Label: Information for the User

SCANLUX 300 mg/ml, Injectable Solution EFG

Iopamidol

Read this label carefully before starting to use the medication.

1. What is SCANLUX 300 mg/ml, Injectable Solution EFG and how it is used

2. Before using SCANLUX 300 mg/ml, Injectable Solution EFG

3. How to use SCANLUX 300 mg/ml, Injectable Solution EFG

4. Possible adverse effects

5. Storage of SCANLUX 300 mg/ml, Injectable Solution EFG

6. Additional information

This medication is for diagnostic use only.

It belongs to a group of medications called iodinated X-ray contrast media.

Iopamidol Juste 300 mg/ml is indicated as a radiological contrast medium for the following indications:

Adults:

- Lumbar, thoracic, and cervical myelography.

- Cerebral angiography.

- Peripheral arteriography and phlebography.

- Left ventriculography and angiocardiography.

- Coronary arteriography.

- Selective renal 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.

Do not use SCANLUX 300 mg/ml if:

- You are allergic (hypersensitive) to the active ingredient or any of the other components.

- You have Waldenström's Paraproteinemia.

- You have multiple myeloma.

- You have a severe liver and kidney disease.

- You have an epileptic disease.

- You have blood detected in the cerebrospinal fluid.

- You have a history of severe adverse reactions to contrast media.

- You are allergic (hypersensitive) to iodine.

Be especially careful with SCANLUX 300 mg/ml:

- If you have previously experienced allergy, asthma, or mild to moderate adverse reactions to iodinated contrast media. Your doctor may consider administering corticosteroids or H1 and H2 histamine 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 attacks. Also, if you are an alcoholic or drug-dependent, as you may have a higher risk of suffering attacks and neurological reactions. Some patients have experienced temporary hearing loss or even deafness after myelography, probably due to a decrease in cerebrospinal fluid pressure.

- If you have renal insufficiency, diabetes mellitus, and paraproteinemias (diseases that involve the excessive production of certain proteins, such as multiple myeloma and Waldenström's macroglobulinemia), as you may experience a decompensation or worsening of your renal insufficiency that may lead to acute renal failure after administration of the contrast medium.

- If you are diabetic and being treated with metformin, as the administration of the contrast medium 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 experience a significant delay in the elimination of the contrast medium. If you are a patient undergoing hemodialysis, you may receive the contrast medium for radiological procedures when dialysis is performed immediately afterwards.

- If you have myasthenia gravis (a disease in which muscles weaken and fatigue easily), as your symptoms may worsen.

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

- There is a possibility of transient hypothyroidism in premature infants who receive contrast media.

- Before starting treatment with SCANLUX 300 mg/ml, ensure adequate hydration before and after administration, especially in patients with multiple myeloma, diabetes mellitus, renal failure, as well as in infants, small children, and the elderly.

- If you are undergoing analytical tests, note that high concentrations of the contrast medium in serum and urine may interfere with bilirubin, protein, or inorganic substance (e.g. iron, copper, calcium, and phosphate) analyses. These substances should not be analyzed on the day of the examination.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medications:

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

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

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

Neuroleptics should be avoided absolutely, as they lower the epileptogenic threshold, as well as analgesics, antiemetics, antihistamines, and sedatives in the phenothiazine group.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant, you should know that only procedures with radiation should be performed during pregnancy, and only when the benefit to the mother outweighs the risk to the fetus, taking into account that the safety of using SCANLUX 300 mg/ml in pregnant women is not guaranteed.

Contrast media are excreted in small amounts through breast milk and absorbed in minimal amounts by the intestine. Damage to infants is therefore unlikely.

Driving and operating machines:

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

Important information about some components of SCANLUX 300 mg/ml, injectable solution EFG.

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

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

Consult your doctor or pharmacist if you have any doubts.

SCANLUX 300 mg/ml is a medication used for diagnostic testing, which should be performed by qualified personnel or preferably under the supervision of a doctor who will instruct you at all times on the steps to follow.

You should drink plenty of water before and after administration of SCANLUX 300 mg/ml. This is especially important if you have multiple myeloma (a type of blood cancer in the bone marrow), diabetes mellitus, renal dysfunction, or if you are a baby, young child, or elderly person. Small babies (age <1

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

The dose you will receive will vary depending on the type of examination, age, weight, cardiac output, and overall condition you present, as well as the technique used.

After administration of the contrast medium, 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 chest elevated 20° for one hour. After that, you should walk carefully but avoid bending forward. Your head and chest should be kept elevated for the first 6 hours if you remain in bed. If you are at higher risk of developing epilepsy, you should be observed during this period. If you do not remain in the hospital after the examination, you should not be alone during the first 24 hours.

If you use more SCANLUX 300mg/ml injectable solution EFG than you should

Overdose symptoms are unlikely if you have normal renal function, unless you have received more than 2000 mg/kg of body weight over a short period of time.

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

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

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

Like all medications, SCANLUX 300 mg/ml may cause side effects, although not everyone will experience them.

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

Very common:means that more than 1 in 10 people are likely to experience it.

Common:means that more than 1 in 100 people, but less than 1 in 10 people, are likely to experience it.

Uncommon:means that more than 1 in 1,000 people, but less than 1 in 100 people, are likely to experience it.

Rare:means that more than 1 in 10,000 people, but less than 1 in 1,000 people, are likely to experience it.

Very rare:means that fewer than 1 in 10,000 people are likely to experience it.

General (applicable to all uses of iodinated contrast media)

The following possible adverse reactions are general to procedures involving the use of non-ionic, monomeric contrast media.

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

Intra-arterial and intravenous use

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

The nature of the specific side effects observed during intra-arterial use depends on the site of injection and the dose administered. In selective arteriography and other procedures in which the contrast medium reaches a particular organ at high concentrations, complications may occur in that particular organ.

Intrathecal use

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

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 a lumbar puncture alone.

Use in body cavities

Please read the section called "General" first. The following section only describes the adverse reactions that occur during the use in body cavities of non-ionic monomeric contrast media.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep SCANLUX 300 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 300 mg/ml after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

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

Composition of SCANLUX 300 mg/ml:

• The active ingredient is Iopamidol. 1 ml of injectable solution contains 612 mg of Iopamidol (equivalent to 300 mg of iodine).
• The other components are trometamol, calcium and sodium edetate, and water for injectable preparations.

Appearance of the product and contents of the package:

SCANLUX 300 mg/ml is an injectable solution, sterile, transparent, colorless to pale yellow, ready for use, packaged in transparent glass bottles.

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

Marketing Authorization Holder:

IBEROINVESA PHARMA, S.L.

C/ Zurbarán 18,6º

28010 Madrid

Spain

Responsible for manufacturing:

Sanochemia Pharmazeutika AG

Langeggerstrasse 7; A-2491 Neufeld/Leitha

Austria

This leaflet has been approved in:January 2010

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

This medication should be administered exclusively by authorized personnel.

For intravenous use.

Autoinjectors/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, and the technique used. Normally, the same concentration of iodine and the same volume as with other iodinated contrast media currently in use are used. As with other contrast media, adequate hydration should be ensured before and after administration.

The following doses may serve as a guide.

Adults:

Orientations for intravenous use:

Orientations for intra-arterial use:

* Repeat if necessary

Orientations for intrathecal use:

Orientations for intra-articular use:

Children:

Orientations for intra-arterial use:

Orientations for intravenous use:

Warnings and special precautions for use:

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

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

Iodinated contrast media may cause anaphylactic/anaphylactoid reactions or other manifestations of hypersensitivity. Therefore, plan the course of action 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 administrations 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, if necessary, specific therapy should be installed via the vascular route. Patients taking beta-blockers may experience 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 to newborns, small children, and the elderly. Small newborns (<1

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 predisposed to suffer new attacks and deserve special care. Also, alcoholics and drug addicts may have a higher risk of suffering attacks and neurological reactions. Some patients have experienced temporary hearing loss or even deafness after myelography, which is believed to be due to a decrease in spinal fluid pressure caused by 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 (multiple myeloma and Waldenström's macroglobulinemia) are also a high-risk group.

Preventive measures include:

- Identifying high-risk patients.

- Ensuring adequate hydration. If necessary, maintaining an i.v. 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, angioplasty, or major surgery, until the contrast medium has been eliminated.

- Postponing a contrast 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.

Serum creatinine / normal renal function: The administration of metformin 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. Serum creatinine / altered renal function: Metformin administration should be suspended, and the contrast examination should be postponed for 48 hours. Only metformin administration should be resumed if renal function / serum creatinine is unchanged. In emergency cases where renal function is altered or unknown, the doctor should evaluate the risk/benefit of the contrast examination, and these precautions should be taken: metformin medication should be suspended, the patient should be kept hydrated, renal function should be monitored, and possible symptoms of lactic acidosis should be observed.

There is a potential risk of transient hepatic dysfunction. Special care should be taken in patients with severe hepatic and renal dysfunction, as they may have a significant delay in clearing the contrast medium. Patients on hemodialysis can receive the contrast medium for radiological procedures when dialysis is performed immediately afterwards.

Administration of iodinated contrast media may exacerbate symptoms of myasthenia gravis. In patients with pheochromocytoma 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. Also, be aware of the possibility of inducing transient hypothyroidism in premature infants receiving contrast media.

Extravasation of the contrast medium may, in rare cases, cause local pain and edema, which usually resolves without sequelae. However, inflammation and even tissue necrosis have been seen. Elevating and cooling the affected area is recommended as a routine measure. Surgical decompression may be necessary in cases of compartment syndrome.

Normal diet can be maintained until 2 hours before the examination. During the last 2 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 may occur.

Patients with severe hepato-renal insufficiency should not be examined unless 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 chest elevated 20° for 1 hour. Then, they should walk carefully, but they should avoid bending forward. The head and chest should be kept elevated for the first 6 hours if they remain in bed. Patients suspected of having a low seizure threshold should be observed during this period. Ambulatory patients should not be left alone during the first 24 hours.

Angiography

In pediatrics, right heart angiocardiography 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 may also cause renal infarction, spinal cord lesions, retroperitoneal hemorrhage, intestinal infarction, and necrosis.

Determining renal function once the test is completed is recommended.

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

Special precautions for use and disposal:

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

As with all parenteral products, SCANLUX 300 mg/ml should be visually inspected to detect particles, discoloration, and integrity of the container before use.

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

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

Any amount of contrast medium not used that remains in the single-dose vial should be discarded after each examination.