Label:Information for the patient

Dotagraf 0.5mmol/ml injectable solution EFG

Gadoteric acid

Read the label carefully before the medication is administered to you,because it contains important information for you.

- Conserve this label, as you may need to read it again.

-If you have any doubts, consult your doctor or radiologist.

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

1.What Dotagraf is and for what it is used

2.What you need to knowabefore starting to use Dotagraf

3.How to use Dotagraf

4.Possible adverse effects

1. Storage of Dotagraf

6.Contents of the package and additional information

Dotagraf is a contrast medium that contains gadoteric acid. It is for diagnostic use only.

Dotagraf is indicated 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)

• Magnetic resonance (MR) imaging of the central nervous system, including defects (lesions) of the brain, spinal cord, and adjacent tissues.

-Magnetic resonance imaging 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) or narrowing (stenosis) of arteries, except for coronary arteries.

No use Dotagraf

• 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 magnetic resonance imaging procedures).

Advertencias y precauciones

Consult your doctor or radiologist before starting to use Dotagraf if you:

• Have had a reaction to contrast media during a previous test
• Have asthma
• Have a history of allergy (such as shellfish allergy, urticaria, hay fever)
• Are being treated with a beta-blocker (medications used for heart problems and blood pressure alterations, such as metoprolol)

blood pressure, such as metoprolol)

• 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

In all these cases, your doctor or radiologist will evaluate the benefit-risk ratio and decide whether or not to administer Dotagraf. If you are administered Dotagraf, your doctor or radiologist will take the necessary precautions and the administration of Dotagraf 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 Dotagraf, especially if you are 65 years or older.

Recién nacidos 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, Dotagraf should be used in these patients only after a careful evaluation by the doctor.

Remove all metal objects you may be 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 is important because magnetic resonance imaging equipment uses very strong magnetic fields, which can cause serious problems.

Uso de Dotagraf con otros medicamentos

Inform your doctor or radiologist if you are taking, have recently taken, or may need to take other medications.

Particularly, 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 Dotagraf con los alimentos y bebidas

No known interactions exist between Dotagraf and food or drink. 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. Dotagraf 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 administering Dotagraf.

Conducción y uso de máquinas

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

Dotagraf will be administered by intravenous injection.

During the test, you will be under the supervision of a doctor or a 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 Dotagraf will be stopped.

Dotagraf can be administered manually or using 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 medical staff knows the precautions that must 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 Dotagraf is not recommended in patients with severe kidney problems or in patients who have recently had or will soon have a liver transplant. However, if use is required, only one dose of Dotagraf should be received during the procedure and no second injection should be received until at least 7 days have passed.

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, Dotagraf should only be used after careful evaluation by a doctor. Newborns and infants should only receive one dose of Dotagraf during the procedure and should not receive a second injection until at least 7 days have passed.

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

Older adults

If you are 65 years old 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 you use more Dotagraf than you should

It is highly unlikely that you will receive an overdose. Dotagraf will be administered in medical facilities and by a trained person. In a true case of overdose, Dotagraf can be removed from the body by hemodialysis (blood cleaning).

You will find additional information on use and handling by the doctor or medical professional at the end of this prospectus.

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

In case of overdose or accidental ingestion, contact the Toxicological Information Service (phone 915620420).

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, occasionally, in a delayed manner. Some effects may occur up to seven days after the Dotagraf injection.

There is a small risk that you may have an allergic reaction to Dotagraf. Such reactions can be severe and, exceptionally, may cause shock(an allergic reaction that could put your life in danger). Any of the symptoms described below may be the first signs of shock. Immediately report to 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

• Dizziness (low blood pressure)

• Difficulty breathing

• Wheezing while breathing

• Coughing

• Itching

• Runny nose

• Sneezing

• Eye irritation

• Urticaria

• Skin eruptions

Rare side effects (may affect up to 1 in 100 patients)

• Hypersensitivity (allergic reactions)

• Headache

• Unusual taste in the mouth

• Dizziness

• Drowsiness (sleep)

• Tingling sensation, heat/flushing, cold, and/or pain

• Low or high blood pressure

• Nausea (feeling of dizziness)

• Abdominal pain

• Rash

• Feeling of heat, feeling of cold

• Asthenia (loss of energy, weakness)

• Discomfort at the injection site, reaction at the injection site, cold at the injection site, swelling 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 eyes
• Palpitations
• Sneezing
• Vomiting (with dizziness)
• Diarrea
• Increased saliva secretion

• Urticaria, itching, sweating

• Chest pain, chills

Very rare side effects (may affect up to 1 in 10,000 patients)

• Anaphylactic reactions or anaphylactoid type (severe allergic reaction potentially life-threatening)

• Agitation

• Coma, convulsions, syncope (brief loss of consciousness),

disturbances of the sense of smell (frequent perception of unpleasant odors), tremor

• Conjunctivitis, red eyes, blurred vision, increased tear secretion
• Cardiac arrest, rapid or slow heart rate, irregular heartbeat, vasodilation, pallor
• Respiratory arrest, pulmonary edema, difficulty breathing, wheezing, nasal congestion, coughing, dry throat, constriction of the throat with a feeling of asphyxia, respiratory spasms, inflammation of the throat
• Eczema, redness of the skin, localized inflammation of the lips and mouth
• Muscle cramps, muscle weakness, back pain
• General malaise, chest discomfort, fever, swelling of the face, diffusion of the product outside the blood vessels that may cause necrosis of the tissue at the injection site, inflammation of a vein
• Decreased oxygen levels in the blood

Systemic nephrogenic fibrosis (which causes skin hardening and may also affect soft tissues and internal organs) has been reported, most of which were in patients who received Dotagraf 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, report to 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 of 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 storage conditions.

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 occurred in controlled and validated aseptic conditions.

Do not use this medication after the expiration date appearing on the vial and on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Dotagraf

• The active principle is gadoteric acid.1 ml of injectable solution contains279.32mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid (as meglumine salt).
• The other components are meglumine, 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) and water for injection.

Aspect of the product and content of the package

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

The content of the Dotagraf vials is 1 or 10 vials containing 60 ml or 100 ml of injectable solution.

Only some package sizes may be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

Sanochemia Pharmazeutika GmbH

Landegger Strasse 7

2491 Neufeld/Leitha, Austria

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Other sources of information

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: November 2024

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This information is intended solely for healthcare professionals

Dosage

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

• Brain and spinal cord MRI: 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. 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 per kilogram of body weight (equivalent to 0.2 ml per kilogram of body weight) to provide adequate contrast for diagnosis.

Angiography: In exceptional circumstances (e.g. when satisfactory images cannot be obtained with the first dose of a large vascular territory), 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 Dotagraf are to be administered before starting angiography, it is recommended to administer only 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.

• Paediatric population:

Brain and spinal cord MRI / Whole-body MRI: The recommended and maximum dose of Dotagraf is 0.1 mmol per kilogram of body weight. Only one dose should be used during the procedure.

Due to the immaturity of renal function in newborns up to 4 weeks of age and in infants up to 1 year of age, Dotagraf should only be used in these patients after careful consideration, with a dose not exceeding 0.1 mmol per kilogram of body weight. Only one dose should be used during the procedure. Due to the lack of information on repeated administration, Dotagraf injections should not be repeated unless an interval of at least 7 days has elapsed between injections.

Dotagraf is not recommended for angiography in children under 18 years of age due to insufficient safety and efficacy data in this indication.

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

Administration

Dotagraf should only be administered intravenously. Do not use by intrathecal route. Care should be taken to maintain the injection strictly intravenously: extravasation may lead to local intolerance reactions, requiring usual local care.

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

Optimal image acquisition: Approximately 45 minutes after injection.

Optimal image acquisition sequence: Enhanced in T1.

Whenever possible, intravenous administration of the contrast medium should be performed with the patient in a supine position. After injection, the patient should be observed for at least 30 minutes, as experience shows that most adverse effects occur during this time interval.

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

The extraction device should have the following characteristics: trocar, sterile air filter, Luer connector and sealing plug.

It can be used with a single-use sterile syringe (spike) filled to perform a single-dose protocol, or to inject a second bolus of contrast if clinically necessary.

The contrast medium can only be administered via an automatic injector for a single patient to perform repeated administrations.

At the end of the examination, the amounts of product remaining in the vial and the disposable device should be discarded within 24 hours of the rubber stopper being punctured. The specific instructions of the equipment manufacturer should be carefully followed.

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

Paediatric population

Depending on the amount of Dotagraf to be administered to the child, it is recommended to use Dotagraf vials with a single-use syringe with an adapted volume to achieve better precision of the injected volume.

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

Renal insufficiency

Before administration of Dotagraf, it is recommended to evaluate all patients to detect possible renal dysfunction by laboratory tests.

Cases of systemic fibrosis nephrogenica (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 of FNS occurring with Dotagraf, it should only be used in patients with severe renal insufficiency and in patients in the perioperative period of a liver transplant after careful consideration of the benefit-risk ratio and if the diagnostic information is essential and cannot be obtained without contrast-enhanced MRI. If Dotagraf use is necessary, the dose should not exceed 0.1 mmol per kilogram of body weight. During the examination, only one dose should be administered. Due to the lack of information on repeated administration, Dotagraf administration should not be repeated unless an interval of at least 7 days has elapsed between injections. Haemodialysis shortly after Dotagraf administration may be useful for the elimination of Dotagraf from the body. There is no evidence to support the initiation of haemodialysis for the prevention or treatment of FNS in patients not undergoing haemodialysis.

Older patients

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

Newborns and infants

See the section Posology and administration, paediatric population.

Pregnancy and lactation

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

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

Handling instructions

The detachable label on the vials should be stuck 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 the patient's electronic medical history is used, the name of the medicinal product, batch number and dose should be included in the same.