Product Information for the Patient

Cyclolux 0.5mmol/ml Injectable Solution EFG

Gadoteric Acid

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or radiologist.
• If you experience any adverse effects,consult your doctor, radiologistor pharmacist,eveniftheyare not listed in this product information. See section 4.

Cyclolux is a contrast medium containing gadoteric acid. It is for diagnostic use only.

Cyclolux is used for enhancing the contrast of images obtained by magnetic resonance (MR) imaging. Enhanced contrast improves visualization and delineation in:

Adults and pediatric population (0-18 years)

• MR of the central nervous system, including defects (lesions) of the brain, spinal cord, and adjacent tissues.
• MR of the whole body, including defects (lesions) of the liver, kidneys, pancreas, pelvis, lungs, heart, breasts, and musculoskeletal system.

Adults

Magnetic resonance angiography (MRA), including defects (lesions) and narrowing (stenosis) of arteries, except for coronary arteries.

.No use Cyclolux

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic to medications containing gadolinium (such as other contrast agents used in MRI).

Warnings and precautions

Consult your doctor or radiologist before starting to use Cyclolux if you:

• Have had a reaction to contrast media during a previous study.
• Have asthma.
• Have a history of allergy (such as shellfish allergy, urticaria, hay fever).
• Are being treated with a beta-blocker (a medication used for heart problems and blood pressure alterations; such as metoprolol).
• Your kidneys do not function correctly.
• Recently had, or are about to have, a liver transplant.
• Have a disease affecting the heart or blood vessels.
• Have had seizures or are being treated for epilepsy.

Your doctor or radiologist will evaluate the benefit-risk ratio and decide whether you should be given Cyclolux. If you are given Cyclolux, your doctor or radiologist will take necessary precautions and the administration of Cyclolux will be closely monitored.

Your doctor or radiologist may decide to perform a blood test to check the proper functioning of your kidneys before deciding to use Cyclolux, especially if you are 65 years or older.

Newborns and infants

Due to the immaturity of renal function in newborns up to 4 weeks of age and in infants up to 1 year of age, Cyclolux should be used in these patients only after a careful evaluation by the doctor.

Remove all metal objects you are wearing before the examination. Inform your doctor or radiologist if you have:

• A pacemaker.
• A vascular clip.
• An infusion pump.
• A neurostimulator.
• A cochlear implant (implant in the inner ear).
• Any suspected metal foreign body, particularly in the eye.

This information is extremely important as these may cause serious problems, as MRI devices use very powerful magnetic fields.

Use of Cyclolux with other medications

Inform your doctor or radiologist if you are taking, have recently taken, or may take other medications.

In particular, please inform your doctor, radiologist, or pharmacist if you are taking or have recently taken medications for the heart or blood pressure alterations such as beta-blockers, vasodilators, angiotensin-converting enzyme inhibitors, or angiotensin II receptor antagonists.

Use of Cyclolux with food and drinks

No known interactions exist between Cyclolux and food or drinks. However, please consult your doctor, radiologist, or pharmacist if you need to avoid eating or drinking before the test.

Pregnancy and breastfeeding

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

Pregnancy

Gadoteric acid can cross the placenta. Its effects on the fetus are unknown. Cyclolux should not be used during pregnancy unless absolutely necessary.

Breastfeeding

Your doctor or radiologist will evaluate whether you should continue or interrupt breastfeeding 24 hours after Cyclolux administration.

Driving and operating machinery

No information is available on the effects of Cyclolux on the ability to drive and operate machinery.If you feel unwell after the test, you should not drive or operate machinery.

Cyclolux will be administeredviaintravenous injection.

During the test, you will be under the supervision of a doctor or radiologist. A needle will be left in your vein; this will allow the doctor or radiologist to inject emergency medications if necessary. If you experience an allergic reaction, the administration of Cyclolux will be stopped.

Cyclolux may be administered manually or using an automatic injector. In newborns and infants, the product will only be administered manually.

The procedure will be performed in a hospital, clinic, or private consultation. The medical staff is aware of the precautions that need to be taken for the test. They are also aware of any possible complications that may occur.

Dosage

Your doctor or radiologist will determine the dose you will receive and supervise the injection.

Dosage in special populations

The use of Cyclolux is not recommended in patients with severe kidney problems or in patients who have recently had or are about to have a liver transplant. However, if use is required, you should only receive a single dose of Cyclolux during the procedure and should not receive a second injection for at least 7 days.

Newborns, infants, children, and adolescents

Due to the immaturity of renal function in newborns up to 4 weeks of age and in infants up to 1 year of age, Cyclolux will only be used in these patients after careful evaluation by a doctor. Newborns and infants should only receive a single dose of Cyclolux during the procedure and should not receive a second dose for at least 7 days.

The use for angiography is not recommended in children under 18 years.

Older adults

If you are 65 years or older, it is not necessary to adjust the dose, but you may be required to have a blood test to check the proper functioning of your kidneys.

If too much Cyclolux has been administered

It is highly unlikely that you will receive an overdose. Cyclolux will be administered in a medical setting by a trained person. In the event of a true overdose, Cyclolux may be removed from the body by hemodialysis (blood cleansing).

At the end of this prospectus, you will find additional information on the use and handling by the doctor or medical professional.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

After administration, you will be kept under observation for at least half an hour. Most side effects occur immediately or sometimes appear later. Some effects may appear up to 7 days after the Cyclolux injection.

There is a small risk that you may have an allergic reaction to Cyclolux. Such reactions can be severe and exceptionally may cause shock(a life-threatening allergic reaction). Any of the symptoms described below may be the first signs of shock. Immediately inform your doctor, radiologist, or healthcare professional if you have any of them:

• swelling of the face, mouth, or throat that may cause difficulty swallowing or breathing.
• swelling of the hands or feet.
• drowsiness (low blood pressure).
• difficulty breathing.
• whistling when breathing.
• coughing.
• itching.
• runny nose.
• stuffy nose.
• eye irritation.
• hives.
• skin eruptions.

Rare side effects (may affect up to 1 in 100 patients)

• hypersensitivity (allergic reaction).
• headache.
• unusual taste in the mouth.
• dizziness.
• drowsiness (sleep).
• sensation of tingling, heat, cold, and/or pain.
• high or low blood pressure.
• nausea (feeling unwell).
• stomach pain.
• eruption.
• sensation of heat, sensation of cold.
• asthenia (loss of energy, weakness).
• discomfort at the injection site, cold at the injection site, diffusion of the product outside

the blood vessels that may cause inflammation (redness and pain at the local site).

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

• anxiety, fainting (dizziness and feeling of impending loss of consciousness)
• inflammation of the eyelids
• palpitations
• stuffy nose
• vomiting (feeling unwell)
• diarrhea
• increased salivation
• hiccups, itching, sweating
• chest pain, chills

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

• anaphylactic reactions or anaphylactoid-like reactions
• agitation
• coma, convulsions, syncope (brief loss of consciousness), alteration of the sense of smell (perception of unpleasant odors), tremor
• conjunctivitis, red eyes, blurred vision, increased tear secretion
• cardiac arrest, rapid or slow heart rate, irregular heart rhythm, vasodilation, pallor
• respiratory arrest, pulmonary edema, difficulty breathing, whistling, nasal congestion, coughing, dry throat, constriction of the throat with a sensation of choking, respiratory spasms, inflammation of the throat
• eczema, redness of the skin, inflammation of the lips and localized in the mouth
• muscle cramps, muscle weakness, back pain
• uncomfort, chest discomfort, fever, inflammation of the face, diffusion of the medication outside the blood vessels that may lead to tissue death at the injection site, inflammation of a vein
• decreased oxygen level in the blood

Systemic nephrogenic fibrosis (which causes skin hardening and may also affect soft tissues and internal organs) has been reported, most of which were in patients who received Cyclolux together with other gadolinium-based contrast agents. If, during the weeks after the MRI study, you notice changes in color and/or thickness of your skin in any part of your body, inform the radiologist who performed the examination.

Reporting of side effects:

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

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

This medication does not require special conditions for conservation.

Chemical and physical stability has been demonstrated during use for a period of 72 hours at room temperature. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the user and should normally not exceed 24 hours at temperatures of 2°C to 8°C, unless the opening has taken place in controlled and validated aseptic conditions.

Do not use this medication after the expiration date that appears on the vial and on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Cyclolux

• The active principle is gadoteric acid.1 ml of injectable solution contains279.32mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid (as meglumine salt).
• The other components (excipients) are meglumine, 2,2’,22’’,2’’’- (1,4,7,10-Tetraazaciclododecano-1,4,7,10-tetril)tetraacetic acid (DOTA) and water for injectable preparations.

Aspect of the product and content of the packaging

Cyclolux is a transparent, colorless to yellowish solution for intravenous injection, free of visible particles.

The content of Cyclolux vials is 1 or 10 vials containing 10, 15 or 20ml of injectable solution.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Sanochemia Pharmazeutika GmbH

Landegger Straße 7

2491 Neufeld an der Leitha, Austria

Local representative:

Juste Farma S.L.U

Avda. de San Pablo, 27

28823 Coslada (Madrid),Spain

This medicinal product is authorized in the Member States of theEuropean Economic Area and in the United Kingdom (Northern Ireland)with the following names:

• Germany: Cyclolux 0.5 mmol/ml Injektionslösung
• Austria:Cyclolux 0.5 mmol/ml Injektionslösung im Einzeldosisbehältnis
• Belgium:Macrocyclolux 0.5 mmol/ml oplossing voor injectie
• Croatia:Cyclolux 0.5 mmol/ml otopina za injekciju
• Cyprus:Macrocyclolux 0.5 mmol/mlεν?σιμο δι?λυμα
• Czech Republic:Cyclolux
• Estonia:Cyclolux
• Greece:Cyclolux 0.5 mmol εν?σιμο δι?λυμα
• Ireland:Cyclolux 279.32 mg/ml solution for injection
• Italy:Macrocylux
• Latvia:Cyclolux 0.5 mmol/ml injekcinis tirpalas
• Lithuania:Cyclolux
• Netherlands:Cyclolux 0.5 mmol/ml, oplossing voor injectie
• Poland: Cyclolux
• Portugal: Cyclolux
• Hungary:Cyclolux 0.5 mmol/ml oldatos injekció, egyadagos
• Romania:Cyclolux 0.5 mmol/ml solutie injectabila
• Spain:Cyclolux 0.5 mmol/ml solución inyectable EFG
• Slovakia:Cyclolux 0.5 mmol/ml Injekcný roztok
• Slovenia:Cyclolux 0.5 mmol/ml raztopina za injiciranje
• United Kingdom(Northern Ireland):Cyclolux 0.5 mmol/ml solution for injection

Other sources of information

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

Date of the last review of this leaflet:May 2024

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This information is intended solely for healthcare professionals

Dosage

Use the lowest dose that provides sufficient enhancement for diagnostic purposes. The dose should be calculated based on the patient's body weight and should not exceed the recommended dose per kilogram of body weight indicated in this section.

• Magnetic Resonance (MR) of the brain and spine: In neurological studies, the dose may vary from 0.1 to 0.3 mmol per kilogram of body weight (mmol/kg b.w.), equivalent to 0.2 to 0.6 ml/kg b.w. In some cases, after administration of 0.1 mmol/kg b.w. to patients with brain tumors, an additional dose of 0.2 mmol/kg b.w. may improve tumor characterization and facilitate therapeutic decision-making.
• MR of the whole body and angiography: The recommended dose for intravenous injection is 0.1 mmol/kg b.w. (i.e., 0.2 ml/kg b.w.) to provide adequate contrast for diagnosis.Angiography: In exceptional circumstances (e.g., when satisfactory images of an extensive vascular territory cannot be obtained), a second consecutive injection of 0.1 mmol/kg b.w., equivalent to 0.2 ml/kg b.w., may be justified. However, if two consecutive doses of Cyclolux are anticipated before starting angiography, it may be beneficial to use 0.05 mmol/kg b.w., equivalent to 0.1 ml/kg b.w., for each dose, depending on the MR equipment to be used to obtain the images.
• Paediatric population(0-18 years): (MR) cerebral and (MR) spinal/body: the maximum and recommended dose of Cyclolux is 0.1 mmol/kg b.w.

Due to the immaturity of renal function in newborns up to 4 weeks of age and in infants up to 1 year of age, Cyclolux should only be used in these patients after careful consideration, at a dose not exceeding 0.1 mmol/kg of body weight. During an examination, no more than one dose should be administered. Due to the lack of information on repeated administration, the administration of Cyclolux should not be repeated unless an interval of at least 7 days has elapsed between injections. Cyclolux is not recommended for angiography in children under 18 years of age because the data on safety and efficacy in this indication are insufficient.

• Patients with renal insufficiency: The adult dose applies to patients with mild to moderate renal insufficiency (GFR ≥30 ml/min/1.73 m2). See below the section “Renal insufficiency”.
• Patients with hepatic insufficiency: The adult dose applies to these patients. Caution should be exercised, especially in the perioperative period of a liver transplant.

Administration form

Cyclolux is indicated only for intravenous administration.Do not use by intrathecal route. Be careful to maintain the injection strictly intravenously: extravasation may lead to local intolerance reactions, requiring local measures.

Infusion rate: 3-5 ml/min (for angiographic procedures, infusion rates up to 120 ml/min, i.e., 2 ml/sec, may be used).

Optimal image acquisition: Approximately 45 minutes after injection.

Optimal image acquisition sequence: Enhanced in T1.

The intravascular administration of the contrast medium should be performed, if possible, with the patient lying down. After administration, the patient should remain under observation

for at least half an hour, as experience shows that most adverse effects

occur during that time.

Prepare a syringe with a needle. Remove the plastic plug. After cleaning the stopper with a cotton swab soaked in alcohol, pierce the stopper with the needle. Remove the amount of product needed for the examination and inject it intravenously.

This medicinal product is intended for single use, unused solution should be discarded.

The injectable solution should be visually inspected before use.Only use transparent and particle-free solutions..

Paediatric population

Depending on the amount of gadoteric acid administered to the child, it is preferable to use vials of gadoteric acid with a single-use syringe with an adapted volume to ensure greater accuracy of the injected volume.

In newborns and infants, the required dose should be administered manually.

Renal insufficiency

Before administration of Cyclolux, it is recommended to evaluate all patients to detect possible renal dysfunction by laboratory tests.

Cases of systemic nephrogenic fibrosis (SNF) have been reported associated with the use of some gadolinium-containing contrast media in patients with severe acute or chronic renal insufficiency (GFR <30)2). Patients undergoing liver transplantation have a special risk since the incidence of acute renal failure is high in this group. Since there is a possibility that SNF may occur with Cyclolux, it should only be used in patients with severe renal insufficiency and in patients in the perioperative period of a liver transplant after careful consideration of the benefit-risk ratio and if the diagnostic information is essential and cannot be obtained without contrast-enhanced MR. If Cyclolux is necessary, the dose should not exceed 0.1 mmol/kg of body weight. During an examination, no more than one dose should be administered. Due to the lack of information on repeated administration, the administration of Cyclolux should not be repeated unless an interval of at least 7 days has elapsed between injections. Haemodialysis shortly after administration of Cyclolux may be useful for the elimination of Cyclolux from the body. There is no evidence to support the initiation of haemodialysis for the prevention or treatment of SNF in patients not undergoing haemodialysis.

Older patients

Since renal elimination of gadoteric acid maybe reduced in older patients, it is especially important to evaluate patients aged 65 years or older to detect possible renal dysfunction.

Paediatric population (newborns and infants)

See above the section Dosage and Administration, Paediatric population.

Pregnancy and lactation

Cyclolux should not be used during pregnancy unless the woman's clinical situation requires the use of gadoteric acid.

The continuation or interruption of breastfeeding during a period of 24 hours after administration of Cyclolux will be at the discretion of the doctor and the breastfeeding mother.

Handling instructions

The removable label of the vials should be stuck to the patient's medical history to allow for precise recording of the gadolinium-containing contrast medium used. The dose used should also be recorded. If the patient's electronic medical history is used, the name of the medicinal product, batch number, and dose should be included in the same.