Dotarem

Leaflet accompanying the packaging: information for the user

DOTAREM, 0.5 mmol/ml

injection solution in a vial
Gadoteric acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or a radiologist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, radiologist, or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is DOTAREM and what is it used for
• 2. Important information before using DOTAREM
• 3. How to use DOTAREM
• 4. Possible side effects
• 5. How to store DOTAREM
• 6. Contents of the packaging and other information

1. What is DOTAREM and what is it used for

DOTAREM is a diagnostic agent for use in adults and children. It belongs to a group of contrast agents used in magnetic resonance imaging (MRI). DOTAREM is used to increase the contrast of images obtained during MRI examinations. Such contrast enhancement improves the visibility and definition of:

• pathological changes in the brain, spinal cord, and surrounding tissues;
• pathological changes in the liver, kidneys, pancreas, pelvis, lungs, heart, breast, and musculoskeletal system;
• pathological changes and stenosis in arteries, especially coronary arteries (only in adults).

This medicine is intended for diagnostic use only.

2. Important information before using DOTAREM

When not to use DOTAREM

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to gadolinium-containing contrast agents (such as other MRI contrast agents).

Warnings and precautions

You should inform your doctor or radiologist if any of the following apply to you:

• you have had a reaction to a contrast agent during an examination;
• you have asthma;
• you have had an allergic reaction in the past (e.g., allergy to shellfish, hives, hay fever);
• you are being treated with a beta-blocker (a medicine used to treat heart rhythm disorders and high blood pressure, such as metoprolol);
• your kidneys do not work properly;
• you have recently undergone or are awaiting a liver transplant;
• you have a heart or blood vessel disease;
• you have had seizures or are being treated for epilepsy.

In all such cases, your doctor or radiologist will assess the benefit-risk ratio and decide whether DOTAREM can be used in your case. If DOTAREM is used, your doctor or radiologist will take the necessary precautions, and the administration of DOTAREM will be closely monitored. Your doctor or radiologist may decide to perform a blood test to check your kidney function before using DOTAREM, especially if you are 65 years of age or older. 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, DOTAREM will only be used in these patients after careful consideration by the doctor. Before the examination, you should remove any metal objects that you may be wearing. You should inform your doctor or radiologist if you have:

• 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 MRI equipment uses very strong magnetic fields.

DOTAREM and other medicines

You should tell your doctor or radiologist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, you should inform your doctor, radiologist, or pharmacist about taking or recently taking medicines for heart rhythm disorders and high blood pressure, such as beta-blockers, vasodilators, angiotensin-converting enzyme inhibitors, or angiotensin II receptor antagonists.

DOTAREM with food and drink

There are no known interactions between DOTAREM and food or drink. However, you should ask your doctor, radiologist, or pharmacist if you need to avoid eating or drinking before the examination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or radiologist before using this medicine. PregnancyGadoteric acid may pass through the placenta. It is not known whether this affects the fetus. DOTAREM should not be used during pregnancy unless absolutely necessary. BreastfeedingYour doctor or radiologist will discuss with you whether you can continue breastfeeding or should stop for 24 hours after receiving DOTAREM.

Driving and using machines

There is no available data on the effect of DOTAREM on the ability to drive or use machines. If you feel unwell after the examination, e.g., nausea, you should not drive or use machines.

3. How to use DOTAREM

DOTAREM will be administered by intravenous injection. During the examinationyou will be closely monitored by your doctor or radiologist. A needle will be left in your vein, so that your doctor or radiologist can quickly inject any life-saving medication if needed. If you experience an allergic reaction, the administration of DOTAREM will be stopped immediately. DOTAREM can be injected manually or using an automatic injector. In newborns and infants, the medicine is administered manually only. The procedure can be performed in a hospital, clinic, or private office. Medical personnel know what precautions to take during the examination and are also aware of potential complications. Dosage Your doctor or radiologist will determine the dose suitable for you and will supervise the administration of the medicine.

Dosage in special patient groups

DOTAREM is not recommended for use in patients with severe kidney function disorders or in patients who have recently undergone or are awaiting a liver transplant. However, if DOTAREM needs to be used, the patient should receive only one dose of the medicine during the examination 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, DOTAREM will only be used in these patients after careful consideration by the doctor. Children should receive only one dose of the medicine during the examination and should not receive another dose for at least 7 days. DOTAREM is not recommended for use in angiography in children under 18 years of age.

Elderly patients

There is no need to adjust the dose in patients aged 65 and over, but it may be necessary to perform a blood test to check kidney function.

Overdose of DOTAREM

It is very unlikely that you will receive too much of the medicine. DOTAREM will be administered in a medical facility by properly trained personnel. In case of actual overdose, DOTAREM can be removed from the body by hemodialysis (blood purification). Additional information on the use and handling of this medicine by medical personnel is provided at the end of this leaflet. If you have any further doubts about the use of this medicine, you should consult your doctor or radiologist.

4. Possible side effects

Like all medicines, DOTAREM can cause side effects, although not everybody gets them. After administrationyou will be monitored for at least half an hour. Most side effects occur immediately or with some delay. Some side effects may occur even up to seven days after receiving the DOTAREM injection. There is a small risk of an allergic reaction to DOTAREM. 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 you notice any of the following symptoms, you should immediately inform your 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
• feeling of dizziness (hypotension)
• difficulty breathing
• wheezing
• coughing
• itching of the skin
• 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, warmth, or cold and/or pain
• increased or decreased blood pressure
• nausea (feeling sick)
• abdominal pain
• rash
• feeling of heat, feeling of cold
• weakness
• discomfort at the injection site, reaction at the injection site, feeling of cold at the injection site, swelling at the injection site, extravasation of the product, which may lead to tissue necrosis (redness and local pain)

Rare side effects (may affect up to 1 in 1,000 people)

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

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

• anaphylactic and anaphylactoid reactions
• agitation
• coma, seizures, fainting (brief loss of consciousness), olfactory disorders (perception of unpleasant odors), convulsions
• conjunctivitis, blurred vision, increased tearing
• sudden cardiac arrest, accelerated or slowed heart rate, arrhythmia, vasodilation, pallor
• respiratory arrest, pulmonary edema, difficulty breathing, wheezing, stuffy nose, coughing, dry throat, laryngospasm with a feeling of suffocation, bronchospasm, swelling of the throat
• flushing, redness of the skin, swelling of the lips, local swelling in the mouth
• muscle spasms, muscle weakness, back pain
• weakness, discomfort in the chest, fever, swelling of the face, extravasation of the product, which may lead to tissue necrosis at the injection site, phlebitis
• decreased oxygen content in the blood.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium-containing contrast agents, including DOTAREM, in patients with acute or chronic kidney function disorders (GFR <30 ml min 1.73 m). patients who have undergone liver transplantation are particularly at risk due to the high frequency of acute kidney injury in this group. nsf associated with dotarem, medicine should only be used severe function disorders and undergoing after careful assessment benefit-risk ratio when diagnostic information is essential cannot obtained using mri without contrast enhancement. if dotarem used, dose not exceed 0.1 mmol kg body weight. you receive more than one during examination. lack on repeated administration, injections unless interval between least 7 days.< p>

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or radiologist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products – Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected] 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 medicine.

5. How to store DOTAREM

The medicine should be stored out of sight and reach of children. There are no special storage instructions. Do not use this medicine after the expiry date stated on the vial and carton after "EXP". The expiry date refers to the last day of the month stated. It is very unlikely that you will be asked to dispose of any leftover DOTAREM.

6. Contents of the packaging and other information

What DOTAREM contains

• The active substance of DOTAREM is gadoteric acid. One milliliter of the injection solution 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 DOTAREM are meglumine and water for injections.

What DOTAREM looks like and contents of the pack

DOTAREM is a clear, colorless solution for intravenous injection, colorless or in various shades of yellow. The packaging of DOTAREM contains one vial containing 5, 10, 15, 20, or 60 ml of the injection solution. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

GUERBET BP 57400 95943 Roissy CdG cedex France

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

DOTAREM

Date of last revision of the leaflet: 08.05.2024

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Information intended for healthcare professionals only:

Dosage

Adults:

• MRI of the brain and spinal cord: In studies 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, administration of 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 contrast suitable for diagnosis, is 0.1 mmol/kg body weight (i.e., 0.2 ml/kg body weight).
• Angiography: In exceptional circumstances (e.g., when images of satisfactory quality covering an extensive vascular area cannot be obtained), a second consecutive 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 DOTAREM 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 (0-18 years):

• MRI of the brain and spinal cord / whole-body MRI: The recommended and maximum dose of DOTAREM is 0.1 mmol/kg body weight. You should not receive more than one dose during the examination. Due to the immaturity of kidney function in newborns up to 4 weeks of age and infants up to 1 year of age, DOTAREM should only be used in these patients after careful consideration by the doctor. The dose should not exceed 0.1 mmol/kg body weight. You should not receive more than one dose during the examination. Due to the lack of information on repeated administration, you should not receive repeated injections of DOTAREM unless the interval between injections is at least 7 days.

Special patient groups:

• Patients with kidney function disorders: In patients with mild to moderate kidney function disorders (GFR ≥30 ml/min/1.73 m), the doses recommended for adults should be used. See "Kidney function disorders" below.
• Patients with liver function disorders: In such patients, the doses recommended for adults should be used. Caution is recommended, especially in the perioperative period related to liver transplantation.

Method of administration

DOTAREM is indicated for intravenous use only. DOTAREM should not be administered by subarachnoid or intrathecal injection. Infusion rate: 3-5 ml/min (at angiographic examinations, a higher infusion rate of up to 120 ml/min, i.e., 2 ml/sec, can be used). Optimal imaging: within 45 minutes after 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 disk. Clean the stopper with a swab or cotton ball soaked in alcohol and then puncture the stopper with the needle. Draw up the required volume of DOTAREM and inject it intravenously into the patient. For single use only; any unused solution should be discarded. The injection solution should be inspected visually before use. Only a clear solution without visible particles is suitable for use. Children and adolescents (0-18 years) Depending on the amount of DOTAREM to be administered to the child, it is recommended to use vials of DOTAREM in combination with a single-use syringe of a capacity adapted to this amount, in order to maintain higher precision of the injected dose. In newborns and infants, the required dose should be administered manually.

Kidney function disorders

It is recommended that all patients undergo laboratory tests to check kidney function before administration of DOTAREM.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium-containing contrast agents, including DOTAREM, in patients with acute or chronic kidney function disorders (GFR <30 ml min 1.73 m). patients who have undergone liver transplantation are particularly at risk due to the high frequency of acute kidney injury in this group. nsf associated with dotarem, medicine should only be used severe function disorders and undergoing after careful assessment benefit-risk ratio when diagnostic information is essential cannot obtained using mri without contrast enhancement. if dotarem used, dose not exceed 0.1 mmol kg body weight. you receive more than one during examination. lack on repeated administration, injections unless interval between least 7 days. hemodialysis performed shortly administration may facilitate elimination from body. there no evidence suggest that started as a preventive measure or treatment for currently receiving hemodialysis.< p>

Elderly patients

Since the renal clearance of gadoteric acid may be decreased in elderly patients, it is particularly important to check kidney function before administration of DOTAREM in patients aged 65 and over.

Newborns and infants

See "Dosage and method of administration, use in children".

Pregnancy and breastfeeding

DOTAREM should not be used during pregnancy unless the clinical condition of the woman requires the use of gadoteric acid. The continuation or discontinuation of breastfeeding for 24 hours after administration of DOTAREM should be left to the discretion of the doctor and the breastfeeding mother.

Instructions for use of DOTAREM

The detachable labels from the vials should be attached to the patient's documentation to enable accurate identification of the contrast agent used. The administered dose should also be recorded. In the case of an electronic patient record, the product name, batch number, and administered dose should be entered.