia, coma and somnolence are uncommon.

Respiratory disorders.

Transient disturbance in respiratory rate, dyspnoea, respiratory distress and coughing are common. Bronchospasm and laryngeal spasm occur uncommonly.
Respiratory arrest and pulmonary oedema are very rare reactions.

Gastrointestinal disorders.

Nausea, vomiting and abdominal pain are common reactions.
Diarrhoea occurs very rarely.

Hepatobiliary disorders.

A transient elevation of liver values in blood serum (e.g. ALT (GPT), AST (GOT), GGT, LDH, ALP, bilirubin) may occur especially in patients with pre-existing hepatobiliary disorders.

Skin disorders.

Itching of the skin, angioedema, flush, erythema, urticaria, pruritus and exanthema have been commonly observed.

Renal disorders.

Temporary renal failure may occur in very rare cases.

General disorders and administration site conditions.

Restlessness, flushing, salivation and pressure in the upper abdomen. A general feeling of warmth and headache have been reported as being common. Malaise, chills or sweating and vasovagal reactions are rare.
In very rare cases alterations in body temperature are possible.
Extravasation of Biliscopin gives rise to local pain and oedema, and in rare cases also to more severe tissue reactions.

Toxic effects on liver or kidneys.

Rises in liver function tests, jaundice, pale stools, dark urine, centrilobular necrosis of the liver, azotaemia, casts in the urine, uricosuria.

Other reactions.

Precipitation of Bence-Jones protein (myelomatosis patients), acute pancreatitis, precipitation of proteins associated with Waldenstrom's disease.

Adverse drug reactions from post-marketing spontaneous reports.

Endocrine disorders.

Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been reported with unknown frequency following iodinated contrast media administration to adult and paediatric patients, including infants. Some patients were treated for hypothyroidism.

Life-threatening reactions.

These may be:
Circulatory insufficiency and collapse, ventricular fibrillation, asthma, fever, blanching, weakness, gagging and a feeling of suffocation, gasping, itching, other kinds of skin eruption, oedema and lacrimation.
The greater the infusion rate of Biliscopin for infusion, the higher is the incidence of commonplace side effects, such as unpleasant sensations of taste, nausea, vomiting, erythema, a sensation of pain or sensations of heat. These side effects are rare if the recommended rate of administration is adhered to. If they do occur they can usually be ameliorated quite rapidly by reducing the rate of infusion still further or by allowing a brief pause in the procedure. Too rapid an administration may put the patient's life at risk, particularly if he has previous manifest or latent cardiovascular damage or if his general condition is poor.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: iodinated X-ray contrast media. ATC code: V08AC02.

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Distribution.

In vitro iotroxate meglumine binds to plasma proteins to the extent of 60-90% depending on concentration.

Excretion.

Following intravenous administration, Biliscopin is rapidly excreted, mainly by the liver into the bile. Visualisation of the hepatic and common bile ducts and the gallbladder can, therefore, be achieved. Visualisation of the biliary ducts is usually possible 30-60 minutes after completion of administration.

5.3 Preclinical Safety Data

In animals it crosses the placental barrier.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Biliscopin for infusion contains sodium calcium edetate, sodium bicarbonate and sodium chloride in aqueous solution.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

5 years.

6.4 Special Precautions for Storage

Infusion bottle of 100 mL containing 105 mg of iotroxate meglumine/mL, boxed to protect from light and X-rays.

6.5 Nature and Contents of Container

Infusion bottle of 100 mL.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Each 1 mL Biliscopin for infusion contains 0.105 g iotroxate meglumine (3,3'-(3,6,9- trioxaundecanedioyl-diimino) -bis-(2,4,6-triiodobenzoic acid), N-methylglucamine salt) along with small amounts of sodium calcium edetate, sodium bicarbonate and sodium chloride in aqueous solution. The solution is clear, colourless to faintly yellowish and odourless. It should be protected from light.

Physico-chemical properties.

Molecular formula: C₂₂H₁₈I₆N₂O₉.
Molecular weight: 1215.83.
Iodine content per bottle of 100 mL: 5 g.
Iodine concentration: 5% w/v.
Iotroxate meglumine content per bottle of 100 mL: 10.5 g.
Iotroxate meglumine concentration: 10.5% w/v.
Osmotic pressure at 37°C: 0.69-0.77 mPa.

Chemical structure.

CAS number.

CAS No. 72704-51-9.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

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Consumer medicine information

Biliscopin

Iotroxate meglumine

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