Clariscan 0.5 mmol/ml solution for injection in pre-filled syringe EFG

Package leaflet: Information for the user

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 the entire leaflet carefully before you start using this medicine because it contains important information for you.

? Keep this leaflet as you may need to read it again.

? If you have any 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.

Leaflet contents:

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

Contents of the pack and other information

1. What Clariscan is and what it is used for

What Clariscan is

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

What Clariscan is used for

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

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

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

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

• Whole-body MRI, including abnormalities (lesions)

In adults only:

• Magnetic resonance angiography (MRA), including abnormalities (lesions) or narrowing (stenosis) of arteries, except coronary arteries.

This medicine is for diagnostic use only.

How Clariscan works

Clariscan makes MRI images easier to see. It achieves this by increasing the contrast between the part of the body being examined and the rest of the body. This enables doctors or radiologists to better visualize different parts of the body.

2. What you need to know before using Clariscan

Do not be given Clariscan:

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

Warnings and precautions

Remove all metallic objects you may be wearing before the scan.

Consult your doctor or radiologist before using Clariscan if:

• you have previously had a reaction to a contrast agent during an imaging scan
• you have asthma
• you have a history of allergies, such as allergy to shellfish, hay fever, or hives (intense itching)
• you are being treated with a beta-blocker (a medicine used for heart or blood pressure problems such as metoprolol)
• your kidneys are not working properly
• you have recently undergone, or are soon to undergo, a liver transplant
• you have had seizures or are being treated for epilepsy
• you have a serious heart condition
• you have a disease affecting your heart or blood vessels
• you have a cardiac pacemaker, a ferromagnetic clip, an implant or insulin pump, or suspect having any metallic 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 adverse reactions

As with any contrast agent used for MRI, there is a risk of adverse reactions. Adverse reactions are usually mild and temporary, but they cannot be predicted. However, there is a risk that could be life-threatening:

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

Tests and monitoring

Your doctor or radiologist may decide to perform a blood test before you receive Clariscan, especially if you are over 65 years of age. This test is to check proper kidney function.

Children and adolescents

In children under 18 years of age, use for angiography is not recommended.

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 of age and in infants up to 1 year of age.

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

Using Clariscan with other medicines

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

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

Using Clariscan with food and drink

Administration of contrast agents for MRI may cause nausea and vomiting as adverse effects. Therefore, patients should remain fasting for 2 hours prior to the scan.

Pregnancy and breastfeeding

Pregnancy

Gadoteric acid may cross the placenta. It is unknown whether it affects the fetus. Clariscan should not be used during pregnancy unless 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

Inform your doctor or radiologist if you are breastfeeding or about to start breastfeeding. Your doctor or radiologist will discuss 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 consider the possible occurrence of dizziness (a symptom of low blood pressure) and nausea. If you feel unwell after the scan, you should not drive or operate machinery.

3. How to use Clariscan

How Clariscan is administered

You will be given Clariscan as an intravenous injection.

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

Medical personnel are aware of the precautions that must be taken.

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

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

• A needle will remain in your vein,
• This will allow the doctor or radiologist to administer emergency medications 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 renal impairment or in patients who have recently undergone, or are about to undergo, a liver transplant.

However, if your doctor or radiologist decides to administer Clariscan:

• a single dose of Clariscan should be given during the MRI, and
• a second injection should not be administered 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 should be given during an MRI scan, and
• a second injection should not be administered until at least 7 days have passed.

Use in children under 6 months of age is not recommended for whole-body MRI.

Use for angiography is not recommended in children under 18 years of age.

Elderly patients

If you are 65 years of age or older, dose adjustment is not required. However, you may first have a blood test to check that your kidneys are functioning properly.

If you have been given too much Clariscan

It is highly unlikely that an overdose will occur, as you will receive Clariscan in a medical setting administered by trained personnel.

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

Additional information on use and handling for doctors and healthcare professionals is provided at the end of this leaflet.

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

4. Possible adverse effects

Like all medicines, this one may cause adverse effects, although not everyone experiences them.

After administration, you will be under observation for at least half an hour. Most of the side effects occur immediately, although in some cases they may be delayed. Some effects may occur up to seven days after the injection of Clariscan.

There is a small (rare) risk that you may have an allergic reaction to Clariscan. These reactions can be serious and may cause shock (a type of allergic reaction that could be life-threatening).

Any of the symptoms described below may be the first signs of shock. Inform your doctor, radiologist, or healthcare professional immediately if you experience any of them:

• swelling of the face, mouth, or throat that may cause difficulty swallowing or breathing
• swelling of the hands or feet
• dizziness (hypotension)
• difficulty breathing
• wheezing
• cough
• itching
• runny nose
• sneezing
• eye irritation
• hives
• skin rash

Uncommon adverse effects: may affect up to 1 in 100 people

• hypersensitivity
• headache
• unusual taste in the mouth
• dizziness
• somnolence
• tingling sensation, feeling of heat, cold, and/or pain
• high or low blood pressure
• nausea (feeling unwell)
• stomach pain
• rashes
• sensation of warmth, sensation of cold
• asthenia
• discomfort at injection site, reaction at injection site, cold sensation at injection site, swelling at injection site, extravasation of the product outside blood vessels which may cause inflammation (redness and local pain).

Rare adverse effects: may affect up to 1 in 1,000 people

• anxiety, fainting (dizziness and feeling of imminent loss of consciousness)
• eyelid swelling
• palpitations
• sneezing
• vomiting (feeling unwell)
• diarrhea
• increased salivary secretion
• hives, itching, sweating
• chest pain, chills

Very rare adverse effects: may affect up to 1 in 10,000 people

• anaphylactic or anaphylactoid reactions
• agitation
• coma, seizures, syncope (brief loss of consciousness), olfactory disturbance (perception of smells, often unpleasant), tremors
• conjunctivitis, red eyes, blurred vision, increased lacrimation
• cardiac arrest, accelerated or slowed heartbeat, irregular heartbeat, vascular dilation, pallor
• respiratory arrest, pulmonary edema, difficulty breathing, wheezing, nasal congestion, cough, dry throat, throat tightness with sensation of suffocation, respiratory spasms, throat swelling
• eczema, skin redness, swelling of the lips and localized swelling in the mouth
• muscle cramps, muscle weakness, back pain
• malaise
• chest discomfort
• fever
• facial swelling
• extravasation of the product outside blood vessels which may cause inflammation or destruction of skin cells at the injection site
• decreased blood oxygen levels

Cases of nephrogenic systemic fibrosis (which causes hardening of the skin and may also affect soft tissues and internal organs) have been reported, most of which occurred in patients who received gadoteric acid along with other contrast agents containing gadolinium. If, during the weeks following the MRI, you notice changes in the color and/or thickness of your skin anywhere on your body, inform the radiologist who performed the examination.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or radiologist, even if they are adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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/bottles do not require any special storage conditions.

The pre-filled syringe must not be frozen.

Do not use this medicine after the expiry date stated on the vial, bottle, pre-filled syringe or carton, following “EXP”.

The expiry date refers to the last day of the month indicated.

Chemical and physical in-use stability has been demonstrated for 48 hours at 30°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2 to 8°C, unless the container was opened under strictly controlled and validated aseptic conditions.

6. Contents of the pack and other information

Composition of Clariscan

• The active substance is gadoteric acid. One mL of injectable solution contains 279.32 mg of gadoteric acid (as gadoterate meglumine), 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 contents of the container

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

Clariscan is available in the following pack sizes:

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

Polymer pre-filled syringes filled to 10, 15, and 20 mL.

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

All packs are packaged in an outer carton containing 1 or 10 units.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Calle Gobelas, 35-37, La Florida

28023 Madrid

Manufacturer

GE Healthcare AS

Nycoveien, 1

0485 Oslo

Norway

or

GE Healthcare Ireland Limited

IDA Business Park

Carrigtwohill, Cork

Ireland

This leaflet was last reviewed in: May 2024

This information is intended for healthcare professionals only:

Dosage

Adults

MRI of the brain and spinal cord

The recommended dose is 0.1 mmol/kg body weight (b.w.), equivalent to 0.2 mL/kg b.w. In patients with brain tumours, an additional dose of 0.2 mmol/kg b.w. (equivalent to 0.4 mL/kg b.w.) may improve tumour characterisation and assist in therapeutic decision-making.

Whole-body MRI (including lesions of the liver, kidneys, pancreas, pelvis, lungs, heart, breasts, and musculoskeletal system)

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

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.

In exceptional circumstances (e.g., when satisfactory imaging of a large 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 Clariscan are anticipated before starting the angiography, it may be preferable to administer only 0.05 mmol/kg b.w. (equivalent to 0.1 mL/kg) for each dose, depending on the MRI equipment used for imaging.

Special populations

Renal impairment

The adult doses apply to patients with mild to moderate renal impairment (GFR ≥ 30 mL/min/1.73 m²).

Clariscan should only be used in patients with severe renal impairment (GFR or glomerular filtration rate < 30 mL/min/1.73 m²) and in patients in the perioperative period of liver transplantation, after careful risk/benefit assessment and only if the diagnostic information is essential and cannot be obtained by non-contrast MRI. If Clariscan use is necessary, the dose should not exceed 0.1 mmol/kg body weight.

No more than one dose should be administered during a single examination. Due to the lack of information on repeated administration, Clariscan should not be re-administered unless at least 7 days have elapsed between injections.

Elderly patients (population aged 65 years and older)

Dose adjustment is not considered necessary. Caution should be exercised in elderly patients.

Hepatic impairment:

The adult dose applies to these patients. Caution is recommended, especially during the perioperative period of liver transplantation (see above, renal impairment).

Paediatric population (population aged 0 to 18 years)

Cerebral and spinal 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 in a single examination.

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

Due to the immaturity of renal function in neonates up to 4 weeks of age and 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 a single examination. Due to the lack of information on repeated administration, Clariscan should not be re-administered unless at least 7 days have elapsed between injections.

Angiography:

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

Method of administration

This product is administered intravenously only.

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

For instructions on preparation and disposal, see section Precautions for use and handling below.

Paediatric population (population aged 0 to 18 years). Depending on the amount of Clariscan to be administered to the child, it is preferable to use Clariscan vials with a single-use syringe of an appropriate volume to allow more precise control of the injected volume.

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

Warnings and special precautions for use

Renal impairment

Before administration of Clariscan, it is recommended to evaluate all patients for potential renal dysfunction using laboratory tests.

Cases of nephrogenic systemic fibrosis (NSF) have been reported following the use of some gadolinium-based contrast agents in patients with severe acute or chronic renal impairment (GFR or glomerular filtration rate < 30 mL/min/1.73 m²). Patients undergoing liver transplantation are at particular risk, as the incidence of acute renal failure is high in this group. Since there is a possibility that NSF may occur with Clariscan, it should only be used in patients with severe renal impairment and in patients in the perioperative period of liver transplantation after careful benefit-risk assessment and only if the diagnostic information is essential and cannot be obtained by non-contrast MRI.

Since renal elimination of Clariscan may be reduced in elderly patients, it is especially important to evaluate patients aged 65 years and older for potential renal dysfunction.

Haemodialysis shortly after administration of Clariscan may be helpful in eliminating Clariscan from the body. There is no evidence to support initiating haemodialysis for the prevention or treatment of NSF in patients not already undergoing haemodialysis.

Pregnancy and lactation

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

The decision to continue or interrupt 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 only

The injectable solution should be visually inspected before use. Only solutions free from visible particles should be used.

Vials and bottles: Prepare a syringe with a needle. For vials, remove the plastic disc. For polypropylene bottles, remove the plastic screw cap or the plastic top cap. After cleaning the stopper with an alcohol-moistened swab, pierce the stopper with the needle. Withdraw the volume of product required for the examination and administer intravenously.

Pre-filled syringes: Administer the required volume of product for the examination intravenously.

Any unused contrast medium remaining in the vial/bottle, connecting lines, and all disposable components of the injection system must be discarded after the examination.

The detachable label from the vials, bottles, or syringes should be affixed to the patient's medical record to allow accurate documentation of the gadolinium contrast agent used. The administered dose should also be recorded. If an electronic patient record is used, the drug name, batch number, and dose should be included.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.