Ciclolux

Package Leaflet: Information for the User

Cyclolux, 0.5 mmol/ml, Solution for Injection

Gadoteric Acid

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Radiologist.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Inform Your Doctor, Radiologist, or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet

• 1. What is Cyclolux and What is it Used For
• 2. Important Information Before Using Cyclolux
• 3. How to Use Cyclolux
• 4. Possible Side Effects
• 5. How to Store Cyclolux
• 6. Contents of the Package and Other Information

1. What is Cyclolux and What is it Used For

Cyclolux is a Contrast Agent Containing Gadoteric Acid. It is Used Exclusively for Diagnostic Purposes.
Cyclolux is Used to Increase the Contrast of Images Obtained During Magnetic Resonance Imaging (MRI) Exams. This Contrast Enhancement Improves the Visibility and Definition of Boundaries in:
Adults, Children, and Adolescents (0-18 Years)

• MRI of the Central Nervous System (CNS), Including Pathological Changes in the Brain, Spinal Cord, and Surrounding Tissues;
• Whole-Body MRI, Including Pathological Changes in the Liver, Kidneys, Pancreas, Pelvis, Lungs, Heart, Breast, and Musculoskeletal System.

Adults

• MR Angiography, Including Pathological Changes and Stenosis in Arteries, Except for Coronary Arteries.

2. Important Information Before Using Cyclolux

When Not to Use Cyclolux

• If the Patient is Allergic to the Active Substance or Any of the Other Ingredients of this Medicinal Product (Listed in Section 6).
• If the Patient is Allergic to Gadolinium-Containing Contrast Agents (Such as Other Contrast Agents Used in MRI Exams).

Warnings and Precautions

Inform the Doctor or Radiologist if Any of the Following Apply to the Patient:

• The Patient has Experienced a Reaction to a Contrast Agent During an Exam;
• The Patient has Asthma;
• The Patient has a History of Allergies (e.g., Allergy to Shellfish, Hives, Hay Fever);
• The Patient is Being Treated with a Beta-Adrenergic Blocker (a Medication Used to Treat Heart Disorders and High Blood Pressure, Such as Metoprolol);
• The Patient has Kidney Problems;
• The Patient has Recently Undergone or is Scheduled to Undergo a Liver Transplant;
• The Patient has a Heart or Blood Vessel Disorder;
• The Patient has a History of Seizures or is Being Treated for Epilepsy.

In All These Cases, the Doctor or Radiologist Will Assess the Risk-Benefit Ratio and Decide Whether to Use Cyclolux in the Patient. If Cyclolux is Used, the Doctor or Radiologist Will Take the Necessary Precautions and Monitor the Administration of the Medicinal Product Closely.
The Doctor or Radiologist May Decide to Perform a Blood Test to Check the Patient's Kidney Function Before Using Cyclolux, Especially in Patients Over 65 Years of Age.

Newborns and Infants

Due to the Immaturity of Kidney Function in Newborns Up to 4 Weeks of Age and Infants Up to 1 Year of Age, Cyclolux Will Only be Used in These Patients After Careful Consideration by the Doctor.
Before the Exam, All Metal Objects That the Patient May be Wearing Should be Removed. Inform the Doctor or Radiologist if the Patient has:

• A Pacemaker,
• A Vascular Clip,
• An Infusion Pump,
• A Nerve Stimulator,
• A Cochlear Implant (an Implant in the Inner Ear),
• Any Suspected Metal Foreign Body, Especially in the Eye. This is Very Important, as it Can Cause Serious Problems, Since MRI Equipment Uses Very Strong Magnetic Fields.

Cyclolux and Other Medicinal Products

Inform the Doctor or Radiologist About All Medicinal Products the Patient is Currently Taking or Has Recently Taken, as Well as Any Medicinal Products the Patient Plans to Take. In Particular, Inform the Doctor, Radiologist, or Pharmacist if the Patient is Currently Taking or Has Recently Taken Medicinal Products for Heart Disorders or High Blood Pressure, Such as Beta-Adrenergic Blockers, Vasoactive Agents, Angiotensin-Converting Enzyme Inhibitors, or Angiotensin II Receptor Antagonists.

Using Cyclolux with Food and Drink

No Interactions Between Cyclolux and Food or Drink are Known. However, Ask the Doctor, Radiologist, or Pharmacist if it is Necessary to Avoid Eating or Drinking Before the Exam.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant, or Plans to Have a Child, She Should Consult the Doctor or Radiologist Before Using this Medicinal Product.
Pregnancy
Gadoteric Acid May Cross the Placenta. It is Not Known if this Affects the Fetus. Cyclolux Should Not be Used During Pregnancy Unless it is Absolutely Necessary.
Breastfeeding
The Doctor or Radiologist Will Discuss with the Patient Whether She Can Continue Breastfeeding or Should Stop for 24 Hours After Administration of Cyclolux.

Driving and Using Machines

There is No Available Data on the Effects of Cyclolux on the Ability to Drive or Use Machines.
If the Patient Feels Unwell After the Exam, She Should Not Drive or Use Machines.

3. How to Use Cyclolux

Cyclolux Will be Administered by Intravenous Injection.
During the Examthe Patient Will be Closely Monitored by the Doctor or Radiologist. A Needle Will be Left in the Patient's Vein, So that in Case of an Emergency, the Doctor or Radiologist Can Quickly Administer Life-Saving Medications. If the Patient Experiences an Allergic Reaction, the Administration of Cyclolux Will be Stopped Immediately.
Cyclolux Can be Injected Manually or Using an Automatic Injector.
In Newborns and Infants, this Medicinal Product is Administered Exclusively by Manual Injection.
This Procedure Can be Performed in a Hospital, Clinic, or Private Office. Medical Personnel Know What Precautions to Take During the Exam and are Also Aware of the Potential Complications that May Arise.

Dosage

The Doctor or Radiologist Will Determine the Dose Suitable for the Patient and Will Supervise the Administration of the Medicinal Product.

Dosage in Special Patient Groups

Cyclolux is Not Recommended for Use in Patients with Severe Kidney Impairment or in Patients Who Have Recently Undergone or are Scheduled to Undergo a Liver Transplant.
However, if the Use of Cyclolux is Necessary, the Patient Should Receive Only One Dose of the Medicinal Product During the Exam and Should Not Receive Another Dose for at Least 7 Days.
Use in Newborns, Infants, Children, and Adolescents
Due to the Immaturity of Kidney Function in Newborns Up to 4 Weeks of Age and Infants Up to 1 Year of Age, Cyclolux Will Only be Used in These Patients After Careful Consideration by the Doctor. Newborns and Infants Should Receive Only One Dose of Cyclolux During the Exam and Should Not Receive Another Dose for at Least 7 Days.
Cyclolux is Not Recommended for Use in Angiography in Children Under 18 Years of Age.
Elderly Patients
No Dose Adjustment is Necessary in Patients Over 65 Years of Age, However, it May be Necessary to Perform a Blood Test to Check Kidney Function.

Overdose

It is Very Unlikely that the Patient Will Receive an Overdose of Cyclolux. Cyclolux Will be Administered in a Medical Facility by Trained Personnel. In Case of Accidental Overdose, Cyclolux Can be Removed from the Body by Hemodialysis (Blood Purification).
Additional Information on the Use and Handling of this Medicinal Product by Medical Personnel is Provided at the End of this Package Leaflet.
If You Have Any Further Questions About the Use of this Medicinal Product, Ask Your Doctor or Radiologist.

4. Possible Side Effects

Like All Medicinal Products, Cyclolux Can Cause Side Effects, Although Not Everybody Gets Them.
After Administrationthe Patient Will be Monitored for at Least Half an Hour. Most Side Effects Occur Immediately or with Some Delay. Some Side Effects May Occur Up to Seven Days After Administration of Cyclolux.

There is a Small Risk of the Patient Experiencing an Allergic Reaction to Cyclolux. Such

Reactions Can be Severe and Cause Anaphylaxis(a Type of Allergic Reaction that Can be Life-Threatening). The Following Symptoms May be the First Signs of Anaphylaxis. If the Patient Notices Any of the Following Symptoms, She Should Immediately Inform the Doctor, Radiologist, or Other Medical Personnel:

• Swelling of the Face, Lips, and (or) Throat, Which May Cause Difficulty Swallowing or Breathing,
• Swelling of the Hands or Feet,
• Dizziness (Low Blood Pressure),
• Shortness of Breath (Difficulty Breathing),
• Wheezing,
• Coughing,
• Itching of the Skin,
• Runny Nose,
• Sneezing,
• Irritation of the Eyes,
• Hives,
• Rash.

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• Hypersensitivity (Allergic Reactions)
• Headache,
• Unusual Taste in the Mouth,
• Dizziness,
• Drowsiness,
• Feeling of Tingling, Heat, and (or) Burning, Cold and (or) Pain,
• Low or High Blood Pressure,
• Nausea (Vomiting),
• Abdominal Pain,
• Rash,
• Feeling of Heat, Feeling of Cold,
• Asthenia (Loss of Energy, Weakness),
• Discomfort at the Injection Site, Reactions at the Injection Site, Feeling of Coolness at the Injection Site, Extravasation (Leakage of the Medicinal Product Out of the Blood Vessels), Which May Lead to Inflammation (Redness and Local Pain).

Rare Side Effects (May Affect Up to 1 in 1,000 People)

• Anxiety, Presyncope (Dizziness and Feeling of Impending Loss of Consciousness),
• Swelling of the Eyelids,
• Palpitations,
• Sneezing,
• Vomiting,
• Diarrhea
• Increased Salivation,
• Unusual Taste in the Mouth,
• Hives, Itching, Excessive Sweating,
• Chest Pain, Chills.

Very Rare Side Effects (May Affect Up to 1 in 10,000 People)

• Anaphylactic or Anaphylactoid Reactions (Severe, Potentially Life-Threatening Allergic Reactions),
• Agitation,
• Coma, Seizures, Syncope (Short-Term Loss of Consciousness), Olfactory Disorders (Perception of Unpleasant Odors), Muscle Twitching,
• Conjunctivitis, Redness of the Eyes, Blurred Vision, Increased Tear Production,
• Cardiac Arrest, Accelerated or Slowed Heart Rate, Arrhythmia, Vasodilation, Pallor,
• Respiratory Arrest, Pulmonary Edema, Breathing Difficulties, Wheezing, Stuffy Nose, Coughing, Dryness of the Throat, Laryngospasm with a Feeling of Suffocation, Bronchospasm, Laryngeal Edema,
• Rash, Redness of the Skin, Swelling of the Lips and (or) Mouth,
• Muscle Spasms, Muscle Weakness, Back Pain,
• Malaise, Discomfort in the Chest, Fever, Swelling of the Face, Extravasation (Leakage of the Medicinal Product Out of the Blood Vessels), Which May Lead to Tissue Necrosis (Death of Tissue) at the Injection Site, Phlebitis,
• Decreased Oxygen Levels in the Blood.

There Have Been Reports of Nephrogenic Systemic Fibrosis (NSF) (a Condition that Causes Thickening of the Skin and May Also Affect Soft Tissues and Internal Organs) in Patients Who Have Received Cyclolux Along with Other Gadolinium-Containing Contrast Agents. If the Patient Notices Any Changes in Skin Color and (or) Thickness at Any Site on the Body Within Weeks of the MRI Exam, She Should Inform the Radiologist Who Performed the Exam.

Reporting Side Effects

If the Patient Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, She Should Inform the Radiologist, Pharmacist, Doctor, or Nurse.
Side Effects Can be Reported Directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products – Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of the Medicinal Product.

5. How to Store Cyclolux

Store the Medicinal Product Out of Sight and Reach of Children.
No Special Precautions for Storage of this Medicinal Product are Necessary.
Chemical and Physical Stability of the Medicinal Product After First Use has Been Demonstrated for 72 Hours at Room Temperature. From a Microbiological Point of View, the Medicinal Product Should be Used Immediately. If Not Used Immediately, the Responsibility for the Storage Conditions and the Storage Time Before Use Lies with the User. The Storage Time Should Not Exceed 24 Hours at 2 to 8°C, Unless the Opening is Done in Controlled and Validated Aseptic Conditions.
Do Not Use this Medicinal Product After the Expiration Date Stated on the Vial and the Carton After "EXP". The Expiration Date Refers to the Last Day of the Month Stated.

6. Contents of the Package and Other Information

What Cyclolux Contains

• The Active Substance of Cyclolux is Gadoteric Acid. One Milliliter of the Solution for Injection Contains 279.32 mg of Gadoteric Acid (as Meglumine Salt), Which Corresponds to 0.5 mmol of Gadoteric Acid (as Meglumine Salt).
• The Other Ingredients of Cyclolux are Meglumine, 2,2',2'',2'''-(1,4,7,10-Tetraazacyclododecane-1,4,7,10-Tetrayl)tetraacetic Acid (DOTA), and Water for Injections.

What Cyclolux Looks Like and What the Package Contains

Cyclolux is a Clear Solution for Intravenous Injection, Colorless or in Various Shades of Yellow, Free from Visible Particles.
The Package of Cyclolux Contains One or Ten Vials; One Vial Contains 10, 15, or 20 ml of the Solution for Injection.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

Sanochemia Pharmazeutika GmbH
Landegger Straße 7
2491 Neufeld an der Leitha
Austria

Manufacturer

Sanochemia Pharmazeutika GmbH
Landegger Straße 7
2491 Neufeld an der Leitha, Austria

This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under 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/ml ενέσιμο διάλυμα
Czech Republic: Cyclolux
Estonia:Cyclolux
Greece: Cyclolux 0,5 mmol ενέσιμο διάλυμα
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 soluţie injectabilă
Spain: Cyclolux 0,5 mmol/ml solución inyectable EFG
Slovakia: Cyclolux 0,5 mmol/ml Injekčný roztok
Slovenia:Cyclolux 0,5 mmol/ml raztopina za injiciranje
United Kingdom (Northern Ireland): Cyclolux 0.5 mmol/ml solution for injection

Date of Last Revision of the Package Leaflet: 08-05-2024

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Information Intended for Healthcare Professionals Only:

Dosage

Use the Smallest Dose That Provides Sufficient Contrast 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.

• MRI of the Brain and Spinal Cord: In Exams of the Nervous System, Doses Range from 0.1 to 0.3 mmol/kg Body Weight, Which Corresponds to 0.2 to 0.6 ml/kg Body Weight. After Administration of 0.1 mmol/kg Body Weight to Patients with Brain Tumors, an Additional Dose of 0.2 mmol/kg Body Weight May Improve Tumor Visibility and Facilitate Treatment Decisions.
• MRI of the Whole Body and Angiography: The Recommended Dose for Intravenous Injection, Providing Adequate Radiological Contrast for Diagnostic Purposes, is 0.1 mmol/kg Body Weight (i.e., 0.2 ml/kg Body Weight). Angiography: In Exceptional Cases (e.g., When Images of Satisfactory Quality, Covering an Extensive Vascular Area, are Not Obtained), a Second, Subsequent Dose of 0.1 mmol/kg Body Weight (Corresponding to 0.2 ml/kg Body Weight) May be Justified. However, if Two Consecutive Doses of Cyclolux are Planned Before the Start of Angiography, it May be Beneficial to Administer 0.05 mmol/kg Body Weight (i.e., 0.1 ml/kg Body Weight) in Each Dose, Depending on the Available Imaging Equipment.
• Children and Adolescents: MRI of the Brain and Spinal Cord / Whole-Body MRI: The Recommended and Maximum Dose of Cyclolux is 0.1 mmol/kg Body Weight. Do Not Administer More Than One Dose During the Imaging Exam. Due to the Immaturity of Kidney Function in Newborns Up to 4 Weeks of Age and 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 Body Weight. Do Not Administer More Than One Dose During the Imaging Exam. Since There is a Lack of Information on Multiple Administrations, Do Not Repeat Injections of Cyclolux Unless the Interval Between Injections is at Least 7 Days. Cyclolux is Not Recommended for Use in Angiography in Children Under 18 Years of Age Due to Insufficient Data on Efficacy and Safety in this Indication.
• Patients with Kidney Impairment: In Patients with Mild to Moderate Kidney Impairment (GFR ≥ 30 ml/min/1.73 m), Use the Doses Recommended for Adults. See "Kidney Impairment" Below.
• Patients with Liver Impairment: In These Patients, Use the Doses Recommended for Adults. Caution is Advised, Especially in the Perioperative Period of Liver Transplantation.

Method of Administration

Cyclolux is Indicated Exclusively for Intravenous Administration. Do Not Administer Intrathecally. Administer Intravenously Only: Extravasation May Cause Local Reactions of Intolerance, Requiring Local Treatment.
Infusion Rate: 3-5 ml/min (in Angiographic Exams, a Higher Infusion Rate of Up to 120 ml/min, i.e., 2 ml/second, May be Used).
Optimal Imaging: Within 45 Minutes of Injection.
Optimal Imaging Sequence: T1-Weighted Images.
Whenever Possible, the Contrast Agent Should be Administered Intravenously to the Patient in a Supine Position. After Administration, the Patient Should be Monitored for at Least Half an Hour, as Experience Shows that Most Side Effects Occur During this Period.
Prepare a Syringe with a Needle. Remove the Plastic Disc. Clean the Stopper with a Swab or Cotton Ball Soaked in Alcohol, Then Pierce the Stopper with the Needle. Draw Up the Required Volume of the Medicinal Product for the Exam and Administer it Intravenously to the Patient.
For Single Use Only; All Unused Portions of the Solution Should be Discarded.
The Solution for Injection Should be Visually Inspected Before Use. Only a Clear Solution Without Visible Particles is Suitable for Use.
Children and Adolescents
Depending on the Volume of Cyclolux to be Administered to the Child, it is Recommended to Use Vials of Cyclolux Along with a Single-Use Syringe with a Capacity Adapted to the Volume to be Administered, in Order to Maintain Greater Accuracy of the Administered Volume.
In Newborns and Infants, the Required Dose Should be Administered Manually.

Kidney Impairment

It is Recommended that All Patients Undergo Laboratory Tests to Check Kidney Function Before Administration of Cyclolux.

There Have Been Reports of Nephrogenic Systemic Fibrosis (NSF) in Association with the Use of Gadolinium-Containing Contrast Agents in Patients with Acute or Chronic Kidney Impairment (GFR <30 ml min 1.73 m). patients who have undergone or are scheduled to undergo a liver transplant particularly at risk, due the high frequency of acute kidney injury in this group. risk nsf associated with use cyclolux, medicinal product should only be used severe impairment and perioperative period transplantation after careful risk-benefit assessment when diagnostic information is essential cannot obtained mri without contrast enhancement. if cyclolux necessary, dose not exceed 0.1 mmol kg body weight. do administer more than one during imaging exam. since there lack on multiple administrations, repeat injections unless interval between least 7 days.
Hemodialysis Performed Shortly After Administration of Cyclolux May Facilitate the Elimination of Cyclolux from the Body. There is No Evidence to Support the Initiation of Hemodialysis as a Preventive Measure or Treatment for NSF in Patients Who are Not Currently Receiving Hemodialysis.

Elderly Patients

Since the Renal Clearance of Gadoteric Acid May be Decreased in Elderly Patients, it is Especially Important to Check Kidney Function in Patients Over 65 Years of Age.

Newborns and Infants

See "Dosage and Method of Administration, Children and Adolescents".

Pregnancy and Breastfeeding

Cyclolux Should Not be Used During Pregnancy Unless the Clinical Condition of the Woman Requires the Administration of Gadoteric Acid.
The Continuation or Discontinuation of Breastfeeding for 24 Hours After Administration of Cyclolux Should be Left to the Discretion of the Doctor and the Breastfeeding Mother.

Instructions for Handling the Medicinal Product

The Detached Label from the Vials Should be Attached to the Patient's File to Allow for Accurate Identification of the Contrast Agent Used. The Administered Dose Should Also be Recorded. If Electronic Patient Cards are Used, the Name of the Medicinal Product, Batch Number, and Dose Should be Entered in the Patient's File.