CLARISCAN 0.5 mmol/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Clariscan 0.5 mmol/mL Solution for Injection EFG

Clariscan 0.5 mmol/mL Solution for Injection in Pre-filled Syringe EFG

Gadoteric Acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

? Keep this 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, talk to your doctor, radiologist or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Clariscan and what is it used for
2. What you need to know before you use Clariscan
3. How to use Clariscan
4. Possible side effects
5. Storage of Clariscan

6. Contents of the Pack and Further Information

1. What is Clariscan and what is it used for

What is Clariscan

Clariscan contains gadoteric acid as the active substance. It belongs to a group of medicines called "contrast agents" used in magnetic resonance imaging (MRI) studies.

What is Clariscan used for

Clariscan is used to enhance the contrast of images obtained during MRI examinations.

In adults and in children and adolescents from 0 to 18 years:

• MRI of the central nervous system (CNS) including defects (lesions) of the brain, spinal cord, and surrounding tissues

In adults and in children and adolescents from 6 months to 18 years:

• MRI of the whole body including defects (lesions)

In adults only:

• MRI angiography including defects (lesions) or narrowing (stenosis) of arteries, except for coronary arteries.

This medicine is for diagnostic use only.

How Clariscan works

Clariscan makes it easier to see the images obtained by MRI. This is achieved by increasing the contrast between the part of the body to be examined and the rest of the body. This allows doctors or radiologists to see the different parts of the body more clearly.

2. What you need to know before you use Clariscan

Clariscan must not be administered:

• if you are allergic to gadoteric acid or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any medicine that contains gadolinium or other contrast agents used in MRI studies.

Warnings and Precautions

Remove all metal objects you may be wearing before the examination

Talk to your doctor or radiologist before using Clariscan if:

• you have previously had a reaction to a contrast agent during an examination
• you have asthma
• you have a history of allergy, such as shellfish allergy, hay fever, urticaria (intense itching)
• you are being treated with a beta-blocker (a medicine used for heart or blood pressure problems, such as metoprolol)
• your kidneys do not work properly
• you have recently had, or are about to have, a liver transplant
• you have had seizures or are being treated for epilepsy
• you have a serious heart problem.
• you have a disease that affects your heart or blood vessels
• you have a heart pacemaker, a metal clip (ferromagnetic), an implant, or an insulin pump, or suspect you have any metal foreign body, especially in the eye. In these cases, MRI is not suitable.

Talk to your doctor or radiologist if you are in any of the above situations before using Clariscan.

Risk of Serious Side Effects

As with any contrast agent used for MRI, there is a risk of side effects. Side effects are usually mild and temporary, but they cannot be predicted. However, there is a risk that could put your life in danger:

• serious side effects may occur immediately after or within an hour of using this medicine.
• some side effects may occur up to 7 days after treatment. Side effects are more likely if you have had a reaction to a contrast agent used for MRI in the past (see section 4 "Possible side effects").
• tell your doctor or radiologist before using Clariscan if you have had a reaction in the past. Your doctor or radiologist will only administer Clariscan if the benefits outweigh the risks. If you are given Clariscan, your doctor or radiologist will closely monitor you.

Tests and Checks

Your doctor or radiologist may decide to perform a blood test before you receive Clariscan, especially if you are over 65 years old. This test is to check that your kidneys are working properly.

Children and Adolescents

In children under 18 years, it is not recommended for use in angiography.

Newborns and Infants

Your doctor or radiologist will carefully consider whether your baby can receive Clariscan. This is due to the immaturity of the kidneys in newborns up to 4 weeks and in infants up to 1 year.

In children under 6 months of age, it is not recommended for use in whole-body MRI.

Using Clariscan with Other Medicines

Tell your doctor or radiologist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor, radiologist, or pharmacist if you are taking or have recently taken medicines for heart and blood pressure problems, such as beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists.

Using Clariscan with Food and Drink

Administration of contrast agents for MRI may cause nausea and vomiting as side effects. Therefore, the patient should fast for 2 hours before the examination.

Pregnancy and Breastfeeding

Pregnancy

Gadoteric acid may cross the placenta. It is not known if it affects the fetus. Clariscan should not be used during pregnancy unless it is strictly necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or radiologist before using this medicine.

Breastfeeding

Tell your doctor or radiologist if you are breastfeeding or about to start. Your doctor or radiologist will assess with you whether you should continue or interrupt breastfeeding for a period of 24 hours after administration of Clariscan.

Driving and Using Machines

There are no available data on the effects of Clariscan on the ability to drive. However, if you drive or use machines, you should be aware of the possible occurrence of dizziness (a symptom of low blood pressure) and nausea. If you feel unwell after the examination, you should not drive or use machines.

3. How to Use Clariscan

How Clariscan is Administered

Clariscan will be administered to you by intravenous injection.

Administration will take place in a hospital, clinic, or private clinic.

Medical staff are aware of the precautions to be taken.

They are also aware of the possible complications that may occur.

During the test, you will be under the supervision of your doctor or radiologist.

• A needle will be left in your vein,
• This will allow the doctor or radiologist to inject emergency medication if necessary.

If you experience an allergic reaction, the doctor or radiologist will stop the administration of Clariscan.

Dosage

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

Patients with Liver or Kidney Problems

The use of Clariscan 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 your doctor or radiologist decides to administer Clariscan to you:

• you will be given a single dose of Clariscan during the MRI and
• a second injection will not be given until at least 7 days have passed.

Newborns, Infants, Children, and Adolescents

Clariscan should only be used in these patients after careful consideration by the doctor or radiologist. However, if your doctor or radiologist decides to administer Clariscan to your child:

• a single dose of Clariscan will be given during the MRI examination and
• a second injection will not be given until at least 7 days have passed.

In children under 6 months of age, it is not recommended for use in whole-body MRI.

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

Elderly Patients

If you are 65 years or older, it is not necessary to adjust the dose. However, you may have a blood test first to check that your kidneys are working properly.

If You Have Been Given Too Much Clariscan

It is highly unlikely that you will be given an overdose, as you will receive Clariscan in a medical center by a trained person.

In the event of an overdose, Clariscan can be removed from the body by hemodialysis (blood cleansing).

At the end of this leaflet, further information is provided for doctors and healthcare professionals.

If you have any further questions on the use of this medicine, ask your doctor or radiologist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

After Administration, you will be under observation for at least half an hour. Most side effects occur immediately or may be delayed. Some effects may occur up to seven days after the injection of Clariscan.

There is a Small Risk (Rare) that You May Have an Allergic Reaction to Clariscan.These reactions can be serious and can cause shock(a life-threatening allergic reaction).

Any of the Following Symptoms May be the First Signs of Shock. Tell Your Doctor, Radiologist, or Healthcare Professional Immediately 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
• dizziness (low blood pressure)
• difficulty breathing
• wheezing
• coughing
• itching
• runny nose
• sneezing
• eye irritation
• hives
• rash

Uncommon Side Effects: May Affect up to 1 in 100 People

• hypersensitivity
• headache
• unusual taste in the mouth
• dizziness
• drowsiness
• tingling, heat, cold, and/or pain sensation
• high or low blood pressure
• nausea (feeling sick)
• stomach pain
• rash
• heat sensation, cold sensation
• asthenia
• injection site reactions, including pain, swelling, or redness at the injection site

Rare Side Effects: May Affect up to 1 in 1,000 People

• anxiety, fainting (dizziness and feeling of impending loss of consciousness)
• swelling of the eyelids
• palpitations
• sneezing
• vomiting (feeling sick)
• diarrhea
• increased salivation
• hives, itching, sweating
• chest pain, chills

Very Rare Side Effects: May Affect up to 1 in 10,000 People

• anaphylactic or anaphylactoid reactions
• agitation
• coma, convulsions, syncope (brief loss of consciousness), altered sense of smell (perception of unpleasant odors), tremors
• conjunctivitis, red eyes, blurred vision, increased tear production
• cardiac arrest, rapid or slow heartbeat, irregular heartbeat, vasodilation, pallor
• respiratory arrest, pulmonary edema, difficulty breathing, wheezing, nasal congestion, coughing, dry throat, throat constriction with a feeling of choking, respiratory spasms, throat inflammation
• eczema, skin redness, inflammation of the lips and localized in the mouth
• muscle cramps, muscle weakness, back pain
• discomfort
• chest discomfort
• fever
• facial swelling
• extravasation of the product from the blood vessels, which can cause inflammation or destruction of skin cells at the injection site
• decreased oxygen in the blood

There have been reports of nephrogenic systemic fibrosis (which causes skin hardening and may also affect soft tissues and internal organs), most of which occurred in patients who received gadoteric acid along with other gadolinium-containing contrast agents. If, in the weeks following the MRI, you notice changes in the 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 side effects, talk to your doctor or radiologist, even if they are not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clariscan

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

The vials/ampoules do not require special storage conditions.

The pre-filled syringe must not be frozen.

Do not use this medicine after the expiry date which is stated on the vial, ampoule, pre-filled syringe, or carton, after "EXP".

The expiry date is the last day of the month stated.

Chemical and physical stability has been demonstrated for 48 hours at 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2 to 8°C, unless the opening has taken place in controlled and validated aseptic conditions.

6. Container Contents and Additional Information

Composition of Clariscan

• The active ingredient is gadoteric acid. One mL of injectable solution contains 279.32 mg of gadoteric acid (as meglumine gadoterate), equivalent to 0.5 mmol of gadoteric acid.

• The other components are meglumine, tetraxetan (DOTA), and water for injectable preparations.

Appearance of the Product and Container Contents

Clariscan is a clear, colorless to yellowish solution for intravenous injection.

Clariscan is available in the following containers:

Glass vials (Type 1, colorless) filled up to 5, 10, 15, and 20 mL.

Prefilled polymer syringes filled up to 10, 15, and 20 mL.

Glass bottles (Type 1, colorless) and polypropylene bottles filled up to 50 and 100 mL.

All containers are packaged in an outer box of 1 and 10 units.

Only some package sizes may be marketed.

Marketing Authorization Holder

GE Healthcare Bio-Sciences, S.A.U.

Gobelas Street, 35-37, La Florida

28023 Madrid

Manufacturer

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen

NO-0401 Oslo

Norway

or

GE Healthcare Ireland Limited

IDA Business Park

Carrigtwohill, Cork

Ireland

This leaflet was last revised in: May 2024

This information is intended for healthcare professionals only:

Posology

Adults

Brain and Spinal Cord MRI

The recommended dose is 0.1 mmol/kg body weight (bw), equivalent to 0.2 mL/kg bw. In patients with brain tumors, an additional dose of 0.2 mmol/kg bw (equivalent to 0.4 mL/kg bw) may improve tumor characterization and facilitate therapeutic decision-making.

Whole Body MRI (including liver, kidney, pancreas, pelvis, lung, heart, breast, and musculoskeletal system lesions)

The recommended dose is 0.1 mmol/kg bw (equivalent to 0.2 mL/kg bw) to provide adequate contrast for diagnosis.

Angiography

The recommended dose for intravenous injection is 0.1 mmol/kg bw (equivalent to 0.2 mL/kg bw) to provide adequate contrast for diagnosis.

In exceptional circumstances (e.g., when it is impossible to obtain satisfactory images of an extensive vascular territory), a second consecutive injection of 0.1 mmol/kg bw (equivalent to 0.2 mL/kg bw) may be justified. However, if it is presumed that two consecutive doses of Clariscan will be administered before starting angiography, it may be convenient to administer only 0.05 mmol/kg bw (equivalent to 0.1 mL/kg) for each dose, depending on the MRI equipment used to obtain the images.

Special Populations

Renal Insufficiency

The adult dose applies to patients with mild to moderate renal insufficiency (GFR ≥ 30 mL/min/1.73m2).

Clariscan should only be used in patients with severe renal insufficiency (GFR or glomerular filtration rate <30 ml min 1.73m2) and in patients the perioperative period of a liver transplant, after careful assessment risk benefit if diagnostic information is essential cannot be obtained by mri without contrast. use clariscan necessary, dose should not exceed 0.1 mmol kg body weight.< p>

During an examination, no more than one dose should be administered. Due to the lack of information on repeated administration, Clariscan should not be repeated unless at least 7 days have passed between injections.

Elderly Patients (population 65 years and older)

No dose adjustment is considered necessary. Caution should be exercised in elderly patients.

Hepatic Insufficiency:

The adult dose applies to these patients. Caution is recommended, especially in the perioperative period of a liver transplant (see above, renal insufficiency).

Pediatric Population (population 0 to 18 years of age)

Brain and Spinal Cord MRI, Whole Body MRI:

The maximum recommended dose of Clariscan is 0.1 mmol/kg body weight. No more than one dose should be used during an examination.

In children under 6 months of age, its use is not recommended for whole-body MRI.

Due to the immaturity of renal function in newborns up to 4 weeks and in infants up to 1 year of age, Clariscan should only be used in these patients after careful consideration, with a dose not exceeding 0.1 mmol/kg body weight. No more than one dose should be administered during an examination. Due to the lack of information on repeated administration, Clariscan should not be repeated unless at least 7 days have passed between injections.

Angiography:

Clariscan is not recommended for angiography in children under 18 years of age because safety and efficacy data for this indication are insufficient.

Method of Administration

This product is administered exclusively by the intravenous route.

Infusion rate: 3-5 mL/min (higher infusion rates of up to 120 mL/min, equivalent to 2 mL/sec, can be used in angiographic procedures).

To consult the instructions for preparation and disposal, see the Precautions for Use and Handlingsection below.

Pediatric Population (population 0 to 18 years of age). Depending on the amount of Clariscan administered to the child, it is preferable to use Clariscan vials with a single-use syringe and a volume adapted to that amount to more precisely control the injected volume.

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

Special Warnings and Precautions for Use

Renal Insufficiency

Before administering Clariscan, it is recommended to evaluate all patients for possible renal dysfunction through laboratory tests.

Cases of nephrogenic systemic fibrosis (NSF) associated with the use of some gadolinium-based contrast agents have been reported in patients with severe acute or chronic renal insufficiency (GFR or glomerular filtration rate <30 ml min 1.73m2). patients undergoing liver transplantation have a special risk since the incidence of acute renal failure is high in this group. there possibility that nsf may occur with clariscan, it should only be used severe insufficiency and perioperative period transplant after careful assessment benefit-risk if diagnostic information essential cannot obtained by mri without contrast.< p>

Given that the renal elimination of Clariscan may be reduced in elderly patients, it is especially important to evaluate patients 65 years and older for possible renal dysfunction.

Hemodialysis shortly after administration of Clariscan may be useful for the elimination of Clariscan from the body. There is no evidence to support the initiation of hemodialysis for the prevention or treatment of NSF in patients who are not undergoing hemodialysis.

Pregnancy and Lactation

Clariscan should not be used during pregnancy unless the clinical condition of the woman requires treatment with gadoteric acid.

The continuation or interruption of breastfeeding 24 hours after administration of Clariscan will be at the discretion of the physician and the breastfeeding mother.

Precautions for Use and Handling

For single use

The injectable solution should be visually inspected before use. Only solutions that do not contain visible particles should be used.

Vials and bottles:Prepare a syringe with a needle. On the vials, remove the plastic disc. On the polypropylene bottles, remove the plastic screw cap or the upper plastic cap. After cleaning the cap with a swab moistened with alcohol, pierce the cap with the needle. Extract the necessary amount of product for the examination and inject intravenously.

Prefilled syringes:Inject the necessary amount of product for the examination intravenously.

The contrast medium remaining in the vial/bottle, the connection lines, and all disposable components of the injector system should be discarded after the examination.

The detachable label of the vials, bottles, or syringes should be stuck in the patient's medical history to allow for accurate recording of the gadolinium-based contrast agent used. The dose used should also be recorded. If an electronic patient record is used, the name of the medication, batch number, and dose should be included in it.

Unused medication or leftover materials should be disposed of according to local regulations.