UROGRAFIN 370 MG IODINE/ML INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Leaflet:Information for the patient

Urografin 370 mg Iodo/ml injectable solution and for perfusion

Meglumine amidotrizoate and sodium amidotrizoate (DCI)

Read the entire leaflet carefully before starting to use this medicine,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or the person administering Urografin (the radiologist) or the hospital or center staff where the test is performed.
• If you experience side effects, consult your doctor or radiologist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Urografin is and what it is used for
2. What you need to know before starting to use Urografin
3. How to use Urografin
4. Possible side effects
   1. Storage of Urografin

1. Package contents and additional information

1. What Urografin is and what it is used for

This medicine is for diagnostic use only.

It belongs to the group of medicines called X-ray contrast media, iodinated, high-osmolar, water-soluble, and nephrotoxic.

Urografin is an iodinated radiological contrast medium that is used for:

• intravenous urography (radiological technique for visualizing the urinary tract by injecting a contrast medium intravenously),
• angiographic examinations (of blood vessels) such as aortography, angiocardiology, and coronary arteriography,
• arthrography (radiological technique for visualizing joints),
• intraoperative cholangiography (radiological technique for visualizing the gallbladder and bile ducts),
• endoscopic retrograde cholangiopancreatography (ERCP; radiological technique for visualizing the gallbladder, bile ducts, and pancreatic ducts),
• sialography (radiological technique for visualizing the salivary gland ducts),
• fistulography (radiological technique for visualizing fistulas [abnormal communication between two organs or an organ and the exterior]),
• hysterosalpingography (radiological technique for visualizing the uterus and fallopian tubes/uterine tubes)
• galactography (radiological technique for visualizing the galactophorous ducts in mammograms)

2. What you need to know before starting to use Urografin

Do not use Urografin

• If you are allergic to the active ingredients or any of the other components of this medicine (listed in section 6).
• If you have overt hyperthyroidism
• If you have decompensated heart failure.
• For hysterosalpingography, if you are pregnant or have an acute inflammatory pathology of the pelvic cavity.
• For endoscopic retrograde cholangiopancreatography, if you have acute pancreatitis.
• For myelography (radiological technique for visualizing the spinal cord and subarachnoid spaces), ventriculography, or cisternography (radiological technique for visualizing the cerebral cisterns), as it is likely to produce neurotoxic symptoms (pain, convulsions, and coma, often with a fatal outcome) in these examinations.

Warnings and precautions

Consult your doctor before starting to use Urografin.

For all indications

The following warnings and precautions apply to any form of use of the contrast medium, although the risks indicated are greater in the case of intravascular administration:

• If you have experienced an allergic hypersensitivity reactionafter using radiological contrast media. These reactions usually manifest as mild respiratory or skin symptoms, such as mild breathing difficulties, skin redness (erythema), urticaria (skin condition characterized by hives, papules, and itching, among other symptoms and signs), itching, and facial edema. Severe reactions such as angioedema (anaphylactic/allergic reaction characterized by subcutaneous edematous areas without itching, with a normal external appearance of the skin), subglottic edema (an area inside the throat), bronchospasm, and allergic shock are possible. These reactions usually occur within the first hour after administration of the contrast medium. However, in rare cases, delayed reactions (after hours or days) can occur.

If you have a history of reaction to contrast media, iodine sensitivity, history of allergy (e.g., shellfish allergy, allergic rhinitis, hives), or asthma, you have a higher incidence of adverse reactions to contrast media and a greater risk of experiencing a severe reaction. Pre-treatment with antihistamines and/or glucocorticoids may be considered.

Hypersensitivity reactions can be exacerbated if you are being treated with beta-blockers, particularly if you have asthma. Additionally, you may not respond to standard treatment for hypersensitivity reactions with beta-agonists.

• If you have overt hyperthyroidism(hyperactivity of the thyroid gland) or goiter(enlargement of the thyroid gland), as iodinated contrast media can interfere with thyroid function, worsen or induce hyperthyroidism, and thyrotoxic crisis (a serious complication of hyperthyroidism).

If you have hyperthyroidism or subclinical hyperthyroidism, your thyroid function should be evaluated before administration of Urografin and/or preventive thyroid medications.

It is recommended to monitor thyroid function in newborns, especially premature babies, who have been exposed to Urografin during pregnancy or at birth, as they may require treatment for excessive iodine exposure.

• If you have cardiovascular disease, as it increases the risk of experiencing a severe adverse reaction, particularly in those with heart failure and coronary artery disease.

• If you are of advanced age, as vascular disease and neurological disorders that are common in these patients increase the risk of adverse reactions.

• If you have a significant deterioration in your health status.

In these cases, your doctor will carefully evaluate the need for the examination.

• Adequate hydrationshould be ensured before and after administration of the contrast medium. This is especially important if you have multiple myeloma (a type of blood cell cancer), diabetes mellitus that affects the kidneys, polyuria (increased urine volume), oliguria (decreased urine volume), and hyperuricemia (increased uric acid in the blood), as well as in newborns, infants, young children, and elderly patients. Any alteration related to hydration and electrolyte content in your body should be corrected before the examination.

• Newborns (< 1 month) and children (1 month to 2 years)

Children under 1 year, especially newborns, are susceptible to alterations in both blood dynamics and electrolyte content. Caution should be exercised with the dose of contrast medium to be administered, the technical performance of the radiological procedure, and their general condition.

• States of excitement, anxiety, and intense pain can increase the risk of adverse reactions or the intensity of reactions associated with contrast media. In these cases, your doctor may recommend that you take a sedative.

It is not recommended to perform sensitivity testsusing small doses of contrast medium, as they have no predictive value. Additionally, sensitivity tests have occasionally caused severe and even fatal hypersensitivity reactions.

Before you receive Urografin, tell your doctor if any of these cases apply to you. Your doctor will decide if the planned diagnostic test is possible.

Your thyroid function may be examined before receiving Urografin, and you may be given a thyroid medication.

The doctor should monitor the thyroid function of newborns, especially premature babies, who have been exposed to Urografin, either during pregnancy or after birth, as excessive iodine exposure can cause hypothyroidism (underactive thyroid gland), which may require treatment.

For intravascular administration

• If you are a patient at high risk of experiencing transient renal failure, e.g., patients with a history of kidney disease, pre-existing renal failure, previous renal failure after contrast medium administration, diabetes mellitus with nephropathy (kidney disease), decreased fluid volume, multiple myeloma (blood cell cancer), age over 60, advanced vascular disease, paraproteinemia (disease in which excessive amounts of certain proteins are produced), chronic and severe hypertension, gout, or patients receiving high or repeated doses.

• If you are being treated with metformin(biguanide: a medication used to treat some forms of diabetes mellitus), the administration of contrast media can cause lactic acidosis due to altered renal function. Treatment with biguanides (metformin) should be suspended 48 hours before administration of the contrast medium and not resumed until 48 hours after it, and only when normal renal function has been restored.

• If you have any cardiovascular disease.

If you are of advanced age and have pre-existing heart disease, reactions involving ischemic changes (lack of oxygen) in the ECG (electrocardiogram) and significant arrhythmias (abnormal heart rhythms) are more frequent.

If you have valvular disease and pulmonary hypertension, the administration of contrast media can cause significant changes in blood dynamics.

If you have heart failure, intravascular injection of contrast media can precipitate pulmonary edema.

• If you have any central nervous system (CNS) disease

Your doctor will pay special attention to the administration of the contrast medium if you have had cerebrovascular accidents (acute stroke, acute intracranial hemorrhage) and other diseases that involve damage to the blood-brain barrier (histo-physiological structure that separates the cerebral nervous tissue from the blood), cerebral edema, acute demyelination (loss of myelin: a substance in the CNS that facilitates and increases the speed of nerve impulse transmission).

If you have tumors or intracranial metastases and a history of epilepsy, you are at higher risk of presenting neurological complications (e.g., convulsions).

If you have symptomatic cerebrovascular disease, recent stroke, or frequent transient ischemic attacks, you are at higher risk of experiencing neurological complications.

Neurological symptoms due to cerebrovascular disease, tumors or intracranial metastases, and degenerative or inflammatory diseases can be exacerbated by the administration of contrast media.

Intra-arterial injection of contrast media can cause vasoconstriction (decrease in blood vessel diameter) with consequent cerebral ischemic phenomena (lack of oxygen).

• If you have severe hepatic dysfunction. The coexistence of severe hepatic dysfunction and renal failure can delay the excretion of the contrast medium, potentially requiring hemodialysis.

• If you have multiple myeloma(blood cell cancer) or paraproteinemia(disease in which excessive amounts of certain proteins are produced), as it predisposes to renal function deterioration.

• If you have been diagnosed with pheochromocytoma(a type of tumor), as you may develop a severe hypertensive crisis (occasionally uncontrollable).

• If you have any autoimmune disease(diseases of the immune system that recognize the body's own tissues as foreign and attack them), as severe cases of vasculitis (inflammation of blood vessels) and Stevens-Johnson syndrome (disease characterized by polymorphic erythema and mucocutaneous, ocular, and other manifestations) have been described.

• If you have myasthenia gravis(disease in which muscles weaken and fatigue easily), as the symptoms of this disease can be exacerbated.

• If you suffer from alcoholism, acute or chronic, as it can increase the permeability of the blood-brain barrier (histo-physiological structure that separates the cerebral nervous tissue from the blood). This facilitates the passage of the contrast medium into the brain tissue, which may cause CNS reactions. Alcoholics and drug addicts should be cautious due to the possibility of a decreased convulsive threshold.

• If you have homocystinuria(disease of protein metabolism) due to the risk of inducing thrombosis and embolism.

For administration in body cavities

• For endoscopic retrograde cholangiopancreatography or cholangiography, if you have bile duct inflammation.

• For hysterosalpingography, if you have inflammation of the fallopian tubes. Additionally, remember that before performing a hysterosalpingography, any possibility of pregnancy should be ruled out.

Use of Urografin with other medications

Tell your doctor if you are using, have recently used, or may need to use any other medication.

If you are being treated with interleukin, you should know that the prevalence of delayed reactions to contrast media (e.g., fever, rash, flu-like symptoms, joint pain, and itching) is higher.

If you are going to undergo tests for thyroid disease diagnosis, note that after administration of iodinated contrast media, the ability of the thyroid tissue to capture radioisotopes for thyroid disease diagnosis is reduced for 2 weeks, and even longer in individual cases.

Use of Urografin with food and beverages

Dietary recommendations

In the case of some urinary tract examinations (urographies), better images are obtained when the intestine is free of residues and gases. Therefore, during the two days prior to the examination, you should avoid gas-producing foods, especially peas, beans, and lentils, salads, fruits, bread, and all types of raw vegetables. On the day before the examination, you should not ingest any food after 6 pm. Additionally, it may be appropriate to administer a laxative at night. However, in newborns, infants, and young children, prolonged fasting and laxative administration before the examination are contraindicated.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

• Pregnancy

It has not been sufficiently demonstrated that contrast media are safe for use in pregnant patients. Since, whenever possible, exposure to radiation should be avoided during pregnancy, the benefits of any radiological examination, with or without contrast medium, should be carefully weighed against the potential risks.

• Breastfeeding

Renally excreted contrast media, such as Urografin, are only excreted in breast milk in very small amounts.

Some data suggest that the risk to the infant is low in the case of Urografin administration to the mother. Probably, breastfeeding is safe.

Driving and using machines

Delayed reactions can occur. In such cases, avoid driving, as the use of Urografin could impair your ability to drive safely, and your ability to use any tool or machine may be affected. You will not be able to react quickly and deliberately in case of unexpected and sudden events. Do not drive a car or any other vehicle.

Urografin contains sodium

This medicine contains 72.40 - 181.00 mg of sodium (main component of table/cooking salt) per dose (20-50 ml). This is equivalent to 3.62 - 9.05% of the maximum recommended daily sodium intake for an adult.

This medicine contains 362.00 mg of sodium (main component of table/cooking salt) per dose (100 ml). This is equivalent to 18.1% of the maximum recommended daily sodium intake for an adult.

3. How to use Urografin

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again.

Urografin is a contrast medium used for a diagnostic test, which should be performed in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at all times.

For intravenous and intraarterial administration routes, the dose may vary depending on age, body weight, cardiac output, and the patient's general condition.

Dosage in adults:

Dosage in pediatric population:

At the end of the prospectus, additional information on the administration and handling of Urografin is included.

Dosage in special populations

Renal / cardiac insufficiency

If you have marked cardiovascular or renal insufficiency, or are in poor general condition, you should be administered the lowest possible dose of contrast medium. Additionally, your renal function should be monitored for at least 3 days after the examination.

Elderly patients (population over 65 years of age):

No dose adjustment is recommended compared to younger adults, as the iodine concentrations required for imaging diagnosis are independent of age, as with other iodinated contrast agents.

Patients with hepatic insufficiency:

No additional dose adjustment is considered necessary.

If you think the effect of Urografin is too strong or too weak, tell your doctor or pharmacist.

Your doctor will inform you about all the characteristics related to the administration of Urografin.

If you use more Urografin than you should

Water and electrolyte losses should be compensated by perfusion. It is necessary to monitor renal function for at least three days. If necessary, hemodialysis can be used to eliminate most of the contrast medium.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or radiologist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Adverse effects associated with intravascular administration of iodinated contrast media are usually mild to moderate and transient in nature. However, serious life-threatening reactions, including deaths, have also been described. The prevalence of pharmacological adverse reactions in patients administered iodinated contrast media is higher than 12%, compared to more than 3% in patients administered non-ionic contrast media. The most common adverse effects reported are nausea, vomiting, sensation of pain, and generalized sensation of heat.

Adverse effects after administration in body cavities are rare. Most of them occur several hours after administration, due to the slow absorption from the site of administration and distribution throughout the body, mainly through controlled diffusion processes. In relation to hysterosalpingography, cases of vasovagal reactions (sudden and transient loss of consciousness followed by rapid recovery) are infrequent.

The following are possible adverse effectsthat have been reported by patients treated with Urografin during intravascular and body cavity administration, according to their probability:

Common adverse effects(may affect up to 1 in 10 people):

• Anaphylactoid/hypersensitivity reactions (angioedema, conjunctivitis, cough, pruritus, rhinitis, sneezing, and urticaria)
• Sensation of heat, local pain, edema
• Nausea, vomiting
• Headache
• Transient changes in respiratory rate, dyspnea, respiratory difficulty, cough
• Erythema
• Flushing with vasodilation

Uncommon adverse effects(may affect up to 1 in 100 people):

• Hypotension, bronchospasm, laryngeal spasm, laryngeal edema
• Discomfort, chills, sweating
• Transient changes in heart rate, transient changes in blood pressure, changes in cardiac rhythm or function, cardiac arrest
• Hearing disorder
• Transient blindness, photophobia, vision disorder
• Abdominal pain
• Vasovagal reactions, dizziness, agitation, confusion, amnesia, speech disorders, convulsions, tremor, paresis/paralysis, coma, somnolence

Rare adverse effects(may affect up to 1 in 1,000 people):

• Type IV hypersensitivity reaction (delayed reactions to contrast medium)
• Myocardial infarction
• Swelling of the salivary glands, pancreatitis, necrotizing pancreatitis
• Fluctuation in body temperature, increased amylase (pancreatic enzyme)
• Stroke
• Changes in renal function, renal insufficiency
• Respiratory arrest, pulmonary edema
• Mucocutaneous syndrome (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis/Lyell syndrome)
• Thrombophlebitis, venous thrombosis, embolism

Very rare adverse effects(may affect up to 1 in 10,000 people):

• Inflammation, tissue necrosis

1 In the context of anaphylactoid/hypersensitivity reactions.

2 Mainly in association with peripheral angiography.

3 In association with extravasation of contrast media, usually disappearing without sequelae.

4 Transient neurological symptoms and/or complications associated with procedures in which the contrast medium reaches the brain in high concentrations.

5 In association with the injection site.

6 In isolated cases, fatal.

7 In relation to hysterosalpingography

8 Rarely found in association with use in body cavities.

9 Post-endoscopic retrograde cholangiopancreatography (ERCP)

Description of some adverse reactions

Intravascular administration

Anaphylactoid/hypersensitivity reactions (e.g., mild angioedema, conjunctivitis, cough, pruritus, rhinitis, sneezing, and urticaria) may occur, regardless of the amount administered and the route of administration, and may be the first signs of an impending shock state. Administration of the contrast medium should be stopped immediately, and if necessary, specific treatment should be initiated intravenously.

Severe anaphylactoid/hypersensitivity reactions or cardiac disorders requiring emergency treatment may present as a circulatory reaction accompanied by peripheral vasodilation and subsequent hypotension, reflex tachycardia, dyspnea, agitation, confusion, and cyanosis, which can lead to loss of consciousness.

Rarely, serious thromboembolic episodes have been reported, leading to stroke, in isolated cases fatal, and myocardial infarction.

Administration in body cavities

Systemic hypersensitivity is rare, mostly mild, and usually occurs in the form of skin reactions. However, the possibility of a severe hypersensitivity reaction cannot be entirely excluded.

Some elevation of amylase levels after endoscopic retrograde cholangiopancreatography (ERCP) is common. It has been shown that acinar opacification (visualization of contrast in the pancreatic acinar ducts) after ERCP is associated with a higher risk of post-ERCP pancreatitis. Rarely, cases of necrotizing pancreatitis have been described.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or radiologist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Urografin

Keep this medication out of sight and reach of children.

Do not store above 25 °C. Keep in the original packaging to protect from light and ionizing radiation (X-rays).

Do not use this medication after the expiration date shown on the label and packaging after EXP. The expiration date is the last day of the month indicated.

This medication is a clear, colorless to pale yellow solution, ready for use. Do not use this medication if you observe significant changes in color or the presence of particles, or if the packaging appears defective.

Unused contrast medium in an examination session should be discarded.

Medicines should not be thrown away through wastewater or household waste. The healthcare professional will dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

Composition of Urografin

The active ingredients are sodium amidotrizoate and meglumine amidotrizoate.

1 ml of Urografin contains 0.1 g of sodium amidotrizoate and 0.66 g of meglumine amidotrizoate (sodium diatrizoate and meglumine diatrizoate) in aqueous solution.

The other components are: calcium and sodium edetate and water for injectable preparations.

Appearance of the Product and Container Content

Urografin is a clear, colorless to pale yellow solution, ready for use.

Presentations of Urografin:

• Ampoules of 20 ml.
• Bottles of 50 and 100 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

BERLIMED, S.A.

C/ Francisco Alonso, 7 - Polígono Industrial Sta. Rosa

28806 Alcalá de Henares (Madrid)

Spain

Date of Last Revision of this Prospectus:October 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Before Administration of Urografin

Contrast media that are heated to body temperature before administration are better tolerated and can be administered more easily due to the decrease in their viscosity. If a heater is used, only the estimated number of bottles to be used on the day of the examination should be heated to 37°C. If Urografin is protected from sunlight, it can be stored at this temperature for longer periods without changes in the chemical purity of the product. However, this period should not exceed 3 months.

Urografin is supplied ready for use as a clear, colorless to pale yellow solution. Contrast media should not be used if they show significant changes in color, appearance of particles in suspension, or if the container is defective.

Handling

The solution of the contrast medium should not be drawn into the syringe, nor should the bottle be connected to the perfusion equipment, until immediately before the examination.

The rubber stopper should not be punctured more than once to avoid large amounts of microparticles from the stopper passing into the solution. The use of long-tip cannulas with a maximum diameter of 18 G is recommended to puncture the stopper and extract the contrast medium (special extraction cannulas with a lateral opening are particularly suitable).

For single use. Do not use the same container for several patients. Unused contrast medium in an examination should be discarded.

The disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.

Incompatibilities

This medicinal product should not be mixed with others to avoid the risk of possible incompatibilities.

Special Warnings and Precautions for Use(see also section 2: What you need to know before starting to use Urografin)

Hypersensitivity Reactions

Occasionally, hypersensitivity reactions of an allergic type have been observed in patients after the use of radiological contrast media such as Urografin.

Patients with hypersensitivity or previous reactions to iodinated contrast media have a higher risk of suffering a severe reaction.

Before injecting any contrast medium, the patient should be questioned about possible allergic history, e.g., shellfish allergy, allergic rhinitis (hay fever), hives, sensitivity to iodine or radiographic agents, and bronchial asthma, since the incidence of adverse effects to contrast media is higher in patients with these conditions. Pre-treatment with antihistamines and/or glucocorticoids may be considered.

Patient with bronchial asthma have a special risk of suffering bronchospasms or a hypersensitivity reaction.

Hypersensitivity reactions can be exacerbated in patients treated with beta-blockers, particularly in patients with bronchial asthma. Additionally, it should be taken into account that patients treated with beta-blockers may be refractory to standard treatment of hypersensitivity reactions with beta-receptor agonists.

If hypersensitivity reactions occur, administration of the contrast medium should be suspended immediately and, if necessary, specific treatment should be initiated intravenously. Therefore, it is recommended to use a permanent flexible cannula for intravenous administration of the contrast medium. To be able to act immediately in case of emergency, the appropriate medications, an endotracheal tube, and an artificial respirator should be readily available.

Pre-administration Tests

It is not recommended to perform sensitization tests using small doses of contrast medium, as they have no predictive value. Additionally, sensitization tests have occasionally caused severe and even fatal hypersensitivity reactions.

For Intravascular Administration

Renal Insufficiency

Transient renal insufficiency can rarely occur. Preventive measures against acute renal insufficiency after administration of contrast media include:

Identification of high-risk patients (e.g., patients with a history of renal pathology, pre-existing renal insufficiency, previous renal insufficiency after administration of contrast media, diabetes mellitus with nephropathy, volume reduction, multiple myeloma, age over 60 years, advanced vascular disease, paraproteinemia, chronic and severe hypertension, gout, or patients receiving high or repeated doses).

Ensuring adequate hydration in risk patients before administration of the contrast medium, preferably by intravascular transfusion before and after the procedure and until the contrast medium has been eliminated by the kidneys.

Avoiding additional renal overload, in the form of nephrotoxic drugs, oral cholecystographic agents, arterial clamping, renal artery angioplasty, major surgery, etc., until the contrast medium has been eliminated.

Delaying a new examination with contrast medium until renal function has completely returned to pre-examination levels.

Contrast media can be administered for radiological examinations to patients on dialysis, as iodinated contrast media are eliminated in the dialysis process.

Pheochromocytoma

Patient with pheochromocytoma may develop a severe hypertensive crisis (sometimes uncontrollable) after intravascular administration of contrast media. Pre-treatment with alpha-adrenergic receptor blockers is recommended.

Coagulation

Iodinated contrast media inhibit blood coagulation in vitromore than non-ionic contrast media. However, healthcare personnel performing vascular catheterization procedures should consider that, in addition to the contrast medium, numerous factors can contribute to the development of thromboembolic events, such as the duration of the procedure, the number of injections, the type of catheter and syringe material, the patient's underlying pathology, and concomitant medication.

Therefore, all this should be taken into account when performing a vascular catheterization procedure, paying special attention to the angiographic technique used, and frequently irrigating the catheter with physiological saline solution (adding heparin whenever possible), as well as minimizing the duration of the procedure, with the aim of minimizing the risk of thromboembolic events related to the diagnostic procedure performed.

It has been reported that the use of plastic syringes instead of glass syringes decreases, but does not eliminate, the possibility of in vitrocoagulation phenomena.

Dosage(see also section 3: How to use Urografin)

Between separate injections, sufficient time should be allowed for the diffusion or movement of intravascular fluid to normalize the increase in serum osmolality. In adequately hydrated patients, a period of 10-15 minutes is necessary to achieve this. In special situations in adults, where it is necessary to exceed a total dose of 300 to 350 ml, hydration and possibly electrolyte replacement should be performed.

Intravenous Urography

• Intravenous Urography by Injection

Generally, the injection rate is 20 ml/min. If 100 ml or more are administered to patients with heart failure, an injection time of at least 20-30 minutes is recommended.

• Intravenous Urography by Perfusion

Adults and Adolescents

Generally, the perfusion time should not be less than 5 minutes or much more than 10 minutes. In patients with heart failure, a perfusion time of 20-30 minutes is necessary.

Compression is contraindicated in newborns and children up to 2 years of age, and it is also not advisable during perfusion of large amounts of contrast media in children, adolescents, and adults, as if drainage is obstructed, the increase in diuresis can produce a rupture of the fornix as a result of increased pressure. However, compression can be applied about 10 minutes after the end of perfusion to distinguish organic filling defects from functional ones.

Angiographic Examinations

The 76% solution is suitable for those angiographic examinations that require a particularly high iodine concentration, e.g., aortography, angiocardiology, and coronary arteriography. The dosage depends on the clinical situation, the diagnostic technique to be performed, and the nature and volume of the vascular region to be studied.

Image Acquisition

Intravenous Urography by Injection

The renal parenchyma is best visualized when the radiograph is taken immediately after concluding the administration of the contrast medium.

For visualization of the renal pelvis and urinary tract, the first radiograph is taken 3-5 minutes and the second 10-12 minutes after administration of the contrast medium. Within these intervals, the time closest to injection should be chosen for younger patients and the time farthest from injection for older patients.

In newborns, infants, and young children, it is recommended to take the first radiograph as soon as approximately 2 minutes after administration of the contrast medium.

Insufficient contrast may require subsequent radiographs.

Intravenous Urography by Perfusion

The first radiograph should be taken towards the end of perfusion. Other radiographs can be taken during the following 20 minutes or later in case of excretion alterations.

Indications other than Intravenous Urography

The details of the image acquisition technique depend on the technology of the exploration used. Users should follow the specifications of the device of the respective exploration equipment used.