Consumer medicine information

Biliscopin

Iotroxate meglumine

BRAND INFORMATION

Brand name

Biliscopin

Active ingredient

Iotroxate meglumine

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Biliscopin.

SUMMARY CMI

BILISCOPIN®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I given BILISCOPIN?

BILISCOPIN contains the active ingredient iotroxate meglumine. BILISCOPIN is a contrast agent used during an X-ray examination of the liver, bile ducts and gallbladder or other areas where bile flows.

For more information, see Section 1. Why am I given BILISCOPIN? in the full CMI.

2. What should I know before I am given BILISCOPIN?

Do not use if you have ever had an allergic reaction to BILISCOPIN or any of the ingredients listed at the end of the CMI.

Talk to your doctor, radiographer or nurse if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

You may be asked to change your diet for the day prior and to not eat (fast) the evening before your procedure. It is important that you still drink fluids as normal.

For more information, see Section 2. What should I know before I am given BILISCOPIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BILISCOPIN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given BILISCOPIN?

BILISCOPIN is given by a small needle into a vein usually in your hand or arm by the doctor, radiographer or nurse. It is a drip infusion and will be given slowly over 30 to 60 minutes.

More instructions can be found in Section 4. How am I given BILISCOPIN? in the full CMI.

5. What should I know while receiving BILISCOPIN?

Things you should doTell your doctor, radiographer or nurse if you:
  • experience violent yawns, tickling in the throat, hoarseness, asthma (tight chest, difficulty breathing), swollen mouth or swollen eyelids, red rash or red flushed skin, hives, coughing, runny nose or sneezing
  • experience any of the severe symptoms of loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock.
Driving or using machinesBILISCOPIN may cause delayed reactions that could impair the ability to drive and use machines.
Laboratory testsBILISCOPIN can affect the results of some thyroid tests, blood tests and urine tests.

For more information, see Section 5. What should I know while receiving BILISCOPIN? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.

Serious side effects can include severe allergic reactions, difficulty breathing, heart rhythm changes and epileptic fits. Common side effects can include nausea, vomiting, abdominal pain, headache, itchy or red skin and general feeling of warmth.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

BILISCOPIN® (Bill-ee-SCO-pin)

Active ingredient: iotroxate meglumine


Consumer Medicine Information (CMI)

This leaflet provides important information about using BILISCOPIN. You should also speak to your doctor, radiographer, nurse or pharmacist if you would like further information or if you have any concerns or questions about using BILISCOPIN.

Where to find information in this leaflet:

1. Why am I given BILISCOPIN?
2. What should I know before I am given BILISCOPIN?
3. What if I am taking other medicines?
4. How am I given BILISCOPIN?
5. What should I know while receiving BILISCOPIN?
6. Are there any side effects?
7. Product details

1. Why am I given BILISCOPIN?

BILISCOPIN contains the active ingredient iotroxate meglumine.

BILISCOPIN is an injectable contrast medium (a dye) which contains iodine. It is used to clearly show on X-rays the liver, bile ducts and gallbladder or other areas where bile flows.

2. What should I know before I am given BILISCOPIN?

Warnings

Do not use BILISCOPIN if you:

  • are allergic to iotroxate meglumine, or any of the ingredients listed at the end of this leaflet
  • have severe heart conditions or circulatory conditions like heart failure
  • have an overactive thyroid which isn't being treated
  • have severe impairment of liver or kidney function
  • have myelomatosis
  • have monoclonal IgM gammopathy, such as macroglobulinaemia or Waldenstrom's disease
  • have Dubin-Johnson syndrome
  • are under 14 years of age
  • are pregnant
  • always check the ingredients to make sure you can use this medicine.

Check with your doctor, radiographer or nurse if you have:

  • any allergies to other iodine -containing contrast or any other allergies (e.g. shellfish, hay fever, hives, anaphylaxis) or asthma
  • overactive thyroid gland or goitre (swelling in the neck)
  • kidney or liver problems
  • coronary artery disease
  • a very poor state of general health
  • diabetes
  • multiple myeloma or paraproteinaemia
  • high blood pressure
  • gout
  • pheochromocytoma
  • pronounced or heightened anxiety, excitement or pain
  • are dehydrated and your body needs more fluids
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

You may be asked to stay in the X-ray department for a period of time after your examination so that the medical staff can monitor you for side effects.

Pregnancy and breastfeeding

Advise your doctor, radiographer or nurse if you are pregnant or intend to become pregnant.

Talk to your doctor, radiographer or nurse if you are breastfeeding or intend to breastfeed.

Use in children

BILISCOPIN is approved for use in adolescents above 14 years. Safety and effectiveness in children below 14 years has not been established.

Food and drink before your procedure

The X-ray picture is improved if your bowels are emptied. On the day (24 hours) prior to your X-ray procedure avoid fibre and gas-forming food such as eggs, rusks, fruit, pulpy foods, paste or milk products. Eat easily digestible foods and clear liquids such as tea without milk, fruit juice or clear fat-free soup.

You may be asked to not eat the evening before the procedure (fasting) and may also be asked to take a laxative the day before. Do not eat or smoke on the day of the examination.

It is important that you still drink clear fluids (such as water or weak tea) as normal. You will be advised to take fluids before and after the examination to help protect your kidneys.

3. What if I am taking other medicines?

Tell your doctor, radiographer, nurse or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

  • are taking or been given pethidine used for pain
  • are taking oral contraceptives
  • are taking beta-blockers used for high blood pressure or heart conditions
  • are taking interleukin used to treat some cancers
  • are taking metformin, a medicine used to treat diabetes.

Some medicines may interfere with BILISCOPIN and affect how it works.

If you experience an allergy-like reaction to BILISCOPIN, any treatment given to you may be affected by these medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BILISCOPIN.

4. How am I given BILISCOPIN?

How much to be given

  • The dosage of BILISCOPIN is based on the x-ray examination time. The doctor, radiographer or nurse will calculate the right dose for you.

When BILISCOPIN is given

  • BILISCOPIN will be given during your examination.

How BILISCOPIN is given

BILISCOPIN is given by a small needle into a vein usually in your hand or arm by the doctor, radiographer or nurse. It is a drip infusion and will be given slowly over 30 to 60 minutes.

If you are given too much BILISCOPIN

If you think that you have been given too much BILISCOPIN, ask the doctor, radiographer or nurse. As BILISCOPIN is given by the doctor, radiographer or nurse, overdose is unlikely. If it does happen, a doctor will treat any symptoms that follow.

You should immediately:

  • phone the Poisons Information Centre
    (by calling Australia: 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Depar tment at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while receiving BILISCOPIN?

Things you should do

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

Call your doctor, radiographer or nurse straight away if you:

  • experience violent yawns, tickling in the throat, hoarseness, asthma (tight chest, difficulty breathing), swollen mouth or swollen eyelids, red rash or red flushed skin, hives, coughing, runny nose or sneezing
  • experience any of the severe symptoms of loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock.

Remind any doctor, dentist or pharmacist you visit that you have been given BILISCOPIN.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how BILISCOPIN affects you.

BILISCOPIN may cause delayed reactions that could impair the ability to drive and use machines.

Laboratory tests

BILISCOPIN can affect the results of some blood and urine tests after receiving it as follows:

  • thyroid tests for up to 8-10 weeks
  • urine tests for up to three (3) days afterwards
  • liver function tests temporarily (a few days)

Remind your doctor or medical staff after you have received BILISCOPIN.

Looking after your medicine

  • The X-ray unit will store BILISCOPIN under the conditions advised by the manufacturer.
  • Shelf life and storage conditions are printed on the bottle.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

A high level of excitement, anxiety and pain may increase the risk of side effects or make contrast agent related reactions more intense.

Allergic reaction

Some people may experience symptoms of an allergic reaction such as loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock.

Allergic reactions occur more frequently in people with a history of allergies to other contrast agents, to foods (e.g. seafood) or those who suffer from anaphylaxis, hay fever or bronchial asthma.

Most of these reactions occur within one (1) hour of receiving BILISCOPIN. Rarely, some of these reactions may be delayed (up to several days after receiving BILISCOPIN).

Less serious side effects

Less serious side effectsWhat to do
Gastrointestinal disorders
  • Nausea
  • Vomiting
  • Stomach pain
Nervous system disorders
  • Headache
  • Dizziness
  • Light sensitivity
General disorders
  • Coughing
  • Itchy skin
  • Skin redness, flushing
  • Increased saliva
  • Feeling hot
  • Malaise (fatigue)
  • Sweating
  • Chills or feeling cold
  • Unpleasant change of taste
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Immune system disorders
  • Experience swelling of the face, eyelids, lips, tongue or other parts of the body
  • Violent yawns
  • Sneezing, runny rose
  • Coughing or throat irritation
  • Itching or hives
  • Conjunctivitis
  • Wheezing, shortness of breath, difficulty breathing, gasping
  • Gagging, feeling of suffocation
  • Low blood pressure
Nervous system disorders
  • Vasovagal reaction (fainting)
  • Loss of consciousness
  • Seizures (fits)
  • Confusion
  • Convulsions, tremors
  • Altered speech, vision or hearing
Cardiac disorders
  • Irregular heartbeat
  • Abnormal heartbeat (maybe faster)
  • Heart attack
Respiratory disorders
  • Difficulty breathing
  • Change in breathing rate
  • Slow or shallow breathing
Renal disorders
  • Temporary kidney failure
  • Dark or little urine output
  • Severe back pain
  • Pale stools
  • Yellowing of skin
General disorders
  • Injection site reaction or pain
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor, radiographer, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available in an X-ray unit.

What BILISCOPIN contains

Active ingredient
(main ingredient)
Iotroxate meglumine
(contains iodine)
Other ingredients
(inactive ingredients)
Sodium chloride
Sodium calcium edetate
Sodium bicarbonate
Water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What BILISCOPIN looks like

BILISCOPIN is a clear, colourless to slightly yellow solution for infusion and is supplied in a 100 mL glass bottles.

100 mL glass bottle – AUST R 52765

Who distributes BILISCOPIN

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
www.bayer.com.au

This leaflet was prepared in December 2020.

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

® Registered trademark

Published by MIMS February 2021

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.

Summary Table of Changes