SCANLUX 370 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

SCANLUX 370 mg/ml, Injectable Solution EFG

Iopamidol

Read the entire package leaflet carefully before starting to use the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is SCANLUX 370 mg/ml, Injectable Solution EFG and what is it used for
2. Before using SCANLUX 370 mg/ml, Injectable Solution EFG
3. How to use SCANLUX 370 mg/ml, Injectable Solution EFG
4. Possible side effects
5. Storage of SCANLUX 370 mg/ml, Injectable Solution EFG
6. Additional information

1. What is SCANLUX 370 mg/ml INJECTABLE SOLUTION EFG and what is it used for

This medicine is for diagnostic use only.

It belongs to the group of medicines called iodinated X-ray contrast agents.

Iopamidol Juste 370 mg/ml is indicated as a radiological contrast agent for the following indications:

Adults:

• Lumbar, thoracic, and cervical myelography.
• Cerebral angiography.
• Peripheral arteriography and phlebography.
• Angiocardiography, left ventriculography.
• Coronary arteriography.
• Retrograde aortography.
• Selective visceral angiography: hepatic, celiac, superior mesenteric, and inferior mesenteric.
• Computed Tomography (CT) with contrast.
• Intravenous urography.
• Arthrography.

Children:

• Cerebral angiography.
• Peripheral arteriography and phlebography.
• Angiocardiography and left ventriculography.
• Selective renal arteriography.
• Intravenous urography.

2. BEFORE USING SCANLUX 370 mg/ml INJECTABLE SOLUTION EFG

Do not use SCANLUX 370 mg/ml if:

• You are allergic (hypersensitive) to the active substance or to any of the other components.
• You have Waldenström's paraproteinemia.
• You have multiple myeloma.
• You have severe hepato-renal disease.
• You have a history of epileptic disease.
• You have been detected with blood in the cerebrospinal fluid.
• You have a history of severe adverse reactions to contrast agents.
• You are allergic (hypersensitive) to iodine.

Be careful with SCANLUX 370 mg/ml:

• If you have previously presented allergy, asthma, or mild or moderate adverse reactions to iodinated contrast agents. Your doctor may consider administering corticosteroids or histamine H1 and H2 antagonists in these cases.

• If you have severe heart disease and pulmonary hypertension, as you may develop hemodynamic changes or arrhythmias.

• If you have acute cerebral pathology, tumors, or a history of epilepsy, as you may suffer new seizures. Also, if you are an alcoholic or drug addict, as you may have a higher risk of suffering seizures and neurological reactions. Some patients have experienced hearing loss or even temporary deafness after myelography, probably due to a decrease in spinal fluid pressure.

• If you have renal insufficiency, diabetes mellitus, and paraproteinemias (diseases that involve excessive production of certain proteins, such as myelomatosis and Waldenström's macroglobulinemia), as you may suffer a decompensation or worsening of your renal insufficiency, which can lead to acute renal failure after administration of the contrast agent.

• If you are diabetic and are being treated with metformin, as the administration of iodinated contrast agents may cause lactic acidosis.

• If you have severe liver function disorders, as there is a potential risk of transient liver dysfunction.

• If you have severe renal function disorders, as you may have a significant delay in the elimination of the contrast agent. If you are a patient on hemodialysis, you may receive the contrast agent for radiological procedures when it is ensured that dialysis will be performed immediately after.

• If you have myasthenia gravis (a disease in which muscles weaken and fatigue easily), as the symptoms of this disease may worsen.

• If you have hyperthyroidism or multinodular goiter, as you have a risk of developing hyperthyroidism.

• There is a possibility that transient hypothyroidism may occur in premature infants who receive contrast agents.

• Before starting treatment with SCANLUX 370 mg/ml, adequate hydration should be ensured before and after administration, especially in patients with multiple myeloma, diabetes mellitus, renal failure, as well as in infants, young children, and the elderly.

• If you are going to have analytical tests, keep in mind that high concentrations of the contrast agent in serum and urine may interfere with the analysis of bilirubin, proteins, or inorganic substances (e.g., iron, copper, calcium, and phosphate). These substances should not be analyzed on the day of the examination.

Consult your doctor, even if any of the above circumstances have occurred to you at some point.

Taking other medicines:

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

If you are diabetic and are being treated with metformin, the administration of iodinated contrast agents may cause lactic acidosis.

If you have been treated with interleukin-2 during the two weeks prior to the examination, you have a higher risk of suffering late reactions (symptoms similar to flu or skin reactions).

Neuroleptics should be avoided at all costs, as they lower the epileptogenic threshold, as well as analgesics, antiemetics, antihistamines, and sedatives of the phenothiazine group.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant, you should know that only strictly necessary radiological procedures should be performed during pregnancy, and when the benefit to the mother outweighs the risk to the fetus, taking into account that it is not certain whether the use of SCANLUX 370 mg/ml is safe in pregnant women.

Contrast agents are excreted in small amounts in breast milk and are minimally absorbed by the intestine. Harm to breastfed infants is therefore unlikely.

Driving and using machines:

Do not drive or operate tools or machines during the first 24 hours after an intrathecal examination.

Important information about some of the components of SCANLUX 370 mg/ml, injectable solution EFG.

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. HOW TO USE SCANLUX 370 mg/ml INJECTABLE SOLUTION EFG

Follow the administration instructions of SCANLUX exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

SCANLUX 370 mg/ml is a medicine used for a diagnostic test, which should be performed by qualified personnel or preferably under the supervision of a doctor who will indicate the instructions to follow at all times.

You should drink plenty of water before and after the administration of SCANLUX 370 mg/ml. This is especially important if you have multiple myeloma (a type of blood cell cancer of the bone marrow), diabetes mellitus, renal dysfunction, as well as in infants, young children, and the elderly. Small babies (age <1 year) and especially neonates are susceptible to suffering from electrolyte disorders in the blood alterations dynamics.< p>

You can maintain a normal diet until two hours before the test. During the two hours prior to the test, you should abstain from eating and drinking.

The dose that will be administered to you will vary depending on the type of examination, age, weight, cardiac output, and general condition you present, as well as the technique used.

After the administration of the contrast agent, you should remain under observation for at least 30 minutes, as most adverse reactions occur during this time. However, late reactions can occur.

After myelography, you should rest with your head and thorax elevated 20° for one hour. Afterward, you should walk carefully but avoid bending down. Your head and thorax should remain elevated during the first 6 hours if you stay in bed. If you have a higher risk of suffering from epilepsy, you should be observed during this period. If you do not stay in the hospital after the examination, you should not be alone during the first 24 hours.

If you use more SCANLUX 370mg/ml injectable solution EFG than you should

Symptoms of overdose are unlikely if you have normal renal function, unless you have received more than 2000 mgI/kg of body weight during a limited period.

The reactions that may occur due to the side effects described above and those that may occur due to overdose can be treated with antihistamines and corticosteroids and with possible oxygen therapy. In the case of cardiovascular disorders, it may be necessary, in addition to the above treatment, to administer vasopressors, plasma, and electrolytes.

Seizures can be controlled with Diazepam, and tetanic seizures that may occur can be controlled with calcium gluconate injection.

In case of overdose or accidental ingestion, consult the Toxicology Information Service; Telephone 91 562 04 20

4. Possible Adverse Effects

Like all medicines, SCANLUX 370 mg/ml can cause adverse effects, although not all people suffer from them.

To provide an approximate indication of the frequency of possible effects, the following definitions are applied:

Very frequent:means that it is likely to affect more than 1 in 10 people.

Frequent:it is likely to affect more than 1 in 100 people, but less than 1 in 10 people.

Uncommon:it is likely to affect more than 1 in 1,000 people, but less than 1 in 100 people.

Rare:it is likely to affect more than 1 in 10,000 people, but less than 1 in 1,000 people.

Very rare:it is likely to affect less than 1 in 10,000 people.

General (applicable to all uses of iodinated contrast media)

The following are possible general adverse reactions in relation to radiological procedures that include the use of non-ionic, monomeric contrast media.

Adverse reactions associated with the use of iodinated contrast media are normally mild to moderate and transient in nature, and less frequent with non-ionic contrast media than with ionic ones. Both serious reactions and deaths have only been observed in very rare cases.

Intraarterial and Intravenous Use

Please first read the section called "General". The following are only the adverse reactions that occur during the intravascular use of non-ionic, monomeric contrast media.

The nature of the adverse effects specifically observed during intraarterial use depends on the injection site and the administered dose. In selective arteriography and other procedures where the contrast medium reaches a particular organ at high concentrations, it may be accompanied by complications in that particular organ.

Intrathecal Use

Please first read the section called "General". The following are only the adverse reactions that occur during the intrathecal use of non-ionic, monomeric contrast media.

The adverse reactions that follow intrathecal use may be delayed and present several hours or even days after the procedure. The frequency is similar to that of lumbar puncture alone.

Use in Body Cavities

Please first read the section called "General". The following are only the adverse reactions that occur during the use of non-ionic, monomeric contrast media in Body Cavities.

The extravasation of the contrast medium, in rare cases, can cause local pain and edema (swelling), which normally resolves without sequelae. However, inflammation and even tissue necrosis have been seen.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of SCANLUX 370 mg/ml INJECTABLE SOLUTION EFG

Keep SCANLUX 370 mg/ml out of the reach and sight of children.

Store in the original packaging to protect it from light.

Do not store at a temperature above 25°C.

Do not use SCANLUX 370 mg/ml after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of SCANLUX 370 mg/ml:

• The active ingredient is Iopamidol. 1 ml of injectable solution contains 755 mg of Iopamidol (equivalent to 370 mg of iodine).
• The other components are: trometamol, calcium and sodium edetate, water for injectable preparations.

Appearance of the product and package contents

SCANLUX 370 mg/ml is a sterile, transparent, colorless to pale yellow injectable solution, ready to use, packaged in transparent glass bottles.

Each package contains: 50, 100, or 200 ml bottles.

Marketing authorization holder:

IBEROINVESA PHARMA, S.L.

C/ Zurbarán 18, 6th floor

28010 Madrid

Spain

Manufacturer:

Sanochemia Pharmazeutika AG

Langeggerstrasse 7; A-2491 Neufeld/Leitha

Austria

This leaflet was approved in:

January 2010

INFORMATION FOR HEALTHCARE PROFESSIONALS

This medication should be administered exclusively by authorized personnel.

For intravenous use.

Auto-injectors/pumps should not be used in small children.

Dosage and administration

The dose varies depending on the type of examination, age, weight, cardiac output, and general condition of the patient, as well as the technique used. Normally, the same concentration of iodine and the same volume as other radiological contrast media currently in use are used. As with other contrast media, adequate hydration should be ensured before and after administration.

The following doses can serve as a guide.

Adults:

Guidelines for intravenous use

Guidelines for intra-arterial use

• Repeat if necessary

Guidelines for intrathecal use

Guidelines for intra-articular use

Children:

Guidelines for intra-arterial use

Guidelines for intravenous use

Special warnings and precautions for use

Special precautions for the use of non-ionic monomeric contrast media in general

A positive history of allergy, asthma, or mild or moderate adverse reactions to iodinated contrast media indicates the need for special care. Premedication with corticosteroids or histamine H1 and H2 antagonists may be considered in these cases. The benefit must clearly outweigh the risk in such patients.

Iodinated contrast media can cause anaphylactic/anaphylactoid reactions or other hypersensitivity manifestations. Therefore, the course of action should be planned in advance, with the necessary medications and equipment available for immediate treatment if a severe reaction occurs. It is recommended to use a catheter or cannula for intravenous administration of the contrast medium, as well as for arterial use.

Anaphylactic/anaphylactoid reactions can occur regardless of the dose and mode of administration, and mild symptoms of hypersensitivity may represent the first signs of a severe reaction (see section 4.8). Administration of the contrast medium should be interrupted immediately, and specific therapy should be initiated via the vascular route if necessary. Patients taking beta-blockers may present atypical symptoms of anaphylaxis, which may be misinterpreted as a vagal reaction.

Adequate hydration should be ensured before and after administration of the contrast medium.

This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction, as well as infants, small children, and the elderly. Small infants (age <1 year) and especially neonates are susceptible to electrolyte disorders hemodynamic alterations.< p>

Special care should be taken in patients with severe cardiac disease and pulmonary hypertension, as they may develop hemodynamic changes or arrhythmias.

Patients with acute cerebral pathology, tumors, or a history of epilepsy are prone to new seizures and deserve special care. Alcoholics and drug addicts may also have a higher risk of seizures and neurological reactions. Some patients have experienced hearing loss or even temporary deafness after myelography, which is believed to be due to a decrease in spinal fluid pressure due to the lumbar puncture itself.

To prevent decompensation or worsening of renal insufficiency that may lead to acute renal failure after administration of the contrast medium, special care should be taken in patients with renal insufficiency and diabetes mellitus, as they are at high risk. Patients with paraproteinemias (myelomatosis and Waldenström's macroglobulinemia) are also a risk group.

Preventive measures include:

- Identification of high-risk patients.

• Ensuring adequate hydration. If necessary, maintaining an intravenous infusion from before the procedure until the contrast medium has been eliminated by the kidneys.

• Avoiding additional kidney damage in the form of nephrotoxic drugs, cholecystographic agents, arterial obstruction, renal artery angioplasty, or major surgery until the contrast medium has been eliminated.

• Postponing a contrast medium examination until renal function returns to pre-examination levels.

To prevent lactic acidosis, serum creatinine levels should be measured in diabetic patients treated with metformin before intravascular administration of an iodinated contrast medium.

Normal serum creatinine / renal function: Metformin administration should be suspended at the time of contrast medium administration and not resumed until 48 hours later, or until renal function / serum creatinine is normal. Altered serum creatinine / renal function: Metformin administration should be suspended, and the contrast medium examination should be postponed for 48 hours. Metformin administration will only be restored if renal function / serum creatinine is unaltered. In emergency cases where renal function is altered or unknown, the physician should evaluate the risk/benefit of the contrast medium examination and take these precautions into account: metformin medication will be suspended, the patient will be kept hydrated, renal function will be monitored, and possible symptoms of lactic acidosis will be observed.

There is a potential risk of transient hepatic dysfunction. Special care is required in patients with severe hepatic and renal impairment, as they may have a significant delay in the clearance of the contrast medium. Patients on hemodialysis may receive the contrast medium for radiological procedures when dialysis is ensured immediately after.

Administration of iodinated contrast media may exacerbate symptoms of myasthenia gravis. In patients with pheochromocytoma who are undergoing interventional procedures, alpha-blockers should be administered as prophylaxis to prevent a hypertensive crisis. Special care should be taken in patients with hyperthyroidism. Patients with multinodular goiter may have a risk of developing hyperthyroidism after injection of iodinated contrast media. There is also a risk of inducing transient hypothyroidism in premature infants who receive contrast media.

Extravasation of the contrast medium can, in rare cases, cause local pain and edema, which usually resolves without sequelae. However, inflammation and even tissue necrosis have been observed. It is recommended to elevate and cool the affected area as routine measures. Surgical decompression may be necessary in cases of compartment syndrome.

A normal diet can be maintained until two hours before the examination. During the last two hours, the patient should abstain from eating and drinking.

Observation time

After administration of the contrast medium, the patient should be observed for at least 30 minutes, as most adverse reactions occur during this time. However, late reactions can occur.

Patients with severe hepato-renal insufficiency should not be examined unless it is absolutely indicated. The second administration should be delayed by 5 to 7 days.

Intrathecal use

After myelography, the patient should rest with the head and thorax elevated 20° for one hour. Then, they should walk carefully but avoid bending down. The head and thorax should be kept elevated during the first 6 hours if they remain in bed. Patients with suspected low seizure threshold should be observed during this period. Ambulatory patients should not be alone during the first 24 hours.

Angiography

In pediatrics, right heart angiography requires special caution in cyanotic newborns with pulmonary hypertension and cardiac dysfunction.

In angiography of the supra-aortic trunks, particular attention should be paid to the placement of the catheter tip. Excessive pressures transmitted by the automatic pump can also cause renal infarction, spinal cord lesions, retroperitoneal hemorrhages, intestinal infarction, and necrosis.

It is convenient to determine renal function once the test is finished.

The radiological examination in women should be performed, if possible, during the pre-ovulatory phase of the menstrual cycle.

Nature and contents of the container

SCANLUX 370 mg/ml is presented in transparent glass bottles Type II Ph. Eur. of 50, 100, 200, or 500 ml.

Special precautions for use and disposal

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

Like all parenteral products, SCANLUX 370 mg/ml should be visually inspected for particles, discoloration, and container integrity before use.

The product should be introduced into the syringe immediately before use.

After disinfecting the stopper, the solution should be extracted through the stopper using a single-use syringe and sterile single-use needles.

Any unused contrast medium remaining in the monodose bottle should be discarded after each examination.