Label:Patient Information

Urografin 370 mg Iodo/ml injectable and for perfusion solution

Amidotrizoate meglumine and amidotrizoate sodium (DCI)

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or the person administering Urografin (the radiologist) or hospital or center staff where the test is performed.
• If you experience any adverse effects,consult your doctor or radiologist, eveniftheydo not appear in this label. See section 4.

1.What Urografin is and for what it is used

2.What you need to knowbeforestarting to use Urografin

3.How to use Urografin

4.Possible adverse effects

1. Storage of Urografin

6.Contents of the package and additional information

This medication is solely for diagnostic use.

It belongs to the group of medications known as high osmolar, iodinated, water-soluble, and nephrotropic contrast media for X-rays.

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

• intravenous urography (radiological technique for the visualization of the urinary tract through the intravenous injection of a contrast medium),
• angiographic explorations (of blood vessels) such as aortography, angiocardiography, and coronary arteriography,
• arthrography (radiological technique for the visualization of joints),
• intraoperative cholangiography (radiological technique for the visualization of the gallbladder and bile ducts),
• retrograde endoscopic cholangiopancreatography (CPRE; radiological technique for the visualization of the gallbladder, bile ducts, and pancreatic ducts),
• sialography (radiological technique for the visualization of salivary gland ducts),
• fistulography (radiological technique for the visualization of fistulas [abnormal communication between two organs or an organ and the exterior]),
• hysterosalpingography (radiological technique for the visualization of the uterus and fallopian tubes),
• galactography (radiological technique for the visualization of milk ducts in mammograms)

No use Urografin

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

Warnings and precautions

Consult your doctor before starting to use Urografin.

For all indications

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

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

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

Allergic hypersensitivity reactions may worsen if you are being treated with beta-blockers, particularly if you have asthma. Additionally, you may not respond to standard treatment for allergic hypersensitivity reactions with beta-agonists.

• If you have or are suspected to havehyperthyroidism(hyperactivity of the thyroid gland)or goiter(enlargement of the thyroid gland), as iodinated contrast media may interfere with thyroid function, exacerbate or induce hyperthyroidism, and thyroid crisis (a severe complication of a hyperactive thyroid).

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

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

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

• If you have anadvanced ageas vascular pathology and neurological disorders that are frequently observed in these patients increase the risk of adverse reactions.

• If you have asignificant deterioration of your health.

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

• You must ensure adequatehydrationbefore and after administration of the contrast medium. This is especially important if you have multiple myeloma (a type of blood cancer), diabetes mellitus that affects the kidneys, polyuria (increased urine volume), oliguria (decreased urine volume), 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 procedure.

• Newborns (<1

Newborns under 1 year and especially newborns are susceptible to experiencing alterations in both blood dynamics and electrolyte content in the body. You should exercise caution with the dose of contrast medium to be administered, the technical performance of the radiological procedure, and your overall condition.

• States of excitement,anxietyand 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 performallergy testsusing small doses of contrast medium, as these have no predictive value. In rare cases, allergy tests have caused severe and even fatal hypersensitivity reactions.

Before you receive Urografininform your doctor if any of these cases apply to you.Your doctor will decide whether the planned diagnostic procedure is or is not possible.

Your thyroid function may be evaluated before receiving Urografin, and you may be administered a thyroid-stimulating medication.

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

For intravascular administration

• If you are a patient at high risk of experiencing atransient renal insufficiency, 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 (renal pathology), decreased normal fluid volume, multiple myeloma (blood cancer of the bone marrow), age over 60, advanced vascular pathology, paraproteinemia (disease in which an excessive amount of certain proteins is produced), hypertension, gout, or patients receiving high or repeated doses.

• If you are being treated with metformin(biguanide: a medication used in the treatment of certain forms of diabetes mellitus), the administration of contrast media may produce 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 administration, and only when normal renal function has been restored.

• If you have acardiovascular pathology

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

If you have a valvular pathology and pulmonary hypertension, the administration of contrast media may produce significant changes in blood dynamics.

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

• If you have acentral nervous system (CNS) pathology

Your doctor will payspecial attention to the administration of the contrast mediumif you have experienced a cerebrovascular accident (acute cerebral infarction, acute intracranial hemorrhage) and other pathologies that involve damage to the blood-brain barrier (a histophysiological structure that separates the cerebral nervous tissue from the blood), cerebral edema, acute demyelination (loss of myelin: a substance of the CNS that facilitates and increases the speed of nerve impulse transmission), or intracranial tumors or metastases, and a history of epilepsy, as you have a higher risk of experiencing neurological complications (e.g., seizures).

If you have cerebrovascular disease, recent cerebrovascular accidents, or frequent transient ischemic attacks, you have a higher risk of experiencing neurological complications.

Neurological symptoms due to cerebrovascular disease, intracranial tumors or metastases, and degenerative or inflammatory pathologies may worsen with the administration of contrast media.

The intra-arterial injection of contrast media may produce vasoconstriction (decreased diameter of the blood vessel) with the consequent cerebral ischemic phenomena.

• If you have asevere liver dysfunctionThe coexistence of severe liver dysfunction and renal insufficiency may delay the excretion of the contrast medium, potentially requiring hemodialysis.

• If you havemultiple myeloma(blood cancer of the bone marrow) orparaproteinemia(disease in which an excessive amount of certain proteins is produced), as it predisposes to a deterioration of renal function.

• If you have been diagnosed with apheochromocytoma(a type of tumor) as you may develop a severe and potentially uncontrolled hypertensive crisis.

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

• If you havemyasthenia gravis(a disease in which muscles become weakened and fatigued easily) as symptoms of this disease may worsen.

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

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

For administration in body cavities

• For the performance of a retrograde endoscopic cholangiopancreatography or a cholangiography, if you have aninflammation of the bile ducts.

• For the performance of a hysterosalpingography, if you have aninflammation of the uterine tubes. Additionally, remember that before performing a hysterosalpingography, all possibility of pregnancy should be excluded.

Use of Urografin with other medications

Inform your doctor if you are using, have used recently, 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 pruritus) is higher.

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

Use of Urografin with food and beverages

Dietary recommendations

In the case of some urinary tract explorations (urographies), better images are obtained when the intestine is free of residues and gases. Therefore, during the 2 days preceding the exploration, you should avoid gas-producing foods, especially beans, lentils, and peas, salads, fruits, bread, and all types of raw vegetables. The day before the exploration, 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 administration of a laxative before the exploration are contraindicated.

Pregnancy and lactation

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

• Pregnancy

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

• Lactation

Contrast media of renal elimination, such as Urografin, are excreted in breast milk in very small amounts.

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

Driving and operating machinery

Reactions may occur. In such cases, avoid driving because the use of Urografin may prevent you from driving safely, and your ability to use any tool or machine may be affected. You will not be able to react quickly and deliberately in the event of unexpected and sudden events. Do not drive a car or any other vehicle.

Urografin contains sodium

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

This medication contains 362.00 mg of sodium (main component of table salt/for cooking) in each dose (100 ml). This corresponds to 18.1% of the recommended daily maximum sodium intake for an adult.

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

Urografin is a contrast medium used for diagnostic testing, which must be performed in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at each moment.

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

Dosage in adults:

Dosage in pediatric population:

Additional information on the administration and handling of Urografin is included at the end of the prospectus.

Dosage in special populations

Renal insufficiency / Heart failure

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

Geriatric population (population over 65 years of age):

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

Patients with liver insufficiency:

No additional dose adjustment is considered necessary.

If you estimate that the action of Urografin is too strong or too weak, inform 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. Your renal function should be monitored for at least 3 days. If necessary, hemodialysis can be used to eliminate most of the contrast medium.

In case of overdose or accidental ingestion, consult the Toxicology 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.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The side effects associated with the intravascular administration of iodinated contrast media are normally mild to moderate in nature and transient in character. However, severe life-threatening reactions and even deaths have also been described. The prevalence of pharmacological adverse reactions in patients to whom ionic contrast media are administered is higher than 12%, compared to more than 3%in patients to whom non-ionic contrast media are administered.The most frequent side effects reported are nausea, vomiting, a sensation of pain, and a general feeling of heat.

Side 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 their distribution throughout the body, mainly through diffusion-controlled processes. In relation to hysterosalpingography, cases of vasovagal reactions (sudden and transient loss of consciousness followed by rapid recovery) are infrequent.

The following arepossible side effectsthat have been reported by patients treated with Urografin during intravascular and body cavity use according to their probability:

Frequent side effects(may affectup to 1 in 10 people):

• Anaphylactoid/hypersensitivity reactions (angioedema, conjunctivitis, cough, pruritus, rhinitis, sneezing, and urticaria)
• Sensation of heat, local pain2,3,5, edema3,5
• Nausea, vomiting
• Headache
• Transient alterations in respiratory frequency, dyspnea, respiratory difficulty, cough
• Erythema
• Syncope with vasodilation

Infrequent side effects(may affect up to 1 in 100 people):

• Hypotension1, bronchospasm1, laryngeal spasm1, laryngeal edema1
• Discomfort, chills, sweating
• Transient alteration in heart rate, transient alteration in blood pressure, alteration of cardiac rhythm or function, cardiac arrest
• Auditory disturbance4
• Transient blindness4, photophobia4, visual disturbance4
• Abdominal pain
• Vasovagal reactions7, dizziness4, agitation4, confusion4, amnesia4, speech disturbances4, convulsions4, tremor4, paresis/paralysis4, coma4, somnolence4

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

• Delayed hypersensitivity reaction (contrast medium reactions)
• Myocardial infarction
• Salivary gland swelling, pancreatitis8,9, necrotizing pancreatitis8,9
• Body temperature fluctuation, elevated amylase (pancreatic enzyme)8,9
• Cerebrovascular accident6
• Renal function alterations, renal insufficiency
• Respiratory arrest, pulmonary edema
• Mucocutaneous syndrome (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis/Lyell syndrome)
• Thrombophlebitis5, venous thrombosis5, embolism

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

• Inflammation5, tissue necrosis5

1In the context of anaphylactoid/hypersensitivity reactions.

2Primarily in association with peripheral angiography.

3In association with contrast medium extravasation, generally disappearing without sequelae.

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

5In association with the injection site.

6In isolated cases, fatal.

7In relation to hysterosalpingography

8Rarely found in association with use in body cavities.

9Post-ERCP (endoscopic retrograde cholangiopancreatography)

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. The administration of the contrast medium should be suspended immediately and, if necessary, specific treatment should be initiated intravenously.

Severe life-threatening anaphylactoid/hypersensitivity reactions or cardiac disturbances that require emergency treatment may present as a circulatory reaction accompanied by peripheral vasodilation and the resulting hypotension, reflex tachycardia, dyspnea, agitation, confusion, and cyanosis, which may lead to loss of consciousness.

In rare cases, severe thromboembolic episodes have been reported, leading to a cerebrovascular accident, 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 ruled out entirely.

Some elevation of amylase levels is common after ERCP. It has been demonstrated that acinar opacification (visualization of contrast in pancreatic acinar ducts) after ERCP is associated with a higher risk of post-ERCP pancreatitis. In rare cases, necrotizing pancreatitis has 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Usehttps://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

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

Do not use this medication after the expiration date that appears on the label and packaging after CAD. 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 color changes, or the presence of particles, or if the packaging appears defective.

The contrast medium not used in an examination session must be discarded.

Medications should not be thrown down the drain or in the trash.The healthcare professional will dispose ofthepackaging andmedications that are no longerneeded.By doing so, they will help protect the environment.

Composition of Urografin

The active principles 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 injection.

Appearance of the product and contents of the container

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

Urografin presentations:

• 20 ml ampoules.
• 50 and 100 ml vials.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer

BERLIMED, S.A.

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

28806 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet:October 2021

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

Before administering Urografin

The 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 warmer is used, only the estimated number of vials 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 of time 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 present significant color changes, the appearance of particles in suspension, or if the container is defective.

Handling

The contrast solution should not be drawn into the syringe, nor should the vial be connected to the infusion equipment, until immediately before the examination.

The rubber stopper should not be pierced more than once to avoid large amounts of microparticles from the stopper passing into the solution. The use of long, 18 G or less, needles is recommended for piercing the stopper and extracting the contrast medium (special extraction needles with a lateral opening are particularly suitable).

For single use only. Do not use the same container for multiple patients. Unused contrast medium must be discarded.

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Incompatibilities

This medicine should not be mixed with other products to avoid the risk of possible incompatibilities.

Warnings and precautions for use(see also section 2: What you need to know before using Urografin)

Reactions of Hypersensitivity

Occasionally, allergic reactions of type I hypersensitivity 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 experiencing a severe reaction.

Before injecting any contrast medium, the patient should be questioned about possible allergic antecedents, e.g., shellfish allergy, allergic rhinitis (hay fever), asthma, sensitivity to iodine or radiographic contrast media, and asthma bronchial, as 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.

Patients with asthma bronchial have a special risk of experiencing bronchospasm or hypersensitivity reactions.

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

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

Pre-administration tests

No pre-administration tests are recommended using small doses of contrast medium, as they have no predictive value. In addition, pre-administration tests have occasionally caused severe and even fatal hypersensitivity reactions.

For intravascular administration

Renal Insufficiency

Transient renal insufficiency may occur in rare cases. 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 disease, pre-existing renal insufficiency, previous renal insufficiency after contrast media administration, diabetes mellitus with nephropathy, reduced volume, multiple myeloma, age over 60 years, advanced vascular disease, paraproteinemia, severe and chronic hypertension, gout, or patients receiving high or repeated doses).

Ensuring adequate hydration in high-risk patients before contrast medium administration, preferably through 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 angioplasty, major surgery, etc., until the contrast medium has been eliminated.

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

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

Phaeochromocytoma

Patients with phaeochromocytoma may develop a severe and uncontrolled hypertensive crisis after intravascular administration of contrast media. Pre-treatment with alpha-adrenergic receptor antagonists is recommended.

Coagulation

Iodinated contrast media inhibit blood coagulationin 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 of these factors should be taken into account when performing a vascular catheterization procedure, and special attention should be paid to the angiographic technique used and frequent irrigation of the catheter with physiological saline solution (adding heparin whenever possible), as well as minimizing the duration of the procedure to minimize 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 reduces, but does not eliminate, the possibility of coagulationin vitro.

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

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

Intravenous urography

• Intravenous urography by injection

Generally, the injection speed is 20 ml/min. If 100 ml or more are administered to patients with heart failure, a 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 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 under 2 years of age, and it is not recommended during perfusion of large amounts of contrast medium in children, adolescents, and adults, as, if drainage is obstructed, the increase in pressure may cause rupture of the fornix. However, compression can be applied 10 minutes after the perfusion has ended to distinguish between organic and functional filling defects.

Angiographic examinations

The 76% solution is suitable for angiographic examinations that require a particularly high iodine concentration, e.g., aortography, angiocardiography, 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 the administration of the contrast medium has ended.

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

A insufficient amount of contrast may require additional radiographs.

Intravenous urography by perfusion

The first radiograph should be taken towards the end of the perfusion. Additional radiographs can be taken during the next 20 minutes, or later if there are alterations in excretion.

Different indications for intravenous urography

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