Label:Information for the patient

Cyclolux Rep 0.5mmol/ml injectable solution EFG

Gadoteric acid

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 radiologist.

• If you experience adverse effects,consult your doctor, radiologistor pharmacist,eveniftheyare not listed in this label. See section 4.

6. Contents of the container and additional information

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

Cyclolux Rep 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 Rep

• 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).

Advertencias y precauciones

Consult your doctor or radiologist before starting to use Cyclolux Rep 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 metopropol).
• Your kidneys do not function correctly.
• Recently had, or will soon 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 administered Cyclolux Rep. If you are administered Cyclolux Rep, your doctor or radiologist will take necessary precautions and the administration of Cyclolux Rep 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 Rep, especially if you are 65 years or older.

Neonatos y lactantes

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 Rep 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 due to the powerful magnetic fields used in MRI imaging devices.

Uso de Cyclolux Rep con otros medicamentos

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.

Uso de Cyclolux Rep con los alimentos y bebidas

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

Embarazo y lactancia

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

Embarazo

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

Lactancia

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

Conducción y uso de máquinas

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

Cyclolux Rep will be administered via intravenous 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 Rep will be interrupted.

Cyclolux Rep may be administered manually or via 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 clinic. The healthcare 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.

Special populations dosage

The use of Cyclolux Rep 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 dose of Cyclolux Rep 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 Rep will only be used in these patients after careful evaluation by a doctor. Newborns and infants should only receive a dose of Cyclolux Rep 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 old.

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 Rep has been administered

It is highly unlikely that you will be given an overdose. Cyclolux Rep will be administered in a medical setting by a trained person. In a true case of overdose, Cyclolux Rep 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 healthcare 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 seven days after the Cyclolux Rep injection.

There is a small risk that you may have an allergic reaction to Cyclolux Rep. 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.
• Irritation of the eyes.
• Hives.
• Rashes on the skin.

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.
• Low or high blood pressure
• Nausea (feeling unwell).
• Stomach pain.
• Rash.
• Sensation of heat, sensation of cold.
• Asthenia (lack of energy, weakness)
• Discomfort at the injection site, reaction 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)
• Swelling of the eyelids
• Palpitations
• Stuffy nose
• Vomiting (feeling unwell)
• Diarrhea
• Increased salivation
• Tickling, 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), tremors
• Conjunctivitis, red eyes, blurred vision, increased tear production
• Cardiac arrest, rapid or slow heart rate, irregular heartbeat, 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 crampsmuscular weakness, back pain
• Discomfort, chest discomfort, fever, inflammation of the face, diffusion of the medicine outside the blood vessels that may lead to death of the tissue at the injection site, inflammation of a vein
• Decreased oxygen level in the blood.

Se have reported cases of systemic nephrogenic fibrosis (which causes skin hardening and may also affect soft tissues and internal organs), most of which were in patients who received Cyclolux Rep 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 took 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 Rep

• The active principle is gadoteric acid. 1 ml of injectable solution contains 279.32 mg 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’, 2’’,2’’’-(1,4,7,10-Tetraazaciclododecano-1,4,7,10-tetril) tetraacetic acid (DOTA), and water for injection preparations.

Aspect of the product and content of the package

Cyclolux Rep is a transparent, colorless to yellowish, particle-free solution for intravenous injection.

The contents of the Cyclolux Rep packages are 1 or 10 vials containing 60 ml or 100 ml of injectable solution.

Only some package sizes may be marketed.

Holder of the marketing authorization and manufacturer:

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 the European Economic Area with the following names:

• Germany:Cyclolux 0.5 mmol/ml Injektionslösung
• Austria:Cyclolux 0.5 mmol/ml Injektionslösung
• Belgium:Macrocyclolux 0.5 mmol/ml oplossing voor injectie
• Italy:Macrocyclolux
• Poland:Cyclolux multidose
• Hungary:Cyclolux 0.5 mmol/ml oldatos injekció, többadagos
• Spain:Cyclolux REP 0.5 mmol/ml solución inyectable EFG
• Slovakia:Cyclolux Multi 0.5 mmol/ml Injekcný roztok

Other sources of information

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

Last review date of this leaflet: May 2024

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This information is intended solely for healthcare professionals

Dosage

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

• Brain and spinal cord MRI: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.
• Whole-body MRI and angiography:The recommended dose for intravenous injection is 0.1 mmol/kg b.w. (equivalent to 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 Rep 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 MRI equipment used to obtain the images.
• Pediatric population (0-18 years):(MR) cerebral and (MR) spinal/corporeal: The maximum and recommended dose of Cyclolux Rep 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 Rep should be used only 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 Rep should not be repeated unless an interval of at least 7 days has elapsed.

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

Administration form

Cyclolux Rep is indicated only for intravenous administration. Do not use by intrathecal route. Care should be taken to maintain the injection strictly intravenously: extravasation may lead to local intolerance reactions, requiring standard local measures.

Infusion rate: 3-5 ml/min (for angiographic procedures, infusion rates up to 120 ml/min, equivalent to 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 this time.

The rubber stopper should be pierced only once with an appropriate extraction device (spike).

The extraction device should have the following characteristics: trocar, sterile air filter, Luer connection, and protective seal cap.

A single-use sterile syringe may be used to perform a single-dose protocol or to inject a second bolus of contrast medium if clinically necessary.

A single-patient automatic injector may be used for repeated administrations.

After the examination session, the remaining contrast medium in the vial, as well as the remaining medium in the disposable device, should be discarded within 24 hours of piercing the rubber stopper. The manufacturer's specific instructions for the equipment used should be carefully followed.

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

Pediatric population

Depending on the amount of gadoteric acid administered to the child, it is recommended to use vials of gadoteric acid with a single-use syringe of 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 administering Cyclolux Rep, it is recommended to evaluate all patients to detect possible renal dysfunction using laboratory tests.

Cases of systemic nephrogenic fibrosis (FNS) 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 FNS may occur with Cyclolux Rep, it should only be used in patients with severe renal insufficiency and in patients in the perioperative period of a liver transplant after careful assessment of the benefit-risk ratio and if the diagnostic information is essential and cannot be obtained without contrast-enhanced MRI. If Cyclolux Rep 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 Rep should not be repeated unless an interval of at least 7 days has elapsed. Hemodialysis shortly after administration of Cyclolux Rep may be useful for the elimination of Cyclolux Rep from the body. There is no evidence to support the initiation of hemodialysis for the prevention or treatment of FNS in patients not undergoing hemodialysis.

Geriatric population

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

Pediatric population (neonates and infants)

See above the section Dosage and Administration, Pediatric Population.

Pregnancy and lactation

Cyclolux Rep 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 24-hour period after administration of Cyclux Rep will be at the discretion of the doctor and the breastfeeding mother.

Handling instructions

The removable label from the vials should be attached 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 electronic patient history is used, the name of the medicinal product, batch number, and dose should be included in the same.