Consumer medicine information

Urografin

Amidotrizoate meglumine; Sodium amidotrizoate

BRAND INFORMATION

Brand name

Urografin

Active ingredient

Amidotrizoate meglumine; Sodium amidotrizoate

Schedule

Unscheduled

SUMMARY CMI

UROGRAFIN^®

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 UROGRAFIN?

UROGRAFIN contains the active ingredients sodium amidotrizoate and amidotrizoate meglumine. UROGRAFIN is a contrast agent used during an X-ray examination.

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

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

Do not use if you have ever had an allergic reaction to UROGRAFIN 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.

If you are to have an X-ray of your abdominal area or kidneys, you may be asked to change your diet for 2 days prior and to not eat (fast) after 6pm 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 UROGRAFIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with UROGRAFIN 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 UROGRAFIN?

UROGRAFIN is injected by the doctor or radiographer into different parts of your body depending on the area of your body to be examined.

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

5. What should I know while receiving UROGRAFIN?

Things you should do	Tell your doctor, radiographer or nurse if you: 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 experience any asthma symptoms e.g. chest tightening.
Driving or using machines	UROGRAFIN may cause delayed reactions that could impair the ability to drive and use machines.
Laboratory tests	UROGRAFIN can affect the results of some thyroid tests up to several weeks after receiving it.
Looking after your medicine	The X-Ray unit will store UROGRAFIN as required by the manufacturer.

For more information, see Section 5. What should I know while receiving UROGRAFIN? 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 and heart attack. Common side effects can include nausea, vomiting, red skin (flushing), pain sensation and feeling warm.

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

UROGRAFIN^® (YOU-row-graf-in)

Active ingredients: sodium amidotrizoate and amidotrizoate meglumine

Consumer Medicine Information (CMI)

This leaflet provides important information about using UROGRAFIN. 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 UROGRAFIN.

Where to find information in this leaflet:

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

1. Why am I given UROGRAFIN?

UROGRAFIN contains the active ingredients sodium amidotrizoate and amidotrizoate meglumine.

UROGRAFIN is an injectable contrast medium (a dye) which contains iodine. It is used to clearly show on X-rays the area of your body that your doctor wants to investigate, for example, your kidney, bladder, blood vessels, uterus, joints, bile ducts, fistula, spleen or seminal vesicles in the pelvis. It can also be used with computer - assisted X-ray machines (CT scanners).

UROGRAFIN is also used during an angiogram in a cardiac catheterization procedure to help the doctor visualise the blood vessels in your heart and body using an X-ray machine.

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

Warnings

Do not use UROGRAFIN if:

you are allergic to sodium amidotrizoate and/or amidotrizoate 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
are pregnant or if you have pelvic inflammatory disease
acute pancreatitis
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)
heart or cardiovascular disease, including heart valve failure, coronary artery disease or pulmonary hypertension
cerebral arteriosclerosis
impaired kidney or liver function
emphysema of the lungs
a very poor state of general health
diabetes
disorder of the central nervous system, including previous brain bleeds, brain injury, stroke, swelling on the brain or epilepsy
cerebral spasmodic conditions
demyelinating disease, such as multiple sclerosis or optic neuritis
multiple myeloma or paraproteinaemia
pheochromocytoma
an auto-immune disease
myasthenia gravis
alcoholism or drug addiction
homocysteinuria, a genetic disorder
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 or have any infections of the uterus or vagina. X-ray examinations of the uterus must not be performed during pregnancy or if you have pelvic inflammatory disease.

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

Use in children

UROGRAFIN is approved for use in adults, adolescents and children including full-term newborns.

Food and drink before your procedure

If you are to have an X-ray of your abdominal area or kidneys, the X-ray picture is improved if your bowels are emptied. On the two days prior to your X-ray procedure avoid flatulent food such as peas, beans, lentils, salads, fruit, dark and fresh bread and all kinds of uncooked vegetables.

You may be asked to not eat after 6pm the evenin g before the procedure (fasting) and may also be asked to take a laxative the evening before. If it is your child undergoing the procedure, you may be given different instructions by your doctor, radiographer or nurse.

It is important that you still drink fluids 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 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 UROGRAFIN and affect how it works.

If you experience an allergy-like reaction to UROGRAFIN, 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 UROGRAFIN.

4. How am I given UROGRAFIN?

How much to be given

The dosage of UROGRAFIN is based on the area of your body that will be examined. The doctor or radiographer will calculate the right dose for you.

When UROGRAFIN is given

UROGRAFIN will be given immediately before or during your examination.

How UROGRAFIN is given

UROGRAFIN is given different ways by the doctor or radiographer depending on the area of your body to be examined:

by a small needle into a vein usually in your hand or arm or
injected via a catheter into different parts of your body directly.

If you are given too much UROGRAFIN

If you think that you have been given too much UROGRAFIN, ask the doctor, radiographer or nurse. As UROGRAFIN 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 New Zealand 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department 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 UROGRAFIN?

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 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
experience any asthma symptoms e.g. chest tightening.

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

Driving or using machines

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

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

Laboratory tests

UROGRAFIN can affect the results of some thyroid tests up to several weeks after receiving it
Remind your doctor or medical staff after you have received UROGRAFIN.

Looking after your medicine

The X-ray unit will store UROGRAFIN under the conditions advised by the manufacturer.
Shelf life and storage conditions are printed on the vial or 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, radiographer, nurse 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 r ate, 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 UROGRAFIN. Rarely, some of these reactions may be delayed (up to several days after receiving UROGRAFIN).

Less serious side effects

Less serious side effects

What to do

Gastrointestinal disorders

Nausea
Vomiting
Stomach pain

Nervous system disorders

Headache
Dizziness

General disorders

Feeling hot
Malaise (fatigue)
Sweating
Chills or feeling cold
Swollen saliva glands
Flushing
Skin redness

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Immune system disorders

Experience swelling of the face, eyelids, lips, tongue or other parts of the body
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)
Tremors
Short term loss of sensation
Altered speech or hearing
Short term blindness or vision issues
Light sensitivity

Cardiac disorders

Irregular heartbeat
Abnormal heartbeat (maybe faster)
Heart attack

Psychiatric disorders

Agitation
Confusion

Respiratory disorders

Difficulty breathing
Change in breathing rate
Slow or shallow breathing

Renal disorders

Temporary kidney failure
Dark or little urine output

General disorders

Blue hands or feet
Injection site reaction or pain
Pain sensation
Fluid under skin at injection site
Rash
Fever
Swelling and redness along a vein or a blood clot in a vein

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 in Australia online at www.tga.gov.au/reporting-problems or in New Zealand nzphvc.otago.ac.nz/reporting. 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 UROGRAFIN contains

Active ingredient (main ingredient)	Sodium amidotrizoate and Amidotrizoate meglumine (contains iodine)
Other ingredients (inactive ingredients)	Sodium calcium edetate Water for injections

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

What UROGRAFIN looks like

UROGRAFIN is a clear, colourless to slightly yellow solution for injection and is supplied in glass vials or glass bottles of various sizes.

UROGRAFIN 30%:
10 x 10 mL glass ampoules – AUST R 42161
1 x 250 mL glass bottle – AUST R 42163

UROGRAFIN 76%:
10 x 50 mL glass bottle – AUST R 42157
10 x 100 mL glass bottles – AUST R 48496

Not all presentations may be marketed in Australia or New Zealand.

Who distributes UROGRAFIN

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

Bayer New Zealand Limited
PO Box 2825
Shortland Street
Auckland 1140
Free phone 0800 2 29 376

This leaflet was prepared in December 2020.

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information or on the Medsafe website (www.medsafe.govt.nz) for New Zealand.

^® Registered trademark

Published by MIMS February 2021

BRAND INFORMATION

Brand name

Urografin

Active ingredient

Amidotrizoate meglumine; Sodium amidotrizoate

Schedule

Unscheduled

1 Name of Medicine

Sodium amidotrizoate/ amidotrizoate meglumine.

2 Qualitative and Quantitative Composition

Urografin 30% contains 40 mg/mL sodium amidotrizoate and 260 mg/mL amidotrizoate meglumine in aqueous solution.
Urografin 76% contains 100 mg/mL sodium amidotrizoate and 660 mg/mL amidotrizoate meglumine in aqueous solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Presentation.

Urografin is a clear, colourless to faintly yellowish aqueous solution for injection or infusion.

4 Clinical Particulars

4.1 Therapeutic Indications

Intravenous and retrograde urography. Computerized tomography.
Also for all angiographic examinations as well as for amniography, arthrography, intraoperative cholangiography, fistulography, hysterosalpingography, splenoportography, vesiculography and others.
Urografin is not to be used for myelography, ventriculography or cisternography, since it is likely to provoke neurotoxic symptoms in these examinations.

4.2 Dose and Method of Administration

General information.

Dietary suggestions.

In the case of abdominal angiography and urography, the diagnostic yield is increased if the bowels are emptied of faecal matter and gas. On the two days prior to the examination patients should therefore avoid flatulent food, in particular peas, beans and lentils, salads, fruit, dark and fresh bread and all kinds of uncooked vegetables. On the day before the examination, patients should refrain from eating after 6 p.m. Moreover, it can be appropriate to administer a laxative in the evening. In babies and young children, however, prolonged fasting and the administration of a laxative before the examination are contraindicated.

Hydration.

Adequate hydration must be assured before and after contrast medium administration. This applies especially to patients with multiple myeloma, diabetes mellitus and nephropathy, polyuria, oliguria, hyperuricaemia, as well as to newborns, infants, small children and elderly patients. Disturbances of the water and electrolyte balance must be corrected before the examination.

Newborns (< 1 month) and infants (1 month-2 years).

Young infants (age < 1 year) and especially newborns are susceptible to electrolyte imbalance and haemodynamic alterations. Care should be taken regarding the dose of contrast medium to be given, the technical performance of the radiological procedure and the patient status.

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.

Instructions for use/handling.

The contrast medium solution should not be drawn into the syringe or the infusion bottle attached to the infusion set until immediately before the examination. Contrast media should not be used in case of severe discoloration, the occurrence of particulate matter or defective container.
Vials containing contrast medium solutions are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once to prevent large amounts of microparticles from the stopper getting into the solution. The use of cannulas with a long tip and a diameter of maximally 18 G is recommended for piercing the stopper and drawing up the contrast medium (dedicated withdrawal cannulas with a side hole, e.g. Nocore-Admix cannulas, are particularly suitable).
Contrast medium solution not used in one examination session must be discarded.
The patient must attend for examination fasting but adequately hydrated. Disorders of the water and electrolyte balance must be corrected. This applies in particularly to patients who are predisposed to such disturbances.

Anxiety.

Pronounced states of excitement and anxiety may increase the risk of side effects or intensify contrast medium related reactions. They can be counteracted by calm management and the use of suitable drugs.

Warming prior to use.

Experience shows that contrast medium is tolerated better if it is warmed to body temperature.

Dosage for intravascular use.

Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least 30 minutes, since experience shows that the majority of all severe incidents occur within this time.
The dosage may vary depending on the age, weight, cardiac output and general condition of the patient.
In patients suffering from marked renal or cardiovascular insufficiency and in patients in a poor general condition, the contrast medium dose must be kept as low as possible. In these patients it is advisable to monitor renal function for at least 3 days following the examination.
Should diagnostic clarification necessitate several high single doses, the opportunity should be given between injections to compensate for the increased serum osmolarity by the influx of interstitial fluid.
To achieve this, a period of 10-15 minutes is necessary in adequately hydrated patients. The intravascular administration of water and electrolytes is indicated if more than 300 mL contrast medium are required for a single examination.

Recommended doses.

Intravenous urography. Injection. Urografin 76% is used for intravenous urography. In general, the rate of injection is 20 mL/minute. If patients with cardiac insufficiency are given 100 mL or more, an injection time of 20-30 minutes is recommended.

Adults.

The dose is 20 mL Urografin 76%. Increasing the dose to 50 mL considerably increases the diagnostic yield. The dose may be increased yet again if this is considered necessary in special indications.

Children.

The physiologically weak concentrating ability of the still immature nephron of infantile kidneys necessitates relatively high doses of Urografin 76%. Up to 1 year: 7-10 mL; 1-2 years: 10-12 mL; 2-6 years: 12-15 mL; 6-12 years: 15-20 mL; above 12 years: adult dose.

Filming times.

The renal parenchyma can be demonstrated best when the film is taken immediately after the end of the administration.
For visualization of the renal pelvis and urinary tract, the first film is taken 3-5 minutes and the second 10-12 minutes after the administration of the contrast medium. In young patients one should generally choose the earlier and in older patients the later times.
In babies and young children it is advisable to take the first film as soon as about 2 minutes after the administration of the contrast medium.
Insufficient contrast can necessitate later films.
Infusion.

Adults and adolescents.

1 bottle of 100 mL Urografin 76% or 1 bottle of 250 mL Urografin 30%.
In general, the infusion time should not be less than 5 minutes nor much more than 10 minutes. Infusion times of 20-30 minutes are indicated in patients with cardiac insufficiency.

Children.

1 bottle of 250 mL Urografin 30% for infusion. 3-12 months: 6 mL/kg body weight; 1-8 years: 4 mL/kg body weight; over 8 years: 3 mL/kg body weight.
Infusion time: 8-10 minutes.
Compression is contraindicated in babies and is also inadvisable during the infusion of large amounts of contrast medium in children, adolescents and adults, since, if drainage is obstructed, the increased diuresis can lead to rupture of the fornix as a result of the high pressure. Compression may, however, be applied about 10 minutes after the end of the infusion to demarcate organic from functional filling defects.

Filming times.

The first film should be taken towards the end of the infusion. Further films may be taken within the next 20 minutes (or later in case of excretory disturbances).

Administration into body cavities.

Retrograde urography.

Because of its good tissue tolerance Urografin 30% is especially well suited for retrograde urography. It is advisable to warm the contrast medium to body temperature to avoid low-temperature stimulus and resultant ureteral spasms.
Urografin 76% solution may also be used if greater opacification is desirable for special examinations. Signs of irritation are observed extremely rarely despite the high concentration.

Angiography.

Urografin 76% is also suitable for angiographic examinations, preferably for those which require a particularly high iodine concentration, e.g. aortography, angiocardiography, coronary arteriography. The dosage depends on age, weight, cardiac output, general state of health, the clinical problem, examination technique, kind and volume of the region to be examined.
Other body cavities. During arthrography, hysterosalpingography and especially ERCP, injections of contrast medium should be monitored by fluoroscopy. Consult special literature for further indications.

4.3 Contraindications

Manifest hyperthyroidism, decompensated cardiac insufficiency.
Hysterosalpingography must not be performed during pregnancy or in the presence of acute inflammatory processes in the pelvic cavity.
Endoscopic retrograde cholangiopancreatography (ERCP) is contraindicated in acute pancreatitis.
Urografin is not to be used for myelography, ventriculography or cisternography, since it is likely to provoke neurotoxic symptoms (pain, convulsions and coma, often with lethal outcome) in these examinations.

4.4 Special Warnings and Precautions for Use

The need for examination merits particularly careful consideration in hypersensitivity to iodinated contrast media, severe impairment of hepatic or renal function, cardiac and circulatory insufficiency, pulmonary emphysema, poor general health, cerebral arteriosclerosis, diabetes mellitus requiring treatment, cerebral spasmodic conditions, latent hyperthyroidism, bland nodular goitre and multiple myeloma.
Fluid intake should not be restricted before the use of hypertonic contrast media in patients with multiple myeloma, diabetes mellitus requiring treatment, polyuria, oliguria or gout and in babies, young children and patients in a very poor general state of health.
The following precautions apply to any mode of administration, however the risks mentioned are higher in intravascular administration.

Hypersensitivity.

Occasionally, allergy-like hypersensitivity reactions have been observed after use of X-ray contrast media, such as Urografin (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 edema, 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. However contrast media and prophylactic agents should not be administered together.
Patients with bronchial asthma are at special risk of having bronchospasms or a hypersensitivity reaction.
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.

Thyroid dysfunction.

Particularly careful risk-benefit assessment is required in patients with known or suspected hyperthyroidism or goiter, as iodinated contrast media may interfere with thyroid function, aggravate or induce hyperthyroidism and thyreotoxic crisis.
Testing of thyroid function prior to Urografin administration and/or preventive thyreostatic medication may be considered in patients with known or suspected hyperthyroidism.
In neonates, especially preterm infants, who have been exposed to Urografin, 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.

Cardiovascular disease.

There is an increased risk of severe reactions in individuals with severe cardiac disease and particularly in those with heart failure and coronary artery disease.

Very poor state of health.

The need for examination merits particularly careful consideration in patients with very poor general state of health.

Intravascular use.

Renal failure.

Temporary renal failure may occur in rare cases. Preventative 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 and 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.
Ensuring adequate hydration in risk patients before contrast medium administration preferably by maintaining intravascular infusion before and after the procedure and until the contrast medium has been cleared by the kidneys.
Avoiding additional strain on the kidneys in the form of nephrotoxic drugs, oral cholecystographic agents, arterial clamping, renal arterial angioplasty, major surgery etc., until the contrast medium has been cleared.
Postponing a new contrast medium examination until renal function returns to pre-examination levels.

Metformin therapy.

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

Cardiovascular disease.

In patients with valvular disease and pulmonary hypertension, contrast medium administration may lead to pronounced hemodynamic changes. Reactions involving ischemic ECG changes and major arrhythmia are more common in older patients and in those with pre-existing cardiac disease.
The intravascular injection of contrast media may precipitate pulmonary edema in patients with heart failure.

CNS disorders.

Particular care should be paid to the intravascular administration of contrast media in patients with acute cerebral infarction, acute intracranial hemorrhage, and other conditions involving blood-brain barrier damage, cerebral edema or acute demyelination. Intracranial tumours or metastases and a history of epilepsy may increase the incidence of convulsive seizures after administration of iodinated contrast media. Neurological symptoms due to cerebrovascular diseases, intracranial tumours or metastases, degenerative or inflammatory pathologies may be exacerbated by contrast medium administration. Vasospasm and subsequent cerebral ischemic phenomena may be caused by intra-arterial injections of contrast media. Patients with symptomatic cerebrovascular diseases, recent stroke or frequent transient ischemic attacks have an increased risk of neurological complications.

Severe liver dysfunction.

In the case of severe renal insufficiency the coexistence of severe hepatic dysfunction can seriously delay contrast medium excretion, possibly necessitating haemodialysis.

Myeloma and paraproteinemia.

Myeloma or paraproteinemia may predispose to renal impairment following contrast medium administration. Adequate hydration is mandatory.

Pheochromocytoma.

Patients with pheochromocytoma may develop a severe (occasionally uncontrollable) hypertensive crisis following intravascular contrast medium use. Premedication with alpha-receptor blockers is recommended because of the risk of blood pressure crises.

Patients with autoimmune disorders.

Cases of severe vasculitis or Stevens-Johnson-like syndrome have been reported in patients with pre-existing autoimmune disorders.

Myasthenia gravis.

The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis.

Alcoholism.

Acute or chronic alcoholism may increase blood-brain barrier permeability. This facilitates the passage of the contrast medium into cerebral tissue, possibly leading to CNS reactions. Caution must also be exercised in alcoholics and drug addicts because of the possibility of a reduced seizure threshold.

Coagulation.

Ionic iodinated contrast media inhibit blood coagulation in vitro, more than non-ionic contrast media. Nevertheless medical personnel performing vascular catheterization procedures should consider that numerous factors in addition to the contrast medium, including length of procedure, number of injections, catheter and syringe material, underlying disease state and concomitant medication may contribute to the development of thromboembolic events. Therefore, when performing vascular catheterization procedure one should be aware of this and pay meticulous attention to the angiographic technique and flush the catheter frequently with physiological saline (if possible with the addition of heparin) and minimize the length of the procedure so as to minimize the risk of procedure related thrombosis and embolism.
The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.
Caution is advised in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

Use in body cavities.

The possibility of pregnancy must be excluded before performing hysterosalpingography.
Inflammation of the bile ducts or salpinx may increase the risk of reactions following cholangiography, ERCP or hysterosalpingography procedures.

Use in the elderly.

Underlying vascular pathology and neurological disorders often seen in the elderly constitute an increased risk of adverse reactions to iodinated contrast media.

Paediatric use.

See Section 4.6 Fertility, Pregnancy and Lactation, Use in paediatrics.

Effects on laboratory tests.

Interference with diagnostic tests.

Following the administration of iodinated renal contrast media, the capacity of the thyroid tissue to take up radioisotopes for diagnosing disorders of the thyroid is reduced for up to 2 weeks, and even longer in individual cases.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Hypersensitivity reactions can be aggravated in patients on beta-blockers particularly in the presence of bronchial asthma. Moreover, it should be considered that patients on beta-blockers may be refractory to standard treatment of hypersensitivity reactions with beta-agonists.
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.
It has not yet been demonstrated that Urografin is safe for use in pregnant patients. Since, wherever possible, radiation stress should be avoided during pregnancy, the benefits of any X-ray examination, with or without contrast material, should be carefully weighed against the possible risk.
Caution should be exercised when using Urografin in pregnant women. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction, Paediatric use.
It is not known whether Urografin enters the breast milk. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction, Paediatric use.

Use in paediatrics.

In neonates, especially preterm infants, who have been exposed to Urografin, 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.

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 of the following definitions apply when the words "common", "uncommon" and "rare" appear in the text. Common: incidence ≥ 1:100; uncommon: incidence < 1:100, but ≥ 1:1000; rare: incidence < 1:1000.

Intravascular use.

Side effects in association with the intravascular use of iodinated contrast media are usually mild to moderate and transient in nature. However, severe and life threatening reactions, even fatal ones, have been reported.
Nausea, vomiting, erythema, a sensation of pain and a general feeling of warmth are the most frequently recorded reactions on intravascular administration. Subjective complaints such as sensations of warmth or nausea can usually be alleviated quickly by reducing the rate of administration or interrupting the administration briefly.

Anaphylactoid reactions/ hypersensitivity.

Mild 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 (see Section 4.4 Special Warnings and Precautions for Use).
Experience shows that hypersensitivity reactions occur more frequently in patients with an allergic disposition.
Severe reactions requiring emergency treatment can occur in the form of a circulatory reaction accompanied by peripheral vasodilatation and subsequent hypotension, reflex tachycardia, dyspnoea, agitation, confusion and cyanosis and possibly leading to unconsciousness.
Hypotension, bronchospasm and laryngeal spasm or oedema occurs uncommonly.
Delayed reactions can occasionally occur.
Paravascular administration of the contrast medium rarely leads to severe tissue reactions.

Body as a whole.

Heat sensations and headache have been reported as being common. Malaise, chills or sweating and vasovagal reactions are uncommon.
In rare cases alterations in body temperature and swelling of salivary glands are possible.

Respiratory.

Transient disturbances in respiratory rate, dyspnea and respiratory distress and coughing are common.
Respiratory arrest and pulmonary edema are rare reactions.

Cardiovascular.

Clinically relevant transient disturbance in heart rate, blood pressure, disturbance in cardiac rhythm or function and cardiac arrest are uncommon.
Severe reactions requiring emergency treatment can occur in the form of a circulatory reaction accompanied by peripheral vasodilatation and subsequent hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis possibly leading to unconsciousness.
Serious thromboembolic events causing myocardial infarction have been reported in rare cases.

Gastrointestinal.

Nausea and vomiting are common reactions. Abdominal pain has been reported as being uncommon.

Cerebrovascular.

It is known that cerebral angiography and other procedures in which the contrast medium reaches the brain with the arterial blood can be accompanied uncommonly by transient neurological complications. These include dizziness, headache, coma, amnesia, photophobia, temporary states, agitation or confusion and somnolence, convulsions, transient paresis/paralysis, tremor, disturbed speech, hearing, temporary blindness, vision or slack facial muscles and - particularly in epileptics and patients with focal brain damage - epileptic fits.
Serious, in isolated cases fatal, thromboembolic events causing stroke have been reported on rare occasions.

Renal.

Temporary renal failure may occur in rare cases.

Skin.

Mild angioedema, flush reaction with vasodilatation, urticaria, pruritus and erythema have been commonly observed.
Toxic skin reactions such as the mucocutaneous syndrome (e.g. Stevens-Johnson's or Lyell syndrome) may develop in rare cases.

Local irritation (injection site).

Local pain occurs commonly mainly in peripheral angiography. Extravasation of contrast media including Urografin gives rise to local pain and edema, but usually recedes without sequela. However inflammation and even tissue necrosis have been seen on very rare occasions. Thrombophlebitis and venous thrombosis are uncommon.

Use in body cavities.

Reactions after the administration into body cavities are rare. The majority of them occur some hours after the administration due to the slow absorption from the area of administration and distribution in the whole organism primarily through diffusion controlled processes.
Some elevation of amylase levels is common following ERCP. Acinar opacification following ERCP has been shown to be associated with an increased risk of post-ERCP pancreatitis. Rare cases of necrotizing pancreatitis have been described.
In connection with hysterosalpingography, cases of vasovagal reactions are uncommon.

Anaphylactoid reactions/ hypersensitivity.

Systemic hypersensitivity is rare, mostly mild and occurs generally in the form of skin reactions. However, the possibility of a severe hypersensitivity reaction cannot be totally excluded. For corresponding section on intravascular use, see Section 4.8 Adverse Effects (Undesirable Effects) for full information on anaphylactoid reactions.

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.

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 in Australia: http://www.tga.gov.au/reporting-problems; in New Zealand: https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

In the event of accidental intravascular overdose in humans, the water and electrolyte losses must be compensated by infusion. Renal function needs monitoring for at least the next 3 days.
If needed, hemodialysis can be used to eliminate the bulk of the contrast medium from the patient's system.
For information on the management of overdose, contact Australia: The Poison Information Centre on 131126 (Australia); New Zealand: The National Poisons Centre on 0800 POISON (0800 764766).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Urografin also contains sodium calcium edetate and water for injections.

6.2 Incompatibilities

Contrast media must not be mixed with any other drugs to avoid the risk of possible incompatibilities.

6.3 Shelf Life

5 years.
One day after first opening the container and without withdrawal of any contrast medium.

6.4 Special Precautions for Storage

Store below 30°C.
Protect from light and secondary X-rays.

6.5 Nature and Contents of Container

Urografin 30%.

10 x 10 mL in clear type I glass ampoule with rubber stopper closures; 1 x 250 mL in clear type II glass bottle with rubber stopper closures.

Urografin 76%.

10 x 50 mL in clear type II glass bottle with rubber stopper closures; 10 x 100 mL in clear type II glass bottle with rubber stopper closures.
Not all presentations are marketed in Australia or New Zealand.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Sodium amidotrizoate.

Molecular formula: C₁₁H₈I₃N₂NaO₄. Chemical name: sodium 3,5-diacetamido -2,4,6-triiodobenzoate. Molecular weight: 635.90. Solubility in water: freely soluble.

Amidotrizoate meglumine.

Molecular formula: C₁₈H₂₆I₃N₃O₉. Chemical name: N-methylglucamine 3,5-diacetamido- 2,4,6-triiodobenzoate. Molecular weight: 809.13. Solubility in water: freely soluble. See Table 1.

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Amidotrizoate meglumine; Sodium amidotrizoate

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