Clariscan

Package Leaflet: Information for the User

Clariscan, 0.5 mmol/ml, Solution for Injection

Clariscan, 0.5 mmol/ml, Solution for Injection in Pre-filled Syringe

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, Radiologist or Pharmacist.
• If You Experience any Side Effects, Including Those Not Listed in this Package Leaflet, Inform Your Doctor, Radiologist or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Clariscan and What is it Used for

What is Clariscan

Clariscan Contains the Active Substance Gadoteric Acid.
It Belongs to a Group of Contrast Agents Used in Magnetic Resonance Imaging (MRI).

What is Clariscan Used for

Clariscan is Used to Increase the Contrast of Images Obtained During MRI Exams.
Adults, Children and Adolescents (from 0 to 18 Years):

• MRI of the Central Nervous System (CNS), Including Pathological Changes in the Brain, Spinal Cord and Surrounding Tissues.

Adults, Children and Adolescents (from 6 Months to 18 Years):

• Whole Body MRI, Including Pathological Changes.

Adults:

• Magnetic Resonance Angiography (MRA) Including Pathological Changes and Stenosis in Non-coronary Arteries.

The Product is Intended for Diagnostic Use Only.

How Clariscan Works

Clariscan Makes it Easier to Read the Images Obtained During MRI Exams.
This is Possible Due to the Enhanced Contrast Between the Diagnosed Parts of the Body and the Rest of the Body, Allowing Doctors or Radiologists to Improve the Visibility of Different Parts of the Body.

2. Important Information Before Using Clariscan

When Not to Use Clariscan:

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

Warnings and Precautions

Before the Exam, Remove any Metal Objects the Patient May Have with Them.
Inform the Doctor or Radiologist Before Administering Clariscan if:

• The Patient has Previously 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 Seafood, Hay Fever, Urticaria (Severe Itching);
• 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 History of Seizures or Epilepsy or is Being Treated for Epilepsy;
• The Patient has Severe Heart Disease;
• The Patient has a Disease Affecting the Heart or Blood Vessels;
• The Patient has a Pacemaker, a Vascular Clip Made of Ferromagnetic Material, an Implant or an Insulin Pump, or There is any Suspicion of a Metal Foreign Body, Especially in the Eye. In all these Cases, MRI is Not Recommended.

Before Administering Clariscan, Inform the Doctor or Radiologist if any of the Above Applies to the Patient.

Risk of Serious Side Effects

As with Other Contrast Agents Used in MRI, there is a Risk of Side Effects.
Side Effects are Usually Mild and Transient, but they Cannot be Predicted. However, there is a Risk that they May be Life-Threatening.

• Serious Side Effects May Occur Immediately or Within 60 Minutes of Administering the Medicinal Product.
• Side Effects May Also Occur Within 7 Days of Administering the Medicinal Product. There is a Higher Risk of Side Effects in Patients who have Already Experienced an Allergic Reaction to a Contrast Agent Used in MRI (See Section 4 "Possible Side Effects").
• Before Administering Clariscan, Inform the Doctor or Radiologist if You have a History of Allergic Reactions. In all these Cases, the Doctor will Assess the Risk-Benefit Ratio and Decide whether to Use Clariscan in the Patient. The Administration of Clariscan will be Closely Monitored by the Doctor or Radiologist.

Examinations and Monitoring

The Prescribing Doctor or Radiologist May Decide to Perform a Blood Test to Check the Patient's Kidney Function Before Using Clariscan, Especially in Patients Over 65 Years of Age.

Children and Adolescents

Angiography is Not Recommended in Children Under 18 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, Clariscan will Only be Used in these Patients After Careful Consideration by the Doctor.
It is Not Recommended to Perform a Whole Body MRI Scan Using Clariscan in Children Under 6 Months of Age.

Clariscan and Other Medicinal Products

Inform the Prescribing 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 Prescribing 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 Substances, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Receptor Antagonists.

Clariscan with Food and Drink

Common Side Effects of Contrast Agents Used in MRI Include Nausea and Vomiting. The Patient Should Avoid Eating for 2 Hours Before the Exam.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant or is Planning to Have a Child, She Should Consult a Doctor or Radiologist Before Using this Medicinal Product.
Pregnancy
Gadoteric Acid May Cross the Placenta. It is Not Known Whether this Affects the Fetus. Clariscan Should Not be Used During Pregnancy, Unless the Doctor Decides 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 Administering Clariscan.

Driving and Using Machines

There is No Available Data on the Effects of Clariscan on the Ability to Drive and Use Machines.
Consider the Possibility of Dizziness (Low Blood Pressure) and Nausea. If the Patient Feels Unwell After the Exam, She Should Not Drive or Operate Machines.

3. How to Use Clariscan

Administration of Clariscan

Clariscan will be Administered by Intravenous Injection.
This Procedure May 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.
During the Exam, the Patient will be Closely Monitored by the Doctor.

• A Needle will be Left in the Patient's Vein.
• This will Allow the Doctor to Quickly Administer any Life-Saving Medicinal Products if Necessary. If the Patient Experiences an Allergic Reaction, the Administration of Clariscan will be Stopped Immediately.

Recommended Dose

The Radiologist will Determine the Appropriate Dose for the Patient and will Supervise the Administration of the Medicinal Product.

Patients with Kidney or Liver Impairment

Clariscan is Not Recommended for Patients with Severe Kidney Impairment or for Patients who have Recently Undergone or are Scheduled to Undergo a Liver Transplant.
However, if the Prescribing Doctor or Radiologist Decides to Use Clariscan:

• The Patient Should Receive Only One Dose of the Medicinal Product During the MRI Exam,
• The Patient Should Not Receive Another Dose of the Medicinal Product for at Least 7 Days.

Use in Newborns, Infants, Children and Adolescents

The Use of Clariscan in these Patients is Possible After Careful Consideration by the Prescribing Doctor or Radiologist.
However, if the Prescribing Doctor or Radiologist Decides to Use Clariscan in these Patients:

• The Patient Should Receive Only One Dose of the Medicinal Product During the MRI Exam,
• The Patient Should Not Receive Another Dose of the Medicinal Product for at Least 7 Days. It is Not Recommended to Perform a Whole Body MRI Scan Using Clariscan in Children Under 6 Months of Age. It is Not Recommended to Use Clariscan for Angiography in Children Under 18 Years of Age.

Elderly Patients

There is No Need to Adjust the Dose 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 the Medicinal Product.
Clariscan will be Administered in a Medical Facility by Trained Personnel.
In the Event of an Actual Overdose, Clariscan 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, Clariscan can Cause Side Effects, although Not Everybody Gets them.
After Administration, the Patient will be Monitored for at Least Half an Hour.
Most Side Effects Occur Immediately or with Some Delay. Some Side Effects May Occur Even Several Days After the Administration of Clariscan.

There is a Small Risk of an Allergic Reaction to Clariscan.

Such Reactions can be Severe and Cause Anaphylactic Shock(a Life-Threatening Allergic Reaction).
The Following Symptoms May be the First Signs of Anaphylactic Shock. If the Patient Notices any of the Following Symptoms, She Should Immediately Inform the Prescribing Doctor, Radiologist or Other Qualified Medical Personnel:

• Swelling of the Face, Lips and/or Throat, which May Cause Difficulty in Swallowing or Breathing,
• Swelling of the Hands or Feet,
• Dizziness (Low Blood Pressure),
• Breathing Difficulties,
• Wheezing,
• Coughing,
• Itching,
• Rhinitis,
• Sneezing
• Irritation of the Eyes,
• Urticaria,
• Rash.

Uncommon Side Effects(May Affect up to 1 in 100 Patients)

• Allergic Reaction,
• Headache,
• Unusual Taste in the Mouth,
• Dizziness,
• Drowsiness,
• Feeling of Tingling, Heat, Cold and/or Pain,
• Low or High Blood Pressure,
• Nausea (Vomiting),
• Abdominal Pain,
• Rash,
• Feeling of Heat, Feeling of Cold,
• Asthenia (Chronic Fatigue),
• Discomfort at the Injection Site, Reaction at the Injection Site, Feeling of Coolness at the Injection Site, Swelling at the Injection Site, Extravasation (Leakage of the Medicinal Product into the Surrounding Tissue), which May Lead to Inflammation (Redness and Local Pain).

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,
• Sneezing,
• Vomiting,
• Diarrhea,
• Increased Salivation,
• Urticaria, Itching, Sweating,
• Chest Pain, Chills.

Very Rare Side Effects(May Affect Less than 1 in 10,000 Patients)

• Anaphylactic or Anaphylactoid Reactions,
• Agitation,
• Coma, Seizures, Fainting (Transient Loss of Consciousness), Disturbances of Smell (Frequent Perception of Unpleasant Odors), Tremors,
• Conjunctivitis, Redness of the Eyes, Blurred Vision, Increased Tear Production,
• Cardiac Arrest, Accelerated or Slow Heart Rate, Irregular Heartbeat, Vasodilation, Pallor,
• Respiratory Arrest, Pulmonary Edema, Breathing Difficulties, Wheezing, Stuffy Nose, Cough, Dryness of the Throat, Feeling of Pressure in the Throat with a Feeling of Suffocation, Bronchospasm, Swelling of the Throat,
• Rash, Redness of the Skin, Swelling of the Lips and Swelling Limited to the Mouth,
• Muscle Spasms, Muscle Weakness, Back Pain,
• Malaise, Discomfort in the Chest, Fever, Swelling of the Face, Extravasation of the Product, which May Lead to Necrosis of the Tissue at the Injection Site, Phlebitis,
• Decreased Oxygen Level in the Blood.

There have been Reports of Nephrogenic Systemic Fibrosis (NSF) Associated with the Use of Gadolinium-Containing Contrast Agents, Most of which Involved Patients with Acute or Chronic Severe Kidney Impairment (GFR <30 ml min 1.73 m). patients who have undergone or are scheduled to undergo a liver transplant at particular risk, due the high frequency of acute kidney injury in this population. risk nsf associated with clariscan, medicinal product should only be used severe impairment and recently after careful assessment risk-benefit ratio if diagnostic information is essential cannot obtained using mri without contrast enhancement.< p>

Reporting of Side Effects

If You Experience any Side Effects, Including those Not Listed in this Package Leaflet, Inform Your Doctor, Pharmacist or Nurse. Side Effects can be Reported Directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medicinal Product.

5. How to Store Clariscan

Store the Medicinal Product Out of the Sight and Reach of Children.
Vials and Bottles: No Special Storage Conditions.
Pre-filled Syringe: Do Not Freeze.
Do Not Use this Medicinal Product After the Expiration Date Stated on the Vial, Bottle, Pre-filled Syringe, Carton After "EXP". The Expiration Date Refers to the Last Day of the Month Stated.
The Batch Number is Stated After "Lot".
The Chemical and Physical Stability of the Medicinal Product has been Demonstrated for 48 Hours After Preparation at a Temperature of 30°C. From a Microbiological Point of View, the Medicinal Product Should be Used Immediately. If the Medicinal Product is Not Used Immediately, the User is Responsible for Ensuring the Appropriate Storage Conditions and Storage Time Before Administration, Typically Not Exceeding 24 Hours at 2°C - 8°C, Unless the Medicinal Product has been Opened in Controlled and Validated Aseptic Conditions.
Medicinal Products Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicinal Products that are No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Clariscan Contains

• The Active Substance of Clariscan is Gadoteric Acid. One Milliliter of the Solution for Injection Contains 279.32 mg of Gadoteric Acid (as Meglumine Salt), Equivalent to 0.5 mmol of Gadoteric Acid.
• The Other Ingredients are: Meglumine, Tetraazacyclododecanetetraacetic Acid (DOTA) and Water for Injections

What Clariscan Looks Like and Contents of the Package

Clariscan is a Clear, Colorless to Light Yellow Solution for Intravenous Injection.
Clariscan is Available in the Following Packages:
Vials Made of Type I Colorless Glass, Containing 5, 10, 15, 20 ml of the Medicinal Product,
Polymer Pre-filled Syringes, Containing 10, 15, 20 ml of the Medicinal Product,
Bottles Made of Type I Colorless Glass and Polypropylene Bottles, Containing 50 or 100 ml of the Medicinal Product,
Packaged in Single or 10 Units per Carton.
Not all Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

GE Healthcare AS
Nycoveien 1
0485 Oslo
Norway

Manufacturer

GE Healthcare Ireland Limited
IDA Business Park
Carrigtwohill
Cork
Ireland

Date of Last Revision of the Package Leaflet: July 2025

Information Intended for Healthcare Professionals Only:
Dosage

Adults

MRI of the Brain and Spinal Cord

The Recommended Dose is 0.1 mmol/kg Body Weight, Equivalent to 0.2 ml/kg Body Weight. In Patients with Brain Tumors, the Administration of an Additional Dose of 0.2 mmol/kg Body Weight, Equivalent to 0.4 ml/kg Body Weight, May Improve the Visibility of the Tumor and Facilitate Treatment Decisions.
Whole Body MRI (Changes in the Liver, Kidneys, Pancreas, Pelvis, Lungs, Heart, Breast
and Musculoskeletal System)
The Recommended Dose Providing Diagnostic Contrast is 0.1 mmol/kg Body Weight, Equivalent to 0.2 ml/kg Body Weight.
Angiography: The Recommended Dose for Intravenous Injection Providing Diagnostic Contrast is 0.1 mmol/kg Body Weight, Equivalent to 0.2 ml/kg Body Weight.
In Exceptional Circumstances (e.g. if Images of Satisfactory Quality Covering an Extensive Vascular Area are Not Obtained), it May be Justified to Administer a Second Consecutive Dose of 0.1 mmol/kg Body Weight, Equivalent to 0.2 ml/kg Body Weight. However, if Two Consecutive Doses of Clariscan are Planned Before the Start of Angiography, it May be Beneficial to Administer 0.05 mmol/kg Body Weight, Equivalent to 0.1 ml/kg Body Weight, in Each Dose, Depending on the Available Imaging Equipment.

Special Populations

Kidney Impairment
The Dose for Adults is Applicable to Patients with Mild to Moderate Kidney Impairment (GFR ≥ 30 ml/min/1.73 m).
Clariscan Should be Used with Caution in Patients with Severe Kidney Impairment (GFR <30 ml min 1.73 m) and in patients who have recently undergone or are scheduled to undergo a liver transplant, only after careful assessment of the risk-benefit ratio if diagnostic information is essential cannot be obtained using mri without contrast enhancement. prescribing doctor radiologist decides use clariscan, dose should not exceed 0.1 mmol kg body weight. do administer more than one medicinal product during exam. due lack data on repeated administration, repeat injections unless interval between consecutive at least 7 days.
Patient Over 65 Years of Age
It is Considered that there is No Need to Adjust the Dose. Caution Should be Exercised in Elderly Patients.
Liver Impairment
In Patients with Liver Impairment, the Doses Prescribed for Adults are Applicable. Caution is Advised, Especially in the Perioperative Period of Liver Transplantation (See also "Kidney Impairment" Above).
Children and Adolescents (0-18 Years)
MRI of the Brain and Spinal Cord / Whole Body MRI:
The Recommended and Maximum Dose of Clariscan is 0.1 mmol/kg Body Weight.
Do Not Administer More than One Dose of the Medicinal Product During the Scan.
It is Not Recommended to Perform a Whole Body MRI Scan Using Clariscan in Children Under 6 Months of Age.
Due to the Immaturity of Kidney Function in Newborns up to 4 Weeks of Age and Infants up to 1 Year of Age, Clariscan will Only be Used in these Patients After Careful Consideration by the Doctor, at a Dose Not Exceeding 0.1 mmol/kg Body Weight. Do Not Administer More than One Dose of the Medicinal Product During the Scan. Due to the Lack of Data on Repeated Administration, Do Not Repeat Injections of Clariscan, Unless the Interval Between Consecutive Injections is at Least 7 Days.
Angiography:
Clariscan is Not Indicated for Use in Angiography in Children Under 18 Years of Age, Due to Insufficient Data on Efficacy and Safety in this Indication.

Method of Administration

Clariscan is Intended for Intravenous Use Only.
Infusion Rate: 3-5 ml/min (at Angiographic Exams, a Higher Infusion Rate of up to 120 ml/min, i.e. 2 ml/sec, can be Used). Instructions for Preparation and Disposal of the Medicinal Product, See Warnings and Precautions for UseBelow.
Children and Adolescents (0-18 Years).
Depending on the Amount of Clariscan to be Administered to the Child, it is Recommended to Use Vials of Clariscan in Combination with a Single-Use Syringe with a Capacity Adapted to the Amount to be Administered, in Order to Ensure Higher Precision of the Administered Dose.
In Newborns and Infants, the Required Dose Should be Administered Manually.

Warnings and Precautions for Use

Kidney Impairment

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

There have been Reports of Nephrogenic Systemic Fibrosis (NSF) Associated with the Use of Gadolinium-Containing Contrast Agents in Patients with Acute or Chronic Severe Kidney Impairment (GFR <30 ml min 1.73 m). patients who have undergone or are scheduled to undergo a liver transplant at particular risk, due the high frequency of acute kidney injury in this population. risk nsf associated with clariscan, medicinal product should only be used severe impairment and recently after careful assessment risk-benefit ratio if diagnostic information is essential cannot obtained using mri without contrast enhancement.
Since Kidney Clearance of Clariscan May be Reduced in Elderly Patients, it is Especially Important to Check Kidney Function in Patients Over 65 Years of Age.
Hemodialysis Performed Shortly After Administration of Clariscan May Facilitate its Elimination from the Body. There is No Evidence to Support the Initiation of Hemodialysis as a Preventive or Therapeutic Measure for NSF in Patients who are Not Currently Receiving Hemodialysis.

Pregnancy and Breastfeeding

Clariscan Should Not be Used During Pregnancy, Unless the Clinical Condition of the Woman Requires the Use of Gadoteric Acid.
Continuation or Discontinuation of Breastfeeding for 24 Hours After Administration of Clariscan Should be Left to the Decision of the Doctor or Radiologist and the Breastfeeding Mother.

Instructions for Use

For Single Use Only
The Solution for Injection Should be Visually Inspected Before Use. Only Clear Solutions Without Visible Particles Should be Used.
Vials and Bottles: Prepare a Syringe with a Needle. Remove the Plastic Disc from the Vial. Remove the Plastic Cap from the Polypropylene Bottle or Remove the Upper Plastic Cover. After Cleaning the Cork with an Alcohol-Soaked Swab, Pierce it with a Needle. Draw Up the Required Amount of the Medicinal Product and Administer it Intravenously to the Patient.
Pre-filled Syringes: Administer the Required Volume of the Medicinal Product Intravenously.
Any Unused Residual Amounts of the Medicinal Product Left in the Vial/Bottle, Materials Used During Administration of the Medicinal Product, and Components of the Pre-filled Syringe Should be Disposed of After the Exam.
Removable Labels:
Removable Labels from Pre-filled Syringes, Vials, Bottles 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 an Electronic Patient Card is Used, the Product Name, Batch Number and Administered Dose Should be Entered.
Any Unused Residual Amounts of the Medicinal Product or its Waste Should be Disposed of in Accordance with Local Regulations.